Search Results

The DJS Massager is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in people who are in good health. The DJS Massager simulates kneading and stroking of tissues by using an inflatable garment.

Powered Inflatable Tube Massager

This is a 510(k) clearance letter for the DJS Massager (Powered Inflatable Tube Massager). It does not contain the detailed information about acceptance criteria and study results typically found in a clinical study report or a detailed 510(k) summary. The provided document is essentially a regulatory approval letter based on substantial equivalence.

Therefore, many of the requested details cannot be extracted from this document. However, I can infer some information based on the nature of a 510(k) submission for a massager.

Here's what can be stated based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided: This document does not contain specific performance data or acceptance criteria for a clinical study comparing the DJS Massager to a benchmark. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical performance data with predefined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Cannot be provided: This information is not present in the regulatory clearance letter. For a massager, a "test set" in the context of clinical performance might not even be a required component if substantial equivalence can be demonstrated through other means (e.g., design, materials, intended use, energy output comparison to a predicate).

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

• Cannot be provided: This document does not describe the establishment of ground truth by experts for a test set. This type of detail is typical for AI/CAD device submissions where diagnostic accuracy is assessed.

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

• Cannot be provided: Not applicable or not included in this type of regulatory letter.

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:

• Cannot be provided: This is highly unlikely for a powered inflatable tube massager. MRMC studies are typically for diagnostic imaging devices where AI assists in interpretation.

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

• Cannot be provided: Not applicable, as this device does not contain an "algorithm" in the sense of an AI or diagnostic software. It's a physical massager.

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

• Cannot be provided: There is no mention of ground truth establishment in this document.

8. The sample size for the training set:

• Cannot be provided: This device does not have a "training set" in the context of machine learning or AI.

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

• Cannot be provided: Not applicable.

Summary of what can be extracted from the document:

• Device Name: DJS Massager (Powered Inflatable Tube Massager)
• Regulatory Status: 510(k) clearance, deemed substantially equivalent to a legally marketed predicate device.
• Regulatory Class: Class II
• Product Code: IRP
• Indications for Use: The DJS Massager is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in people who are in good health. The DJS Massager simulates kneading and stroking of tissues by using an inflatable garment.
• Use Environment: Over-The-Counter Use (21 CFR Subpart C)
• Date of Clearance: December 7, 2011

This document is a formal notification of FDA clearance, not a detailed technical report or clinical study summary. For a medical device like a massager, the detailed performance data and acceptance criteria would typically be found in the 510(k) summary (a public document) or the full 510(k) submission (confidential). However, for a device of this classification and type, the "study" demonstrating performance is often a comparison of technical specifications, safety data, and intended use against a predicate device, rather than a clinical trial with specific performance endpoints and ground truth.

Ask a specific question about this device