(90 days)
The OASIS Disposable N-PE (Precision Edge) Microkeratome Blade (Catalog #0412) is a replacement blade for the Nidek MK-2000 Microkeratome for lamellar resection of the cornea.
The OASIS Disposable N-PE Microkeratome Blades are replacement stainless steel blades for the Nidek MK-2000 Microkeratome blade. The Disposable N-PE Microkeratome Blades are made of 400 Series Stainless Steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.
The OASIS Disposable N-PE Microkeratome Blades are replacement blades for the Nidek MK-2000 Microkeratome, intended for lamellar resection of the cornea. The study aimed to demonstrate substantial equivalence to the legally marketed Nidek MK-2000 microkeratome blades (K990900).
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Predicate Device K990900) | Reported Device Performance (OASIS N-PE Blade) |
|---|---|---|
| Intended Use | As indicated by the predicate device manufacturer (for lamellar resection of the cornea). | Same (for lamellar resection of the cornea). |
| Target Population | As indicated by the predicate device manufacturer. | Same. |
| Performance | Compatibility with Nidek MK-2000 Microkeratome. | Dimensional Equivalency Test: Physical measurements are substantially equivalent. |
| Sharpness Tests: Performs as well as the predicate device. | ||
| Fit Test: Fit into the Nidek MK-2000 Microkeratome has been tested and shown to be acceptable. | ||
| Non-clinical Testing: Corneal lamellar sections on porcine eyes are equivalent to the predicate devices. | ||
| Blade Material | Low carbon stainless steel. | Same (400 Series Stainless Steel). |
| Biocompatibility | Biocompatibility for Stainless Steel Blades. | Same (for Stainless Steel Blades). |
| Mechanical Safety | Assured. | Same (Assured). |
| Sterilization | Sterilized by a validated process (e.g., ethylene oxide with SAL of 10^-5^). | Sterilized by exposure to ethylene oxide to a SAL of 10^-5^ according to a validated process in compliance with EN 550. |
| Labeling | Pouch indicates manufacturer name, address, product identification, lot number, sterilization process, single use, and federal law statements. | Pouch indicates OASIS name, address, product identification, lot number, sterilization process, single use, and federal law statements. |
Study Details:
The provided document describes a 510(k) Premarket Notification Summary which aims to demonstrate substantial equivalence of the OASIS Disposable N-PE Microkeratome Blades to a predicate device. This is primarily a comparative study against a legally marketed device rather than a standalone study with defined acceptance criteria for de novo clinical performance. The "acceptance criteria" are effectively the characteristics and performance of the predicate device that the new device must match or be equivalent to.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly mentions non-clinical testing on porcine eyes. It does not specify the exact number of porcine eyes used, making the sample size for this part of the testing unknown from the provided text. The data provenance for this specific test would be non-human (animal model), likely conducted in a laboratory setting. No country of origin is specified. The study is retrospective in the sense that it aims to demonstrate equivalence to a pre-existing medical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of human experts to establish ground truth for the test set. The evaluations appear to be based on objective physical measurements (dimensional equivalency), biomechanical tests (sharpness, fit), and direct comparison of lamellar sections from porcine eyes.
4. Adjudication Method for the Test Set:
No adjudication method is described, as the evaluation methods are primarily quantitative and comparative against the predicate rather than involving subjective interpretation by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The device is a surgical blade, and the assessment focuses on its physical and functional equivalence, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This question is not applicable. The device is a physical surgical tool and does not involve an algorithm or AI.
7. Type of Ground Truth Used:
The "ground truth" for the equivalence demonstration is primarily established through:
- Physical measurements and specifications of the predicate device.
- Performance characteristics (sharpness, fit) as demonstrated by the predicate device.
- Resulting tissue sections (corneal lamellar sections) obtained using the predicate device.
Specifically for the OASIS blade, the "ground truth" for its performance is its ability to produce measurements, sharpness, fit, and lamellar sections equivalent to those of the predicate device.
8. Sample Size for the Training Set:
This question is not applicable. The device is a physical product and does not involve machine learning algorithms or a "training set" in the computational sense. The "training" for the manufacturing process would be part of Standard Operating Procedures (SOPs) and Quality System Regulations (QSRs), not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the reasons stated above.
§ 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.