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The Frye Adjusting Instrument is intended for chiropractic adjustment of the spine and extremities.

The Frye Adjusting Instrument is a chiropractic, adjusting instrument for use in spinal manipulative therapy. The Frye Adjusting Instrument is a modification of the Full Spectrum Activator® III Adjusting Instrument developed to offer easier use to those chiropractors that have limited strength or dexterity in their hands. Typically, these are chiropractors that have arthritis, age-related problems, or have a physical disability of their upper extremity. Thus, these chiropractors have difficulties using currently available adjusting instruments. The main differences between currently available adjusting instruments, such as the FS Activator® III, and the Frye adjusting instrument are that the Frye adjusting instrument is activated pneumatically by a simple push-button and it is shaped in a 'gun-like' configuration rather than a 'plunger-like' configuration.

The provided text describes a 510(k) premarket notification for the Frye Adjusting Instrument. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the manner of AI/software or diagnostic devices.

Therefore, many of the requested categories related to AI/software performance studies, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this submission.

Here's an analysis based on the provided text:

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

The concept of "acceptance criteria" for a novel device is usually tied to specific performance metrics demonstrated through testing against predefined thresholds. In this 510(k), the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, the FS Activator® III. The performance reported is the similarity in function and outcome.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated as "sample size" in the context of clinical trials or data sets. The "test set" was the comparison of the Frye Adjusting Instrument against the FS Activator® III. It involved bench testing of the devices themselves.
• Data Provenance: Bench data performed by an independent laboratory. No country of origin for the data is specified, but the manufacturer is in the USA. The data would be prospective in that it was generated for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a mechanical device comparison, not a diagnostic or AI performance study requiring expert ground truth for classification. The "ground truth" here is the physical measurement of force.

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

• Not applicable. This is a mechanical device comparison, not a study requiring adjudication of expert interpretations.

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 a mechanical device, not an AI or diagnostic tool involving human readers.

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

• This concept is not directly applicable to a mechanical chiropractic adjusting instrument. The device itself is "standalone" in that it performs its function without an explicit human-in-the-loop analytical component (like an AI system providing a diagnosis that a human then acts upon). However, it is an instrument used by a human practitioner.

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

• The "ground truth" in this context is the physically measured peak dynamic loads produced by the device at various settings. This is an objective measurement of a mechanical property.

8. The sample size for the training set

• Not applicable. This is a mechanical device; there is no "training set" in the machine learning sense. The device's design and engineering would be based on mechanical principles and iterative development, not a data-driven training process.

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

• Not applicable, as there is no "training set" in the context of this device.

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