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The Horizon Epikeratome™ is indicated when it is desired to use a single-use microkeratome system that is intended to be used solely to make anterior lamellar connections of preselected thickness and diameter and for the separation of the epithelium from the comea for subsequent surgical procedures and thatleter

The device consists of a control console and disposable HORIZON EPIKERATOME™ microkeratome hand pieces. The control console contains a suction pump, electronics, and a flexible cable to actuate the disposable microkeratome. The basic system sold consists of the control unit, disposable microkeratomes (sold sterile) for corneal resection, a special microkeratome for epithelial separation, practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals.

The HORIZON EPIKERATOME™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes a separator also made of biocompatible polycarbonate plastic.. It is sold sterile and is for single use only. Each individual microkeratome is separately packaged in Tyvek, and is sterilized by gamma radiation. The hand ieces for corneal resection use a surgical -grade steel blade instead of a plastic separartor.

The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by a flexible mechanical transmission cable. The motors are ULand CE approved. The central unit also supplies the suction. The single cable transmits both the motion to cause the blade (or separator) to oscillate and translate the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the central unit must be made before the operation. Separate units are available for different resection diameters and depths. The suction tubes are sold sterile one unit for a patient, and are sold with the microkeratomes.

The Horizon Epikeratome is a medical device designed for ophthalmological procedures, specifically for separating the epithelium from the cornea for subsequent surgical interventions. The information provided outlines the regulatory submission and claims of equivalence rather than a detailed performance study with specific acceptance criteria tables.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there is no explicit table of acceptance criteria or quantified performance metrics presented for the Horizon Epikeratome itself. The submission primarily relies on the device being "identical to the predicate device" in technology and principles, implying that the performance of the predicate device serves as the de facto benchmark.

However, the non-clinical tests conducted suggest implied acceptance criteria in certain areas:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "tests with enucleated eyes" for animal studies, but the number of eyes or animals is not provided.
• Data Provenance:
  • Animal Studies: Performed on "enucleated eyes." The species or origin of these eyes is not specified.
  • Clinical Studies: No human clinical test set was used for the Horizon Epikeratome's performance evaluation as it was deemed not required due to equivalence with a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. As no human clinical test set was required for the Horizon Epikeratome due to its equivalence claim, there was no need for experts to establish ground truth in this context. The animal studies would likely have been evaluated by veterinarians or ophthalmic researchers, but specific details are not provided.

4. Adjudication Method for the Test Set:

Not applicable. Since no human clinical test set or formal multi-reader evaluation was conducted and reported, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Since there is no change in technology or principles, a clinical test is not required" for the Horizon Epikeratome.

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

Not applicable. The Horizon Epikeratome is a mechanical microkeratome system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used:

• Animal Studies: For the animal studies on enucleated eyes, the ground truth would likely have been based on direct observation and measurement of the outcomes of the corneal and epithelial separation, potentially compared against the known effects of the predicate devices. This would involve surgical assessment, potentially histology, or other direct physical measurements on the excised eyes.
• Clinical Equivalence Claim: The ultimate "ground truth" for the device's market approval relied on its substantial equivalence to legally marketed predicate devices (Hawken Flapmaker, K981155, and the Norwood Abbey Centurion, K051486), asserting that their established safety and efficacy serve as the ground truth for an equivalent device.

8. The Sample Size for the Training Set:

Not applicable. The Horizon Epikeratome is a mechanical device and does not involve AI or machine learning, thus there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

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The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.

The device consists of a control console and disposable FLAPMAKER™ microkeratomes. The control console contains a suction pump, electronics, and flexible cables to actuate the disposable microkeratome. The basic system sold consists of the control unit, 20 disposable microkeratomes (sold sterile), 5 practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals.

The FLAPMAKER™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes the blade made from surgical-grade steel. It is sold sterile and is for single use only. Each individual microkeratome is separately packaged in Tyvek, and is sterilized by gamma radiation.

The microkeratome is based upon the principle of the carpenter's plane. The blade, made from surgical stainless steel, oscillates at 12,500 rpm and is controlled by a unique patented flexible cable that is electronically driven. The blade extends a fixed distance from a transparent fixed plate and is at a 26° angle to the plate. Microkeratomes that create resection depths of 130 or 160 microns and resection diameters of 8.5mm and 10.5 mm are available. The microkeratome is mounted in a suction plate and is driven across the suction plate and protruding cornea at 6.8 mm/sec. by a patented flexible cable that is electrically actuated. The plastic suction ring, which supports the unit on the cornea, is made from biocompatible polycarbonate plastic.

The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by mechanical transmission cables. The motors are UL approved. The central unit also supplies the suction. One cable transmits the motion to cause the blade to oscillate, and the other drives the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the connections to the central unit must be made before the operation. Separate units are available for different resection diameters and depths. The suction tubes are sold sterile one unit for a patient, and are sold with the microkeratomes.

The provided document for the Hawken Industries FlapMaker microkeratome does not contain acceptance criteria or study data demonstrating device performance in a clinical context.

Instead, the submission relies on a claim of substantial equivalence to predicate devices, stating:

"This device is identical to the predicate devices, except that the motors have been moved to a central unit and the energy is transmitted by cables. Since there is no change in technology or principles, a clinical test is not required."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the given text.

The document focuses on:

• Device Description: Explaining the components and mechanism of the FlapMaker.
• Intended Use: Specifying its purpose (anterior lamellar corneal resections).
• Non-Clinical Tests: Mentioning electrical safety tests, biocompatibility of materials, and UL approval for motors.
• Claim of Equivalence: Arguing that clinical testing is unnecessary due to perceived technological similarity to existing devices.
• FDA Correspondence: The FDA's letter confirming substantial equivalence based on the provided information, not on new clinical performance data.

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