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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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The Automated Corneal Trephine is intended for preparation of recipient and donor comeas for lamellar and penetrating keratoplasty.

The Automated Corneal Trephine consists of a sterile, single use, disposable corneal trephine made of medical grade injection-molded plastic and stainless steel. The trephine is used to create a partial or full-thickness circular cut for lamellar or penetrating keratoplasty. This trephine features a DC motor which automatically rotates the trephine, eliminating cumbersome manual rotation. The blade depth is preset at the factory so that the extent of penetration is very precise.

The provided text is a 510(k) summary for the Automated Corneal Trephine (K981063) and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, detailed study designs, or performance results in the way typically expected for answering your request.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria and detailed statistical analysis, especially for Class I devices like this one.

Therefore, I cannot fully answer your request with the information provided. I can only report what is directly stated or inferred from the document.

Here's a breakdown of what can be extracted or inferred, and what is missing:

The core of the submission for K981063 is based on substantial equivalence to the Barron-Hessburg manual corneal trephine (K864520). The performance criteria are implicitly met by demonstrating that the new device operates similarly and achieves the same intended purpose as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria (e.g., "blade depth variability must be less than X microns") or quantitative performance data from a specific study. The "reported device performance" is descriptive and aims to show functional equivalence to the predicate.

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

• Sample Size: Not specified. It is highly unlikely a "test set" in the context of clinical data was used for this type of submission. Performance was likely demonstrated through pre-clinical testing, engineering specifications, and comparison to the predicate.
• Data Provenance: Not specified. Given the nature of the device and the submission type, any data would likely be from engineering tests or simulated use, not human clinical data.

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

• Not Applicable. The document does not describe a study involving expert assessment of device outputs or "ground truth" derived from experts in the context of a diagnostic or subjective assessment device. The "ground truth" for a surgical instrument would be its ability to perform its mechanical function consistently and accurately, which is typically assessed through engineering measurements and bench testing.

4. Adjudication method for the test set

• Not Applicable. No human adjudication method is described as there's no mention of subjective assessment or an expert panel reviewing test results in this document.

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 device is a surgical instrument (corneal trephine), not an AI-powered diagnostic or image analysis tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this device.

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

• Not Applicable. This is a mechanical surgical instrument, not an algorithm or AI system. There is no "standalone algorithm only" performance to evaluate.

7. The type of ground truth used

• Implied Mechanical/Engineering Specifications and Performance: For a surgical instrument like a trephine, the "ground truth" would relate to its ability to create a precise, circular cut of a specified depth and diameter, its sharpness, sterility, material integrity, and safety during use. This would be established through engineering measurements, material testing, and simulated use models, not expert consensus, pathology, or outcomes data in the clinical sense mentioned.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not a machine learning model. There is no "training set."

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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