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The JTECH Commander Algometer is a calibrated pressure or force stimulus device. It measures I he 51 LC1 Conninential response for pain tolerance, pain tolerance, pain threshold and trigger point tenderness. It is also used to screen for finger strength.

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The provided text is a 510(k) clearance letter from the FDA for the JTECH Commander Algometer. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts used or their qualifications for ground truth establishment.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is solely an FDA clearance letter based on substantial equivalence, not a detailed technical report or clinical study summary.

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