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510(k) Data Aggregation
(107 days)
K770956B,K961405
Patients at risk for DVT. These include a. Major orthopedic procedures, e.g. knee surgery Major abdominal, thoracic surgery including urogenital surgery Neurosurgery, subarachnoid hemorrhage and stroke Bedridden Medical patients b. Patients with chronic venous insufficiency
Pulstar Logix Intermittent Pneumatic Compression System
This document is an FDA 510(k) clearance letter for the Pulstar Logix Intermittent Pneumatic Compression System. It does not contain information about a study proving the device meets acceptance criteria, an AI/ML component, or detailed performance data. Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for a study.
- Types of ground truth or training set details.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." This indicates the clearance is based on substantial equivalence to existing devices, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria for an AI/ML algorithm.
The "Indications for Use Statement" only lists the medical conditions for which the device is intended. It does not provide any performance data or study results.
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(87 days)
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:
| Acceptance Criteria (Performance Tests) | Reported Device Performance (Conclusion) |
|---|---|
| Biocompatibility | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices. |
| Sterilization Validation | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices. |
| Function Test(s) | Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and sterilization operations. Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices. |
| Packaging Validations | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices. |
| Overall Safety and Effectiveness | "Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices as described herein." |
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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