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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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The JTECH Adjuster Reflex Gun is designed to be used when the practitioner deems manual adjustment not to be effective, possible or desirable. It can be used for stimulating segments of the cervical spine, thoracic spine and lumbar spine as well as the sacrum, ilium and extremities.

JTECH Adjuster Reflex Gun

I'm sorry, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is an FDA 510(k) clearance letter for the "JTECH Adjuster Reflex Gun," indicating it has been found "substantially equivalent" to predicate devices. This type of document does not contain the detailed information you're asking for regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on regulatory clearance, not on providing the results of a specific performance study against defined acceptance criteria. Therefore, I cannot extract the requested information from the given text.

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