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used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremittles. This is accomplished by intermittent compression of the muscles in the calf and thigh.

upgrade of the Jobst Athrombic Pump System 2000 to the System 2100. It also covers the use of thigh length sleeves with the System 2100. This device is classified as a compressible limb sleeve under 21 CFR 870.5800.

This document is a 510(k) summary for a medical device called the "Jobst Athrombic Pump System 2100." It primarily focuses on demonstrating substantial equivalence to a previously cleared device (System 2000) and another marketed device (Flowtron DVT/thigh sleeve system).

Unfortunately, the provided text does not contain the detailed information necessary to answer most of your questions regarding acceptance criteria and a study proving device performance as you've outlined. This type of 510(k) summary typically focuses on substantial equivalence arguments rather than detailed performance studies with acceptance criteria, sample sizes, ground truth establishment, or expert involvement for AI-driven devices.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

• Cannot be provided. The document states that the System 2100 "is substantially equivalent" to existing devices and "has proven effective for several years." It does not provide specific acceptance criteria (e.g., minimum effectiveness rates, sensitivity/specificity targets) or report quantified device performance metrics against such criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe a new performance study with a test set. It relies on the established effectiveness of predicate devices.

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)

• Cannot be provided. No new test set or ground truth establishment is described.

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

• Cannot be provided. Not applicable as no new test set is described.

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

• Cannot be provided. This device is a mechanical pump system, not an AI-driven diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Cannot be provided. Not applicable; this is a mechanical device, not an algorithm.

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

• Cannot be provided directly. The document implies that the ground truth for the predicate devices' effectiveness for "preventing deep vein thrombosis and pulmonary embolism" would be clinical outcomes data (i.e., whether DVT/PE actually occurred). However, it doesn't specify how this was measured or established in detail for those predicate devices.

8. The sample size for the training set

• Cannot be provided. This is not an AI/machine learning device, so there is no "training set."

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

• Cannot be provided. Not applicable.

Summary of what the document does provide:

• Device Name: Jobst Athrombic Pump System 2100
• Device Classification: Compressible limb sleeve (21 CFR 870.5800)
• Indications for Use: To help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremities.
• Mode of Operation: Intermittent compression of the muscles in the calf and thigh.
• Predicate Devices:
  • Jobst Athrombic Pump System 2000 (for pump console)
  • Flowtron DVT/thigh sleeve system (for use with thigh length sleeves and overall system comparison)
• Argument for Equivalence: Minor modifications from System 2000, and similar operation/indications to Flowtron DVT/thigh sleeve system, both of which have "proven effective for several years."

For detailed performance data, acceptance criteria, and specific study designs, one would typically need to consult the full 510(k) submission, clinical study reports (if any were required beyond reliance on predicate device performance), or peer-reviewed publications associated with the device or its predicates. A 510(k) summary is designed to be a high-level overview.

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