(168 days)
The VisuMax Femtosecond Laser is cleared for the following indications for use:
· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
· In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty;
· In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting;
· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
The VisuMax Femtosecond Laser is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
The provided text describes the 510(k) premarket notification for the Carl Zeiss Meditec VisuMax Femtosecond Laser (K173371). The focus of this submission is on software modifications to enable an additional indication for use: "creation of tunnels for placement of corneal ring segments."
The submission concludes that the device is substantially equivalent to predicate devices, but it does not contain specific acceptance criteria, comprehensive study designs, or detailed results typically found in a clinical study report. Instead, it provides a summary of the performance testing.
Here's an attempt to extract the requested information based only on the provided text, with acknowledgments for missing data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| For Tunnel Cuts (expanded indication): | |
| Accuracy of corneal tunnel lateral dimensions (implied quantitative range) | "Test acceptance criteria for all cut length dimension and cut angular dimensions were met." |
| Repeatability of corneal tunnel lateral dimensions (implied quantitative range) | "Test acceptance criteria for all cut length dimension and cut angular dimensions were met." |
| Accuracy of corneal tunnel depth dimensions (implied quantitative range) | "Test acceptance criteria for all cut depth dimensions were met." |
| Repeatability of corneal tunnel depth dimensions (implied quantitative range) | "Test acceptance criteria for all cut depth dimensions were met." |
| Quality of tunnel cuts (ease of tissue separation) | "All corneas tested in this manner were judged to be of good cut quality, meeting the performance test acceptance criteria." |
| For Software (general): | |
| Performance, accuracy, functionality, and safety of software modifications (implied comprehensive criteria) | "The software verification and validation testing results demonstrate that the VisuMax Femtosecond Laser meets all requirements for performance, accuracy, functionality and safety for the modifications proposed in this 510(k) premarket notification." |
Note: The document states that "Test acceptance criteria...were met" but does not explicitly define the quantitative metrics or thresholds for these criteria. The acceptance criteria above are inferred from the description of the tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "a series of corneal models" and "all corneas tested in this manner," but does not specify the exact number (sample size) of ex vivo corneas or corneal models used for performance testing.
- Data Provenance: The testing involved "ex vivo corneas" and "corneal model material." The country of origin is not specified, and the data is retrospective in the sense that it's laboratory/bench testing and not a prospective clinical trial on human subjects for this specific claim.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document mentions "ex vivo corneas" and "corneal model material" for performance testing. The evaluation of cut quality mentions "judged to be of good cut quality," implying subjective assessment.
- However, the number of experts and their qualifications (e.g., radiologists with X years of experience) used to establish ground truth or evaluate these ex vivo tests are not specified in the provided text.
4. Adjudication Method for the Test Set
- The document implies subjective judgment for cut quality ("judged to be of good cut quality").
- However, a formal adjudication method (e.g., 2+1, 3+1) is not described for any aspect of the performance testing in the provided text. The non-contact optical techniques used for dimensional measurements suggest objective assessment rather than adjudication by human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study to assess improvement in human readers with/without AI assistance was not done/described in this submission. This device is a surgical laser, not an AI diagnostic tool that assists human readers.
6. Standalone Performance Study (Algorithm Only)
- A standalone performance study focused on the algorithm's performance without human-in-the-loop was not explicitly described in the conventional sense of AI diagnostic devices. The performance data presented focuses on the physical output of the laser system (tunnel cuts) after software modifications. The software itself was verified and validated against functional requirements.
7. Type of Ground Truth Used
- For the physical performance tests related to tunnel cuts, the "ground truth" was established based on physical measurements using non-contact optical techniques in ex vivo corneas and corneal model materials. Cut quality was assessed subjectively against "performance test acceptance criteria."
- For the software, the "ground truth" was its adherence to specified performance, accuracy, functionality, and safety requirements during verification and validation (V&V) testing.
8. Sample Size for the Training Set
- The document describes software modifications to an existing device and performance testing, not the development or training of a machine learning model.
- Therefore, a "training set" for an AI algorithm is not applicable/not mentioned in this submission.
9. How Ground Truth for the Training Set Was Established
- As a "training set" for an AI algorithm is not applicable, the method for establishing its ground truth is not mentioned. The software verification and validation process involved testing the modified software against predefined functional specifications and safety requirements.
§ 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.