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The Air Compression Therapy Device are indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

The provided text is an FDA 510(k) clearance letter for an Air Compression Therapy Device. It confirms substantial equivalence to a predicate device and states the indications for use. However, it does not contain the detailed information necessary to answer your specific questions about acceptance criteria for device performance, the study that proves it meets those criteria, or the methodology of such a study.

The letter focuses on regulatory clearance based on substantial equivalence, and while it references labeling and good manufacturing practices, it doesn't describe the clinical or performance studies you're asking about. Such information would typically be found in the manufacturer's 510(k) submission summary or other technical documentation, not in the FDA's clearance letter itself.

Therefore, I cannot provide the requested information from the given input.

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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, lower extremities (leg) and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

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This document is an FDA 510(k) clearance letter for an Electronic stimulator and does not contain information about the acceptance criteria, study details, or performance data of the device.

Therefore, I cannot provide the requested information.

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The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 3 compression chambers. The compression massage direction is from foot to thigh. 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. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

This document is a 510(k) premarket notification for an "Air Compression Therapy Device," which is a powered inflatable tube massager. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, focusing on non-clinical testing. This document does NOT describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, I cannot provide a response that directly addresses the prompt's request for information on acceptance criteria and study proving an AI device's performance, including details like:

• Sample size for the test set and data provenance: The document mentions "non-clinical tests" and "safety and performance tests" but does not detail a test set of patient data.
• Number of experts and qualifications for ground truth: Not applicable for non-clinical device testing.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Explicitly stated "No clinical test data was used to support the decision of substantial equivalence."
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used: Not applicable for non-clinical testing.
• Sample size for the training set: Not applicable as there is no AI/ML component.
• How ground truth for the training set was established: Not applicable.

However, I can extract the acceptance criteria and performance related to the mechanical and electrical safety and manufacturing aspects of this non-AI medical device based on the provided text.

Acceptance Criteria and Device Performance for Shenzhen Dongjilian Electronics Co., Ltd.'s Air Compression Therapy Device (K193354)

The provided submission primarily relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on safety, performance, and adherence to recognized standards. It does not present clinical study data or involve AI/Machine Learning technologies for diagnostic or prognostic purposes, nor does it involve human readers or ground truth established by expert consensus on clinical cases.

The "acceptance criteria" in this context refer to the device conforming to safety and performance standards for its type.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in terms of patient data or clinical cases because no clinical testing was performed. The tests conducted were non-clinical, focusing on the device's physical, electrical, software, and material properties. The data provenance is implied to be from Shenzhen Dongjilian Electronics Co., Ltd.'s internal testing, as it's part of their 510(k) submission. No information on country of origin of patient data (retrospective or prospective) is applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth, in the context of this submission, refers to the device's conformance to recognized engineering and safety standards, not clinical diagnostic accuracy based on expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no information on human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical air compression therapy device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is its conformance to established international and national consensus standards for medical device safety, electromagnetic compatibility, usability, software, biocompatibility, and risk management, along with internal enterprise standards for performance. This is not a clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient cases).

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a "training set."

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

Not applicable, as there is no AI/ML model or training set.

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