(133 days)
The OASIS Disposable M2-PE (Precision Edge) Microkeratome Blade (Catalog #0415) is designed as a replacement blade for the Moria M2 Microkeratome for lamellar resection of the cornea.
The OASIS Disposable M2-PE Microkeratome Blades are replacement stainless steel blades for the Moria M2 Microkeratome Blade. The Disposable M2-PE Microkeratome Blades are made of 400 Series Stainless Steel, packaged and sterilized using the same methods. The OASIS Disposable M2-PE Microkeratome Blades are single-use, disposable blades.
The provided document is a 510(k) Premarket Notification Summary for the OASIS Medical, Inc. Disposable M2-PE Microkeratome Blades. It focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical studies with acceptance criteria in the typical sense of AI/ML device evaluations. Therefore, the information requested might not be fully present or will be interpreted based on the available data.
Here's an analysis based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" as would be defined for an AI/ML device comparing performance metrics (e.g., sensitivity, specificity thresholds) are not explicitly stated. Instead, the demonstration of substantial equivalence is based on the device having "the same" or "substantially equivalent" characteristics and performance compared to the predicate device.
| Characteristic / Test | Acceptance Criteria (Implied from Substantial Equivalence Claim) | Reported Device Performance (OASIS M2-PE Microkeratome Blades) |
|---|---|---|
| Intended Use | Same as predicate (Moria M2 Microkeratome Blade) | Same |
| Target Population | Same as predicate | Same |
| Performance (Compatibility) | Compatible with Moria M2 Microkeratome (as predicate) | Same (Tested and shown to be acceptable) |
| Blade Material | Same as predicate (low carbon stainless steel) | Same |
| Biocompatibility | Same as predicate (for Stainless Steel Blades) | Same |
| Mechanical Safety | Assured, same as predicate | Assured, same as predicate |
| Dimensional Equivalency | Substantially equivalent to predicate in physical measurements | Substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc. |
| Sharpness | Perform as well as the predicate device | Perform as well as the predicate device |
| Fit into Moria M2 Microkeratome | Acceptable fit | Tested and shown to be acceptable |
| Non-clinical Testing (Corneal Lamellar Sections) | Equivalent to the predicate devices | Resulted in corneal lamellar sections equivalent to the predicate devices (on porcine eyes) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For Dimensional Equivalency, Sharpness, and Fit tests: The document does not specify the exact number of blades tested. It only states "physical measurements of the predicate device are substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc." and "sharpness tests show that the OASIS M2-PE blades (0415) perform as well as the predicate device."
- For Non-clinical testing on porcine eyes: The document does not specify the number of porcine eyes used.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a physical device like a blade, the testing would typically be prospective laboratory and possibly animal testing conducted by the manufacturer, or a contract lab on their behalf.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of "experts" in the context of establishing ground truth for a test set, as this is not a study evaluating human-interpretable output where expert consensus would be required (e.g., image reading). The "ground truth" for these performance tests would be objective measurements (dimensions, sharpness metrics) or outcomes from the animal model (quality of lamellar sections).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert readings, which is not relevant for the types of tests (dimensional, sharpness, fit, animal model) conducted for this mechanical device.
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 that involve human interpretation of results, often with AI assistance, to measure the impact of AI on human reader performance. This document pertains to a surgical blade, not a diagnostic imaging or AI-assisted diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense, the performance tests described (Dimensional Equivalency, Sharpness, Fit, Non-clinical testing on porcine eyes) can be considered "standalone" in that they assess the intrinsic characteristics and performance of the blade itself, without direct human-in-the-loop interpretation being the primary focus of the performance evaluation. However, this is not an "algorithm-only" study as described for AI/ML devices.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed was based on:
- Objective Measurements: For dimensional equivalency, sharpness, and fit.
- Observed Outcomes: For non-clinical testing on porcine eyes, the "equivalence" of corneal lamellar sections to those produced by the predicate device would be the observed outcome. While not explicitly stated, this observation would likely be qualitative or semi-quantitative, assessed by experienced personnel.
8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for AI/ML models that learn from data. This document describes the evaluation of a physical medical device (a microkeratome blade), not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical 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.