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The B&J DVT Calf/Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

The 801/830 series of DVT calf/thigh garments are compression devices. When the devices are attached to a pump system, they provide intermittent, sequentially gradient pressure to a patient calf/thigh for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf or thigh.

The provided document is a 510(k) Premarket Notification for a medical device (B&J DVT Calf/Thigh Garments, Models 801/830 Series). It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials as would be required for a PMA (Premarket Approval).

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the non-clinical tests performed to demonstrate that the new device performs at least as well as the predicate device regarding specific physical and functional characteristics.

Here's an analysis based on the provided text for the B&J DVT Calf/Thigh Garments:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "predefined acceptance criteria" but does not explicitly list them in a table format with corresponding performance metrics. Instead, it states that "All the test results demonstrate 801 series and 830 series garments meet the requirements of its predefined acceptance criteria and intended use."

The non-clinical tests conducted are listed as:

Note on Acceptance Criteria: The document implies that the acceptance criteria for these non-clinical tests were based on established standards for similar devices or performance equivalent to the predicate devices. Specific quantitative criteria (e.g., "bladder burst pressure > X mmHg", "leakage < Y ml/min", "Z cycles without failure") are not explicitly stated in this summary.

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

• Sample Size: The document does not specify the exact number of units/garments tested for each non-clinical test (biocompatibility, bladder burst, leak test, pressure cyclic test). It refers to "801 series and 830 series garments" generally.
• Data Provenance: The testing was conducted by B&J Manufacturing Ltd. (the manufacturer) in China. The data provenance is retrospective in the sense that the testing was completed prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of 510(k) clearance based on non-clinical testing for substantial equivalence. "Ground truth" for these engineering tests is established by calibrated instruments and predefined engineering specifications, not by expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers or experts are interpreting outcomes (e.g., medical images). Here, the tests are objective engineering measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not conducted. The document explicitly states: "No clinical testing was used to support the decision of substantial equivalence." MRMC studies are clinical in nature and involve human readers assessing diagnostic performance, which was not part of this 510(k) pathway.

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

This concept is not applicable to the device (DVT Calf/Thigh Garments). This device is a mechanical compression garment, not an algorithm or AI. Standalone performance refers to the performance of an AI algorithm without human involvement.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by:

• Engineering Specifications: e.g., the expected pressure range, acceptable leakage rates, and cycle life determined through design requirements and comparison to predicate devices.
• Material Standards: For biocompatibility, it's adherence to recognized standards for medical device materials.

This is distinct from "expert consensus," "pathology," or "outcomes data" which are typically used for establishing ground truth in clinical diagnostic or prognostic studies.

8. The Sample Size for the Training Set

This information is not applicable. The device is a mechanical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as above. There is no training set for a mechanical device.

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