(76 days)
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
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance (JSA's Reprocessed CSDs) | Predicate Device Performance (Huntleigh CSDs) | Equivalence Conclusion |
|---|---|---|---|---|
| Functional Testing | Pressure Deflation | No functional pressure deflation changes | N/A (implied no changes for new device) | Substantially Equivalent |
| Bladder Leakage | No bladder leakage changes | N/A (implied no changes for new device) | Substantially Equivalent | |
| Burst Strength | No burst strength characteristic changes | N/A (implied no changes for new device) | Substantially Equivalent | |
| Physical Characteristics | Seal Strength | Reduced after several reprocessing cycles | Higher (for new device) | Substantially Equivalent (despite reduction, still meets safety) |
| Elongation | Slightly greater | N/A (implied less for new device) | Substantially Equivalent (despite increase, still meets safety) | |
| Color | Slightly different color | N/A (implied original color) | Substantially Equivalent | |
| Intermediate Disinfection | Pasteurization Efficacy | Fully capable of and qualified for intermediate disinfection | Non-sterile | Technological Advantage (Reprocessed device is disinfected) |
| Biocompatibility/Toxicological | No new hazards | No new biocompatibility or toxicological hazard | N/A (implied safe for new device) | Substantially Equivalent |
| Cleaning Efficacy | Required cleaning endpoint | Capable of meeting required cleaning endpoint | N/A (not applicable, as predicate is new) | Substantially Equivalent |
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.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).