(32 days)
The OASIS N-PE Microkeratome Blades are designed as replacement blades for the Nidek MK-2000 Microkeratome for lamellar resection of the comea.
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 low carbon stainless steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.
The acceptance criteria for the OASIS Disposable N-PE Microkeratome Blades and the study proving its performance are detailed below. It's important to note that this device is a Class I medical device (keratome blade) and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than complex clinical studies typically associated with higher-risk devices or software.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| Intended Use | Same as predicate device (Nidek MK-2000 Microkeratome blade) |
| Target Population | Same as predicate device |
| Performance | Comparable to Nidek MK-2000 Microkeratome blade |
| Fit into Nidek MK-2000 | Tested and shown to be acceptable |
| Material/Design Equivalence: | |
| Blade Material | Low carbon stainless steel (same as predicate) |
| Biocompatibility | For Stainless Steel Blades (same as predicate) |
| Sterilization Method | Ethylene Oxide (same as predicate), SAL of 10-6 |
| Performance Measurements: | |
| Flap Diameter | Measured, shown to be Equivalent to predicate device |
| Flap Thickness | Measured, shown to be Equivalent to predicate device |
| Dimensions | Measured, shown to be Substantially equivalent to predicate device |
| Sharpness | Tests show performance as well as the predicate device |
| Safety: | |
| Mechanical Safety | Assured (same as predicate) |
| Adverse Safety Indications | No adverse safety indications when used per manufacturer's instructions |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a precise numerical sample size for the "test sets" of blades used in the dimensional equivalency, sharpness, and fit tests. It implies that these tests were performed on a sufficient number of OASIS blades to draw conclusions about their equivalence to the predicate.
- Data Provenance: The data provenance for the non-clinical testing is "non-clinical testing on porcine eyes." This indicates that the testing was performed on animal models. There is no mention of country of origin for this data specifically, nor is it specified if it was retrospective or prospective, though non-clinical tests are typically prospective for device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is typically not applicable for a 510(k) submission of a Class I device focused on substantial equivalence to a predicate. The evaluation relies on direct material and performance comparisons, not expert interpretation of results that would require consensus for a "ground truth" in the way it's used in AI/diagnostic studies.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective measurements (dimensions, sharpness, fit) or direct comparisons, not requiring expert adjudication for ambiguous results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation is involved. This submission is for a surgical blade, where performance is assessed through physical and functional equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical tool, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established characteristics and performance of the predicate device (Nidek MK-2000 blade). The OASIS blades are directly compared against these known attributes through:
- Objective Measurements: Such as dimensional equivalency.
- Functional Demonstrations: Such as sharpness testing and fit into the microkeratome.
- Performance Equivalence in a Model: Confirmed by producing "corneal lamellar sections equivalent to the predicate devices" on porcine eyes.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.