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510(k) Data Aggregation
(69 days)
The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only.
The noninvasive 5100C Cerebral/Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.
The Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.
The Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors are intended to be used in the same manner as the predicate devices. They are designed to be applied to the forehead and other appropriate portions of the body to measure regional oxygenation saturation during surgery or other applications related to the use of anesthesia.
1. Table of Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional performance equivalent to OEM sensors | "Functional testing… demonstrates that the reprocessed oximetry sensors perform as intended" |
| Cleaning validation successful | "cleaning validation… demonstrates that the reprocessed oximetry sensors perform as intended" |
| Biocompatibility demonstrated | "biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective." |
| Intended use with Somanetics INVOS 5100C Oximeter | "validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only." |
| Maximum of 2 reprocessing cycles | Specified in the 'PRODUCT SUBMISSION CHART' for both adult and pediatric sensors. |
| For pediatric patients weighing < 40 kg | Specified in "Indications For Use" |
| For adult patients weighing > 40 kg | Specified in "Indications For Use" |
2. Sample size used for the test set and the data provenance:
The document summarizes that "functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended." However, it does not provide details on the specific sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the involvement of experts for establishing ground truth for any tests conducted. The performance assessment appears to be based on engineering functional tests, cleaning validations, and biocompatibility assessments, rather than interpretation by clinical experts.
4. Adjudication method for the test set:
Since the document does not mention the involvement of experts for ground truth establishment, there is no information provided regarding any adjudication method for a 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:
This device is an oximetry sensor, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. Therefore, no MRMC comparative effectiveness study was done, and this information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a reprocessed physical sensor, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance relies on its physical and electrical characteristics when used with a compatible oximeter.
7. The type of ground truth used:
The "ground truth" for the device's performance seems to be based on:
- Functional performance standards: Comparisons to the performance of the original OEM sensors.
- Cleaning validation standards: Criteria for ensuring the device can be effectively reprocessed and cleaned.
- Biocompatibility standards: Criteria for ensuring the reprocessed device is safe for patient contact.
The document states, "The Hygia Health Services CSS are identical to the original OEM devices in reference to the technological characteristics." This implies that the ground truth for functional performance is essentially the performance of the new OEM devices.
8. The sample size for the training set:
As this is a reprocessed physical medical device and not a machine learning model, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established:
Since there is no training set in the context of this device, this question is not applicable.
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(100 days)
The Hygia Health Services Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Hygia Health Services Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.
Here's a breakdown of the acceptance criteria and study information for K090074, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional performance as intended (similar to OEM devices) | Functional Testing demonstrates the reprocessed sleeves/foot cuffs perform as intended. |
| Cleaning validation (safe for reuse) | Cleaning validation demonstrates the reprocessed sleeves/foot cuffs are safe and effective. |
| Biocompatibility (safe for patient contact) | Biocompatibility testing demonstrates the reprocessed sleeves/foot cuffs are safe and effective. |
| Technological characteristics identical to original OEM devices. | "The overall designs, materials, energy sources, modes of operation, and performance characteristics are no different than the original devices." |
| Substantial equivalence to predicate devices | Conclusion states the device is substantially equivalent based on the functional, cleaning, and biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical study with a defined sample size. The performance data refers to "Functional Testing, cleaning validation, and biocompatibility testing," which are typically laboratory or bench tests. Therefore:
- Sample Size for Test Set: Not explicitly stated as a clinical sample size. It would refer to the number of reprocessed devices subjected to bench testing for functional, cleaning, and biocompatibility assessments.
- Data Provenance: The document does not provide details on the country of origin of the data or whether it was retrospective or prospective. Given the nature of the tests (functional, cleaning, biocompatibility), they are almost certainly conducted in a laboratory setting, likely at Hygia Health Services, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the type of testing described. Ground truth established by experts is relevant for studies involving diagnosis, image interpretation, or clinical outcomes. The studies cited are laboratory-based assessments of device integrity and performance.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for subjective assessments or when there's disagreement among independent evaluators (e.g., radiologists interpreting images). The "functional testing, cleaning validation, and biocompatibility testing" are objective, measurable laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for this mechanical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a reprocessed medical sleeve/foot cuff, not an AI algorithm.
7. The Type of Ground Truth Used
For the functional, cleaning validation, and biocompatibility testing, the "ground truth" would be established by:
- Functional Testing: Established engineering specifications and performance benchmarks for the original OEM devices (e.g., pressure output, inflation/deflation cycles, material integrity).
- Cleaning Validation: Established standards and protocols for sterilization and removal of biological contaminants.
- Biocompatibility Testing: Established international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
Essentially, the "ground truth" is adherence to predefined technical and safety standards relevant to the device's original design and intended use, as well as standards for reprocessing.
8. The Sample Size for the Training Set
This is not applicable. The device is a reprocessed medical sleeve/foot cuff and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set mentioned or implied for this device.
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(103 days)
The Hygia Health Services Reprocessed Masimo LNCS Pulse Oximeter sensors are used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate monitoring. This device is intended for prescription use.
The Hygia Health Services reprocessed pulse Oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin.
Here's an analysis of the provided 510(k) summary regarding the Hygia Health Services Reprocessed Sensors, focusing on acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format. However, it indicates the overall performance goal is substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (Safety) | Testing demonstrates safety and effectiveness. |
| Performance/Functional Equivalence | Functional testing demonstrates that the reprocessed devices perform as intended. |
| Clinical Performance (SpO2 monitoring and pulse rate) | Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter perform as intended and are safe and effective. |
| Cleaning Validation | Cleaning validation demonstrates safety and effectiveness. |
| Substantial Equivalence to Predicate | Hygia Health Services concludes that the Hygia Health Services reprocessed pulse Oximeter sensors are substantially equivalent to the Masimo LNCS predicate sensors based on all testing. |
2. Sample Size for Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for the clinical or functional testing. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth Establishment
The 510(k) summary does not provide information on the number of experts used to establish ground truth or their qualifications. Given the nature of a reprocessed medical device, the "ground truth" would likely be the performance of new, original equipment manufacturer (OEM) sensors, but no details are given on how this comparison was rigorously established.
4. Adjudication Method for the Test Set
The 510(k) summary does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this 510(k) summary. The device is a pulse oximeter sensor, which provides objective measurements (SpO2 and pulse rate) rather than relying on interpretation by human readers. Therefore, such a study would not be applicable.
6. Standalone Performance Study (Algorithm Only)
The device itself is a reprocessed sensor, meaning it's a hardware component rather than a standalone algorithm. While the sensor outputs data that an oximeter algorithm interprets, the document focuses on the sensor's performance. The "clinical testing" mentioned likely evaluates the sensor's ability to provide accurate readings when used with an oximeter, implying a form of standalone performance evaluation for the sensor's output. However, it's not an "algorithm-only" study in the typical AI/software sense.
7. Type of Ground Truth Used
The ground truth implicitly used for this device's performance evaluation would be the performance of legally marketed, new (non-reprocessed) OEM pulse oximeter sensors, specifically the Masimo LNCS Pulse Oximeter Sensors. The goal is to demonstrate that the reprocessed sensors perform equivalently. The document states that "Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter perform as intended and are safe and effective," which implies comparison against expected, accurate readings.
8. Sample Size for the Training Set
The product is a reprocessed physical medical device (sensor), not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size does not apply here. The reprocessed sensors are evaluated for their equivalence to new sensors after processing, not "trained" on data.
9. How Ground Truth for the Training Set Was Established
As established above, the concept of a "training set" is not applicable to this device.
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(55 days)
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are used in the management of lymphedema and edema which are disorders associated with venous insufficiency.
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, which attached to an appropriate controller, provide intermittent, sequentially graded pressure to the patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, they collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The timing and deflation of compression is determined by the controller.
The provided text describes a 510(k) premarket notification for Hygia Health Services Reprocessed Sleeves/Foot Cuffs. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a new device.
Therefore, many of the requested sections (e.g., acceptance criteria, detailed device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not explicitly present in the provided document.
However, based on the information available, here's a breakdown:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the reprocessed devices perform as intended and are safe and effective, consistent with their predicate devices. The "acceptance" is based on functional equivalence and safety verification rather than numerical performance thresholds.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Summarized) |
|---|---|---|
| Functional Equivalence | Device operates identically to original equipment manufacturer (OEM) devices in terms of compression mechanism, pressure delivery, and cycle. | Performs "as intended," with "sources, modes of operation, and performance characteristics no different than the original devices." |
| Cleaning Validation | Reprocessing effectively removes contaminants and renders the device safe for reuse. | "Cleaning validation demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Biocompatibility | Reprocessed materials are safe for patient contact and do not induce adverse biological reactions. | "Biocompatibility testing demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Intended Use | Retains the same indications for use as the predicate devices (prevention of deep vein thrombosis, treatment of lymphedema and edema). | Intended to be used "in the same manner as the predicate devices." |
| Safety and Effectiveness | Overall, the reprocessing process does not compromise the safety or effectiveness of the device compared to the original devices. | "Functional Testing, cleaning validation, and biocompatibility testing demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Substantial Equivalence | Demonstrates that the reprocessed device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. | Conclusion: "Hygia Health Services concludes that the reprocessed sleeves are substantially equivalent to the predicate devices." |
Study Details
The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device. It does not detail a clinical study in the traditional sense with test sets, ground truth, or statistical power calculations for performance metrics as might be found for a novel AI/diagnostic device.
1. Sample Sized used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The performance data section vaguely mentions "Functional Testing, cleaning validation, and biocompatibility testing." These are likely laboratory tests on a sample of reprocessed devices, but the exact number of units tested is not provided.
- Data Provenance: Not specified, but generally, such tests would be conducted internally by the manufacturer. The data is retrospective in the sense that the predicate devices have established performance, and the goal is to certify the reprocessed devices meet that standard.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Experts and Qualifications: Not applicable/not specified. For this type of submission, "ground truth" refers to established performance standards for the predicate devices, and the objective is to show the reprocessed devices meet those standards through various tests. It does not involve expert consensus on medical images or clinical outcomes for a "test set" in the diagnostic sense.
3. Adjudication method for the test set:
- Adjudication Method: Not applicable/not specified. No human reader review or adjudication process is mentioned for evaluating the performance of the reprocessed sleeves.
4. 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:
- MRMC Study: No. This is not an AI/diagnostic device. The submission is for reprocessed medical devices (compressible limb sleeves), not an AI-powered diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant and not part of this submission.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This document pertains to a physical medical device. There is no "algorithm only" performance to evaluate.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: For this submission, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices. The reprocessed device's performance is compared against these established characteristics through functional, cleaning, and biocompatibility tests. It does not involve "expert consensus, pathology, or outcomes data" in the context of diagnostic accuracy.
7. The sample size for the training set:
- Sample Size (Training Set): Not applicable. There is no AI model being trained, so no "training set" exists.
8. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable, as there is no training set.
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(63 days)
The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
The Hygia Health Services reprocessed pulse Oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin.
This document is a 510(k) summary for the Hygia Health Services Reprocessed Sensors, which are reprocessed pulse oximeter sensors. It asserts substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the reprocessed sensors in a format that would typically be seen for AI/software-as-a-medical-device (SaMD) performance.
Instead, the summary focuses on demonstrating that the reprocessed sensors are substantially equivalent to predicate devices through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Effectiveness comparable to predicate devices | Biocompatibility, functional testing, and cleaning validation demonstrate equivalence and safety/effectiveness for intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on sample size, data origin (country), or whether the study was retrospective or prospective for the performance testing. It generally refers to "functional testing, cleaning validation, and biocompatibility testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the context of this device. The device is a reprocessed physical sensor, not an AI or diagnostic imaging system that relies on expert interpretation for ground truth.
4. Adjudication Method
This information is not applicable or provided for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable or provided. This is not an AI/SaMD product, so a MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable or provided. The device is a physical sensor, not an algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/diagnostic performance is not directly relevant here. For a a reprocessed physical medical device like this, performance is usually assessed against:
- Predicate device performance specifications: Ensuring the reprocessed device performs within the same range as the original.
- Biocompatibility standards: Ensuring no adverse tissue reactions.
- Cleaning validation: Ensuring proper sterilization and absence of contaminants.
- Functional tests: Verifying physical and electrical properties.
The summary states that "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and are safe and effective for their intended use."
8. Sample Size for the Training Set
This information is not applicable or provided. This device is not an AI/machine learning product and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As mentioned, there is no training set for this type of device.
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(91 days)
The Hygia Health Services Reprocessed Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual or automatic sphygmomanometers as appropriate. The device is non-sterile and is intended as a single patient use device. It is available in neonatal through large adult size.
The Hygia Health Services Reprocessed Blood Pressure Cuff is an accessory used by trained personnel in conjunction with non-invasive blood pressure measurement systems, primarily in a clinical setting.
Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure.
The Hygia Health Services Reprocessed Blood Pressure Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used.
The provided document is a 510(k) Pre-market Notification for a reprocessed blood pressure cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance, and details about a study designed to meet specific performance criteria using AI, are not present.
However, based on the information provided, here's a breakdown of what can be extracted and inferred regarding performance and testing:
1. A table of acceptance criteria and the reported device performance:
Since this is a reprocessed device seeking substantial equivalence, the "acceptance criteria" are implicitly the performance characteristics of the predicate devices. The performance reported centers on demonstrating that the reprocessed device matches these characteristics.
| Acceptance Criterion (Implicitly, from predicate devices) | Reported Device Performance (Hygia Reprocessed BP Cuff) |
|---|---|
| Functional and operational performance characteristics (compression, pressure control, leakage) | "functional and operational performance characteristics including compression, pressure control, leakage... were substantially equivalent." |
| Safety parameters | "safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent." |
| Operational parameters when connected to inflation and measurement equipment | "safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent." |
| Design, materials, energy source, mode of operation | "The technological characteristics... are identical to the originally manufactured Blood Pressure Cuff in design, materials, energy source, mode of operation, and performance characteristics." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Comparative bench testing," but does not provide details on the number of cuffs or tests performed.
- Data Provenance: Not explicitly stated. The testing was "Non-clinical Tests" and conducted by Hygia Health Services, Inc. within the USA. It appears to be prospective testing specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth for this device's performance is not established by expert consensus on clinical findings. Instead, it's established by comparing physical and functional characteristics to new, predicate devices.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable in the context of expert review. The "adjudication" was a comparison of physical and functional test results against established specifications or performance of predicate devices.
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:
- MRMC Study: No.
- Effect Size: Not applicable. This document is for a physical medical device (blood pressure cuff), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Study: Not applicable. This device is a blood pressure cuff and does not involve an algorithm or AI.
7. The type of ground truth used:
- Ground Truth: The "ground truth" for this reprocessed device is effectively the published specifications and demonstrated functional performance of the new, un-reprocessed predicate blood pressure cuffs. The study aimed to show that the reprocessed cuff performs identically or substantially equivalently. The "test conclusions" explicitly state: "Non-clinical test results...indicated substantial equivalence in the measured characteristics to the predicate devices, the as originally manufactured blood pressure cuffs."
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI algorithms, and therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set.
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(717 days)
The Hygia Health Services Reprocessed Nellcor Oxisensor is used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
The Hygia Health Services Oxisensors are non-invasive probes used to provide continuous SpO2 monitoring and pulse rate. The probes contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin.
The provided document is a 510(k) summary for a reprocessed medical device, specifically pulse oximeter sensors, and does not contain the detailed information typically found in a study report for device performance against specific acceptance criteria. The document focuses on demonstrating substantial equivalence to a predicate device.
Therefore, it is not possible to fully answer your request with the provided input.
However, based on the available information, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. It generally states that "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and are safe and effective for their intended use." and "Functional testing, cleaning validation, and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective."
The "performance" referred to here is likely in comparison to the predicate device, aiming for substantial equivalence rather than meeting specific numerical targets for accuracy, sensitivity, or specificity.
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 lists "Functional testing, cleaning validation, and biocompatibility testing" but does not detail the methodology, sample sizes, or data provenance for these tests.
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 concept of "ground truth" as typically used in the context of diagnostic device studies (like those involving image interpretation or disease detection) is not directly applicable to the functional testing of a reprocessed pulse oximeter sensor as described here. The focus is on the device's ability to measure SpO2 and pulse rate, which would be compared to established measurement methods, not expert interpretation of a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As mentioned above, the type of testing described does not typically involve adjudication in the way diagnostic algorithm studies do.
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 information is not applicable/provided. The product is a physical reprocessed medical device (pulse oximeter sensor), not an AI algorithm or a diagnostic tool that involves human readers interpreting results. Therefore, an MRMC study with AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The product is a physical sensor, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the diagnostic sense is not directly applicable. For a pulse oximeter, the "ground truth" for its measurements (SpO2 and pulse rate) would typically be established by highly accurate, reference measurement techniques (e.g., arterial blood gas analysis for oxygen saturation) run concurrently with the device being tested. The document does not specify the ground truth methods used for their functional testing.
8. The sample size for the training set
This information is not applicable/provided. The device is a reprocessed physical sensor, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
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(229 days)
The Hygia Health Services Reprocessed Novamedix ImPad® is designed to enhance circulation of blood. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:
- DVT prophylaxis
- Acute and chronic edema
- Extreme pain after trauma or surgery
- Treat leg ulcers and venous stasis/insuffic
The Hygia Health Services Reprocessed Novamedix ImPad® Garment is an intermittent compressible limb device that is placed around the patient's foot with the compression chamber placed under the plantar arch. The garment is constructed out of brushed nylon over a thin layer of closed cell foam. The device is secured using hook and loop fasteners made of polyethylene. As the garment compresses the plantar plexus, the veins collapse longitudinally, which increases the venous pressure thus ejecting the blood upward. After compression, the devices deflate allowing the veins to refill and bring oxygenated blood to the lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression, hold time , and inflation/deflation time is determined by the controller.
The Hygia Health Services Reprocessed Novamedix ImPad® is a reprocessed medical device. The 510(k) summary focuses on demonstrating that the reprocessed device is substantially equivalent to the original, predicate device (Novamedix ImPad®), rather than providing detailed acceptance criteria and a study for de novo device performance.
Here's an analysis based on the provided document, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a typical "performance metric X must be Y" format. Instead, the acceptance is based on demonstrating "substantial equivalence" of the reprocessed device to the predicate device. The performance data presented indicates that the reprocessed device met the functional and operational characteristics of the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional and Operational Performance | All functional and operational performance characteristics, including compression and pressure capabilities, were found to be substantially equivalent to the predicate device. |
| Safety Parameters | Safety parameters were found to be substantially equivalent to the predicate device. |
| Biocompatibility | No signs of irritation or sensitization were found in a human skin patch test, indicating the high-level disinfection program did not adversely affect biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Functional/Operational Tests: Not explicitly stated. The document refers to "comparative bench testing."
- Sample Size for Biocompatibility Test: Not explicitly stated, described as a "NIH level combination irritation/sensitization human skin patch test."
- Data Provenance: The tests conducted appear to be prospective bench tests and a human skin patch test specifically performed for this 510(k) submission. The location of these tests (e.g., country of origin) is not specified, but given the company location (Birmingham, Alabama) and FDA submission, it's implied to be within the US or compliant with US regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for a device reprocessing and substantial equivalence submission like this. Ground truth in this context would implicitly be the established performance and safety profile of the original, predicate device, which is already FDA-cleared. The tests aim to confirm the reprocessed device matches that established profile, rather than independently establishing a new ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical image reading).
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 an intermittent pneumatic compressible limb sleeve, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device; there is no "algorithm" in the sense of AI software. The device itself operates "standalone" when connected to a controller, but the evaluation is on its physical performance rather than software algorithm performance.
7. The Type of Ground Truth Used
For the functional and operational tests, the "ground truth" was effectively the established performance and safety characteristics of the new, un-reprocessed Novamedix ImPad® (the predicate device). The goal was to prove the reprocessed device's performance was "substantially equivalent" to this predicate.
For biocompatibility, the ground truth was the absence of irritation or sensitization in human subjects, as assessed by standard dermatological evaluation in a skin patch test.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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(242 days)
The Hygia Health Services Reprocessed Huntleigh Foot Wrap is designed to enhance the circulation of blood in the veins and arterioles. It is to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent:
- Deep vein thrombosis
- Reduce wound healing time
- Treat and assist healing of venous leg ulcers
- Reduce edema caused by venous insufficiency in the lower extremities
- Decrease compartmental pressures
The Hygia Health Services Reprocessed Huntleigh Foot Wrap Garment is a compressible limb device that is placed around the patient's foot and when attached to an approved controller, provides intermittent pneumatic compression. The garment is constructed out of brushed nylon with a polyester foam lining. The single bladder is constructed out of the garment itself using an internal polymer coating that provides an airtight surface. The garment does not use an inflation chamber of poly vinyl chloride (PVC). The inflation/deflation tube is however, composed of PVC. The hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The garments are placed around the foot at the area of the plantar arch and secured with a hook and loop fastener. As the garment compresses the plantar plexus, the veins collapse longitudinally, which increases the venous pressure thus ejecting the blood upward. After compression. the devices deflate allowing the veins to refill and bring oxygenated blood to the lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.
The provided 510(k) summary for the Hygia Health Services Reprocessed Huntleigh Foot Wrap does not contain detailed information regarding acceptance criteria, specific performance metrics with numerical results, or the methodology of a formal study with a test set, ground truth establishment, or expert involvement as described in your request.
The submission focuses on demonstrating "substantial equivalence" to a predicate device based on nonclinical comparative bench testing. This type of submission relies on showing that the reprocessed device performs similarly to the original, rather than establishing de novo performance against a set of predefined clinical acceptance criteria.
However, I can extract the available information and, where specific details are missing, state that they are not present in the provided document.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (from "Performance Data" and "Test Conclusions") |
|---|---|
| Functional and operational performance characteristics (including inflation/deflation control, timing sequence) | "All tests found that functional and operational performance characteristics including round that renotional acontrol, timing sequence... were substantially equivalent." |
| Safety parameters | "All tests found that... both safety... parameters used when connected to a controller were substantially equivalent." |
| Operational parameters | "All tests found that... operational parameters used when connected to a controller were substantially equivalent." |
| Efficacy (not directly tested, but implied by substantial equivalence to predicate) | "The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric) |
| Safety (not directly tested, but implied by substantial equivalence to predicate) | "The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric) |
| Composition (not directly tested, but implied by substantial equivalence to predicate) | "The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric) |
| Intended Use (not directly tested, but implied by substantial equivalence to predicate) | "The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric) |
Note: The document only states that the reprocessed device was found "substantially equivalent" to the predicate device in these areas, without specifying numerical acceptance criteria for each characteristic or providing quantitative performance data.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document mentions "comparative bench testing" but does not detail the number of units or test conditions used.
- Data Provenance: The nature of "bench testing" implies laboratory-based data, which is neither retrospective nor prospective in the clinical sense. No country of origin for the data is mentioned, but the submitting company is based in Alabama, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. Bench testing does not involve establishing ground truth through expert review in the way clinical studies often do. The "ground truth" for bench testing would be the measured properties of the predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for nonclinical bench testing as described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No. The document describes nonclinical comparative bench testing, not a clinical MRMC study.
- Effect Size of Human Readers: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance: Not applicable. This device is a physical, reprocessed medical garment, not a software algorithm. Its performance is inherent to its physical properties and function when connected to a controller, not a standalone algorithmic output.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the "comparative bench testing," the implicit ground truth was the established functional and operational characteristics of the predicate device (the original Huntleigh Foot Wrap Garment). The reprocessed device was compared against the original to demonstrate similarity.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The "training" for the reprocessing protocol itself would be the validation studies for the "scientifically validated thermal kill pasteurization process," but details on that are not provided in terms of a "training set."
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable. As there is no training set in the AI/ML context, this question is not relevant to the described device. The device's "training" relates to the validation of its reprocessing method, which is stated to be a "scientifically validated thermal kill pasteurization process," but the details of this validation (including how ground truth for its effectiveness was established) are not part of this 510(k) summary.
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(242 days)
The Hygia Health Services Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Hygia Health Services Reprocessed Huntleigh Flowtron® DVT sleeve is a compressible limb device that, when attached to an approved controller, provides intermittent pneumatic compression. The sleeve is constructed out of brushed nylon with a polyester foam lining. The single bladder is constructed of poly vinyl chloride (PVC), as is the inflation/deflation tube. The binding is a polyester/cotton blend, and the hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The sleeves are placed around the leg and secured with a hook and loop fastener. As the sleeves compress the leg, veins collapse, increasing the venous pressure thus ejecting the blood upward toward the heart. After compression, the sleeves deflate allowing the veins to refill and bring oxygenated blood to the lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hygia Health Services Reprocessed Huntleigh Flowtron® DVT Compression Sleeves:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a reprocessed medical device, and the primary "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device, the Huntleigh Flowtron® DVT Garment. This means the reprocessed device must perform functionally and safely in the same way as the original. Specific quantitative acceptance criteria (e.g., a specific pressure range with a tolerance) are not explicitly stated in the provided text as they would be for a novel device, but rather implied by the concept of "substantial equivalence."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional and Operational Performance | All tests found that functional and operational performance characteristics including compression, pressure control, timing sequence, and both safety and operational parameters used when connected to a controller were substantially equivalent. |
| Material Integrity | The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use. |
| Intended Use | Designed to operate in the identical manner as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Comparative bench testing" and "Clinical tests were summarized," but does not provide a specific number of units tested for either bench or clinical evaluation.
- Data Provenance: Not explicitly stated. It describes "bench testing" and "clinical tests," which would typically be conducted by the manufacturer or a contracted lab. The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for a reprocessed device, studies would likely be prospective specifically for reprocessing validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For device reprocessing, "ground truth" would typically relate to objective measures of device performance, material integrity, and sterility, rather than expert interpretation of images or clinical outcomes in the same way an AI diagnostic tool might require. The testing relies on established engineering and clinical measures, not expert consensus on qualitative data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided in the context of this device. Adjudication methods like 2+1 or 3+1 are common in studies where expert interpretation (e.g., reading medical images) forms the ground truth and there's a need to resolve disagreements. For a reprocessed mechanical device, performance is assessed through objective measurements, not by expert consensus on interpretive data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically used for diagnostic or assistive AI tools where the performance of human readers (e.g., radiologists) with and without AI assistance is compared. This submission is for a reprocessed mechanical compression sleeve, which does not involve human "readers" interpreting data in the same way.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable in the context of this device. This is not an AI algorithm. Its "performance" is assessed through its mechanical function, material integrity, and ability to achieve intended physiological effects. The device itself (the reprocessed sleeve) is standalone in that it performs its compression function when connected to a controller, but "standalone" in the AI sense does not apply.
7. The Type of Ground Truth Used
The ground truth used for this type of device (a reprocessed compression sleeve) is based on objective measurements of performance characteristics and material properties compared against the specifications and performance of the original, new device. This includes:
- Compression pressure profiles
- Timing sequences (inflation/deflation cycles)
- Material integrity after reprocessing (e.g., no degradation affecting safety or efficacy)
- Safety parameters
- Operational parameters
- Efficacy in preventing DVT (implied by equivalence to predicate device with established efficacy).
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a reprocessed physical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As stated above, this is not an AI model.
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