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The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The Primary and only purpose of this device is to produce cuts necessary for the corneal transplantation.

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The provided text does not contain detailed information about specific acceptance criteria, device performance, or a study design in the way that would typically be presented for a modern AI-powered medical device submission. This document is a 510(k) summary for the ASMOTOM Automated Trephine System, approved in 2001, which is a physical medical device (a trephine), not an AI-powered diagnostic system.

Therefore, many of the requested categories for AI-specific performance evaluation cannot be extracted from this document, such as:

• Sample size for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results or effect size
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

However, based on the information available, I can provide a response focusing on what can be inferred or directly stated from the document, particularly regarding the device's intended use and the comparison to a predicate device.

Acceptance Criteria and Study for ASMOTOM Automated Trephine System (K013151)

The provided K013151 document is a 510(k) Summary for a physical medical device, the ASMOTOM Automated Trephine System, and therefore does not include the detailed performance study information typically required for AI-powered diagnostic devices. The acceptance criteria for such a device at the time would primarily revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness, often through bench testing and mechanical comparisons rather than extensive clinical studies with human interpretion.

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

The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance metrics as would be seen for an AI device. Instead, the substantial equivalence hinges on functional similarity and material comparison to the predicate device. The implicit acceptance criterion is that the device performs its intended function (performing penetrating cuts of the cornea for transplantation) in a manner similar to the predicate device, without raising different questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of clinical data for performance evaluation. For a device like a trephine, testing would typically involve bench testing (e.g., precision of cuts on artificial materials) rather than human patient data sets for diagnostic accuracy. No clinical data or test set provenance (country of origin, retrospective/prospective) is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a surgical instrument, not an AI diagnostic tool requiring expert-established ground truth on clinical images or data. Performance assessment would involve engineering and surgical precision measurements, not expert review of diagnostic interpretations.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set requiring adjudication in this 510(k) summary.

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 not an AI-assisted device, and no MRMC study was conducted or is relevant to its approval.

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

Not applicable. This is a surgical instrument operated by a human, not an algorithm.

7. The type of ground truth used

For a physical device like a trephine, "ground truth" would relate to the physical measurement of cuts made (e.g., depth, diameter, consistency), likely established through engineering measurements and potentially ex-vivo tissue testing, rather than clinical outcomes or diagnostic accuracy. The document does not specify the methods used, but for substantial equivalence, it would involve demonstrating that cuts are comparable to those made by the predicate device.

8. The sample size for the training set

Not applicable. No AI/machine learning training set is relevant for this device.

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

Not applicable. No AI/machine learning training set is relevant for this device.

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