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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 Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a pre-selected thickness and diameter.

This DEVICE is an AC powered device consisting of three main parts: CONTROL BOX, HAND PIECE, and FOOT PEDAL. The CONTROL BOX has LED indicators, a pressure gauge, self test button, and connectors. The HAND PIECE contains the blade running and reversing mechanism, oscillation mechanism, attachment slot for the Suction Ring, Blade Holder, and a connector for the Control Box. It includes a Blade Holder, Applanation Plate (determining flap thickness), a disposable Blade, and a Single Suction Ring (fixing to the eyeball under suction). The FOOT PEDAL has switches for controlling suction, forward motion and oscillation of the blade, and reverse motion of the blade, and a cable for connection to the Control Box.

The provided text describes the Nidek Keratome, MK-2000, a Class I medical device, and its 510(k) submission for market clearance. However, it explicitly states that no clinical performance data or non-clinical performance data was provided to demonstrate the device's effectiveness.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information can be extracted:

• No Acceptance Criteria or Reported Device Performance: The document does not define specific acceptance criteria (e.g., precision of flap thickness, success rate of flap creation) nor does it provide any reported device performance metrics against such criteria.
• No Study Data: The document explicitly states: "No clinical performance data has been provided" and "None provide" for non-clinical performance data.

Information that can be extracted from the provided text, related to your prompt, but indicating a lack of the requested data:

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

   • Acceptance Criteria: Not specified in the document.
   • Reported Device Performance: Not provided in the document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not applicable, as no test set data was provided.
   • Data Provenance: Not applicable, as no data was provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Number of Experts/Qualifications: Not applicable, as no ground truth for a test set was established (no test data provided).

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

   • Adjudication Method: Not applicable, as no test set data requiring adjudication was provided.

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:

   • MRMC Study: No, the device is a Keratome (surgical instrument), not an AI diagnostic tool involving human readers.

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

   • Standalone Performance: Not applicable. The device is a surgical instrument operated by a human, not an algorithm.

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

   • Type of Ground Truth: Not applicable, as no performance data with associated ground truth was provided.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable, as no training data for an algorithm was used or described.

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

   • Ground Truth for Training Set: Not applicable, as no training data was used or described.

Summary of the document's approach to effectiveness:

The document states that the effectiveness of the device "was confirmed by use of QWF050B, Nidek MK-2000 Keratome Validation Test Procedure." However, the details or results of this procedure are not provided in the 510(k) summary. The basis for substantial equivalence is primarily stated as:

• Intended Uses and Operating & Cutting Principles are the same as six predicate devices.
• Operational Features are the same or similar to predicate devices.
• Safety Features are the same or very similar to predicate devices.
• Compliance with electrical standards (UL2601-1, IEC601-1-1, IEC601-1-2) and inclusion of operational safety features (Vacuum Level Gauge, low suction LED and tone, automatic cutting stop, foot pedal controls).

Therefore, the claim for effectiveness and safety is largely based on equivalence to already marketed devices and compliance with safety standards, rather than new performance data presented within this 510(k) summary.

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