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The Therapax DXT 300 is a variable high energy X-Ray system intended for superficial to The Therapy radiotherapy treatments of cancerous tumours and lesions. Typical suboutineous include treatment for basal and squamous cell carcinoma, cancerous lung, breast, ribs, rectal adenocarcinoma and other intracavital sites.

Therapax DXT 300 X-Ray Therapy Device - Model HF-300

This document is a 510(k) clearance letter from the FDA for an X-ray therapy device, the Therapax DXT 300. It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance using the requested metrics.

Therefore, I cannot provide the requested information from this document. The document primarily states that the device is substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

Here's why the requested information is absent:

• Acceptance Criteria & Performance Table: This type of detail is typically found in a clinical study report or a technical performance validation document, not a 510(k) clearance letter. The letter confirms regulatory equivalence, not specific performance metrics.
• Sample Size & Data Provenance: Not mentioned.
• Number & Qualifications of Experts for Ground Truth: Not mentioned.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: Not mentioned as this is a therapy device, not an AI diagnostic tool where MRMC studies are common.
• Standalone Performance Study: Not mentioned.
• Type of Ground Truth: Not mentioned.
• Training Set Sample Size: Not applicable as this is not an AI/ML device.
• Ground Truth for Training Set: Not applicable.

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The Therapax SXT 150 is a variable low energy x-ray system intended for superficial cases and lesions. Typical applications include radiotherapy treatments of cancerous tumors and research. Typical treatments include treatment for basal cell carcinoma, squamous cell carcinoma, Karpos's Sarcoma, rectal adenocarcinoma and other intracavital sites.

variable low energy x-ray system

This is a letter acknowledging the receipt and review of a 510(k) premarket notification for the "Therapax SXT 150 X-Ray Therapy Device." This document itself does not contain any information about acceptance criteria or a study proving device performance against such criteria. It is a regulatory approval letter based on the device being substantially equivalent to legally marketed predicate devices.

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

To address your request, I would need a different document, such as a 510(k) summary, a clinical study report, or a technical specification document that describes the device's performance characteristics and the studies conducted to establish them.

Ask a specific question about this device