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510(k) Data Aggregation
(60 days)
Fogarty Occlusion Catheters are indicated for temporary vessel occlusion.
The Large Occlusion catheters are intended to be used for temporary occlusion in the aorta, vena cava, and internal jugular vein.
The Small Occlusion catheters are intended to be used for temporary occlusion in the peripheral vascular system.
The Fogarty Occlusion Catheters are indicated for temporary vessel occlusion. The Large Occlusion catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal juqular vein. The Small Occlusion catheters are intended to be used for temporary occlusion in the peripheral vascular system. The catheter consists of a single-lumen polyvinylchloride (PVC) catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter to maintain the straight catheter shape and to ensure that the lumen remains opened during storage or sterilization of the product. The device is supplied sterile and for single use only. This Traditional 510(k) is submitted to request clearance for changes to the indications for use statement. The proposed changes to the indications for use statement do not alter the intended use of the Fogarty Occlusion Catheter (i.e., temporary vessel occlusion).
This document is a 510(k) premarket notification for the Fogarty Occlusion Catheter. It outlines the device's indications for use, its description, and a comparison to predicate devices. The key takeaway is that the submission is for a change to the indications for use statement, not a change in the device's design, materials, or technology. Therefore, the "study" described focuses on the analysis of these changed indications rather than performance testing of the physical device.
Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness with Revised Indications for Use: The specific vessels identified for each size catheter (Large: aorta, vena cava, internal jugular vein; Small: peripheral vascular system) are expected to have similar safety and effectiveness compared to the general indications of the predicate device. | Conclusion of Analysis: An analysis was performed, and it was determined that "the specific vessels identified for each size catheter would be expected to have similar safety and effectiveness compared to the general indications for the predicate." The changes to the indications for use do not change the intended use or adversely impact safety and effectiveness. |
| Identical Design, Materials, Technology, and Operating Principles (compared to current legally marketed version): The device with the proposed change must maintain identical core characteristics. | Stated Identity: "The device with the proposed change to the indication for use statement has the identical design, materials, technology, and operating principles as the current legally marketed version of the device." |
| Compliance with Applicable Design Practices and Regulations (for current legally marketed version): The predicate device should already meet these standards. | Stated Compliance: "The current legally marketed version of the Fogarty Occlusion Catheter complies with all applicable design practices and regulations and was most recently cleared by FDA via K093911 (SE 21 Jan 2010) for modifications of its packaging." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission is for a change in indications for use based on an analysis and comparison to a predicate device, not empirical performance testing on a "test set" of patients or data.
- Data Provenance: Not applicable in the context of a traditional performance study. The "data" used is the existing regulatory clearance and performance records of the predicate device (Fogarty Occlusion Catheter, K093911) and a comparative analysis of the proposed indications. This is an analysis based on existing knowledge and regulatory precedent, not new prospective or retrospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not explicitly provided. The "ground truth" here is the regulatory assessment of similar safety and effectiveness for the modified indications. This would have been established by the internal regulatory and medical affairs teams at Edwards Lifesciences through their analysis. The FDA then reviews this submission. The number and qualifications of individuals involved in the applicant's internal analysis are not detailed.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" in the sense of clinical cases requiring expert adjudication. The assessment was an internal analysis by the manufacturer, followed by a regulatory review by the FDA.
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 done. This device is a physical medical device (catheter), not an AI/software product that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone performance study was done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" used in this regulatory submission is a comparative analysis and expert judgment (internal to the manufacturer) that the proposed expanded indications for use for temporary vessel occlusion (specifying large vessels for large catheters and peripheral vessels for small catheters) are equally safe and effective as the more general indications of the legally marketed predicate device. This relies on the established safety and efficacy profile of the existing identical device and the predicate. It is not based on pathology, outcomes data, or a new expert consensus on a novel dataset for this specific submission, but rather on the consistency with existing medical understanding and regulatory clearances for the same device.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not a machine learning or AI device.
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(75 days)
The Edwards Suture Fastening System is indicated for suture fastening in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings.
The Edwards Suture Fastening System is comprised of the fastening instrument and the fastener loader. These components interface together to deploy a nitinol fastener onto a suture and then cut the suture 5 mm proximal to the nitinol fastening instrument has a 3 mm (0.1 inches) diameter shaft which is available in three lengths: 15 cm (5.9 inches), 22 cm (8.7 inches) and 30 cm (11.8 inches). A handle and a trigger are located at the proximal end of the instrument. By activating the trigger, the fastening instrument deploys the nitinol fastener at the intended position and cuts the suture. Each fastener loader holds one nitinol fastener which is pre-loaded in the locking tip.
The provided document is a 510(k) summary for the Edwards Suture Fastening System. It details nonclinical performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in the format of an AI model's performance.
The document describes tests for a physical medical device (a suture fastening system), not an AI algorithm. Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to the content of this regulatory submission for a manual surgical instrument.
The document lists various nonclinical tests and states that "all results met acceptance criteria," but it does not quantify or specify those acceptance criteria for most tests, nor does it provide detailed performance reports for each criterion in a table format suitable for an AI model.
Therefore, I cannot fulfill the request as specified because the input document does not pertain to the evaluation of an AI-powered device or algorithm.
If you are looking for an example of how such a table and study description would be presented for an AI device, please provide a document that describes the evaluation of an AI algorithm.
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(116 days)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
The Edwards Lifesciences Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave Disposable Pressure Transducer has a straight, flow-through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.
The provided document describes a 510(k) premarket notification for the TruWave™ Disposable Pressure Transducer. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission focuses on comparing a new device to an existing one, rather than proving novel efficacy or conducting extensive clinical trials as would be required for a PMA.
Therefore, the information available pertains to the device's performance against a predicate and functional/safety testing, rather than a clinical study establishing diagnostic accuracy or effectiveness in a "predictive" sense, as would be typical for AI/ML devices. Many of the requested fields (such as multi-reader multi-case studies, expert adjudication for ground truth, or effect size of AI assistance) are not applicable to this type of device and submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Key Performance Specifications) | Reported Device Performance |
|---|---|
| Integral flush device flow rate | 3 mL/hr or 30 mL/hr (depending on the variant) |
| Operating Pressure Range | -50 to +300 mmHg |
| Nonlinearity and Hysteresis | ±1.5% of reading or ± 1 mmHg, whichever is greater |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of clinical data for diagnostic accuracy. The testing performed was primarily performance testing to compare the device to a predicate. The document states:
- "Performance testing was conducted to compare the proposed device to the predicate device."
- "The TruWave disposable pressure transducer has successfully passed functional- performance post MRI exposure, the testing included pressure accuracy (nonlinearity and hysteresis)."
The details of the sample size (e.g., number of units tested, number of measurements) for these performance tests are not provided. Similarly, the "data provenance" in terms of subject demographics or clinical setting is not applicable as it's not a clinical study involving human patients to establish diagnostic performance. The tests are likely bench or laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As this is not a diagnostic AI/ML device, there is no "ground truth" established by experts in the context of interpreting medical images or clinical data. The performance criteria (e.g., pressure accuracy) are determined by quantitative laboratory measurements against set standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. There is no "adjudication method" described, as there are no expert interpretations or clinical diagnoses being made that would require 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
No. This is not an AI-assisted device for human interpretation, therefore an MRMC study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware device (a disposable pressure transducer) and does not involve AI algorithms operating in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating the performance of this device is based on technical specifications and established measurement standards, rather than clinical outcomes or expert consensus on a diagnosis. For example, pressure accuracy (nonlinearity and hysteresis) would be measured against a highly accurate reference pressure measurement system.
8. The sample size for the training set
Not Applicable. This is a hardware medical device; it does not involve machine learning or a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not Applicable. There is no training set for this device.
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(89 days)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
The Edwards Lifesciences Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave Disposable Pressure Transducer has a straight, flow-through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.
The provided text describes a 510(k) premarket notification for the "Pressure Monitoring Kit with TruWave Disposable Pressure Transducers" (K141495). This is a submission to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets acceptance criteria in the context of a new diagnostic algorithm or AI system.
Therefore, the information typically requested in your query regarding acceptance criteria and performance studies of AI/diagnostic algorithms (e.g., sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, ground truth establishment) is not present in this regulatory document. This document focuses on demonstrating substantial equivalence to a predicate device through material biocompatibility and performance testing, without the need for the types of clinical performance studies you're asking about for AI/diagnostic algorithms.
However, I can extract the information relevant to what is present, which is comparative analysis and functional/safety testing, rather than an AI algorithm's performance.
Here's an interpretation based on the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Biocompatibility | Successfully passed in compliance with applicable ISO 10993 requirements. |
| Performance Testing | Successfully passed performance testing. |
| Substantial Equivalence | Demonstrated to be safe, effective, and substantially equivalent to the predicate device (Phoenix [TruWave] disposable pressure transducer) for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document states that "performance testing was conducted", but no details about the sample size (number of devices, test conditions, etc.) or data provenance are given.
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)
This information is not provided in the document. The evaluation of this medical device is based on "performance testing" and "biocompatibility testing," not on establishing ground truth for a diagnostic algorithm with expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for diagnostic studies involving human interpretation or subjective assessments, which is not the nature of the testing described for this pressure transducer.
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 is not applicable as the device is a disposable pressure transducer, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device would be its physical and functional specifications. The performance testing would have compared the device's output (e.g., pressure readings) against a known standard or established measurement. The document states that testing was done to "compare the proposed device to the predicate device", implying the predicate device's established performance serves as a comparative benchmark.
8. The sample size for the training set
This is not applicable as the device is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical medical device, not an AI algorithm.
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(154 days)
The Edwards Balloon Catheter is indicated for balloon aortic valvuloplasty.
The Edwards Balloon Catheter, is used for balloon aortic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (Polyether block amide) multidurometer braided shaft with 130cm working length, platinum/iridium radio-detectable markers, and a polycarbonate y-connector that consists of a balloon inflation port and guidewire lumen. The effective length of the balloon is 4cm and is offered in 16mm, 20mm, 23mm and 25mm diameters. The balloon catheter is supplied sterilized by ethylene oxide for single use.
The provided text is a 510(k) summary for the Edwards Balloon Catheter, intended for balloon aortic valvuloplasty. It details non-clinical testing performed to demonstrate performance. However, the document does not contain the specific acceptance criteria or a dedicated study explicitly proving the device meets these criteria in the format requested.
The summary describes general non-clinical testing and refers to a "Summary of Clinical Data" that involved a literature review, complaint analyses, and a review of post-market experience, as well as an IDE study (G030069) with a predicate device. This suggests that the clinical evidence for substantial equivalence was derived from existing data and comparisons rather than a new standalone clinical study with the specific Edwards Balloon Catheter.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here is an attempt to address the request based on the available information, noting where information is not present:
Acceptance Criteria and Device Performance Study for Edwards Balloon Catheter
The provided 510(k) summary for the Edwards Balloon Catheter does not explicitly state quantitative acceptance criteria or a dedicated clinical study designed to demonstrate the device meets those criteria. Instead, it relies on non-clinical performance testing, a literature review, complaint analyses, and a review of post-market experience, along with referencing the pivotal IDE study (G030069) conducted with a predicate device (RetroFlex Balloon Catheter). The underlying assumption is that if the non-clinical performance matches predicate devices and clinical history supports safety and effectiveness, then the device is substantially equivalent.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative "acceptance criteria" for demonstrating substantial equivalence for clinical performance are not delineated in the provided summary, a direct table cannot be constructed. The summary lists various non-clinical tests performed, and implicitly, the device passed these tests to demonstrate manufacturing quality and basic functionality.
| Criterion Category (Non-Clinical) | Acceptance Criteria (Implicit - device met requirements) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Per ISO 10993-1 | Met ISO 10993-1 |
| Sterilization | Validated Ethylene Oxide Sterilization | Validated |
| Package Qualification | Qualified | Qualified |
| Surface/Visual Inspection | Compliant with specifications | Passed |
| Dimensional Inspection (Catheter & Balloon) | Compliant with specifications | Passed |
| Balloon Inflation/Deflation Time | Within specified range | Met specifications |
| Balloon Maximum Inflation Pressure | Maintained nominal volume at max pressure | Met specifications |
| Balloon Diameter at Nominal Volume | Compliant with specifications | Met specifications |
| Balloon Catheter Retrieval Force | Within specified range | Met specifications |
| Balloon Fatigue and Burst | Withstood fatigue and burst pressure | Met specifications |
| Marker Band Bond Verification | Verified | Verified |
| Bond Strength (Shaft/Hub - Normal) | Compliant with specifications | Met specifications |
| Bond Strength (Shaft/Hub - Torque) | Compliant with specifications | Met specifications |
Note: The "Acceptance Criteria" listed above are inferred as "met specifications" since no specific values are provided in the summary. The "Reported Device Performance" simply states that the tests were completed and presumably met the internal requirements for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set: No specific clinical "test set" in the context of a prospective study for the Edwards Balloon Catheter is described. The "clinical assessment" relied on:
- Literature Review: Provenance unspecified.
- Complaint Analyses: For the Edwards Transfemoral Balloon Catheter and RetroFlex Balloon Catheter. Provenance is likely from post-market surveillance data, potentially global, but not specified.
- Review of Post-Market Experience: With the Edwards Transfemoral Balloon Catheter. Provenance is likely from post-market surveillance data, potentially global, but not specified.
- Pivotal IDE Study (G030069) with RetroFlex Balloon Catheter: This was a study for a predicate device. The sample size and provenance for this specific study are not detailed in the provided 510(k) summary, but it would have been prospective clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the summary, as there was no standalone clinical study described for the Edwards Balloon Catheter that would involve experts establishing ground truth for efficacy or safety endpoints. The clinical assessment relies on aggregated literature, complaint data, and a predicate device's IDE study.
4. Adjudication Method for the Test Set
This information is not provided as there was no standalone clinical study for the Edwards Balloon Catheter involving a test set that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was reported. The device is a physical medical device (balloon catheter) and not an imaging or diagnostic AI system, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- Not applicable. This device is a physical, invasive medical device used for a therapeutic procedure, not an algorithm or AI system. Its performance inherently involves human interaction (a surgeon or interventional cardiologist).
7. Type of Ground Truth Used
Given the context of a medical device 510(k) for a balloon catheter, "ground truth" would typically refer to clinical outcomes (e.g., successful valvuloplasty, adverse event rates, hemodynamic improvements). However, for the Edwards Balloon Catheter, the summary indicates that substantial equivalence was demonstrated through:
- Non-clinical testing: Demonstrating that the physical device functions as intended and meets design specifications (e.g., burst pressure, inflation/deflation time).
- Clinical assessment by proxy: Relying on the established safety and effectiveness of predicate devices (including the pivotal IDE G030069 for the RetroFlex Balloon Catheter), literature, and post-market surveillance data. The "ground truth" for the predicate device's IDE study would have been defined clinical outcomes (e.g., patient survival, complication rates, hemodynamic improvements assessed by objective measures) relevant to balloon aortic valvuloplasty.
8. Sample Size for the Training Set
- Not applicable/Not provided. This is not an AI/algorithm-based device that would typically have a "training set" in the computational sense. The "training" for the design and manufacturing of the device would come from engineering principles, predicate device experience, and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. As stated above, this is not an AI/algorithm-based device. For the predicate device's IDE study, the ground truth would have been established through standard clinical trial methodologies, including patient enrollment, clinical follow-up, and objective measurements of outcomes.
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(126 days)
The EV1000 Clinical Platform and the ClearSight™ Finger Cuffs are indicated for patients over 18 years of age in which the balance between. cardiac function, fluid status, and vascular resistance needs continuous assessment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSight™ finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
The EV1000 Clinical Platform with ClearSight Finger Cuffs is a non- invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peňáz - Wesseling. The device measures continuous non-invasive blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform. The EV1000 ClearSight™ System consists of a monitor, a pump-unit, a pressure controller that is worn on the wrist, and ClearSight Finger cuffs. The EV1000 Pump-unit receives incoming signals from the pressure controller and the finger cuffs. The algorithms embedded in the Pump- Unit and the pressure controller process signals from the finger cuffs and provide parameter calculations. The EV1000 Monitor is connected to the Pump-Unit via an Ethernet cable, and the Pump-unit is connected to the pressure controller via a RS485 port. The monitor is a touchscreen panel PC with a graphical user interface (GUI). The monitor displays the measured and calculated parameters from the Pump-Unit.
The provided text describes the EV1000 Clinical Platform with ClearSight™ Finger Cuffs, a non-invasive blood pressure measurement system. The submission focuses on demonstrating substantial equivalence to a predicate device through verification and validation testing, including a clinical study.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it describes meeting acceptance criteria through a comparison to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety | Shown to be safe |
| Effectiveness | Shown to be effective |
| Substantial Equivalence | Shown to be substantially equivalent to the predicate device (ccNexfin) for its intended use |
| Performance and Functionality | Demonstrated to be comparable to the predicate device through side-by-side bench testing and a clinical study |
| Functional/Performance Testing | Successfully passed (including software verification & validation, mechanical & electrical testing, bench studies) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "a clinical study" was conducted. However, it does not specify the sample size used for this clinical study (test set). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).
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)
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. Given that the device measures physiological parameters (blood pressure), ground truth would likely be established through a reference measurement method, rather than expert interpretation of images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set.
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
The document describes a comparative effectiveness study, but it is not an MRMC study comparing human readers with and without AI assistance. This device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool for human readers. The comparative effectiveness study focuses on the device's performance against a predicate device. Therefore, there is no mention of an effect size related to human reader improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone non-invasive blood pressure monitor that measures and calculates parameters. The "clinical study" would inherently assess the performance of this device in a standalone manner against a reference method or predicate device. The document states "a clinical study demonstrated that the device is substantially equivalent to the cited predicate device." This implies standalone performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
While not explicitly stated, for a non-invasive blood pressure monitor, the "ground truth" in a clinical study would typically be established by simultaneous measurements from a reference invasive blood pressure monitoring system (e.g., arterial line) or another highly accurate, validated non-invasive method. The document does not specify the exact method used for ground truth.
8. The sample size for the training set
This document describes a medical device seeking 510(k) clearance, not an AI/Machine Learning model that undergoes explicit "training." Therefore, there is no concept of a training set sample size as it would apply to AI. The device's algorithms are embedded and validated through testing, not iterative training on a large dataset in the AI sense.
9. How the ground truth for the training set was established
As described in point 8, there isn't a "training set" in the context of an AI model for this device. The device's underlying scientific method (Peňáz - Wesseling) and embedded algorithms are based on established physiological principles and likely validated through extensive engineering and clinical testing, not ground truth labeling for a training set.
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(356 days)
The Vigileo™ APCO/Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The monitor also displays parameters, such as stroke volume and stroke volume variation, used to assess fluid status and vascular resistance. The Vigileo™ APCO/Oximetry Monitor may be used in all settings in which critical care is provided.
The Vigileo™ Arterial Pressure Cardiac Output (APCO)/Oximetry Monitor (Vigileo™ Monitor) is a microprocessor-based instrument. When used with an Edwards FloTrac sensor, the Vigileo™ Monitor is capable of continuously monitoring the following parameters: Cardiac Output (CO); Cardiac Index (CI): Stroke Volume (SV): Stroke Volume Variation (SVV); Systemic Vascular Resistance (SVR); Systemic Vascular Resistance Index (SVRI); Oxygen Delivery (DO2); and Oxygen Delivery Index (DO2I). When used with Edwards Oximetry catheters, the Vigileo™ Monitor is capable of continuously monitoring the following parameters: Central venous oxygen saturation (ScvO2); and, Mixed venous oxygen saturation (SvO2).
The Vigileo™ Monitor, version 3.08, is a microprocessor-based instrument designed for continuous monitoring of hemodynamic parameters and oximetry. The provided text, a 510(k) summary, outlines its acceptance criteria and the studies conducted to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical acceptance criteria in a table format for specific performance metrics (e.g., accuracy, precision for CO, CI, etc.). Instead, the acceptance criteria are implicitly stated as demonstrating "substantially equivalent" performance to the predicate device (K103094, Vigileo™ Arterial Pressure Cardiac Output/Oximetry Monitor). The reported device performance is described in terms of successful completion of various tests, confirming this substantial equivalence.
| Parameter/Type of Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| General Performance & Functionality | Substantially equivalent to the predicate device (K103094) in performance and functionality. | "Verification and validation testing was conducted to compare the performance and functionality of the subject and predicate devices. This testing regimen included side-by-side bench, pre-clinical studies, and comparative analysis of clinical data. The Vigileo™ Monitor has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use critical care environments." |
| Functional/Safety Testing | Successful passage of various functional and performance tests. | "The Vigileo™ Monitor has successfully passed functional and performance testing, including software verification and validation, mechanical and electrical testing, bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." |
| Safety and Effectiveness | Safe, effective, and substantially equivalent to predicate devices for intended use in OR and ICU environments. | "The Vigileo™ Monitor has been shown to be safe, effective, and is substantially equivalent to the cited predicate devices for their intended use in the OR and ICU environments." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary mentions "pre-clinical animal studies" and "comparative analysis of clinical data" and "comparison testing of clinical cases" for the test set. However, it does not specify the exact sample size (number of patients, animals, or data points) used for these test sets.
The data provenance is stated as including:
- Bench studies: Likely internal laboratory testing.
- Pre-clinical animal studies: Originating from animal subjects. The country of origin is not specified but typically would be internal to the company or contracted research in a regulated environment.
- Clinical data/cases: Originating from human patients. The country of origin and whether the data was retrospective or prospective is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications. The study relies on "comparative analysis of clinical data" and "comparison testing of clinical cases" against a predicate device, implying that the ground truth for these clinical cases would have been established through a combination of established clinical methods and the predicate device's measurements.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "comparative analysis" and "comparison testing," which suggests direct comparison of the subject device's outputs with the predicate device's outputs or established clinical reference methods, rather than a human expert adjudication process for image interpretation or diagnosis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is a monitor that provides numerical hemodynamic and oximetry parameters, not an imaging device or AI algorithm for diagnosis that would typically involve human readers. The comparative effectiveness focused on the technical performance of the device itself against a predicate, not on how human readers' performance improves with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device is a "Single-Function, Preprogrammed Diagnostic Computer," the term "standalone" in the context of AI often refers to an algorithm making a diagnosis without human input. This device provides physiological measurements to clinicians, rather than a diagnostic interpretation in the way an AI algorithm might. Therefore, the concept of a standalone AI algorithm is not directly applicable here. The device performs its functions (calculating CO, CI, SV, etc.) based on physiological inputs, which is inherently a "standalone" processing of data, but it's not an AI making a medical decision. The primary assessment was device performance and functionality, not an AI algorithm's diagnostic capabilities.
7. The Type of Ground Truth Used
The ground truth for evaluating the Vigileo™ Monitor's performance was established through:
- Comparison to a predicate device (K103094): The primary method of demonstrating substantial equivalence was by comparing the performance and functionality of the subject device against the previously cleared predicate device.
- Established clinical methods/measurements: Implied in the "pre-clinical animal studies" and "comparative analysis of clinical data," the accuracy of the measurements would be referenced against recognized standards or gold standard measurements for cardiac output and oximetry, even if not explicitly detailed in this summary.
8. The Sample Size for the Training Set
The 510(k) summary does not mention a "training set" in the context of machine learning or AI development. This device is a preprogrammed diagnostic computer that likely uses established physiological algorithms, not a machine learning model that requires a training set. Therefore, this question is not applicable in the context of the provided document.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for a machine learning model, the question of how its ground truth was established is not applicable based on the provided information.
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(331 days)
The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.
The EV1000 Clinical Platform consists of Databox and Monitor components, which can be mounted to an IV pole. The EV1000 Clinical Platform measures patient physiologic parameters when it is used as a system with various Edwards components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.
The EV1000 Databox receives incoming signals from the patient through the connections provided by the accessories applied to the patient. The algorithms embedded in the Databox process the signals and provide parameter calculations.
The EV1000 Monitor is connected to the Databox via an ethernet cable. The Monitor is a touchscreen, panel PC with a graphical user interface (GUI). The Monitor displays the measured and calculated parameter values from the Databox.
The EV1000 Clinical Platform, when used with the VolumeView System, measures and/or calculates hemodynamic parameters such as: Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume. Manual-calibrated intermittent parameters: cardiac output, cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index.
When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates auto-calibrated arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.
When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters (specifically mixed venous oximetry (SvO2) and central venous oximetry (ScvO2).
Here's a breakdown of the acceptance criteria and the study information for the EV1000 Clinical Platform, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the EV1000 Clinical Platform is a 510(k) summary and approval letter, not a detailed study report with specific acceptance criteria and quantitative performance metrics. Therefore, a direct table of numerical "acceptance criteria" and "reported device performance" as one might find for accuracy or precision claims is not available in the provided text.
Instead, the acceptance criteria here are broad statements related to safety, effectiveness, and substantial equivalence to a predicate device. The device performance is described in terms of having "successfully passed functional and performance testing."
Here's how we can infer and represent the information:
| Acceptance Criteria Category | General Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Overall Equivalence | Device must be safe, effective, and substantially equivalent to the predicate device (EV1000 Clinical Platform, K110597) for its intended use in critical care environments. | "The EV1000 Clinical Platform has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use in critical care environments." and "The EV1000 Clinical Platform has been shown to be safe, effective, and is substantially equivalent to the cited predicate device for its intended use in critical care environments." (from Conclusion) |
| Functional & Performance | Device must meet functional and performance requirements. | "The EV1000 Clinical Platform has successfully passed functional and performance testing, including software verification and validation, mechanical and electrical testing, bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." |
| Comparative Analysis | Performance and functionality of the device should be comparable to the predicate device. | "Verification and validation testing was conducted to compare the performance and functionality of the EV1000 Clinical Platform to the predicate device. This testing regimen included side-by-side bench and pre-clinical studies, and comparative analysis of clinical data." |
| Intended Use | The device should perform as intended for measuring/calculating hemodynamic parameters (e.g., cardiac output, stroke volume, SVR, EVLW, GEF, GEDVI, ITBV, PVPI, SVV, SvO2/ScvO2) accurately and continuously/intermittently, and for analysis of thermodilution curves to determine fluid volumes, in critical care patients. | The description of the device details its capabilities to measure/calculate these parameters, indicating it is designed to meet these functional aspects of its intended use. The conclusion states it is substantially equivalent "for its intended use in critical care environments," implying it fulfills these functions adequately. (No specific numerical performance data for these parameters is present in the summary, just the assertion of successful testing and equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The text mentions "comparison testing of clinical cases" and "comparative analysis of clinical data" but does not give a number of cases or patients.
- Data Provenance: Not explicitly stated regarding country of origin. The study included "bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." No indication if these were retrospective or prospective, or geographically where they were conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not stated. For a device like the EV1000 Clinical Platform, "ground truth" for its measurements (e.g., cardiac output, stroke volume) would typically be established by validated reference methods or the predicate device itself, not by a panel of human experts reviewing observational data.
- Qualifications of Experts: Not applicable/Not stated for the reason above.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not stated. Since the "ground truth" for this type of device is usually based on empirical measurements and comparison to a predicate, rather than subjective expert interpretation, an adjudication method for conflicting expert opinions is not relevant or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is measured. This device is a physiological monitoring platform, hence such a study design is not relevant here.
- Effect Size with AI vs. Without AI Assistance: Not applicable for the reasons above.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Standalone Study: Yes, implicitly. The nature of the device (a cardiac output/oximetry computer) means its core function is to autonomously process signals and calculate parameters. The "functional and performance testing" and "bench studies" inherently evaluate the algorithms' performance in a standalone manner, separate from human interpretation of raw signals. The comparison to the predicate device also assesses the algorithm's output. While not explicitly termed a "standalone study," the entire evaluation process focuses on the device's algorithmic and hardware performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the EV1000 Clinical Platform would be derived from:
- Validated Reference Methods: For quantitative physiological parameters, this would involve comparing the device's measurements to established, gold-standard methods (though these specific methods are not detailed in the summary).
- Predicate Device Comparison: A significant part of the substantial equivalence claim relies on "side-by-side bench and pre-clinical studies, and comparative analysis of clinical data" against the EV1000 Clinical Platform, K110597 (the predicate). The measurements from the predicate device serve as the reference.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not stated. This summary describes a device that likely uses established physiological algorithms and signal processing, rather than a machine learning or AI model that requires a dedicated "training set" in the modern sense of deep learning. The algorithms are "embedded in the Databox." Therefore, there isn't a "training set" as one would discuss for, say, an image recognition AI. If any form of algorithm tuning or development data was used, it's not documented here.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/Not stated for the same reasons as #8.
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(29 days)
The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.
Edwards Lifesciences' EMBOL-X Introducer Sheath is a 17 Fr, sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen housing and a removable, snap-lock obturator. The housing has a flexible suture flange for attachment to the vessel and orientation markings on the shaft and suture flange to assist in the placement of the EMBOL-X Introducer Sheath. Inside the housing is an internal valve to prevent backbleeding. The housing also has suture loops on the proximal end of the Introducer housing, and vent grooves, vent holes, and a central lumen in the obturator that leads to the vent plug to assist in venting air from the Introducer.
Here's a breakdown of the acceptance criteria and the study details for the EMBOL-X Introducer Sheath, based on the provided text:
Edwards Lifesciences LLC Special 510(k) Premarket Notification EMBOL-X Introducer Sheath (K140398)
1. Acceptance Criteria and Reported Device Performance
The document states that the functional and accelerated aging bench testing was performed to support a specification change and a shelf life increase. It also emphasizes that all data met acceptance criteria, demonstrating that the device is as safe and effective as the predicate device. However, the exact quantitative acceptance criteria for each test (e.g., maximum allowable leak rate, minimum tensile strength) are not explicitly stated in the provided text. The tables below summarize the tests performed and the general reported outcome.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Leak Testing | Met acceptance criteria (no specific values provided) |
| Leak without device inserted | Met acceptance criteria |
| Leak with obturator inserted | Met acceptance criteria |
| Leak with filter inserted | Met acceptance criteria |
| Tensile Testing | Met acceptance criteria (no specific values provided) |
| Introducer bond joints | Met acceptance criteria |
| Obturator vent plug bond joint | Met acceptance criteria |
| Additional Obturator Testing | Met acceptance criteria (no specific values provided) |
| Vent time | Met acceptance criteria |
| Latch compression force | Met acceptance criteria |
| Insertion force | Met acceptance criteria |
| Removal and retention force | Met acceptance criteria |
| Filter Compatibility Testing | Met acceptance criteria (no specific values provided) |
| Insertion force | Met acceptance criteria |
| Deployment capability | Met acceptance criteria |
| Deployment force | Met acceptance criteria |
| Retraction force | Met acceptance criteria |
| Removal and retention force | Met acceptance criteria |
| Additional Introducer Testing | Met acceptance criteria (no specific values provided) |
| Suture flange flex | Met acceptance criteria |
| Design Validation | Validation complete through surgeon evaluation and benchtop study |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the functional/safety tests. It only states that "All data met acceptance criteria." The provenance of the data is not explicitly mentioned (e.g., country of origin). Since these are bench tests and surgeon evaluations, the data would be considered prospective as it's generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
For "Design Validation," the document mentions "surgeon evaluation."
- Number of experts: Not specified (simply "surgeon evaluation" implies at least one, but the exact number is not given).
- Qualifications of experts: Explicit qualifications are not provided, other than being "surgeons."
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth, particularly for the surgeon evaluation mentioned under design validation. The bench testing would likely rely on direct measurement against predefined specifications, rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. The submission relies on bench testing and a general "surgeon evaluation" for design validation, not a comparative study of human readers with vs. without AI assistance. This device is an introducer sheath, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
This question is not applicable. The EMBOL-X Introducer Sheath is a physical medical device, not an algorithm or AI system. Therefore, there is no "standalone" algorithm-only performance to assess.
7. Type of Ground Truth Used
For the bench tests, the "ground truth" would be the predefined engineering specifications and performance targets for each test (e.g., a specific leak rate, tensile strength, or force range). For the "Design Validation," the ground truth was established through surgeon evaluation (user feedback/opinion on device design and functionality) and the results of a benchtop study.
8. Sample Size for the Training Set
This question is not applicable. As the EMBOL-X Introducer Sheath is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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(275 days)
The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.
Edwards Lifesciences' Catheter Introducer Sheath is an 11 Fr. sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen shaft and a hemostasis valve with a side-arm extension tube with a female luer and clamp.
The provided text describes a 510(k) premarket notification for a Catheter Introducer Sheath and does not contain information about studies proving the device meets specific acceptance criteria in the manner of a clinical trial or AI/ML performance evaluation. The document focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for each test performed, nor does it provide specific numerical results of device performance. Instead, it concludes: "The functional data indicate that the Catheter Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device." and "All data met acceptance criteria." This implies that for each test listed below, there were pre-defined acceptance criteria, and the device successfully met them.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility & Sterility | Cytotoxicity | Met Biocompatibility Standards | Met Acceptance Criteria |
| Sensitization | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Irritation/Intracutaneous toxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Systemic toxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Genotoxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Haemocompatibility | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Muscular toxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Subacute/Subchronic toxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| In Vivo thrombogenicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Performance / Shelf Life | Leak Testing (Valve Leak after 72-hour insertion of 7 Fr device, Assembly leak, Valve leak after 6-hour insertion of 9 Fr device, Valve leak after 6-hour insertion of 7 Fr device, Valve leak with no insertion conditioning, Valve leak after multiple insertions, Forward valve leak) | Met Leakage Standards | Met Acceptance Criteria |
| Tensile Testing | Introducer joint tensile | Met Tensile Strength Standards | Met Acceptance Criteria |
| Sideport luer tensile | Met Tensile Strength Standards | Met Acceptance Criteria | |
| Sideport tubing to body | Met Tensile Strength Standards | Met Acceptance Criteria | |
| Compatibility & Additional Testing | 9 Fr balloon catheter insertion force | Met Catheter Insertion Force Standards | Met Acceptance Criteria |
| 9 Fr balloon catheter retraction force | Met Catheter Retraction Force Standards | Met Acceptance Criteria | |
| Dilator insertion force | Met Dilator Insertion Force Standards | Met Acceptance Criteria | |
| Contamination guard connection | Met Connection Integrity Standards | Met Acceptance Criteria | |
| Introducer sheath and dilator transition | Met Transition Smoothness Standards | Met Acceptance Criteria | |
| Valve retention force | Met Valve Retention Standards | Met Acceptance Criteria | |
| Sideport infusion with empty introducer | Met Infusion Performance Standards | Met Acceptance Criteria | |
| Sideport infusion post clamping | Met Infusion Performance Standards | Met Acceptance Criteria | |
| Sideport infusion with 10 Fr device | Met Infusion Performance Standards | Met Acceptance Criteria | |
| Fluoroscopic visibility | Met Visibility Standards | Met Acceptance Criteria | |
| Kink testing | Met Kink Resistance Standards | Met Acceptance Criteria | |
| Packaging Testing | All Packaging Tests | Met Packaging Integrity Standards | Met Acceptance Criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the functional or safety tests. It also does not mention any test sets in the context of clinical data, or the provenance (country of origin, retrospective/prospective) of any data beyond the physical device testing. The "tests" described are laboratory-based, not patient-based clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to the provided document. The "ground truth" here is established by engineering and material standards, and the results of laboratory tests are presumably interpreted by qualified engineers and scientists involved in the testing and regulatory submission, not by medical experts establishing diagnostic ground truth.
4. Adjudication Method
Not applicable. The tests performed are laboratory-based and would involve measurements against established standards, not interpretation by multiple human readers requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a 510(k) submission for a physical medical device (catheter introducer sheath), not an AI/ML-driven diagnostic or assistive technology. Therefore, no MRMC study, human reader improvement effect size, or human-in-the-loop performance is relevant or discussed.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This submission is for a physical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on established engineering standards for medical device performance, material science specifications, biocompatibility guidelines (e.g., ISO standards), and internal performance specifications derived from the predicate device characteristics. For example, "Valve leak" would have a maximum allowable leakage rate, which is the ground truth for that test.
8. Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
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