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The Ultra V Therapeutic Ultrasound device provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with the chronic and sub-chronic conditions of:

1. Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis.
2. Soft tissue injuries and shortened tendons due to past injuries and scar tissue
3. Joint contractures resulting from capsular tightness and scarring.

The XLTek Ultra V is a Therapeutic Ultrasound

The provided text is a 510(k) summary for the XLTek Ultra V Therapeutic Ultrasound device and the FDA's response letter. It primarily focuses on demonstrating substantial equivalence to a predicate device for marketing purposes.

Crucially, this document does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or the other specific elements requested in your prompt.

The 510(k) process for a device like a therapeutic ultrasound often relies on demonstrating that the new device has the same technological characteristics and intended use as a legally marketed predicate device. This typically involves performance testing to ensure the device operates within expected parameters (e.g., ultrasound frequency, intensity, output power accuracy) rather than a clinical study establishing efficacy or comparing it to human readers.

Therefore, I cannot populate the table or answer most of your specific questions based only on the provided text.

Here's a breakdown of what can be extracted and what cannot:

What can be extracted:

• Device Name: Ultra V Therapeutic Ultrasound
• Intended Use/Indications for Use: Provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with chronic and sub-chronic conditions of:
  • Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis.
  • Soft tissue injuries and shortened tendons due to past injuries and scar tissue.
  • Joint contractures resulting from capsular tightness and scarring.
• Predicate Device: Excel Tech Ultra Max [510(k) K944065, formerly called Ultra SX]. Also refers to Ultra SX [510(k) K923076].

What cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone algorithm-only performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

To obtain the information you're seeking, you would typically need to review the full 510(k) submission, which would detail any performance testing, design verification and validation activities, and specific data if they were required and performed for this type of device. Given that this is a therapeutic ultrasound (not an AI-driven diagnostic tool), many of the questions related to AI-specific evaluation (like MRMC studies, ground truth for AI, training sets) are unlikely to be relevant to this particular device.

Ask a specific question about this device