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The 2004-0C and 2008-0C Massage Systems are powered inflatable tube massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The devices are intended for home use by people who are in good health.

The device consists of an air compressor with manually adjustable pressure settings (i.e., the user manually adjusts the pressure, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing four (2004-OC) or eight (2008-OC) discrete, segmented inflatable chambers externally applied to the limb. The pump consists of a compressor capable of a maximum pressure of 150 mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). An in-line check valve limits the output pressure to 80 mmHg, and a calibrated dial gauge displays pressure in the range of 0-125 mmHq. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressures within the distal chambers have a default value set at the factory (60 mmHg distal), and can be adjusted by the user to distal pressures between 30 mmHg and 80 mmHg. Pressures decrease by 5 mmHg in each proximally sequential chamber. Garments are available in sizes to accommodate varying limb lengths. An adapter is available to support bilateral treatment.

The provided text describes a 510(k) submission for the 2004-OC and 2008-OC Massage Systems. It details the device, its intended use, and a comparison to a predicate device, but it does not include a formal study demonstrating the device meets specific quantitative acceptance criteria.

Instead, the document states: "Before being released, every device is tested and must meet all performance specifications. In addition to aesthetic acceptance criteria, functional testing includes electrical leakage, inflation pressure in each segment, pressure adjustment, pressure gradient across the segments, air pressure gauge accuracy, and inflation/deflation cycle times."

This implies that internal quality control and performance verification are conducted for each device, but a structured clinical or performance study with defined acceptance criteria and statistical analysis, as typically required for demonstrating efficacy or substantial equivalence in certain medical devices, is not explicitly provided or referenced in the summary.

Therefore, many of the requested sections (2-9) cannot be filled with the provided information.

Here's a breakdown of what can be extracted based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document speaks to "every device is tested" for internal performance specifications before release, suggesting a 100% inspection or quality control process. It does not describe a distinct "test set" for a larger, formal validation study. Therefore, no information on sample size or data provenance (country of origin, retrospective/prospective) related to a specific validation study is available.

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

Not applicable. No formal ground truth establishment by external experts for a test set is described.

4. Adjudication method for the test set

Not applicable. No formal adjudication method for a test set is described.

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 massage system, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithmic device in the context of standalone performance evaluation for diagnostic or assistive tasks.

7. The type of ground truth used

For the internal performance specifications, the "ground truth" would be the engineering design specifications and calibrated measurement tools for parameters like pressure, cycle times, and electrical safety. It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic device study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. (See #8)

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