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SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:

• · Aid in the prevention of DVT;
• · Enhance blood circulation:
• · Diminish post-operative pain and swelling;
• · Reduce wound healing time;
  • Aid in the treatment and healing of: stasis dernatits, 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.

SyneCare 1100 Deep Vein Thrombosis Prevention Thereinafter as SyneCare 1100) is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies, in which each sleeve has 2 compression chambers.
The device will alternatively inflate and deflate the sleeve to stimulate blood flow in the extremities (muscle contraction). The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle. There are three default modalities. Mode 1 is inflating chamber 1 up to the preset pressure and then deflating, and then inflating chamber 2 up to the preset pressure and then deflating, and repeat the above process with an interval of 40 seconds. Mode 2 is inflating chamber 1 up to the preset pressure and then inflating chamber 2 up to the preset pressure, then deflating at the same time. The above process is repeated with an interval of 40 seconds. The third mode is inflating chamber 1& 2 simultaneously to the preset pressure (50mmHg) and hold for 9 seconds, then deflating to the preset pressure (40mmHg) at the same time and hold for 10 seconds, and then deflating. The above process is repeated with an interval of 30 seconds.

This document is a 510(k) premarket notification for the SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System. The FDA has made a substantial equivalence determination based on non-clinical testing. No clinical study data is provided to prove how the device meets specific acceptance criteria related to its performance in preventing DVT or improving human reader effectiveness.

The document states: "No clinical study is included in this submission."
Therefore, I cannot provide details on the study that proves the device meets acceptance criteria related to clinical efficacy. The information available focuses on non-clinical testing for design specifications, electrical safety, biocompatibility, and software validation.

However, I can extract the acceptance criteria (in terms of non-clinical tests) and the results reported for those tests, and then address the other points based on the available information.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Summary of Non-Clinical Test" section (Page 9), the acceptance criteria are generally implied by the tests conducted to verify that the device design meets its intended function and performance requirements. The document does not provide quantifiable "acceptance criteria" values alongside "reported device performance" values for these specific non-clinical tests. Instead, it states that the tests were conducted and the device "met all design specifications" or that results "showed the material is non-toxic, non-sensitizing and non-irritating."

Regarding Clinical Studies and AI Performance:

The provided document explicitly states: "No clinical study is included in this submission." (Page 9)

Therefore, the following points cannot be answered based on the provided text, as they pertain to clinical studies, AI performance, or human reader studies, none of which were included in this 510(k) submission for the device. The device itself is an intermittent pneumatic compression system for DVT prevention, not an AI imaging or diagnostic device.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used/submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used/submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set was used/submitted.
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 not an AI-assisted diagnostic tool; it is a physical therapy system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study or test set with ground truth was used/submitted.
8. The sample size for the training set: Not applicable, as no clinical training set was used/submitted.
9. How the ground truth for the training set was established: Not applicable, as no clinical training set was used/submitted.

In summary, the FDA's acceptance of this device was based on a "substantial equivalence" determination to a legally marketed predicate device, supported by a comprehensive suite of non-clinical performance, biocompatibility, electrical safety, electromagnetic compatibility, and software verification/validation tests, rather than clinical efficacy studies.

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The Synecare 1000 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).

This 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 SyneCare 1000 deep vein thrombosis prevention therapy system (referred as SyneCare 1000 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies.

The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 60 seconds

The provided document describes the SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System and its substantial equivalence to a predicate device (VenaPro, K133274). The acceptance criteria and the study conducted are primarily focused on engineering performance, biocompatibility, electrical safety, and software verification rather than clinical effectiveness per se.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a non-AI medical device (Deep Vein Thrombosis Prevention Therapy System), the "acceptance criteria" are related to its engineering performance and safety, rather than diagnostic accuracy or clinical outcomes as might be seen for devices using AI or for drug approvals. The device's performance is demonstrated through various engineering tests to show substantial equivalence to the predicate device.

Summary of Device Performance: The device's performance is reported as meeting all tested functional and operational requirements, demonstrating substantial equivalence to the predicate device (VenaPro, K133274) across all comparable features. The differences (e.g., battery voltage) were specifically tested to ensure they do not negatively impact effectiveness.

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

The document specifies that "samples of the device underwent function and mechanical testing." However, the exact sample size (N) for these performance tests (e.g., how many devices were tested for pressure accuracy, battery life, etc.) is not explicitly stated in the provided text.

The data provenance is implicit: the tests were conducted by Jiangsu Synecoun Medical Technology Co., Ltd. and by CCIC Huatongwei International Inspection (Suzhou) Co.,Ltd. The device manufacturer is based in China. The data is retrospective in the sense that the tests were performed on finished product samples for the 510(k) submission.

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

This question is not applicable in the context of this device and submission. This device is a mechanical/pneumatic system, not an AI or diagnostic imaging device that requires expert interpretation to establish ground truth for a test set. The "ground truth" here is objective physical measurements and adherence to engineering standards.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., images) by multiple experts. For this device, the tests are primarily objective engineering measurements and compliance checks against established standards, which do not involve expert adjudication in that sense.

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

This question is not applicable. A Multi-Reader Multi-Case (MRMC) study is relevant for AI-powered diagnostic or screening devices that assist human readers (e.g., radiologists interpreting images). The SyneCare 1000 is a physical compression therapy system and does not involve human "readers" or AI assistance in diagnostic interpretation.

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

This question is not applicable. This device is a physical therapy system and does not have a "standalone algorithm" in the context of AI or diagnostic interpretation. Its performance is evaluated as an integrated system (pump and sleeve).

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

For the engineering and safety tests, the "ground truth" used is:

• Established engineering specifications and standards: For pressure accuracy, cycle time, alarm function, air tightness, electrical safety (IEC standards), and software validation.
• Defined biological response endpoints: For biocompatibility tests (cytotoxicity, sensitization, irritation).
• Defined performance over time: For shelf life/accelerated aging tests.

There is no expert consensus, pathology, or outcomes data used as "ground truth" in the manner typically seen for diagnostic devices, as this is a therapeutic device whose safety and performance are assessed through objective engineering and biocompatibility evaluations.

8. The sample size for the training set

This question is not applicable. Since the device is not an AI/machine learning system, there is no "training set" in the computational learning sense.

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

This question is not applicable as there is no training set for this device.

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