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The Alton PT Stabilizer and Stepper is designed to allow precision ultrasound probe alignment, precise prostate visualization and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. It is also used to allow precision ultrasound alignment and precise prostate visualization in cryotherapy treatments for prostate treatment.

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This document is a 510(k) summary for the ALTONTM PT Stepper and Stabilizing System, a medical device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing performance data from a specific study against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted directly from the provided text.

Here is the information that can be extracted, along with explanations for what cannot be found:

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

This information is not provided in the document. The 510(k) summary for this device focuses on demonstrating substantial equivalence by comparing its intended use, technological characteristics, and materials to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria.

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

This information is not provided. As no specific performance study is detailed, there is no mention of a test set, sample size, or data provenance.

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)

This information is not provided. There is no mention of a ground truth established by experts for a test set.

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

This information is not provided. There is no mention of a test set or an adjudication method.

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

This information is not provided. This device is a mechanical stepping and stabilization system for ultrasound probes in brachytherapy and cryotherapy, not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

This information is not provided. This device is a mechanical instrument, not an algorithm, so a standalone performance study in the context of AI is not applicable.

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

This information is not provided. As no performance study requiring ground truth is detailed, this information is absent.

8. The sample size for the training set

This information is not provided. Not applicable to this type of device and submission.

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

This information is not provided. Not applicable to this type of device and submission.

Summary of Device and Substantial Equivalence Claim:

The document describes the ALTON™ PT Stepper and Stabilizing System. This device is intended to allow precision ultrasound probe alignment, precise prostate visualization, and radioactive seed implantation in brachytherapy treatments, as well as precision ultrasound alignment and prostate visualization in cryotherapy treatments.

The substantial equivalence claim is based on:

1. Same intended use: The device has the same intended use as several predicate devices (e.g., K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-963302 (Tayman Medical), K-972672 and K000960 by Barzell-Whitmeore).
2. Same technological characteristics: The technological characteristics are stated to be the same as the predicate devices.
3. Substantially equivalent materials: The materials used for the Alton™ are reported to be substantially equivalent (nearly identical with some) to those of similar products already on the market.

Conclusion:

The provided text constitutes a 510(k) summary demonstrating substantial equivalence for a medical device. It does not contain information about a specific study designed to meet pre-defined acceptance criteria, as is common for novel devices or those requiring a PMA. Instead, it relies on a comparison to existing, legally marketed predicate devices to establish safety and effectiveness.

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