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This device is used in the treatment and management of muscle spasm and muscle tension.

The proposed changes to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The modifications of design change of "S" shape, adding roller beads and handles, adding interchangeable massage balls and adding a collapsible feature does not change the safety or effectiveness of this device.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "MUSCLE WANDEM" device, based on the given sections:

It's important to note that the provided text is a 510(k) summary for a medical device modification, specifically for the "MUSCLE WANDEM." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing de novo clinical trials to establish new safety and effectiveness criteria. As such, many of the requested data points (like detailed acceptance criteria with performance metrics, sample sizes for test/training sets, expert qualifications, etc.) are not typically included or required in a 510(k) summary for a device modification of this nature. The summary's primary argument is that the modifications do not alter the safety or effectiveness already established by the predicate device.

Analysis of Provided Information:

Based on the provided text, the device is the "MUSCLE WANDEM," which is a modification of a predicate device, the "Thera-Cane K903820." The submission argues that the modifications do not change the safety or effectiveness.

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

   • Acceptance Criteria: The document implies the acceptance criteria are maintaining the safety and effectiveness of the predicate device. Specific quantitative performance metrics are not provided. The key criteria are that the device, with its modifications, "does in no way alter the safety and effectiveness" of the predicate.
   • Reported Device Performance: The document claims that the device, with its modifications, continues to be safe and effective, based on the predicate's established track record. No new performance data from a specific study is reported for the "MUSCLE WANDEM" as a result of these modifications.

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

   • Sample Size: Not applicable/Not provided. The document does not describe a new "test set" being used for a study comparing the MUSCLE WANDEM with the predicate. Its argument relies on the historical performance of the predicate device.
   • Data Provenance: The "proven track record" of the predicate device ("Thera-Cane K903820") is the basis. The document does not specify the country of origin of this historical data or whether it was retrospective or prospective. It refers to the predicate being "sold OTC since 1990."

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

   • Not applicable/Not provided. No new ground truth establishment is described for a test set. The submission relies on the established safety and effectiveness of the predicate device which has been "proven safe" and "an asset" over time.

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

   • Not applicable/Not provided. No new test set or adjudication process 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 is not an AI-assisted device, nor does the document describe an MRMC study. It's a physical therapy aid.

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

   • Not applicable. This is not an algorithmic device.

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

   • The "ground truth" for the claims of safety and effectiveness appears to be based on the historical marketing and regulatory approval of the predicate device ("Thera-Cane K903820") and its "proven track record" as an "asset to the patient experiencing muscle spasm and/or muscle tension" since 1990. This effectively points to market experience and presumably, lack of adverse event reporting, alongside initial regulatory clearance, rather than a specific, controlled outcomes study for this modification.

8. The sample size for the training set:

   • Not applicable/Not provided. The concept of a "training set" is not relevant to this type of device modification submission.

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

   • Not applicable/Not provided.

Summary of Study (Based on 510(k) Approach):

The "study" described in this 510(k) summary is not a traditional clinical trial or performance study comparing the modified device to the predicate. Instead, it's a justification of substantial equivalence.

The core argument is:

• The predicate device (Thera-Cane K903820) has a "proven track record" of safety and effectiveness since 1990.
• The "MUSCLE WANDEM" introduces design modifications ("S" shape, roller beads, handles, interchangeable massage balls, collapsible feature).
• These modifications do not alter the device's intended use, materials, anatomical sites, target population, physical safety, biocompatibility, or performance.
• Therefore, the safety and effectiveness established by the predicate device are maintained for the "MUSCLE WANDEM."

No specific new study data is presented for the MUSCLE WANDEM's performance as an acceptance criterion. The acceptance is based on the argument of non-alteration of existing, established safety and effectiveness.

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