(306 days)
The MICROspecialties, keratome blades are designed to produce a corneal flap when used with the following Moria microkeratomes:
- MICROspecialties 200200 Blade for use on Moria LSK Microkeratome .
- MICROspecialties 600600 Blade for use on Moria CB Microkeratome
The disposable 200200 microkeratome blade is designed to be used with the Moria LSK microkeratome system. The disposable 600600 microkeratome blade is designed to be used with the Moria CB microkeratome system. Both of these blades are designed to produce a corneal flap. The blades are packaged in plastic cases to protect the cutting edge and the placed in a Tyvek/poly pouch. They are sold as ten blades per box or in larger quantities of thirty (three ten-packs). Labeling identifies each quantity per box. The blades are then gamma radiation sterilized.
The blades are made from medical grade stainless steel with a single cutting edge. They are assembled with their compatible head and driver systems.
The provided text describes a 510(k) summary for two styles of microkeratome blades, but it is not a study report that would include detailed acceptance criteria and performance data in the format requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions a "nonclinical evaluation" and "design validation" but does not provide the specific quantitative details needed to fill out a table of acceptance criteria and reported device performance, nor does it detail the methodology of a formal study with the requested elements.
Therefore, I cannot generate the requested table and detailed study information. However, I can extract the available information regarding the evaluation performed:
Summary of Device Evaluation Information from the Document:
- Acceptance Criteria and Reported Device Performance: This information is not provided in a quantitative or systematic way in the document. The text generally states that "Engineering, manufacturing and inspection specifications were finalized based on this evaluation," and "The blades go through 100% inspection to insure that they meet the product specification and follow design controls of MICROspecialties." No specific numerical criteria or performance metrics are given.
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Independent physicians and clinics were used to evaluate the performance," but does not give a specific sample size for the test set or the country of origin. It appears to be a nonclinical evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The document mentions "Independent physicians and clinics," but does not specify how many, their specialties, or their years of experience.
- Adjudication method: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned or described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (surgical blade), not an AI algorithm.
- The type of ground truth used: Not explicitly defined in terms of a formal ground truth process. The evaluation included "package handling, ease of use, performance on the respective Moria microkeratomes" and "appearance, compatibility with the Moria microkeratomes and performance within these systems." This suggests observation-based feedback and functional testing.
- The sample size for the training set: Not applicable and not mentioned. This is a medical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable and not mentioned.
Conclusion:
The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It does not contain the detailed, quantitative study data typically found in a scientific paper or a comprehensive test report that would describe explicit acceptance criteria, performance metrics, ground truth establishment, or statistical methods. It largely relies on a risk analysis, design validation, manufacturing controls, and qualitative user feedback to support its claims of safety and effectiveness relative to a predicate device.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.