(305 days)
- Keratoplasty & corneal harvesting
- Microlamellar keratoplasty
The Summit Krumeich-Barraquer Microkeratome is an automated version of the Eyetech-Barraquer-Krumeich Swinger Refractive Set found substantially equivalent under K954058. Other than the automated cutting action option of the electronic model, both microkeratomes share the following basic description. The Microkeratome is a medical "instrument" exclusively designed for use in ophthalmic surgery. This instrument should only be installed, used and serviced by suitably qualified personnel. The speed of forward movement during cutting and the frequency of oscillation of the blade can be individually set and controlled by the operator. The instrument will remain programmed until the data is overwritten by new data. For safety reasons the instrument is equipped with an electrical energy and vacuum reserve which is maintenance free. There is enough reserve energy and vacuum stored that in the event of an electrical failure or loss of main voltage at an inconvenient point in the procedure, the procedure can still be completed. The primary function of this instrument is to make a thin anterior corneal lamellar section leaving the cornea attached nasally by means of a hinge or to remove or harvest the cornea completely. The suction ring is responsible for positioning the microkeratome over the eye. The microkeratome has an oscillating blade, which, with a defined advancing speed (0.1 to 3.0mm/sec.) is guided over the cornea of the patient. The frequency of oscillation and the advancing speed of the blade greatly influence the quality of the cut surface.
The provided document is a 510(k) premarket notification for a medical device called the Summit Krumeich-Barraquer Microkeratome, dated December 15, 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define specific acceptance criteria in terms of quantitative performance metrics (e.g., cut depth accuracy, flap diameter consistency, complication rates) that the new device must meet. Instead, the "acceptance" in this context is the FDA's determination of substantial equivalence (SE) to a legally marketed predicate device.
The document provides a Feature Comparison Table which implicitly suggests the "performance indicators" considered for SE:
| Feature | Summit K-B Microkeratome Performance | Predicate Device Performance (Eyetech Refractive Set K954058) | SE? |
|---|---|---|---|
| Indications for Use | Keratoplasty & corneal harvesting; Microlamellar keratoplasty | Same | Yes |
| Method of cut | Automatic - Step motor controlled 0.1 to 3.0mm/sec. | Manual advance - micrometer-type dial | Yes |
| Sterilization Method | Autoclave | Same | Yes |
| Blade Oscillation | Adjustable, with preset default | Fixed | Yes |
| Materials | Stainless Steel, Plastic, Glass, Natural Diamond | Same | Yes |
| Manufacturer | Gebauer GMBH | Same | Yes |
Explanation: The "acceptance criteria" here are that the new device's features and indications for use are either identical to the predicate device or do not raise new questions of safety and effectiveness despite differences (e.g., automatic vs. manual cut, adjustable vs. fixed blade oscillation). The document simply states "Yes" for Substantial Equivalence for each feature, implying that the differences are considered acceptable.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific clinical or performance test set with human subjects or derived data for the Summit Krumeich-Barraquer Microkeratome. The submission focuses on technical and descriptive comparison to the predicate device.
Given this is a 510(k) for a Class I device and the emphasis is on substantial equivalence based on device design and function, a formal clinical study with a detailed test set may not have been required or submitted for this particular premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no described "test set" with ground truth determination is provided in the document.
4. Adjudication Method for the Test Set:
Not applicable, as no described "test set" with ground truth determination is provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned or implied. The device is a surgical instrument, not an AI diagnostic tool, so this type of study would not be relevant in this context.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
Not applicable. This is a surgical microkeratome, not an AI algorithm. Its performance is inherent to its mechanical and electronic function, intended for human-in-the-loop use by a surgeon.
7. Type of Ground Truth Used:
Not applicable. The "ground truth" in this submission is the established safety and effectiveness of the predicate device, which the new device aims to be substantially equivalent to, rather than an independent measure of performance against a specific metric.
8. Sample Size for the Training Set:
Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning algorithm.
In Summary:
The provided document is a 510(k) premarket notification for a Class I medical device (keratome). The primary "study" that proves the device meets "acceptance criteria" is the comparative analysis demonstrating substantial equivalence (SE) to a legally marketed predicate device (Eyetech Barraquer-Krumeich-Swinger Refractive Set, K954058).
The acceptance criteria are implicitly that the new device's design, indications for use, and technological characteristics (even if improved, like automatic cutting and adjustable oscillation) do not raise new questions of safety or effectiveness compared to the predicate device. No formal clinical trial data, test set performance metrics, or explicit quantitative acceptance criteria are provided in this specific submission. The FDA's letter states they "determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This determination is the "proof" that the device meets the regulatory acceptance criteria for market entry under the 510(k) pathway.
§ 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.