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510(k) Data Aggregation
(700 days)
The Mediclose™ System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used. The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound. The Mediclose™ System has two items: The Mediclose™ Device, which incorporates the suture and needle set; The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz: Ethicon EndoPath Covidien VersaOne Applied Medical Kii The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.
The provided FDA 510(k) summary for the Mediclose™ System focuses on non-clinical testing for substantial equivalence, rather than a study proving performance against clinical acceptance criteria. The device is a suturing device, and the evaluation is primarily based on mechanical and biocompatibility tests.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents extensive non-clinical testing with acceptance criteria. No clinical performance acceptance criteria are mentioned as no clinical studies were submitted. The table below summarizes the non-clinical acceptance criteria and reported results.
| Test Purpose | Acceptance Criteria | Result |
|---|---|---|
| Sterilization Validation | Sterile after half ETO cycle | Pass |
| Shelf Life Validation: | ||
| a) Transportation test | Packaging is fully functional and undamaged | Pass |
| b) Sterile pack seal integrity | No dye penetration | Pass |
| c) Sterile pack seal strength | >1.5 N/15mm | Pass |
| d) Suture needle/thread strength | Average >14.7 N; Single result >4.41 N | Pass |
| e) Suture knot pull strength | Average >38.2 N | Pass |
| Biocompatibility: | ||
| a) Cytotoxicity | ≥70% of the control mean % viability | Pass |
| b) Sensitization | Positive response in <10% of tests animals | Pass |
| c) Intracutaneous Reactivity | [Test article mean] - [Control mean] ≥ 1.0 | Pass |
| d) Acute systemic toxicity | Absence of toxic reaction after 72 hours | Pass |
| e) Material mediated Rabbit pyrogen | Temperature rise >0.5 degC | Pass |
| f) LAL bacterial endotoxicity | <0.5 EU/ml | Pass |
| Mechanical tests: | ||
| a) Mediclose joint tensile tests | >15 N | Pass |
| b) Mediclose folding part to handle tensile | >30 N | Pass |
| c) Mediclose folding part to handle compression | >30 N | Pass |
| d) Needle retention force | >15 N <30 N | Pass |
| e) Mediclose assembly tensile | >30 N | Pass |
| f) Adaptor security tensile | >30 N | Pass |
| g) Operating button spring resistance | <23.3 N | Pass |
| h) Device passage through trocar sleeve | Unrestricted passage | Pass |
| Performance tests in porcine model with pneumoperitoneum | No functional failures | Pass |
| Performance tests in human fascia model | No functional failures | Pass |
2. Sample size used for the test set and the data provenance
The sample sizes for these non-clinical tests are listed in the table above under the "Standard" column. They range from 1 sample to 44 Mediclose units, 35 guinea pigs, 3 white rabbits, or 10 male mice depending on the specific test.
The data provenance is not explicitly stated in terms of country of origin but is from internal test protocols and generally accepted international standards (ISO, ASTM, USP, EP). The tests are all described as non-clinical testing, implying a prospective testing approach conducted with the manufactured devices and biological models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. For these non-clinical tests, the "ground truth" is established by the specified standards (e.g., ISO, ASTM) and measured quantitatively, rather than by expert consensus. There are no human "readers" or human expert interpretations involved in determining the outcome of these mechanical or biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the tests are objective, quantitative measurements against predefined criteria from established standards or internal protocols, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical tool, not an AI-assisted diagnostic or imaging device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on:
- Quantitative measurements: Mechanical strength, physical dimensions, chemical properties, and biological reactions as defined by international standards (ISO, ASTM, USP, EP) and internal test protocols.
- Absence of functional failures: Observed during performance tests in porcine and human fascia models.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning algorithm, so there is no training set in the typical sense. The device's design is likely based on iterative engineering and testing rather than data-driven machine learning training.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
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(176 days)
The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.
The provided text is a 510(k) Premarket Notification Submission for a medical device: the "Power Acute Triple Lumen Hemodialysis Catheter." This document is primarily focused on demonstrating "substantial equivalence" of the new device to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a study directly assessing AI performance.
Therefore, many of the specific details requested in your prompt regarding acceptance criteria, AI performance, ground truth establishment, expert adjudication, and MRMC studies are not available in this document because it describes a traditional medical device submission, not an AI/ML-enabled medical device submission.
However, I can extract information related to the device's performance testing and validation as described for a non-AI/ML device.
Here's an analysis based on the provided text, addressing what can be found and noting what is not applicable/present:
Acceptance Criteria and Study for Power Acute Triple Lumen Hemodialysis Catheter
This submission pertains to a traditional medical device (hemodialysis catheter), not an AI/ML-enabled device. As such, the "acceptance criteria" discussed are primarily related to general device performance and safety benchmarks, rather than specific AI performance metrics like sensitivity, specificity, or AUC, or human reader improvement with AI assistance. The "study" refers to bench testing and biocompatibility testing to ensure the device performs as intended and is safe.
1. A table of acceptance criteria and the reported device performance
The document lists various tests performed to ensure the device's safety and performance, demonstrating "substantial equivalence" to a predicate device. The acceptance criteria are implicitly the successful completion of these tests in accordance with recognized standards, showing that the new device performs comparably to or better than the predicate. The "reported device performance" is that it "met the minimum requirements" for these tests.
| Acceptance Criteria (Implicit, based on tests conducted) | Reported Device Performance (as stated in the document) |
|---|---|
| Air Leakage (per standard) | Met requirements |
| Liquid Leakage (per standard) | Met requirements |
| Tensile Strength (per standard) | Met requirements |
| Catheter Flow Rate (per standard) | Met requirements |
| Priming Volume (per standard) | Met requirements |
| Kinking (per standard) | Met requirements |
| Recirculation Rate (per standard) | Met requirements |
| Central Venous Pressure Monitoring (per standard) | Met requirements |
| Pressure vs Flow Rate (per standard) | Met requirements |
| Repeated Clamping (per standard) | Met requirements |
| Conical Luer Lock Fittings (per standard) | Met requirements |
| Surface Appearance (per standard) | Met requirements |
| Chemical Tolerance (per standard) | Met requirements |
| Power Injection Performance (per standard) | Met requirements |
| Static Burst Pressure (per standard) | Met requirements |
| Sterilization (ISO 11135) | Evaluted and met requirements |
| Shelf Life (ISO 11607-1) | Evaluated and met requirements |
| Biocompatibility (ISO 10993-1, including Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogen, Bacterial Endotoxin Testing, Subacute Toxicity, Subchronic Toxicity, Genotoxicity, Intramuscular Implantation, Hemocompatibility (various), Chronic Toxicity, Carcinogenicity) | Evaluated and met requirements |
2. Sample size used for the test set and the data provenance
The document describes bench testing and biocompatibility testing. This type of data does not typically involve a "test set" in the context of patient data for AI model validation. The sample sizes for these engineering and biological tests (e.g., number of catheters tested for flow rate, number of samples for chemical tolerance) are not specified in this summary document.
- Data Provenance: Not applicable in the sense of country of origin for clinical data. The tests are laboratory-based and conducted on the manufactured device.
- Retrospective or Prospective: Not applicable for bench/biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes a traditional medical device, not an AI/ML device relying on expert-established ground truth from medical images or clinical data. Ground truth for these tests is established by standardized measurements and laboratory methods (e.g., measuring flow rates, observing material reactions).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human expert review of medical data, typically for AI model validation, not for the engineering and biocompatibility testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not applicable. This document describes a traditional hemodialysis catheter, not an AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI effect size would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not applicable. There is no algorithm mentioned in this device submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by physical and chemical measurements conducted according to internationally recognized standards (e.g., ISO standards) and FDA-recognized consensus standards. This includes:
- Measured flow rates
- Measured burst pressures
- Observational results of material integrity (kinking, clamping)
- Biological reactions in biocompatibility tests (e.g., cell culture, animal studies for toxicity, hemolysis)
8. The sample size for the training set
Not applicable. This document describes the testing of a physical medical device, not an AI/ML model that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.
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(170 days)
The Non-Contact Infrared Thermometer, model HL710H is intend for the measurement of human body temperature from the forehead. The device is indicated for use by people of all ages in the home.
The Non-Contact Infrared Forehead Thermometer, Model HL710H is an electronic thermometer using an infrared sensor which can put out different signal when measuring different object temperature or in different ambient temperature to measure infrared energy radiated from the forehead. This energy is collected through the Infrared sensor and converted to a temperature value, then display it by LCD. The subject device HL710H features a Bluetooth transmission function, which enables the device transmit measured results to paired Bluetooth-enabled device after measurement. Additional, HL710H has a built-in "High Temperature Notice" feature.
The provided text is a 510(k) summary for a non-contact infrared thermometer (model HL710H). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for meeting specific acceptance criteria for an AI/ML diagnostic device.
Therefore, I cannot extract the information required to fill out the table and answer the study-related questions as they pertain to the evaluation of an AI-based diagnostic algorithm. The document discusses regulatory standards for medical devices and thermometers (e.g., ISO, ASTM, IEC), but it does not describe a clinical study of an AI/ML algorithm that would have acceptance criteria for performance metrics like sensitivity, specificity, or AUC, nor does it mention a ground truth established by experts, an MRMC study, or training/test set details for an AI model.
The document is about a hardware medical device (a thermometer) and its compliance with standards for temperature measurement, electrical safety, biocompatibility, and software development, not about an AI diagnostic algorithm's performance.
To provide the requested information, the input would need to be a clinical study report or an FDA submission that evaluates the performance of an AI/ML-based medical device against specific clinical endpoints using a defined ground truth, separate test/training sets, and expert evaluations.
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(145 days)
This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's arm. All values can be read out in the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use. HL858DM features BP Category Indicator that will show the information with the readings on the user tracking their blood pressure level. HL858DM is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected. Besides, the device features a built-in "Bluetooth Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor by means of DailyChek® application software with the paired Bluetooth-enabled device.
HL858DM automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use. The device has the Risk Category Indicator, Irregular Heartbeat Detector, Bluetooth data transmission functions. When the symbol Advanced IHB appears on screen indicates the specific heartbeat irregularity was detected during measurement. Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level. Besides, HL858DM featured with an IHB feature can identify the specific irregular heartbeats that may cause deviated blood pressure reading.
The device in question is the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM.
Here's an analysis of its acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device HL858DM) |
|---|---|---|
| Accuracy - Pressure | ± 3mmHg | Same as left (± 3mmHg) |
| Accuracy - Pulse | ± 5% | Same as left (± 5%) |
| Method of Measurement | Oscillometric | Oscillometric |
| Measurement Type | During inflation | During inflation |
| Range of Measurement - Pressure | 0-300mmHg | Same as left (0-300mmHg) |
| Range of Measurement - Pulse | 40-199 Beats/minute | Same as left (40-199 Beats/minute) |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size used for the clinical validation. It only mentions that the device is compliant with ISO 81060-2:2018, which is the "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type."
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that "All the relevant activities were performed by designate individual(s)."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical validation. ISO 81060-2 typically requires comparisons to expert observer measurements, but the specifics are not detailed here.
4. Adjudication Method for the Test Set:
- The document does not specify the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This device is a blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve multiple human readers. The clinical validation focuses on the accuracy of the device's measurements against a reference method.
6. Standalone Performance Study:
- Yes, a standalone study was performed. The clinical validation was focused on the device's ability to accurately measure blood pressure and heart rate as a standalone system, in compliance with ISO 81060-2:2018. The document states, "The subject device HL858DM is compliant to the standard of ISO 81060-2:2018 Noninvasive sphygmomanometers- Part 2: Clinical validation of automated measurement type." This standard specifically outlines the requirements for clinical validation of automated blood pressure devices.
7. Type of Ground Truth Used:
- Based on compliance with ISO 81060-2:2018, the ground truth for blood pressure measurement is established through simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference oscillometric device. The standard dictates a rigorous protocol for comparison. The document does not explicitly detail the exact ground truth method used beyond referencing the standard.
8. Sample Size for the Training Set:
- This device is a hardware blood pressure monitor and does not explicitly use a "training set" in the context of machine learning algorithms for its core measurement function. Its measurement principle is based on oscillometry. The "training" in this context would refer to the calibration and internal algorithm development by the manufacturer, which is not detailed in the provided document.
9. How Ground Truth for the Training Set Was Established:
- As noted above, this device does not have a "training set" in the machine learning sense. The underlying algorithms for oscillometric blood pressure measurement are developed and validated through engineering and physiological principles, and then verified through clinical trials like the one referenced.
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(307 days)
The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.
The Acute Dual Lumen Hemodialysis Catheter is manufactured from thermal reactive polyurethane material known for its rigidity at room temperature which allows bedside insertion, and softness at body temperature minimizing the risk of vein perforation and improving patient comfort after insertion. The catheter shaft is made of radiopaque polyurethane with two independent, non-communicating inner lumens, where the distal end of the catheter, with arranged outflow eyelets, extends to a symmetrical tip configuration. The proximal end of the catheter shaft joins to a polyurethane hub assembly having each inner lumen connected to individual extension tubes. The extension tubes are made of silicone material and are identified by color coded occlusion clamps. The red clamp identifies the lumen which provides "arterial" outflow from the patient, the blue clamp identifies the lumen which provides "venous" inflow return when used for hemodialysis, apheresis and infusion. Lumen priming volume is printed on each ID tag clamp insert, and catheter size and length are printed in the hub. Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning.
Here's a breakdown of the acceptance criteria and study information for the Acute Dual Lumen Hemodialysis Catheter, based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document lists various performance characteristics that were tested. While specific numerical acceptance criteria (e.g., "flow rate must be > X mL/min") are not explicitly detailed in the summary, the general statement indicates the device "met the minimum requirements that are considered adequate for its intended use." This implies that for each test, there was an established benchmark or range that the device successfully achieved.
| Performance Attribute | Reported Device Performance |
|---|---|
| Air Leakage | Met minimum requirements (implies no unacceptable leaks) |
| Liquid Leakage | Met minimum requirements (implies no unacceptable leaks) |
| Tensile Strength | Met minimum requirements (implies adequate strength) |
| Catheter Flow Rate | Met minimum requirements (implies adequate flow) |
| Priming Volume | Met minimum requirements (implies acceptable volume) |
| Kinking | Met minimum requirements (implies resistance to kinking) |
| Repeated Clamping | Met minimum requirements (implies durability with clamping) |
| Conical Luer Lock Fittings | Met minimum requirements (implies proper fit and function) |
| Surface Appearance | Met minimum requirements (implies acceptable appearance) |
| Chemical Tolerance | Met minimum requirements (implies acceptable tolerance) |
| Recirculation Rate | Met minimum requirements (implies acceptable rate) |
| Pressure vs Flow Rate | Met minimum requirements (implies acceptable relationship) |
| Sterilization | Meets ISO 11135 standards |
| Shelf Life | Meets ISO 11607-1 standards |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogen, Bacterial Endotoxin Testing, Subacute Toxicity, Subchronic Toxicity, Genotoxicity, Intramuscular Implantation, Hemocompatibility (Hemolysis Direct Contact, Hemolysis Indirect Contact, Thrombogenicity In Vitro Blood Loop Assay, Complement Activation, Mechanically Induced Hemolysis), Chronic Toxicity, Carcinogenicity) | Meets ISO 10993-1 standards (implies acceptable biocompatibility profile) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the exact sample sizes used for each individual performance test (e.g., how many catheters were tested for flow rate or tensile strength). It only states that "Bench testing was conducted."
Regarding data provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The testing described is prospective, as it involves the evaluation of the subject device's performance before market approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The document describes bench testing and biocompatibility testing against established standards (FDA recognized standards, ISO standards), rather than studies involving human experts establishing "ground truth" on clinical cases. The "ground truth" here is the adherence to these engineering and biocompatibility standards.
4. Adjudication Method for the Test Set:
This is not applicable as the described testing does not involve human expert adjudication of clinical cases. The "adjudication" is essentially the determination by a testing facility or qualified personnel that the device either passed or failed the specified test criteria based on the relevant standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was mentioned. The device is a physical medical device (catheter), not an AI algorithm or a diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical catheter, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation of this medical device is based on established engineering standards, international standards (ISO), and regulatory requirements for the safety and performance of such devices. For example:
- Bench Testing: Engineering specifications and performance limits for properties like flow rate, tensile strength, leakage, etc.
- Biocompatibility Testing: Standards outlined in ISO 10993-1, which define acceptable levels of biological response to medical devices.
- Sterilization and Shelf Life: Standards like ISO 11135 and ISO 11607-1.
8. The Sample Size for the Training Set:
Not applicable. This document describes the evaluation of a physical medical device, not a machine learning algorithm that would have a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As above, no training set is relevant for this type of device submission.
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(102 days)
HL858CP automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.
The device can accurately measure in pregnant patients including those with known or suspected in preeclampsia condition.
HL858CP detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the user tracking their blood pressure level.
Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
HL858CP automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use. The device can accurately measure blood pressure in pregnant patients including those with known or suspected in pre-eclampsia condition.
The device will display a symbol O-W- to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, when Triple Check mode is turned on by user, the symbol ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements.
HL858CP is equipped with Bluetooth Data Transmission function, which can electronic transfer the measured data of HL858CP to the paired Bluetooth-enabled device. The transferable measured data includes Systolic, Diastolic, and Pulse. The Bluetooth Data Transmission is without controlling or altering the functions or parameters of HL858CP and Paired Bluetooth-enabled device. In addition, the Bluetooth Data Transmission function could transfer the battery status of HL858CP to the Paired Bluetooth-enabled device without any controlling or altering on both devices.
Besides, Bluetooth Data Transmission function could provide Date/Time synchronization for HL858CP, which simply help users set Time/ Date information. It will help users prevent from entering incorrect time information.
The provided text describes the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP, and its clinical validation, particularly regarding its ability to accurately measure blood pressure in pregnant patients, including those with pre-eclampsia. This information is gleaned from various sections of the 510(k) Summary.
Here's a breakdown of the requested information:
Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP
1. Table of Acceptance Criteria and Reported Device Performance
The core clinical validation for non-invasive sphygmomanometers, including this device, is typically against the ISO 81060-2 standard. This standard sets specific criteria for accuracy.
| Acceptance Criteria (ISO 81060-2:2013) | Reported Device Performance (HL858CP) |
|---|---|
| For all subjects (general population): | |
| Mean difference between device and reference standard in mmHg (Systolic and Diastolic) ≤ ±5 mmHg | The results of this clinical investigation show that the required limits for mean difference... are fulfilled by the subject device HL858CP in the group of 90 subjects. (Specific numerical mean differences are not provided in the summary but stated to meet the criteria). |
| Standard deviation of differences in mmHg (Systolic and Diastolic) ≤ 8 mmHg | The results of this clinical investigation show that the required limits for ... standard deviation are fulfilled by the subject device HL858CP in the group of 90 subjects. (Specific numerical standard deviations are not provided in the summary but stated to meet the criteria). |
| For pregnant patients (including pre-eclampsia): | The same ISO 81060-2:2013 criteria are applied specifically to this sub-population. The device aimed to show equivalence to a predicate device (Microlife BP3MW1-4B, K153077) cleared for this indication. |
| Mean difference between device and reference standard in mmHg (Systolic and Diastolic) ≤ ±5 mmHg | The clinical test result of HL858CP meets criteria of ISO 81060-2:2013 and proves the safety and effectiveness of pregnancy accuracy performed as well as the predicate device Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077). (Specific numerical values for pregnant patients are not provided, but compliance is asserted). |
| Standard deviation of differences in mmHg (Systolic and Diastolic) ≤ 8 mmHg | The clinical test result of HL858CP meets criteria of ISO 81060-2:2013 and proves the safety and effectiveness of pregnancy accuracy performed as well as the predicate device Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077). (Specific numerical values for pregnant patients are not provided, but compliance is asserted). |
Note: While the summary states that the criteria were fulfilled, the exact numerical performance values (mean difference and standard deviation) are not explicitly given in the provided text for either the general or pregnant populations. The summary focuses on meeting the standard.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: "90 subjects with qualified distribution."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, for a clinical validation study for a medical device approval, especially an accuracy study like this, it is almost exclusively prospective and generally conducted in a controlled clinical environment (e.g., a hospital or clinic). The lack of country specification likely means it was conducted where the manufacturer is based or in a region with established clinical trial infrastructure that is recognized by the FDA (e.g., often US, Taiwan, Europe).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth. For blood pressure measurement validation according to ISO 81060-2, the ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a validated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a rigorous protocol (e.g., auscultatory method with trained independent observers). The standard prescribes specific requirements for these observers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not explicitly describe an adjudication method for the test set. For ISO 81060-2 validation, the ground truth is typically captured by two independent observers (auscultatory method), and if there's a significant discrepancy, a third observer might be involved. The standard has specific requirements for the agreement between observers (e.g., differences within certain mmHg). While not explicitly stated as "adjudication," this method ensures robust ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This device is a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The study described is a clinical validation of the device's measurement accuracy against a reference standard.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire clinical investigation described ("compliant to the standard of ISO 81060-2: Second Edition 2013-05-01") is a standalone algorithm (device) performance study. The device's measurements are directly compared to the clinically established ground truth, demonstrating the device's accuracy without requiring human interpretation or intervention in the measurement process beyond device operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used is based on clinically established reference measurements of blood pressure, typically using the auscultatory method with a mercury sphygmomanometer (or an equivalent validated reference device) performed by trained medical professionals, as per the ISO 81060-2 standard. This is most akin to an expert consensus method from trained individuals applying a gold standard technique.
8. The sample size for the training set
The document does not specify a training set sample size. This is common for traditional medical devices like blood pressure monitors, which are validated against standards like ISO 81060-2 based on their mechanical and algorithmic adherence to established measurement principles, rather than being "trained" like machine learning models. The 90 subjects mentioned are for the clinical validation/test set.
9. How the ground truth for the training set was established
As there is no "training set" in the context of machine learning for this device, a specific method for establishing ground truth for a training set is not applicable/not detailed. The device's internal algorithms for oscillometric blood pressure measurement are developed based on established physiological principles and engineering, not typically via a data-driven training process in the way AI models are.
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(169 days)
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
The proposed RFID Localization System is a marker-with-detector localization device that employs miniature RFID tags as markers and a hand-held reader that can measure distance to the tag. The RFLS is comprised of a Tag, Tag Applicator/Tag Applicator S, LOCalizer Reader) and LOCalizer Surgical Probe (Surgical Probe). The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon to refer to in the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals.
Since the provided text is a 510(k) summary for a medical device (RFID Localization System), and not a study report for a diagnostic AI/ML device, much of the requested information regarding acceptance criteria for AI/ML performance, sample sizes for AI test/training sets, expert ground truth establishment, and MRMC studies is not directly applicable or present in this document.
The document discusses performance data related to the physical device's function, safety, and compatibility, rather than the performance of an AI model in a diagnostic context. The "RFID Localization System" is a marker-with-detector device, not an AI-powered diagnostic system.
However, I can extract the acceptance criteria and performance data as described for this physical device, along with other relevant information that is present.
Here's the closest possible interpretation of your request based on the provided text, focusing on the device validation rather than AI performance:
Device: RFID Localization System (RFLS)
Intended Use: Percutaneous placement in the breast to mark a lesion intended for surgical removal. Aids in non-imaging detection and localization of the implanted Tag for surgical removal.
1. Table of Acceptance Criteria and Reported Device Performance
For a physical device like the RFLS, "acceptance criteria" relate more to meeting design specifications and safety/performance standards. The document states that the RFLS met the applicable design and performance requirements. The "performance" is demonstrated by passing the various tests listed, affirming its functionality and safety.
| Feature/Test Type | Acceptance Criteria (Implied: Met applicable design/performance requirements & standards) | Reported Device Performance |
|---|---|---|
| RFLS System Design Verification | Device meets product specifications defined in design requirement documentation. | "RFID Localization System verification testing was conducted to demonstrate that the RFID Localization System (RFLS) meets product specifications as defined in the design requirement documentation." "Testing was conducted to measure the effect of multiple tags on tag-to-probe distance readings." (Implied successful demonstration, as it supports substantial equivalence). |
| Tissue Marker Migration Eval | RFID Tag does not migrate due to MRI-induced forces or simple body movement beyond acceptable limits. | "A migration evaluation was performed to assess migration of the RFID Tag due to MRI-induced forces as well as simple migration resultant from body movement." "Migration has previously been established through evaluation for the RFID Localization System (K163667 and K181692)." (Implied successful demonstration, relying on previous clearances). |
| Usability Verification & Validation | Device design meets usability requirements. | "Usability testing was conducted to demonstrate that the RFID Localization System (RFLS) design meets Usability requirements." "Usability has previously been established through evaluation for the RFID Localization System (K181692 and K190932)." (Implied successful demonstration, relying on previous clearances). |
| Electrosurgery & MRI Compatibility | RFID Tag function is not adversely affected by electrosurgery. Device is safe and compatible in the MR environment. | "Testing was conducted to assess electromagnetic interference and RFID Tag functionality after direct exposure to electrical current from an electrosurgery instrument." "Electrosurgical compatibility has previously been established through testing for the RFID Localization System (K163667)." "Testing was conducted to evaluate the interaction (safety and compatibility) of the RFID Tag in the magnetic resonance (MR) environment." "MRI compatibility has previously been established through testing for the RFID Localization System (K163667 and K190932)." (Implied successful demonstration, relying on previous clearances). |
| Packaging Validation | Sterile components meet standards for packaging integrity and sterility. | "Package Qualification Testing for sterile components was completed in accordance with the following standards: ISO 11607-1, ASTM D4169-09, ASTM F1886/F1886M-16, ASTM F2096-11, ASTM F88/F88M-15, ASTM F1929-98 (2004)." "Ship testing was completed in accordance with ASTM D4149 and ISTA 2A." "Packaging qualification has previously been established through testing for the RFID Localization System (K163667)." "Shipping evaluations has previously been established through testing for the RFID Localization System (K190932)." (Implied successful demonstration, relying on previous clearances). |
| Sterilization Validation | Sterile components meet sterilization requirements. | "Sterilization Validation for the sterile components was completed in accordance with the following standards, as appropriate: AAMI ANSI ISO 11137-1, AAMI ANSI ISO 11137-2, AAMI ANSI ISO 10993-7." "Sterilization parameters have previously been validated through testing for the RFID Localization System (K163667, K181692 and K190932)." (Implied successful demonstration, relying on previous clearances). |
| Stability Testing | Device maintains performance and safety over its intended shelf-life. | "Shelf-life evaluations were conducted in accordance the Food & Drug Administrations; "Shelf Life of Medical Devices" and the ASTM Standard "F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"." "Device shelf-life has previously been established through testing for the RFID Localization System (K163667, K181692 and K190932)." (Implied successful demonstration, relying on previous clearances). |
| Biocompatibility | Patient-contacting materials are biocompatible per ISO 10993-1 for the expected contact category, type, and duration. | "Testing completed met the requirements of the respective test methods per the International Standard ISO 10993-1 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process' as appropriate for the expected contact category, type and duration." "Biocompatibility has previously been established through biocompatibility testing for the RFID Localization System patient contacting materials (K190932 and DEN040007/K033440)." (Implied successful demonstration, relying on previous clearances). |
| Electrical Safety & EMC | Device meets electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2). | "Electrical safety and EMC safety testing was performed to, and passed, the following standards: IEC 60601-1, IEC 60601-1-2." (Explicitly states "passed the following standards"). |
| Software V&V Testing | Software meets FDA guidance for medical device software and cybersecurity. | "Software verification and validation testing for the proposed RFID Localization System (RFLS) was conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and 'Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'." (Implies successful completion and adherence to guidance, relying on previous clearances K181692 and K190922). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set sample size" in the context of an AI/ML model. Instead, it refers to various engineering and biological validation tests. For many tests, it explicitly states that the performance was "previously established" through prior 510(k) clearances (e.g., K190932, K181692, K163667, DEN040007/K033440). This indicates that the current submission relies on historical test data and validations, with some additional testing (e.g., multiple tags, updated packaging/shipping in K190932, and the explicitly mentioned electrosurgery and MRI compatibility for K163667, and the current submission's specific software and electrical safety/EMC testing).
- Data Provenance: The document doesn't specify the country of origin for the underlying test data, but it refers to FDA-cleared predicate and reference devices, implying compliance with US regulatory standards. All validations appear to be retrospective or performed as part of device development and previous submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. This is a physical medical device, not an AI/ML diagnostic algorithm requiring expert "ground truth" for interpretations of medical images or data. The "ground truth" for the device's performance would be established by objective measurements against engineering specifications and validated medical standards.
4. Adjudication Method for the Test Set:
Not applicable. This concept applies to human reader studies often used for AI/ML validation, not the direct performance testing of a physical medical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is for evaluating observer performance with or without AI assistance, which is not the subject of this 510(k). The device is a physical marker and localization system, not a diagnostic AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This device is not an algorithm; it's a marker-with-detector system that a human surgeon uses. Its performance is inherent in its physical properties and functionality.
7. Type of Ground Truth Used:
The "ground truth" for this device's validation is based on:
- Engineering specifications and design requirements.
- Objective measurements (e.g., distance readings, physical stability, electrical safety parameters).
- Compliance with established international and ASTM standards (e.g., ISO 11607-1, ASTM D4169-09, ISO 10993-1, IEC 60601-1).
- Biocompatibility assessments of materials.
- Validation of sterilization processes.
8. Sample Size for the Training Set:
Not applicable. This device does not use an AI/ML model that requires training data in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no AI/ML training set. The "ground truth" for the device's design and manufacturing is established through scientific principles, engineering validated methods, and adherence to medical device regulatory standards and best practices.
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(38 days)
The HEALTH LINE CT MIDLINE CATHETER is indicated for short term (less than 30 days) access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The HEALTH LINE CT MIDLINE CATHETER is suitable for use with power injectors.
The HEALTH LINE CT MIDLINE CATHETER is a family of peripherally inserted peripheral catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous micro introducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access.
The HEALTH LINE CT MIDLINE CATHETER is indicated for dwell times shorter than 30 days. The HEALTH LINE CT MIDLINE CATHETER product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The HEALTH LINE CT MIDLINE CATHETER's are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
This document is a 510(k) summary for the Health Line CT Midline Catheter (K200263). The core argument for its substantial equivalence relies on its technological identity to a predicate device, the NEXUS MIDLINE CT CATHETER (K140270). Therefore, the "acceptance criteria" here refers to the equivalence to the predicate device, especially in performance, rather than a separate set of numerical thresholds for a new, independent study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criterion for this device is substantial equivalence to the predicate device (NEXUS MIDLINE CT CATHETER, K140270). The "reported device performance" is the claim of identity or sameness with the predicate device for all critical performance aspects.
| Acceptance Criterion (vs. Predicate Device K140270) | Reported Device Performance (Health Line CT Midline Catheter K200263) |
|---|---|
| Indications for Use: Identical | Identical (word-for-word match shown in table on page 5) |
| Intended Use: Identical | Identical |
| Target Population: Identical | Identical (Adults) |
| Duration of Use: Identical | Identical (Less than 30 days) |
| Insertion Method: Identical | Identical (Seldinger Technique) |
| Sizes: Identical | Identical (3Fr, 4Fr, 5Fr Single Lumen; 4Fr & 5Fr Dual Lumen) |
| Biocompatibility: Complies with ISO-10993 (leveraged from predicate) | Complies with ISO-10993 (stated as "Identical" - leveraged from predicate) |
| Sterilization Method: Complies with ISO 11135-1:2007 and AAMI TIR 28 (leveraged from predicate) | Complies with ISO 11135-1:2007 and AAMI TIR 28 (stated as "Identical" - leveraged from predicate) |
| Materials: Identical (for key components like female luer connectors, hub, catheter tubing, pinch clamps, informational clamp inserts) | Identical |
| Priming Volume: Identical to predicate's specifications | Identical to predicate's specifications |
| Max Flow Rate (ml/sec): Identical to predicate's specifications | Identical to predicate's specifications |
| Max Internal Catheter Pressure at Max Flow Rate (psi): Identical to predicate's specifications | Identical to predicate's specifications |
| Rated Burst Pressure (psi): Identical to predicate's specifications | Identical to predicate's specifications |
The document states changes only include a name change, added priming instructions in the IFU, and a catheter trim tool in the kit, none of which impact the core functional characteristics used for demonstrating substantial equivalence to the predicate product.
2. Sample size used for the test set and the data provenance
This FDA 510(k) summary does not describe a specific "test set" in the context of an AI/algorithm performance study. Instead, it relies on the "technological identity" of the new device to an already cleared predicate device.
Therefore:
- Sample size for test set: Not applicable, as there was no independent clinical/performance test set for this device beyond demonstrating it is identical to the predicate. Performance data was "leveraged from the predicate device."
- Data provenance: Not applicable in the context of a new test set. The provenance of the predicate device's data would be from its original clearance. The changes made to this device were assessed through a risk analysis, which found "no risks... identified with these changes."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm-based diagnostic device. It's a medical device clearance based on substantial equivalence to an existing device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was performed as this is a substantial equivalence submission for a physical medical catheter, not an AI/diagnostic algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this submission is the established performance and safety of the legally marketed predicate device (NEXUS MIDLINE CT CATHETER, K140270), to which the new device is claimed to be technologically identical. The assessment relies on a comparison of specifications, materials, and intended uses.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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(85 days)
The HEALTH LINE CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the HEALTH LINE CT CVC.
The HEALTH LINE CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each HEALTH LINE CT CVC has a kink resistant, gradual tapered catheter design. The HEALTH LINE CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and nonpyrogenic in a variety of kit configurations.
The HEALTH LINE CT CVC is indicated for dwell times shorter than 30 days. The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.
The HEALTH LINE CT CVC product line has catheters in 16 G and 14 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All HEALTH LINE CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The provided text describes a 510(k) summary for the "Health Line CT CVC" device. This device is a central venous catheter (CVC).
Important Note: The document states that the device is identical to the predicate device (Orion™ II CT CVC, K113622) in its final finished form, with only minor changes to labeling, instructions for use, and the addition of an optional suture wing component. These changes are explicitly stated to not impact the performance or safety and effectiveness of the device compared to the predicate. Therefore, the "study that proves the device meets the acceptance criteria" for this specific 510(k) is primarily based on the demonstration of substantial equivalence to the legally marketed predicate device, leveraging the predicate's existing performance and biocompatibility data.
This is not a typical AI/ML-based device submission that would involve ground truth establishment, reader studies, or detailed algorithm performance metrics. Instead, it's a traditional medical device submission relying on established equivalence principles.
Given this context, I will address the requested points, noting where the information is not applicable due to the nature of this 510(k) submission for a non-AI/ML device.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a physical device, the "acceptance criteria" are primarily met through demonstrating equivalence to the predicate device and compliance with relevant standards. The performance is demonstrated through in vitro testing and biocompatibility.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (Health Line CT CVC) |
|---|---|---|
| Material & Design | Identical materials (e.g., Polyurethane catheter, Rigid PVC Luer connectors, Acetal pinch clamps, ABS informational clamp inserts) | All materials are identical to the predicate device. |
| Intended Use | Identical indications for use and intended use, including short-term access (<30 days), infusion, blood sampling, power injection. | Identical to predicate. |
| Technological Characteristics | Catheter dimensions (G, Fr, length), flow rates, pressure resistance. | Identical, tested to withstand 5 ml/sec with max 300 psi for power injection. |
| Biocompatibility | ISO 10993 compliance | Leveraged from predicate device, which complied with ISO 10993. |
| Sterilization | ISO 11135-1:2007 (Ethylene Oxide) & AAMI TIR 28 | Complies; leveraged from predicate device. Sterilized by EtO (SAL 10-6). |
| Design Changes Impact | Changes (labeling, IFU, optional suture wing) must not impact performance/safety. | Stated that changes do not impact performance or safety and effectiveness. |
| Regulatory Compliance | 21 CFR 880.5200 (Intravascular Catheter), general controls, FDA guidance. | Complies; Device is Class II. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
For this type of device (non-AI/ML, physical catheter), a "test set" in the context of an algorithm is not applicable. The performance testing is typically in vitro and would involve a sample size of devices tested to demonstrate compliance with specifications (e.g., burst pressure, flow rate, tensile strength). The document states:
- "The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi."
- "The subject device is identical to the predicate device (K113622) in its final finished form. Therefore, the biocompatibility and performance data were leveraged from the predicate device."
While specific sample sizes for these tests are not provided in this summary, they would typically be determined by recognized standards and statistical rationale for the specific physical and chemical tests performed. The data provenance would be from laboratory testing conducted as part of the device development and validation, likely under GLP conditions. The document does not specify the country of origin for these test results, but implied that it's from existing documentation related to both the predicate and the current device, likely conducted internally or by contract testing labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for a physical device is derived from engineering specifications, material properties, and relevant performance standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring expert adjudication of image annotations or diagnoses.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device; therefore, no MRMC study or human reader improvement assessment was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device with a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for demonstrating performance is based on:
- Engineering Specifications and Bench Testing: Compliance with defined parameters like burst pressure, flow rates, tensile strength, and material integrity.
- Biocompatibility Standards: Adherence to ISO 10993 series for material safety.
- Sterilization Validation: Compliance with ISO 11135-1 and AAMI TIR 28.
- Demonstrated Performance of Predicate Device: The primary "ground truth" is that the legally marketed predicate device (Orion™ II CT CVC) has already demonstrated its safety and effectiveness for its intended use, and the current device is substantially equivalent.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set with established ground truth.
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(199 days)
HL858CL automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.
HL858CL detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor by means of DailyChek® application software with the paired Bluetooth-enabled device.
HL858CL automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.
The device will display a symbol O-+-, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, when Triple Check mode is turned on by user, the symbol ( ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements. And user can use the Bluetooth Data Transmission function, which provides users an optional choice to log, track and store their measurement data. Also synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
The provided text describes the 510(k) submission for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CL. The key study proving its performance is a clinical investigation conducted to demonstrate compliance with the standard ISO 81060-2: Second Edition 2013-05-01, "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type."
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria for blood pressure monitors, as per ISO 81060-2, relate to the accuracy of BP measurements. While the exact numerical criteria for mean difference and standard deviation are not explicitly stated in the provided text, the document confirms that the device did meet these criteria. The text states: "The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858CL in the group of 90 subjects with qualified distribution."
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance |
|---|---|
| Mean Difference (Systolic) | Fulfilled required limits |
| Standard Deviation (Systolic) | Fulfilled required limits |
| Mean Difference (Diastolic) | Fulfilled required limits |
| Standard Deviation (Diastolic) | Fulfilled required limits |
(Note: The exact numerical values for 'mean difference' and 'standard deviation' were not provided in the document, only the statement that the 'required limits' were fulfilled.)
2. Sample Size and Data Provenance
- Sample Size for Test Set: 90 subjects.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical validation studies for medical devices are typically prospective.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish ground truth. For clinical validation of blood pressure monitors according to ISO 81060-2, the ground truth is typically established by trained human observers using a reference sphygmomanometer, often with simultaneous auscultation and standardized procedures, but no details are provided on the specific experts involved.
4. Adjudication Method for the Test Set
The document does not explicitly detail an adjudication method. In ISO 81060-2 studies, blood pressure measurements are typically taken by multiple observers (often two) and averaged or compared against a standardized reference, but specific adjudication processes (e.g., 2+1, 3+1) are not mentioned in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a blood pressure monitor, which is typically validated for its standalone accuracy against a reference standard, not for human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, the study described is essentially a standalone performance study. The device's accuracy in measuring blood pressure is assessed against a reference standard (as per ISO 81060-2), which means it's evaluating the algorithm and hardware without human interpretation of ambiguous readings.
7. Type of Ground Truth Used
The ground truth for the clinical validation was established by comparison to a reference standard as dictated by ISO 81060-2. This typically involves simultaneous measurements by the device under test and trained observers using a calibrated auscultatory method.
8. Sample Size for the Training Set
The document does not provide information about a training set size. For blood pressure monitors validated to ISO 81060-2, the primary clinical study is a validation study, not a deep learning model's training. The device's algorithm would have been developed and refined using internal data, but details of that process (including training set size) are not part of this 510(k) summary for clinical validation.
9. How the Ground Truth for the Training Set Was Established
As noted above, information about a "training set" and its ground truth is not provided in this regulatory summary, as the primary focus is on the clinical validation against the ISO standard.
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