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When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with connectors for pump attachment. Only the compression sleeves are reprocessed.

Ascent Healthcare Solutions' Reprocessed Compression Sleeves were tested against several acceptance criteria through bench and laboratory testing. The study proved that the reprocessed sleeves perform as originally intended, demonstrating safety and effectiveness compared to predicate devices.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly states that "Bench and laboratory testing was conducted," implying a controlled experimental environment rather than patient data.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. Given that the testing involved "bench and laboratory testing" rather than clinical assessment or diagnostic evaluations, the concept of "ground truth established by experts" as typically understood in AI/medical imaging studies may not directly apply. The evaluation would likely have been based on established engineering and materials science standards.

4. Adjudication Method:

The document does not specify an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The device is a reprocessed physical medical device, not a diagnostic algorithm or AI system intended to assist human readers.

6. Standalone Performance (Algorithm Only):

Not applicable. The device is a physical medical device (compression sleeve), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing was based on established engineering and safety standards for medical device function and material properties, as evidenced by the mention of "Biocompatibility," "Validation of reprocessing," and "Function test(s)." It was not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or predictive device. The goal was to show that the reprocessed device met the performance characteristics of its original, non-reprocessed counterparts.

8. Sample Size for the Training Set:

Not applicable. The device is a reprocessed physical medical device, not an AI model requiring a training set. The "reprocessing" itself involves a set of procedures that are validated, rather than an algorithm that is "trained."

9. How Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device. The reprocessing process itself would be validated against established standards to ensure the device performs as intended after reprocessing, which serves a similar role to "ground truth" for the manufacturing/reprocessing process.

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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.

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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SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.

Compression Sleeves are inflatable cuffs designed to apply intermittent pressure to the foot, calf or thigh in order to increase venous return and prevent pooling of blood associated with the formation of Deep Vein Thrombosis (DVT). The devices consist of inflatable vinyl bladder(s) lined with an outer non-woven fabric; the bladder is connected to pneumatic tubing for connection with a compatible pump system that controls the sleeve's pressure cycle. Hook-and-loop fasteners sewn into the fabric are used to secure the sleeve to the foot or leg. Models are available in a range of dimensions in order to fit varying foot, calf and thigh circumferences. Reprocessed sleeves have identical technological characteristics as the predicate devices, i.e. device materials, dimensions, operating principle and system compatibility are unchanged during reprocessing. SureTek sleeves are provided as sterile, while the manufacturer product is provided non-sterile.

The SureTek Reprocessed Compression Sleeve is a medical device intended to increase venous return as a prophylaxis to Deep Vein Thrombosis (DVT) by applying intermittent pressure to the lower extremities. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a reprocessed compression sleeve, and as such, its performance criteria are primarily focused on demonstrating equivalence to new, unused devices and compliance with relevant reprocessing and sterility standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Bench Testing: The document states "maximum number of use and reprocessing cycles." A specific number of devices or cycles is not provided in the summary.
• Data Provenance: The studies described (bench testing, cleaning validation, packaging, sterility, and biocompatibility testing) are all prospective tests performed on the reprocessed devices themselves. The country of origin of the data is not specified, but it can be inferred that the testing was conducted to meet US regulatory requirements.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of device (a reprocessed compression sleeve) does not typically involve human expert interpretation for "ground truth" establishment in the same way an AI diagnostic algorithm would. The listed studies are technical validations against established standards. Therefore, information about the number or qualifications of "experts" to establish a diagnostic ground truth is not applicable or provided. The "truth" is determined by measurements against engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. The studies conducted are not based on expert adjudication of cases, but rather on direct measurements and validations against standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a reprocessed medical device, not an AI-assisted diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers improving with AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device (a reprocessed compression sleeve), not a standalone algorithm.

7. Type of Ground Truth Used

The ground truth used for proving acceptance was based on a combination of:

• Performance Standards: Comparisons to the performance characteristics of new, unused predicate devices.
• Validated Test Methods and Industry Standards: Compliance with international standards such as ISO 11607, EN868-1, ASTM F88-00, F2906-04, D4169-04a, F1980-02, ISO 11135, and ISO 10993.
• Worst-Case Scenario Validation: Specific validation of cleaning efficacy under "worst case operational conditions."

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI algorithm, there is no training set or associated ground truth establishment process in that context.

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Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.

Here's an analysis of the provided 510(k) summary regarding the Reprocessed Compression Sleeves, focusing on acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a tabular format. Instead, it makes a general statement about the testing performed and the conclusion reached.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states that "Bench and laboratory testing was conducted," but no sample sizes for these tests are provided.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. This type of device (reprocessed compression sleeves) typically relies on objective physical, chemical, and functional testing rather than expert interpretation of images or clinical data for ground truth establishment in this context.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As noted above, the assessment of this device type does not typically involve human expert adjudication in the way medical imaging software might. The performance testing would likely involve standardized measurements and observations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. This type of study is not relevant for this device. MRMC studies are typically used to assess the impact of AI on human reader performance, especially in diagnostic imaging.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done? Not applicable. This device is not an algorithm or AI system. Its performance is assessed through physical and functional testing of the reprocessed sleeves.

7. Type of Ground Truth Used

The ground truth for this device's performance would be established through a combination of:

• Objective Measurements: Physical dimensions, material integrity tests, pressure characteristics, flow rates, etc.
• Chemical Analysis: To confirm cleanliness and absence of contaminants after reprocessing.
• Microbiological Testing: To confirm effective decontamination/sterilization.
• Functional Testing: To ensure the sleeve inflates and deflates correctly, holds pressure, and delivers compression as designed, mimicking original device performance.
• Comparison to Predicate Device Specifications: The reprocessed device is intended to perform identically to the original, so the "ground truth" implicitly references the established performance characteristics of a new, predicate device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This product does not involve machine learning or AI, and therefore no "training set" in that sense. The manufacturing process itself could be seen as "trained" through process validation, but this term is not used in the context of device performance data for this product.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Established: Not applicable, as there is no "training set" for an AI algorithm. The methods used to validate the reprocessing procedure would involve standard engineering and quality control practices to ensure consistent and safe reprocessing outcomes.

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Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.

The medical device in question is Reprocessed Compression Sleeves by Alliance Medical Corporation. The provided document is a 510(k) summary, which indicates that the device has undergone a substantial equivalence review by the FDA. This specific document primarily focuses on establishing equivalence to predicate devices and describes general performance testing, not a detailed clinical study with specific acceptance criteria and performance metrics for the reprocessed sleeves that would be typical for an AI/ML device.

Therefore, the requested information, which is highly tailored to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), cannot be fully extracted or accurately inferred from the provided 510(k) summary.

Here's an analysis based on what can be extracted and why other parts cannot be:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document states that "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." The criteria are implicitly tied to the performance of the predicate devices. However, no specific quantitative or qualitative acceptance criteria (e.g., pressure output within X% of original, no leakage above Y, durability for Z cycles) are explicitly listed in this summary.
• Reported Device Performance:
  • Bench and laboratory testing: Conducted to demonstrate "performance (safety and effectiveness)."
  • Biocompatibility: No specific results or metrics are given, only that it was tested.
  • Function Test(s): No specific results or metrics are given, only that it was tested.
  • Validation of Processing: This implies that the reprocessing steps (cleaning, decontamination, individual sleeve testing) were validated, but no specific data or metrics are provided.
  • Overall Conclusion: "Reprocessed Compression Sleeves perform as originally intended."

Without specific numerical or descriptive criteria, a table like the one requested cannot be constructed meaningfully. The document indicates that the reprocessed sleeves perform identically to the predicate devices in terms of "standard mechanical design, materials and sizes," and there are "no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." This implies the performance criteria are simply "meets the original specifications of the new device."

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "individual compression sleeve is tested," but does not provide the number of sleeves tested.
• Data Provenance: Not applicable in the context of the provided information, as this refers to a reprocessed physical device, not an AI/ML algorithm's data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a reprocessed physical medical device, not an AI/ML diagnostic or assistive tool where human expert ground truth would be established for image or data interpretation. The "ground truth" for this device would be its physical and functional specifications.

4. Adjudication method for the test set:

• Not applicable. This refers to how discrepancies in expert opinions are resolved, which is relevant for AI/ML diagnostic studies, not for the functional testing of a physical device.

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 type of study is specifically for AI/ML systems that assist human readers (e.g., radiologists interpreting images). The Reprocessed Compression Sleeves are physical items.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This refers to the performance of an AI/ML algorithm without human intervention. The device is a physical compression sleeve.

7. The type of ground truth used:

• For this physical device, the "ground truth" would be the original specifications and performance characteristics of new, unadulterated compression sleeves (the predicate devices). Each reprocessed sleeve is tested against these established functional parameters.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

In summary of what can be inferred for the Reprocessed Compression Sleeves:

The study proving the device meets its acceptance criteria involves bench and laboratory testing to demonstrate biocompatibility, function, and validation of processing. The inherent acceptance criterion is that the reprocessed sleeves perform identically to the new, predicate compression sleeves in all relevant aspects (design, materials, sizes, intended use, clinical applications, performance specifications, method of operation). The 510(k) summary indicates that these tests were sufficient to conclude "substantial equivalence." However, it does not provide the granular detail requested for AI/ML device studies.

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Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.

The provided text is a 510(k) summary for Reprocessed Compression Sleeves. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria, detailed study designs, or expert qualifications for ground truth establishment.

Here's a breakdown of the available information and where details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Device Performance: The document states, "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." It also mentions, "Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and EO exposure operations." However, specific numerical targets or detailed metrics for "appropriate function" are not provided.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set in the performance studies (biocompatibility, function tests, validation of processing). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature). The studies appear to be bench and laboratory tests, implying they were conducted in a controlled environment rather than involving patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" here would likely be defined by engineering specifications and objective measurements of device function and material properties.

4. Adjudication Method for the Test Set

This information is not applicable and not provided as the tests are not observational studies requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the performance of the reprocessed sleeves itself and its substantial equivalence to the predicate, not on human-in-the-loop performance or the effect of AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are standalone performance tests of the device itself (biocompatibility, function, and processing validation). There is no "algorithm" in the context of this device; it is a physical medical device. The "standalone" performance refers to the device's inherent functional and material characteristics without human intervention during the test aside from operating the test equipment.

7. The Type of Ground Truth Used

For the performance studies (biocompatibility, function tests, validation of processing), the ground truth would be established based on:

• Engineering Specifications/Standards: Performance metrics likely compared against established design specifications for new compression sleeves and relevant industry standards.
• Material Science Properties: For biocompatibility, adherence to material safety standards.
• Functional Parameters: Objective measurements of pressure, inflation/deflation cycles, integrity of components, etc., compared against the predicate device's known performance or design criteria.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical medical device, not an AI/machine learning algorithm, so there is no "training set" in the computational sense. The studies focused on verifying the reprocessing methods and the resulting device's performance.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

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The Jack Speer and Associates, Inc. Huntleigh Reprocessed Compression Sleeve is recommended for use in patients for whom external compression the Huntleigh Flowtron® System is indicated for the prevention of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombus formation. Intraoperative compression therapy is frequently indicated, sometimes adjunctively with medical measures, during orthopedic, trauma, urologic and general surgery, particularly in patients over the age of 40.

Huntleigh's compression sleeve device (CSD) is an SUD component of Huntleigh's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin with a bladder that is attached to a pneumatic compression device called a controller and it is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf (see diagrams in appendix 6). The sleeves are constructed with cells running the length of the patient's thigh or calf that are sequentially inflated and deflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.

The description of JSA's Reprocessed Compression Sleeves is substantially equivalent to the above described Huntleigh CSD. The primary descriptive difference between the two products is that JSA's Reprocessed Compression Sleeves have been reprocessed as several times and are labeled pasteurized and Huntleigh's CSD is a non-sterile product that has not been reprocessed.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for JSA's Reprocessed Compression Sleeve Devices. However, the document is a 510(k) summary for a reprocessed medical device seeking substantial equivalence, not an AI software device. Therefore, many of the requested fields related to AI/ML device studies (e.g., sample size for test set/training set, number of experts for ground truth, MRMC study, standalone performance, data provenance) are not directly applicable or available in this type of document.

Below is an attempt to map the available information to the requested format, with notes indicating when information is not present or not applicable due to the nature of the device and submission.

Acceptance Criteria and Device Performance for JSA's Reprocessed Compression Sleeve Devices

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• The primary "acceptance criteria" here are demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness, despite reprocessing.
• The performance metrics focus on maintaining the physical and functional integrity of the sleeve after reprocessing, along with ensuring user safety (biocompatibility, cleaning, disinfection).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "test results" and "studies" for functional, disinfection, biocompatibility, and cleaning tests, but the number of devices or components tested is not provided.
• Data Provenance: Not explicitly stated. The studies were conducted by JSA to support their 510(k) application for reprocessed devices. Given the context of a medical device company submitting for regulatory approval, the tests would be performed under controlled laboratory conditions rather than patient data collection. Therefore, data provenance in terms of "country of origin of data" or "retrospective/prospective" clinical data is not applicable in the same way as for AI software.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This concept is not applicable to this type of device submission. "Ground truth" established by experts is relevant for diagnostic AI/ML devices where the AI's output is compared against expert interpretations (e.g., radiologists reading images). This submission pertains to the physical and functional characteristics, and safety of a reprocessed medical device. The "truth" is established through engineering and biological testing against defined standards or the predicate device's performance.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human experts in establishing ground truth for diagnostic decisions, not for evaluating the physical properties or disinfection efficacy of a reprocessed medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a submission for a non-AI medical device (reprocessed compression sleeve). MRMC studies are designed to assess the impact of AI on human reader performance in diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a submission for a non-AI medical device. There is no algorithm to evaluate in standalone mode.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily established through physical, functional, mechanical, and biological (biocompatibility, disinfection, cleaning) test results compared against:
  • Pre-defined engineering specifications.
  • Performance characteristics of the predicate (new, unreprocessed) device.
  • Established standards for biocompatibility and disinfection.
• It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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The Wheaton Franciscan Huntleigh Reprocessed Compression Sleeve is recommended for use in whom The Wheath Flanciscan Trancisco Compression Compresses of the prevention of deep vein external compression theraly using the riaming. I to the presence of risk factors for thrombus formation. Intrathromoosis and resuming pumitonaly indicated, sometimes adjunctively with medical measures, during operative compression therepy d general surgery, particularly in patients over the age of 40.

Huntleigh's compression sleeve device (CSD) is an SUD component of Huntleigh's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin with a bladder that is attached to a pneumatic compression device called a controller and it is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf (see diagrams in appendix 6). The sleeves are constructed with cells running the length of the patient's thigh or calf that are sequentially inflated and deflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.

Because the Huntleigh CSD is placed on the patient's intact skin., it falls under the Spaulding non-critical device classification. The CSD procedure is considered a safe, non invasive, less expensive and simple alternative to anti-coagulant drug therapy and it is one of the least expensive, yet most effective non invasive systems available for the prevention of venous thrombosis.

The description of WFSI's Reprocessed Compression Sleeves is substantially equivalent to the above described Huntleigh CSD. The primary descriptive difference between the two products is that WFSI's Reprocessed Compression Sleeves have been reprocessed as several times and are labeled pasteurized and Huntleigh's CSD is a non-sterile product that has not been reprocessed.

The provided text describes the reprocessing and re-marketing of compression sleeve devices (CSDs) by WFSI, asserting their substantial equivalence to Huntleigh's predicate CSDs. This is a medical device submission, primarily focused on regulatory approval rather than a traditional research study with specific acceptance criteria and performance metrics in the way a diagnostic algorithm or new drug might be evaluated.

Here's a breakdown of the requested information based on the provided text, recognizing that some points may not be directly applicable due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "sample size" for a test set in the way a clinical trial or algorithm validation would. Instead, it refers to:

• "Functional Testing": Implies a set of reprocessed CSDs were tested. The number of CSDs or repetitions of the reprocessing cycles isn't specified. It mentions they "can be reprocessed several times."
• "Intermediate Disinfection": Tests were performed on reprocessed CSDs.
• "Biocompatibility/Toxicological Characteristics": Tests were performed on reprocessed CSDs.
• "Cleaning Efficacy": Refers to the cleaning efficacy of the "washer," implying tests were done on CSDs after reprocessing.

The data provenance is internal to WFSI, generated during their reprocessing and testing procedures. It is prospective in the sense that they performed these tests specifically to support this 510(k) submission, rather than analyzing existing data. The country of origin is not explicitly stated but assumed to be the USA, given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" here is established through engineering and laboratory testing against established physical, chemical, and biological standards and comparison to the predicate device's characteristics. There's no subjective interpretation by human experts (like radiologists or pathologists) to establish ground truth for performance metrics in this context.

4. Adjudication Method for the Test Set

This is not applicable as there is no subjective assessment or multiple expert opinions requiring adjudication for the type of testing performed (e.g., burst strength, disinfection efficacy, cytotoxicity).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human performance, often with or without AI assistance, in interpreting medical images or making diagnostic decisions. The WFSI submission is for a physical medical device (compression sleeves) and its reprocessing, requiring engineering and laboratory validation, not human interpretation studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. This submission is about a reprocessed physical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the WFSI Reprocessed CSDs is based on:

• Physical performance standards: E.g., pressure deflation, bladder leakage, burst strength, seal strength, elongation (compared to new predicate device and manufacturing specifications).
• Chemical/Biological performance standards: E.g., intermediate disinfection efficacy (meeting defined reduction targets for microorganisms), cleaning efficacy (meeting defined residuals targets), and biocompatibility/toxicological characteristics (meeting ISO standards or equivalent for medical devices).
• Comparison to the predicate device: The fundamental "ground truth" for substantial equivalence is demonstrating that the reprocessed device performs comparably to the original, legally marketed predicate device (Huntleigh K881632 Compression Sleeve).

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of an AI or algorithm as this submission is for a physical medical device. Manufacturing and reprocessing processes are typically validated through process validation, which involves testing a certain number of units or batches, but this isn't analogous to an AI training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" in this context.

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These devices are designed to increase blood flow in the non-ambulatory patient in order to prevent deep vein thromboses or pulmonary embolism.

The description of JSA's Reprocessed Compression Sleeves is substantially equivalent to the above described Kendall CSD. The primary descriptive difference between the two products is that JSA's Reprocessed Compression Sleeves have been reprocessed as many as eleven (11) times and are labeled pasteurized and Kendall product is a non-sterile product that has not been reprocessed. The studies summarized in section 9.0 Safety and Efficacy and the comparison tables in section 5 demonstrate that JSA's Reprocessed Compression Sleeves are substantially equivalent in physical, performance and safety characteristics to Kendall's CSDs.

Kendall's compression sleeve device (CSD) is an SUD and it is a component of Kendall's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin attached to a pneumatic compression device called a controller that is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf. The sleeves are constructed with a series of cells running the length of the patient's thigh or calf that are sequentially inflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.

Here's a breakdown of the acceptance criteria and study information for the JSA's Reprocessed Compression Sleeve Devices, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • The document mentions "samples reprocessed" for seal strength testing and "test results" for other criteria. However, specific sample sizes for each test set are not explicitly provided in the given text.
   • The data provenance (e.g., country of origin, retrospective/prospective) is not specified. The studies were likely conducted by JSA as part of their 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. The studies described are engineering and biological validations of reprocessing effectiveness and material performance, not diagnostic assessments requiring human expert ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This concept pertains to consensus-based ground truth establishment, which is not relevant to the type of testing performed for this device.

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:

   • Not applicable. This study is not for an AI device or a diagnostic device where human reader performance would be a factor.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a medical accessory, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For this device, the "ground truth" for the tests was based on established engineering standards, material science properties, biological safety standards (biocompatibility, toxicology), and disinfection efficacy protocols. For example, seal strength "ground truth" would be the expected functional performance, and cleaning efficacy "ground truth" would be a defined end-point of cleanliness. The comparison was primarily against the predicate device's performance characteristics.

7. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm requiring a training set. The studies focus on validation of the reprocessing procedure and device characteristics.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set was used.

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UUHC's reprocessing methods do not change the intended use of the compression sfeeve devices (CSDs) from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices. Both UUHC's reprocessed device and Kendall's predicate CSDs are intended to be placed on the intact skin of the patient's limb and to be periodically inflated for preventing pooling of blood in the patient's limb.

The description of UUHC's Reprocessed Compression Sleeves is substantially equivalent to the above described Kendall CSD. The primary descriptive difference between the two products is that UUHC's Reprocessed Compression Sleeves have been reprocessed as many as eleven (11) times and are labeled pasteurized and Kendall product is a nonsterile product that has not been reprocessed. The studies summarized in section 9,0 Safety and Efficacy and the comparison tables in section 5 demonstrate that UUHC's Reprocessed Compression Sleeves are substantially equivalent in physical, performance and safety characteristics to Kendall's CSDs.

Kendall's compression sleeve device (CSD) is an SUD and it is a component of Kendall's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin attached to a pneumatic compression device called a controller that is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf. The sleeves are constructed with a series of cells running the length of the patient's thigh or calf that are sequentially inflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.

The provided 510(k) summary for UUHC's Reprocessed Compression Sleeve Devices describes a submission for substantial equivalence to legally marketed predicate devices (Kendall K94664 and K890938 Compression Sleeve Predicate Devices). This type of submission focuses on demonstrating that the reprocessed device is as safe and effective as the predicate, rather than establishing de novo performance criteria against a disease state or clinical outcome.

Therefore, the "acceptance criteria" here are essentially showing that the reprocessed device does not perform worse than the predicate device across several key attributes. The "study" refers to the testing performed to demonstrate this equivalence.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document states that the devices can be reprocessed "as many as eleven (11) times" and that "the CSDs can be reprocessed several times". It also mentions "the seal strength of the samples reprocessed." However, specific sample sizes for each test (functional, disinfection, seal strength, biocompatibility, cleaning efficacy) are not provided in this summary. The provenance of the data is from UUHC's internal testing as part of their 510(k) submission. This is a prospective set of tests conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This submission is not clinical in nature in the sense of diagnosing a disease, but rather demonstrating the safety and effectiveness of a reprocessed medical device through bench testing. Therefore, there is no concept of "ground truth" derived from expert consensus like in an imaging study. The "ground truth" for each test is the objective measurement against established standards or the performance of the predicate device. The experts involved would be the engineers, microbiologists, and other technical specialists who conducted the tests and interpreted the results according to validated protocols. Their qualifications are not specified in the summary but would be relevant to the specific testing performed (e.g., a microbiologist for disinfection testing, material scientist for seal strength).

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings or diagnoses.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) submission for a reprocessed physical medical device (compression sleeve), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the various tests was based on:

• Objective measurements and engineering specifications: For functional performance, seal strength, and cleaning efficacy, tests would have compared physical properties and cleanliness against predefined acceptable ranges or against the performance of new predicate devices.
• Microbiological standards: For intermediate disinfection, the "ground truth" would be the demonstrated reduction in microbial load to meet specific disinfection levels.
• Biocompatibility standards: For biocompatibility, the "ground truth" would be passing assays and tests against established ISO standards (e.g., ISO 10993).
• Intended Use of Predicate Devices: For intended use, the "ground truth" is the established indications for use of the original, legally marketed predicate devices.

Essentially, the ground truth is the performance of the predicate device and relevant industry/regulatory standards for medical device safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not a machine learning model; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set.

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