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The Air Pressure Therapy System is intended to temporarily relieve minor muscleaches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Air Pressure Therapy System."

This document does not contain any information about:

• Acceptance criteria
• Device performance results
• Details of a study (e.g., sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations. It also includes the "Indications for Use" statement for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The Air Pressure Therapy System is intended to temporarily relieve minor muscleaches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

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The provided document is an FDA 510(k) clearance letter for the "Air Pressure Therapy System (VU-IPC04B)". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on regulatory compliance, outlining general controls, additional controls for Class II devices, and various regulations such as the Quality System regulation, UDI Rule, and adverse event reporting.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This information would typically be found in the 510(k) submission itself or in a separate study report, which is not part of this FDA clearance letter.

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Air Pressure Therapy System (Model:VU-IPC4M) is intended for home to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Air Pressure Therapy System (Model:VU-IPC4M) consists of air pressure sensor, air pump, sleeves Etc. working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.

The provided document is an FDA 510(k) clearance letter for the Xiamen Weiyou Intelligent Technology Co., Ltd. Air Pressure Therapy System (Model: VU-IPC4M). This letter declares the device substantially equivalent to legally marketed predicate devices.

Crucially, this document is a regulatory clearance and not a detailed study report or clinical trial result. It does not contain information about the specific acceptance criteria for an AI/ML device's performance, nor does it present the results of a study designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.

The "Performance Testing - Clinical" and "Performance Testing - Animal" sections explicitly state "Not Applicable," indicating that the manufacturer did not submit clinical or animal study data to support this 510(k) submission. Therefore, it is impossible to extract the requested information (acceptance criteria, device performance, sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance) for an AI/ML component from this document.

The document focuses on non-clinical performance testing related to the physical device itself and its electrical safety, biocompatibility, and mechanical integrity, as summarized under "Performance Characteristic."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design elements (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth) as they are directly linked to performance evaluation against clinical or diagnostic endpoints, which are not detailed in this regulatory submission.

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Air Pressure Therapy System VU-IPC04B is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 6 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process. Cycle time and pressure can be adjusted by purpose to avoid any discomfort.

Air Pressure Therapy System intermittent pneumatic compression could be used in family for improving blood circulation in the treated area, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.

This document is a 510(k) premarket notification for a medical device called "Air Pressure Therapy System: VU-IPC04B". The FDA has determined the device is substantially equivalent to a legally marketed predicate device, "NormaTec Pulse and NormaTec Pulse Pro (K160608)".

Based on the provided text, the device in question is a Powered Inflatable Tube Massager (Product Code IRP), which falls under Class II medical devices.

Here's an analysis of the acceptance criteria and study proving the device meets them, according to the document:

1. A table of acceptance criteria and the reported device performance:

The document directly states: "Performance testing - clinical: Not Applicable." and "Performance testing - animal: Not Applicable." This indicates that for this specific type of device and its indications for use, no clinical or animal performance studies were required by the FDA or provided by the manufacturer to demonstrate meeting acceptance criteria for its therapeutic claims (temporary relief of muscle aches/pains, increased circulation).

Instead, the substantial equivalence hinges on:

• Indications for Use: The subject device's indications for use are identical to the predicate device.
• Technological Characteristics: The core technology (compressor and valve system for sequential inflation) is the same.
• Non-clinical Performance Data: This is where the "acceptance criteria" lie in this context, focusing on safety and technical specifications rather than direct clinical efficacy.

Here's a table summarizing the relevant "performance characteristics" and acceptance based on this document:

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

• Sample Size: Not applicable. No clinical or animal test set data was used for performance validation as per the document. The substantial equivalence is based on comparison to a predicate device and engineering/bench testing against recognized standards.
• Data Provenance: Not applicable.

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

• Not applicable. No expert-adjudicated test set was used for performance assessment in this 510(k).

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

• Not applicable.

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 an Air Pressure Therapy System, not an AI-powered diagnostic or assistive technology for human readers.

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

• Not applicable. The device is not an algorithm; it's a physical medical device.

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

• The "ground truth" for this 510(k) relies on the established safety and effectiveness of the legally marketed predicate device (NormaTec Pulse and NormaTec Pulse Pro), combined with compliance to recognized international and national electrical, safety, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993 series) through non-clinical (bench) testing. There is no "ground truth" derived from patient outcomes or expert consensus for this specific device's clinical performance, as clinical studies were deemed unnecessary for substantial equivalence.

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.

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Air Pressure Therapy System VU-IPC06 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 8 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process. Cycle time and pressure can be adjusted by purpose to avoid any discomfort.

Air Pressure Therapy System intermittent pneumatic compression could be used in family for improving blood circulation in treated areas, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.

The provided text is a 510(k) summary for the "Air Pressure Therapy System: VU-IPC06". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a clinical study proving its own independent performance against acceptance criteria.

The submission explicitly states:

• "Performance Testing - Clinical: NOT Applicable." (Page 4)
• "Performance Testing - Animal: NOT Applicable." (Page 4)

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Instead, it relies on a comparison to a predicate device (NormaTec Pulse and NormaTec Pulse Pro, K160608) to establish substantial equivalence.

The table below summarizes what could be considered acceptance criteria based on standard compliance and a comparison of the subject device's performance to its predicate. However, it's crucial to understand these are not acceptance criteria from an independent performance study of the subject device but rather a demonstration of similarity to a cleared device.

Summary of Device Comparison (No Independent Performance Study Provided)

1. Table of Acceptance Criteria and Reported Device Performance

Since no independent performance study is reported for the subject device against acceptance criteria, the table below reflects a comparison to the predicate device, which is the basis for its 510(k) clearance. The "acceptance criteria" here implicitly refer to being "as safe and effective" as the predicate.

Note: The differences identified (e.g., treatment time, specific modes of compression) are evaluated to ensure they do not raise adversely impact or safety and effectiveness compared to the predicate, rather than meeting specific performance thresholds for the device itself.

2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable, as no clinical performance study on a test set (human subjects or patient data) was conducted or reported for the substantially equivalent device.

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 performance study was conducted.

4. Adjudication Method for the Test Set:
Not applicable, as no clinical performance study was conducted.

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.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device (air pressure therapy system), not an algorithm or software-only device.

7. The type of ground truth used:
Not applicable, as no clinical performance study was conducted. The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate device based on its prior clearance and generally accepted standards for this type of device.

8. The sample size for the training set:
Not applicable, as no algorithm training or performance study was conducted or reported.

9. How the ground truth for the training set was established:
Not applicable, as no algorithm training or performance study was conducted or reported.

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