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The B&I MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

The device can be used in the home or clinical settings to:

• Aid in the prevention of DVT;
• Enhance blood circulation;
• Diminish post-operative pain and swelling;
• Reduce wound healing time;
• Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;
• As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

The B&J MHP800 Deep Vein Thrombosis Prevention System is an intermittent pneumatic compression system that aids in the prevention of deep vein thrombosis a potentially life-threatening condition which can lead to pulmonary embolism. The DVT compression device is a non-invasive mechanical prophylactic system that helps decrease the incidence of deep vein thrombosis. The system consists of a pair of pump and sleeve assemblies.

The DVT pump will inflate each leq cuff to a preset pressure of 45mmhg for 12 seconds, and followed by 48 seconds of deflation period once the pressure is reached. This happens once every minute. The cycles are repeated on each unit until the power is turned off.

Internal rechargeable batteries allow the MHP800 to be completely portable to prevent interruptions in treatment.

This document is a 510(k) submission for the B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance data in a format suitable for the requested table.

The provided text does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance numbers, sample sizes, or ground truth establishment methods as typically found in clinical trials or performance assessments for AI/diagnostic devices.

However, I can extract information related to general performance validation and the types of tests conducted.

Here's a breakdown of what can be inferred and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

The document states: "All the test results demonstrate MHP800 DVD [DVT] compression device meet the requirements of its predefined acceptance criteria and intended use." (Page 8)
However, the specific numerical acceptance criteria were not explicitly defined, nor were the reported device performance values presented in a comparative table. The document lists categories of tests performed.

Missing: Specific numerical values for the acceptance criteria and the device's measured performance in these non-clinical tests.

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified. The document refers to "non-clinical testing" (Page 8) but does not detail the number of units or test cycles performed for each test.
• Data provenance: Not specified. These are non-clinical engineering/performance tests, not human data. The tests were presumably conducted by B&J Manufacturing Ltd. Given the company's address in Shenzhen, China (Page 3), the tests were likely performed there.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. These are non-clinical mechanical/electrical performance tests for a DVT compression device, not a diagnostic device requiring expert interpretation of results for ground truth.

4. Adjudication method for the test set:

• Not applicable. This is for non-clinical performance testing.

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:

• Not applicable. This device is a DVT prevention system, not an AI-powered diagnostic tool requiring human interpretation.

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

• Not applicable. This device is a DVT prevention system, a mechanical compression device, and does not have a standalone "algorithm-only" performance in the context of AI/diagnostic tools. The performance tests mentioned (pressure accuracy, cycle time, etc.) are inherent to its mechanical function.

7. The type of ground truth used:

• Not applicable in the typical sense of expert consensus or pathology for diagnostic devices. For the non-clinical tests listed (pressure accuracy, cycle time, bladder burst, leak), the "ground truth" would be the engineering specifications and established test methodologies (e.g., measuring pressure against a calibrated standard, timing cycles, applying defined force for burst tests).

8. The sample size for the training set:

• Not applicable. This is a physical medical device (DVT compression system), not an AI algorithm that requires a training set.

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

• Not applicable. (See #8)

Summary of what is present in the document regarding validation:

The document lists "Non-clinical Testing" performed to assess the MHP800 DVT compression device, including:

• Biocompatibility
• Software validation
• Electromagnetic compatibility and electrical safety
• Reliability
• Performance (System level software, Pressure accuracy, Cycle time, Bladder burst, Leak)

The claim is that "All the test results demonstrate MHP800 DVD compression device meet the requirements of its predefined acceptance criteria and intended use." (Page 8) However, the details of these "predefined acceptance criteria" and the "test results" (i.e., the specific performance numbers achieved) are not disclosed in this document. The purpose of this 510(k) summary is to assert substantial equivalence, not to provide a detailed study report.

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