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The UltraShaper™ System is an AC-powered device that is intended to shave a partial lamella section of the cornea.

The UltraShaper™ System consists of the following components: (a) cutting head, (b) suction rings / handles, (c) motor handpiece, (d) handpiece-to-console cable, (e) suction tubing set, (g) blade assembly, and (h) console power / suction supply with foot actuated switches. The cutting head and suction rings / handles are constructed entirely from stainless steel. The UltraShaper™ System is designed to perform anterior lamellar circular corneal resections of a predetermined diameter and thickness based upon the principle of a carpenter's plane. A cutting blade emerges from the center of the keratome plane. The stainless steel blade oscillates by a small DC motor (in the motor handpiece) controlled by foot switch. The cutting head slides on dovetail guides on a circular suction ring. The cutting head contains a gear drive train that engages a gear rack on one side of the suction ring to drive the keratome head across the suction ring and cornea. The suction ring provides an annular vacuum chamber for temporary attachment to the ocular globe. The cutting head has a fixed foot plate and is available in three standard head sizes, 130, 160 and 180 microns, depending on the thickness of the corneal section desired. There are also three different suction ring / handle sizes available to accommodate the variations in corneal curvature from patient to patient. A (motor handpiece-to-console) cable is also supplied with each UltraShaper™ keratome. The UltraShaper™ Console Power Supply provides the power to both the keratome motor and the suction supply for holding the ring in place on the cornea. This is the same console which drives the company's ADK disposable keratome. The console has three vacuum suction settings, HIGH, LOW, OFF. The console will only permit the keratome to operate (transverse the cutting plane) while in the HIGH setting. While in the HIGH mode, the console, with its internal barometer, reacts to vacuum suctions values which are below the optimum by signaling the operator with audible and visual warnings. The UltraShaper™ Console Power Supply conforms to IEC-601-1 electrical safety standard. A sterile suction tubing set, which is generic to several keratome systems, is used to connect the suction ring / handle of the UltraShaper™ to the suction port on the console. Suction tubing sets are supplied sterile and are intended for single use. Likewise, keratome blades are supplied sterile and are intended for single use.

This document is a 510(k) premarket notification for a medical device, the UltraShaper™ System, rather than a detailed study report that establishes performance criteria with specific numerical targets and then measures against them. Therefore, many of the requested elements (like a specific acceptance criteria table, detailed sample sizes for test and training sets, expert adjudication methods, MRMC studies, and standalone performance metrics) are not explicitly present or are not applicable in the way they would be for a typical AI/software device evaluation.

The primary goal of this 510(k) submission is to demonstrate "substantial equivalence" to existing, legally marketed predicate devices, not to prove novel performance against pre-defined acceptance criteria through a specific study.

However, I can extract information related to the device's operational characteristics and the basis for its clearance, framed in the context of the requested questions.

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

The 510(k) notification does not present a formal table of acceptance criteria with numerical performance targets and reported results for the UltraShaper™ System itself. Instead, it argues for substantial equivalence based on technological characteristics and a history of acceptable clinical results for similar devices.

The "performance" is implicitly deemed acceptable if it meets the established safety and effectiveness of its predicate devices. The key performance characteristics mentioned are the ability to perform "anterior lamellar circular corneal resections of a predetermined diameter and thickness."

The document highlights these performance-related characteristics:

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

The document does not describe a "test set" in the context of a new, clinical performance study for the UltraShaper™ System. It relies on the established performance and safety record of predicate devices. There is no mention of sample size or data provenance (country of origin, retrospective/prospective) for a study specifically testing the UltraShaper™. The "data provenance" for the claims of safety and effectiveness comes from "published literature on keratomes," generally.

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

Not applicable. No specific test set with a ground truth established by experts for the UltraShaper™ System is described in this 510(k) submission.

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

Not applicable. No specific test set requiring adjudication is described.

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. The UltraShaper™ System is a mechanical surgical device (keratome), not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-assistance effectiveness 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 device, not an algorithm. Performance is inherently tied to human operation; however, its automated features (like blade traverse, oscillation) are designed to provide consistent mechanical operation.

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

For the UltraShaper™ System itself, no new "ground truth" was established through a specific study described here. The implicit "ground truth" for demonstrating substantial equivalence is the long-term, accepted clinical performance of similar keratomes observed in published literature and general clinical use, encompassing outcomes data (postoperative refraction, visual acuity) and complication rates.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/machine learning model. The device's design is based on established engineering principles and the successful design of predicate devices.

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

Not applicable. There is no "training set" or "ground truth" establishment in the context of an AI/machine learning model for this device. The design principles are based on established medical device engineering and historical clinical experience with keratomes.

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