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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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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.

Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

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.

Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and sterilization operations.

The provided text is for a 510(k) premarket notification for reprocessed compression sleeves. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, much of the typical information requested for AI/ML device studies (like sample sizes for test sets with ground truth, expert qualifications, adjudication methods, MRMC studies, and training set details) is not applicable in this context.

Here's an analysis based on the provided document:

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

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 filing is for a reprocessed medical device, where the focus is on maintaining the original device's performance through reprocessing steps. "Bench and laboratory testing" is mentioned, but specific sample sizes for these tests are not detailed. It's highly likely this was internal, retrospective testing, but the document does not specify.

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 applicable/not provided. For device reprocessing, the "ground truth" is typically the performance specifications of the original device. The testing conducted (biocompatibility, sterilization, function) are objective engineering and laboratory tests, not subjective expert assessments.

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

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments (e.g., image interpretation by multiple readers) to establish a consensus ground truth. The tests for reprocessed sleeves are objective performance measurements.

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. This is not an AI/ML device, and no MRMC study was conducted or required for this type of submission.

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

This information is not applicable. This is not an AI/ML device.

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

The "ground truth" for the reprocessed compression sleeves is based on:

• Original Device Specifications: The reprocessed devices are compared against the performance of the legally marketed predicate devices, ensuring "identical" design, materials, intended use, and mechanism of action. The implicitly accepted "ground truth" is that the original, new device performed safely and effectively.
• Objective Performance Metrics: For the specific tests mentioned (biocompatibility, sterilization validation, function tests), the ground truth would be established by validated test methods and predefined quantitative specifications inherent to those tests (e.g., sterility assurance levels, material integrity, pressure output ranges).

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI/ML device, so there is no "training set."

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

This information is not applicable/not provided. As there is no training set for an AI/ML model, this question is irrelevant to this device.

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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.

Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

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 describes the 510(k) summary for "Reprocessed Compression Sleeves" by Alliance Medical Corporation. This submission focuses on demonstrating substantial equivalence to a predicate device rather than a new AI-powered diagnostic device. Therefore, many of the requested categories for AI-specific studies (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, and training set details) are not applicable or not detailed in this document.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to meet them for this reprocessed medical device.

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 "Bench and laboratory testing was conducted." It does not specify the sample sizes used for these tests.
• Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), as the testing appears to be internal laboratory and bench testing of the reprocessed sleeves themselves.

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

• Not applicable as this is not a diagnostic device relying on expert-established ground truth from patient data. The ground truth for performance tests (like function, sterility) would be established by validated test methods and specifications.

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

• Not applicable. This is not a study requiring expert adjudication of patient cases.

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

• Not applicable. This is not an AI-powered device or a study involving human readers.

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

• Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the reprocessed sleeve's ability to meet its functional and safety specifications. The document states that "Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and sterilization operations."

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

• The "ground truth" for this device's performance is based on established specifications and validated test methods for biocompatibility, sterilization, functionality, and packaging integrity. For example, for "Function Test(s)", the ground truth would be that the sleeve performs according to its original design specifications (e.g., pressure output, inflation/deflation cycles).

8. The sample size for the training set:

• Not applicable. This is not an AI device trained on data.

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

• Not applicable. This is not an AI device.

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These devices are reprocessed compression sleeves from various original equipment manufacturers (OEM.) Compression sleeves are designed to provide external intermittent or sequential limb compression to artificially imitate the pumping action of the lower limbs to: prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.

Reprocessed Compression Sleeves are inflatable devices that are fitted to a patient's foot and/or leg. They are connected to a separate pneumatic compressor, which provides intermittent, graduated pressure. When the sleeve compresses, the veins collapse, forcing blood to flow. When pressure is reduced, the sleeve deflates, allowing the veins to fill with blood. The cycle is then repeated. It should be noted that this submission applies to the compression sleeve only. It does not include any other components in a compression system such as the pneumatic compressor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SterilMed Reprocessed Compression Sleeves:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria in a dedicated section. Instead, the performance is demonstrated through a claim of "substantial equivalence" to predicate devices. The functional and safety testing described aims to show that the reprocessed devices perform as well as or similarly to the original, new devices.

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

• Sample Size for Test Set: The document states "Representative samples" were used for bench testing and process validation. However, no specific number or size of the test set is provided.
• Data Provenance: The data is generated internally by SterilMed, Inc. during their "bench testing" and "process validation testing." The document does not specify country of origin for the data (beyond SterilMed's location in Minneapolis, MN) nor explicitly state if it's retrospective or prospective. Given it's for a 510(k) submission, it's almost certainly prospective testing conducted specifically for this submission.

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. The testing described (bench testing, process validation, visual inspection, functional testing) does not typically involve expert "ground truth" establishment in the same way clinical studies or diagnostic AI algorithms do. The "truth" here is based on engineering specifications and performance benchmarks against predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable to the type of testing described. Adjudication methods like 2+1 or 3+1 are used for human review of cases, typically in clinical studies, to establish a consensus ground truth for diagnostic decisions. The described testing is primarily engineering and process validation.

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, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers. The SterilMed Reprocessed Compression Sleeves are physical medical devices, not AI software, and therefore this type of study is not relevant or performed.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to the physical device itself.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is established through engineering specifications and performance characteristics of the predicate devices. The reprocessed devices are compared against these known, legally marketed, and established predicate devices (Kendall Company and Huntleigh Technology Inc. models). The claim of substantial equivalence is based on the reprocessed devices being "essentially identical to the predicate devices in terms of functional design, materials, indications for use, construction, and principles of operation."

8. The Sample Size for the Training Set:

Not applicable. This is a physical reprocessed medical device, not an AI/ML model that requires a training set.

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

Not applicable. As the device is not an AI/ML model, there is no training set or corresponding ground truth establishment process in this context.

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