(32 days)
The MB 102 Millennium blade is intended to be used as a replacement blade for the Hansatome™ Microkeratome.
The MB 102 Millennium Blade is a replacement blade designed to be used with the Hansatome™ Microkeratome. The MB 102 Millennium Blade is a single-use only, disposable device. The blade material is similar to that used in predicate devices (stainless steel).
Acceptance Criteria and Study for MB 102 Millennium Blades
The provided document describes the premarket notification for the Millennium Biomedical Inc. MB 102 Millennium Blades, which are intended as replacement blades for the Hansatome™ Microkeratome. The primary method of demonstrating safety and effectiveness is through substantial equivalence to a predicate device, the B&L Accuglide™ Blade.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner but are implied through the comparison of technological characteristics to the predicate device and the successful functional performance testing. The "reported device performance" is essentially the determination of substantial equivalence based on these comparisons and tests.
| Characteristic | Acceptance Criteria (Implied: Substantially equivalent to predicate) | Reported Device Performance (MB 102 Millennium Blade) |
|---|---|---|
| Intended Use | Indicated for use with the Hansatome™ Microkeratome by surgeons to cut cornea in the form of a hinged flap in LASIK refractive surgery procedures. | Intended to be used as a replacement blade for the Hansatome™ Microkeratome. |
| Operating Principle | Blade held in keratome head, oscillates via turbine, adapts to turbine via threaded part, gas-powered turbine motor. | Blade held in keratome head, oscillates via turbine, adapts to turbine via threaded part, gas-powered turbine motor. |
| Blade Design | Single edge blade with plastic blade holder. | Single edge blade with plastic blade holder. |
| Blade Hardness | 52 Rockwell C. | 52 Rockwell C. |
| Sterilization Method | Cobalt 60 radiation. | Cobalt 60 radiation. |
| Blade Material | Stainless steel. | Stainless steel. |
| Blade Holder Material | Delrin. | Delrin. |
| Patient Contact Portion | Blade cutting edge. | Blade cutting edge. |
| Functional Performance | Acceptable functional performance. | Functional performance was found to be acceptable and substantially equivalent to the predicate blade. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the functional performance testing. It refers to "test results of the functional performance testing" but provides no quantitative details on how many blades were tested or under what conditions.
- Data Provenance: The document does not specify the country of origin of the data. The data appears to be retrospective in the sense that it relies on a comparison to an already marketed predicate device and likely internal testing to confirm equivalence. There is no mention of a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the functional performance testing. The comparison is made against the established characteristics and performance of the predicate device, which is already FDA-cleared.
4. Adjudication Method for the Test Set
No adjudication method is described. The assessment appears to be based on direct comparison of technological characteristics and internal functional performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. The device is a surgical blade, and the evaluation relies on its physical and functional equivalence to a predicate device, not on comparative effectiveness with human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to the device, which is a physical surgical blade. Therefore, no standalone study in this context was performed.
7. Type of Ground Truth Used
The "ground truth" for the MB 102 Millennium Blade's performance is implicitly the established performance and characteristics of the predicate device (B&L Accuglide™ Blade). The study's goal was to demonstrate that the MB 102 Millennium Blades are "substantially equivalent" to this predicate.
8. Sample Size for the Training Set
This concept is not applicable to this device. As a physical medical device, there is no "training set" in the context of an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.