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The device is intended 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 is a powered inflatable tube massager. The device simulates manual kneading and stroking of tissues by sequential inflated cuffs, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It consists of a main unit, a 4-chamber leg cuff, and an air hose for connecting the unit to the cuff. Only one leg is treated during the treatment process. The cuff inflates and deflates sequentially to apply the pressure on the leg which is controlled by the main unit. Each cuff is equipped with a dedicated air hose. It is to be used by adults.

The FDA 510(k) clearance letter for the Intermittent Pressure Compression System (K242615) does not contain information about a study that proves the device meets specific acceptance criteria in the context of clinical performance (e.g., how effectively it relieves muscle aches or increases circulation). Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (K243320) by meeting recognized safety and performance standards relevant to medical devices of its type.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical characteristics to those of the predicate device and highlights regulatory compliance. The acceptance criteria for clearance are primarily based on demonstrating that the subject device is as safe and effective as the predicate device by meeting recognized safety standards and showing that differences in technical characteristics do not raise new safety or efficacy concerns.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "testing was performed and results demonstrated that the Intermittent Pressure Compression System is as safe and effective as the predicate device." However, it does not specify any clinical test set sample size, data provenance, or details of a clinical study to prove efficacy in humans. The testing mentioned refers to compliance with electrical safety and electromagnetic compatibility standards (IEC 60601 series), not clinical trials.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

Not applicable. The clearance is based on substantial equivalence to a predicate device and compliance with device safety standards, not on a clinical ground truth established by experts for performance assessment in humans.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a clinical test set or an adjudication method for human performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is more common for diagnostic imaging devices involving human interpretation. The provided document concerns an intermittent pressure compression system, which is a therapeutic device, and does not mention any MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device, not an AI algorithm. Its performance is inherent in its mechanical and electrical operation, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is primarily established by:

• Substantial Equivalence: Comparison to a legally marketed predicate device (K243320) with known safety and efficacy.
• Compliance with Recognized Standards: Meeting international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). These standards serve as the "ground truth" for basic safety and essential performance.

There is no mention of clinical outcomes data, pathology, or expert consensus specific to the subject device's clinical efficacy in the provided document.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI/ML device.

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The TAO ASPIRATORTM is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand.

The PLASTIC FINGERTM is an accessory to the TAO ASPIRATORTM to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.

The TAO ASPIRATORTM is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand.

The PLASTIC FINGERTM is an accessory to the TAO ASPIRATORTM to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.

The provided text is a 510(k) premarket notification letter from the FDA for the TAO ASPIRATOR™ and PLASTIC FINGER™. This document confirms the substantial equivalence of the devices to legally marketed predicates and outlines their indications for use.

Crucially, the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.

The 510(k) clearance process focuses on substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. While a manufacturer would typically have internal testing and validation data to support their 510(k) submission, this specific FDA letter does not describe or summarize those studies or their acceptance criteria.

Therefore, I cannot provide the requested information based on the given input. The categories in your request (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are all relevant to study design and results, which are not present in this regulatory correspondence.

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