(101 days)
The B&J DVT Foot Garments, Models 820 Series are external pneumatic compression devices intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
The 820 series of DVT foot garments are compression devices. When the devices are attached to a pump system, they provide sequentially gradient pressure to a patient foot 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 foot.
820 series includes 820M, 820L, 820MSQ, 820LSQ. Model variations are distinguished by characters. 820 means foot. M means medium size; L means large size. No SQ means intermittent devices; SQ means sequential devices. For example, 820MSQ means the foot garment is with medium size, and used for a sequential pump.
The provided text is a 510(k) submission for a medical device (B&J DVT Foot Garments, Models 820 Series), which is a type of premarket notification to the FDA. It does not describe a study involving an AI/Machine Learning algorithm, human readers, or image analysis. Instead, it focuses on demonstrating the substantial equivalence of the DVT garments to previously cleared predicate devices through non-clinical performance and safety testing.
Therefore, many of the requested criteria for describing an acceptance study for an AI/ML device cannot be extracted from this document, such as:
- Table of acceptance criteria and reported device performance for an AI/ML device: The document discusses performance tests for the physical DVT garments (bladder burst, leak, pressure cyclic test), not AI/ML performance metrics like sensitivity, specificity, or AUC.
- Sample size for test set and data provenance (e.g., country of origin, retrospective/prospective): Not applicable for a physical device.
- Number of experts and their qualifications for ground truth: Not applicable for a physical device.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable, as there's no AI involved.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable. The "ground truth" here is physical performance specifications.
- Sample size for training set/How ground truth for training set was established: Not applicable, as this is not an AI/ML device.
However, I can extract the acceptance criteria and study information relevant to this specific medical device (DVT Garments), even though it doesn't pertain to an AI/ML system as your prompt implies:
Device Description and Purpose:
The B&J DVT Foot Garments, Models 820 Series, are external pneumatic compression devices. They are designed to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients at risk for thrombosis formation. When attached to a pump system, they provide sequentially gradient pressure to a patient's foot.
Study Type:
This is a non-clinical testing study to assess the safety and performance of the physical device and demonstrate substantial equivalence to predicate devices, not an AI/ML performance study.
1. Table of acceptance criteria and the reported device performance
The document states: "All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria and intended use."
However, the specific "predefined acceptance criteria" values are not explicitly detailed in the provided text for each test. We know the types of tests performed:
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicitly Met) |
|---|---|
| Biocompatibility: Device materials must be biocompatible. | "All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria..." |
| Bladder Burst: The bladder must withstand burst pressure. | "All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria..." |
| Leak Test: The device must not leak. | "All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria..." |
| Pressure Cyclic Test: The device must maintain pressure over cycles with a B&J pneumatic pump. | "All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria..." |
Note: The document only lists the types of tests performed and broadly states that the acceptance criteria were met. It does not provide the specific numerical acceptance thresholds (e.g., "bladder must withstand X mmHg," "leakage rate must be less than Y mL/min," "must withstand Z cycles").
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document refers to "the following safety and performance tests were conducted," implying a sample of prototypes or production units were tested, but exact numbers are not given.
- Data Provenance: Not explicitly stated, however, the DVT garments are manufactured by B&J Manufacturing Ltd. in Shenzhen, China. Tests would likely have been conducted in a validation or manufacturing setting. The data is non-clinical/engineering test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of an AI/ML device. This refers to engineering and material testing, where "ground truth" is established by manufacturing specifications, international standards, and test methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is for an AI/ML device where human readers adjudicate discrepancies. For physical device testing, results are typically objective measurements against predefined engineering specifications.
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:
- No. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML algorithm. The performance tests are on the physical device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Engineering Specifications and Standards: For physical devices like these DVT garments, the "ground truth" for performance is established through predefined engineering specifications, material properties, and relevant international or industry standards (e.g., for bursting strength, leak rates, cyclic fatigue). It's objective measurement against a benchmark.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
§ 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).