(168 days)
The B&J Manufacturing Ltd. MHH800 and MHH800SQ Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
The Deep Vein Thrombosis (DVT) Pumps MHH800 and MHH800SQ are external pneumatic compression (EPC) devices that aid in the prevention of DVT from a potentially life threatening condition which can lead to pulmonary embolism. MHH800 and MHH800SQ are non-invasive mechanical prophylactic devices. The devices function as secondary pumps to propel venous blood for patients whose deep veins thrombosis must be prevented after surgeries in Orthopaedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.
Model variations are distinguished by characters. MHH800 is without SQ, so the device means an intermittent pneumatic compression pump. MHH800SQ is with SQ, so the device means a sequential pneumatic compression pump.
The two devices separately consist of an air pump and a soft pliable compression garment(s) for the foot, calf or thigh. For MHH800, the controller supplies compression on a preset timing cycle (12 seconds inflation and maintenance followed by 48 seconds of deflation) at a suggested pressure setting of 40 mmHg for the Leg and 120mmHg for the Foot. For MHH800SQ, the controller supplies compression on a preset timing cycle (12 seconds inflation followed by 48 seconds of deflation) at a suggested pressure setting, 45mmHg in the 1st chamber, 40 mmHg in the 2nd chamber and 30mmHg in the 3rd chamber for the Leg and 120mmHg for the Foot. The pressure in the garments is transferred to the extremity, augmenting venous blood flow when the leg is compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clot formation.
The DVT pumps produce automatically timed cycles of compressed air. This compressed air forces blood out of the deep veins, helping to prevent slowed or stopped blood flow. Bursts of air are delivered to the specially designed garments wrapped around extremities. This air helps to move blood out of the deep veins and reduce the risk of developing DVT. Garments are lined with tricot fabric to help reduce heat and perspiration.
The provided text describes the 510(k) premarket notification for the B&J DVT Compression Devices MHH800/MHH800SQ. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical efficacy studies with specific acceptance criteria for AI performance. As such, the information typically requested in questions related to AI-driven medical devices (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance with effect sizes) are not relevant to this submission.
However, based on the non-clinical testing section, we can infer some general "acceptance criteria" related to the device's functional and safety performance, and the "study" that proves these criteria were met is the non-clinical testing itself.
Here's a breakdown of the requested information, adapted to the context of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from tests) | Reported Device Performance (Implied "Meets Requirements") |
|---|---|---|
| Pressure Accuracy | Within specified tolerances (e.g., +10/-5mmHg) for Calf/Thigh and Foot garments. | "All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria..." |
| Cycle Time | Within specified tolerances (e.g., Inflation 12 seconds +/- 10%, Deflation 48 seconds +/- 10%). | "All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria..." |
| Bladder Burst | Withstand pressure without bursting. | "All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria..." |
| Biocompatibility | Device materials are safe for patient contact. | "All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria..." |
| Software Validation | Software functions as intended and safely. | "All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria..." |
| Electromagnetic Compatibility (EMC) & Electrical Safety | Meets relevant safety standards (e.g., Class I Type BF, not AP or AGP type). | "All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria..." |
| Reliability | Consistent operation over time and repeated use (especially for reusable models). | "All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria..." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. For non-clinical, bench testing, this would typically refer to the number of units or components tested. This information is not provided in the summary.
- Data Provenance: Not specified. This is non-clinical testing, likely performed in a lab setting, possibly at the manufacturer's facility in China, or at a contracted testing lab. The data would be prospective as the tests are conducted specifically for the submission.
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. This device is a DVT compression pump, a hardware device, not an AI or imaging diagnostic tool. "Ground truth" in the context of expert review for medical image analysis is not relevant here. The ground truth for performance tests is established by calibrated measuring equipment and established test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly for AI evaluations. This is a non-clinical, bench testing scenario.
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. An MRMC study is not applicable to this device. This device is a physical therapy device and does not involve human "readers" or AI assistance in the interpretation of medical data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only device. Its performance is evaluated through direct physical measurements (pressure, cycle time) and material/electrical safety tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests would be established by:
- Calibrated Measurement Standards: For pressure accuracy, cycle time, etc., the "truth" is determined by measurements against known, calibrated equipment.
- Industry Standards & Regulations: For biocompatibility, EMC, and electrical safety, the "truth" is adherence to established national and international standards (e.g., ISO, IEC).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See #8)
In summary, the provided document is a 510(k) premarket notification for a Class II medical device, a DVT compression pump. The "acceptance criteria" and "study" proving they are met refer to a series of non-clinical, bench-top performance and safety tests conducted on the device, rather than clinical trials or AI performance evaluations commonly associated with the detailed questions on ground truth, expert review, and training/test sets. The conclusion states that these tests demonstrate the device meets predefined acceptance criteria and is substantially equivalent to a predicate device.
§ 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).