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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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ADK (Automated Disposable Keratome) is intended to perform anterior, lamellar, circular corneal resections of a predetermined diameter and thickness.

The Automated Disposable Keratome consists of two components: (a) disposable keratome, (b) power / suction supply and DC motor with foot actuated switch. The ADK is a keratome 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 controlled by foot switch. The keratome, which is fabricated from high density engineering plastic (except the blade and motor), has a one piece head that is pre-assembled with a fixed foot plate, and is available in two standard head sizes, 130 or 160 microns, depending upon the thickness of corneal section desired. The keratome head has dovetail guides, which correspond to guides on the suction ring that is placed upon the ocular globe. Tandem gears on both sides of the keratome head and corresponding gears on the suction ring automatically move the cutting blade along the dovetail guides. Whereas gears on competitive keratomes are exposed, the gears on the ADK are covered to minimize entrapment of lashes and lids. A DC motor controls the gears and blade movement via the foot switch control. The cutting principle is the same as with manual keratomes and other automated keratomes. The automatic movement of the keratome allows for a more uniform translation across the suction ring and thusly across the cornea. The power supply provides the power to both the keratome motor and the suction supply for holding the suction ring in place on the cornea. The ADK has three settings for vacuum control: "off", "low", "high"; whereas predicate devices have only two vacuum settings, "on" and "off". The vacuum suction of predicate devices in the "on" position is the same as the suction of the "high" setting of the ADK. The "low" suction setting of the ADK provides the option of using the suction ring to aid in globe fixation after the resection. Predicate devices require the surgeon to use the "off" position for globe fixation after resection, where residual suction declines variably back to 0 mmHg. The keratome is provided sterile in a sealed blister/Tyvek® tray and is discarded after single use.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies for the Automated Disposable Keratome (ADK):

It's important to note that this document is a 510(k) summary, not a full pre-market approval application. 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical efficacy data as would be required for a novel, high-risk device. Therefore, the information provided reflects this regulatory pathway.

No explicit "acceptance criteria" for performance metrics are defined in this document, nor is there a detailed clinical study demonstrating the device meets specific numerical performance targets. The submission relies on substantial equivalence to predicate devices and general safety and effectiveness.

However, we can infer the implied acceptance criteria and the types of evidence used to support them.

Inferred Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, the "acceptance criteria" are largely derived from the substantial equivalence concept and the demonstrated safety and effectiveness of the predicate devices. The "reported device performance" is descriptive, highlighting how the ADK maintains or improves upon these characteristics.

• Dual Parallel Drive Action: Adds a second gear and track to reduce torque-induced jamming (a potential drawback of single-sided drives like the Chiron ACS).
• Covered Gears: Minimizes entrapment of lashes and lids, addressing a potential issue with exposed gears on competitive models.
• Three Vacuum Settings ("low" option): Allows for globe fixation after resection, providing better control than predicate devices with only "on/off" settings. |
  | Biocompatibility: Device materials are not toxic or irritating to ocular tissue. | Meets: High-density plastic materials, excluding the stainless steel blade, have been tested according to FDA Tripartite Guidelines and ISO 10993-1 Standard and are deemed biocompatible. |
  | Sterility: Device can be provided sterile and maintain sterility. | Meets: Provided sterile in a sealed blister/Tyvek® tray, sterilized under a validated gamma irradiation cycle with a SAL of 10⁻⁶, and dosimetric release. |
  | Electrical Safety: Conforms to electrical safety standards. | Meets: The ADK power supply conforms to the IEC-601-1 electrical safety standard. |
  | Elimination of "Drawbacks" of Predicate Devices: Addresses issues associated with cleaning, re-assembly, component wear, and potential tissue jamming. | Meets: The ADK is pre-assembled, pre-sterilized, and disposable after single use, directly addressing human error during cleaning/assembly/wear, and reducing the potential for tissue jamming by covering gears. |
  | Clinical Safety and Effectiveness: Associated with acceptable clinical results in terms of postoperative refraction and visual acuity, and minimal postoperative complications (as demonstrated by long-term use of predicate devices). (This is extrapolated from the general acceptance of keratomes over time). | Supported by Predicate History: A review of published literature on keratomes indicates acceptable clinical results and minimal complications. The ADK's design changes are argued not to affect safety and effectiveness as they do not alter the energy source, cutting parts, or principle of operation, but rather improve usability and reduce potential user-related errors. |

Study Information & Details:

1. A table of acceptance criteria and the reported device performance: (See above table)

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

   • No specific test set of patient data or clinical trial with a defined sample size is mentioned or reported for the ADK.
   • The submission relies heavily on the historical performance and safety of its predicate devices (Automatic Corneal Shaper, Steinway-Barraquer In-Situ Microkeratome Set, Micro Refractive System Model 1000).
   • The "evidence" is primarily based on a literature review regarding the general clinical acceptance of keratomes over 30-45 years, rather than a prospective study on the ADK itself.
   • Provenance: "Published literature on keratomes," implying retrospective data from various sources (not specified, but likely international given medical literature) reflecting decades of use.

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

   • Not applicable. There was no specific "test set" and thus no experts were used to establish ground truth for a novel assessment of the ADK in this submission as typically seen in efficacy trials.
   • The "experts" indirectly involved are the broader ophthalmic community whose published literature established the historical safety and efficacy of keratomes, which forms the basis of the substantial equivalence argument.

4. Adjudication method for the test set:

   • Not applicable. No test set or clinical outcomes requiring adjudication were presented for the ADK.

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 (keratome), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

   • Not applicable. This is a hardware surgical instrument. Performance is always "human-in-the-loop," as a surgeon operates it. The device itself does not perform any task "stand-alone" in a diagnostic or analytical sense.

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

   • The "ground truth" for the overall class of devices (keratomes) is established through historical clinical outcomes data from decades of use, supported by expert consensus reflected in the published literature.
   • For the ADK specifically, the ground truth for its design changes relies on engineering principles (e.g., dual parallel drive reduces torque, covered gears prevent entanglement), biocompatibility testing (ISO 10993-1), and sterilization validation (gamma irradiation).

8. The sample size for the training set:

   • Not applicable. No "training set" in the context of machine learning or deep learning was used. The device is a mechanical instrument.

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

   • Not applicable. As no training set was used, no ground truth needed to be established for it.

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