(69 days)
The BD K-3000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as in Laser In-situ Keratomileuses (LASIK) surgery. The corneal resection is consistently of a predetermined diameter, thickness and uniform surface quality for precise lamellar cuts and consistent flap generation.
The BD K-3000™ Microkeratome System is a battery operated, fully automated Keratome device to produce a corneal resection prior to laser ablation l laser applications and procedures such as, in Laser In-situ Keratomileusus K) surgery. The Microkeratome is a precise cutting device uniquely designed for comfort, speed and accuracy. The BD K-3000™ Microkeratome System enables ons to cut precision flaps quickly and easily. The Microkeratome's unique shape is ned to offer more comfort and efficiency while delivering precision and accuracy. e Microkeratome system features:
- One-piece fully assembled handpiece allows complete assembly prior to positioning on the eve
- he handpiece is ergonomically designed and of titanium construction to increase rgeon comfort
- components are fully interchangeable for flexibility
- keratome system consistently produces a corneal resection of a predetermined er, thickness and uniform surface quality.
- ratome head assures depth consistency. The head houses a precision blade elivers constant drive alignment through a double dovetail suction ri
- keratome handpiece contains dual motors. One controls oscillation of the e and a second translates the head across the eve.
- teratome handpiece automatically returns to home position without oscillating.
The information provided is about the Becton Dickinson K-3000™ Microkeratome System, a device for producing corneal resections in ophthalmic surgery. The document is a 510(k) PreMarket Notification from 2002.
Acceptance Criteria and Device Performance Study
The document indicates that the device's performance was evaluated through in-vitro studies using porcine eyes. The criteria tested were related to the quality and consistency of the corneal resection.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flap thickness consistency, accuracy, and variability | Demonstrated |
| Safety of corneal resection | Demonstrated |
| Good quality of corneal resection | Demonstrated (Qualitatively evaluated by experienced surgeons) |
| Predetermined diameter | The device is intended to produce a corneal resection of a predetermined diameter. The study implies this was achieved. |
| Predetermined thickness | The device is intended to produce a corneal resection of a predetermined thickness. The study explicitly states "Flap thickness consistency, accuracy and variability" were demonstrated, implying the predetermined thickness was met. |
| Uniform surface quality | The device is intended to produce a corneal resection of uniform surface quality. The study reports "Good quality of corneal resection" and mentions qualitative evaluation of "corneal resection quality", implying this criterion was met. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated regarding the number of porcine eyes used. The text only mentions "in-vitro studies on porcine eyes."
- Data Provenance: In-vitro studies on porcine eyes. This means the data is from animal tissue, not human patients. It is prospective testing in an ex-vivo setting. The country of origin of the data is not specified.
3. Number of Experts and Qualifications for Ground Truth of the Test Set:
- Number of Experts: Four (4)
- Qualifications of Experts: Described as "experienced surgeons." No further details on their specific specialties (e.g., ophthalmologists) or years of experience are provided.
4. Adjudication Method for the Test Set:
The document states that the four experienced surgeons "rated the quality of the stromal bed after corneal resection of porcine eyes and qualitatively evaluated the Microkeratome blade sharpness and corneal resection quality." This indicates a qualitative assessment by multiple experts, but no specific adjudication method (like 2+1 or 3+1 consensus) is detailed. It appears to be an independent qualitative evaluation by each surgeon.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The study focuses solely on the performance characteristics of the device itself and compares it to a predicate device for substantial equivalence, not on the improvement of human readers with AI assistance.
6. Standalone Performance (Algorithm Only):
This device is a physical surgical instrument, not an AI algorithm. Therefore, a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable and was not performed. The performance evaluated is of the device as a total system in operation.
7. Type of Ground Truth Used:
The ground truth for the performance evaluation was based on a qualitative assessment by "experienced surgeons" of the "quality of the stromal bed" and "corneal resection quality" on porcine eyes. This can be categorized as expert qualitative assessment / expert consensus on animal tissue.
8. Sample Size for the Training Set:
This device is a mechanical surgical instrument, not a learning algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.