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Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)

This submission is being made for a sterile version of the sleeve used for the Jobst Athrombic Pump System 2500. This product is a Class II device and is classified as a compressible limb sleeve under 21 CFR 870.5800. The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs. Both sleeves are made of PVC and are sterilized with ethvlene oxide.

The provided text is related to a 510(k) submission for a sterile version of a limb sleeve used with the Jobst Athrombic Pump System 2500. This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, a 510(k) submission, especially for this type of device, does not typically involve a "study that proves the device meets acceptance criteria" in the way one might expect for a novel diagnostic AI algorithm. The goal of a 510(k) for a device like this is to show it is substantially equivalent to a predicate device, not necessarily to independently prove its efficacy through a clinical trial with specific performance metrics and corresponding acceptance criteria.

The 510(k) summary provided states:

• "The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use."
• "Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs."
• "The Jobst Athrombic Pump System 2500 with the non-sterile sleeves has been on the market since 1994 and has proven to be safe and effective in that time. The sterile version is being offered for situations where sterile product is preferred."

Given this context, the request for "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format typically applied to AI performance metrics (like sensitivity, specificity, accuracy) is not directly applicable to this document. The "proof" here is the argument for substantial equivalence, primarily based on the predicate device's established safety and effectiveness, and the material/operational similarity of the new sterile sleeve.

Therefore, many of the requested fields about AI-specific study details (sample size for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth types) cannot be filled from this document because it describes a different type of regulatory submission and device evaluation.

However, I can extract information related to the device and its intended use, framed within the context of substantial equivalence.

Acceptance Criteria and Device Performance (as inferred from the 510(k) process for this device type):

• Both sleeves are made of PVC.
• Sterilized with ethylene oxide. |
  | 3. Safety and Effectiveness Equivalence: Device must be as safe and effective as the predicate device. | - The non-sterile version has "proven to be safe and effective" since 1994.
• The sterile version is technologically equivalent, implying similar safety and effectiveness. |
  | 4. Performance (Mechanism of Action) Equivalence: Device achieves its therapeutic effect in a similar manner to the predicate. | "Accomplished by intermittent compression of the muscles in the lower limbs." (Identical to predicate) |
  | 5. Sterility: The sterile version must achieve and maintain sterility. | "Sterilized with ethylene oxide." (Implicitly meets sterility requirements for a sterile product, though specific validation data is not in the summary). |

Study Details (Not applicable in the context of an AI study, but addressing what is relevant to the K970922 submission):

This 510(k) submission for a sterile limb sleeve is for a Class II medical device (a physical device, not an AI algorithm). The "study" isn't a traditional clinical trial with a test set and ground truth in the AI sense, but rather a demonstration of substantial equivalence.

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

   • N/A. This is not an AI algorithm and such a "test set" as typically defined for AI performance evaluation was not used. The submission relies on establishing substantial equivalence to a predicate device. The predicate device's long-standing market presence (since 1994 for the non-sterile version) serves as a form of "proven safety and effectiveness."

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):

   • N/A. Ground truth in the context of expert consensus for AI performance is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (Kendall Healthcare Product's sterile sleeve/SCD compression system) and the existing non-sterile version of the Jobst Athrombic Pump System 2500.

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

   • N/A. Not applicable for this type of device and submission.

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:

   • N/A. This is a physical medical device, not an AI system.

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

   • N/A. This is a physical medical device.

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

   • The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device and the existing non-sterile version of the device based on its market history and regulatory clearance. This effectively functions as "outcomes data" over time, demonstrating its intended therapeutic effect and safety profile.

7. The sample size for the training set:

   • N/A. This is not an AI algorithm.

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

   • N/A. This is not an AI algorithm.

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