(163 days)
The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the comea at a varying depth with respect to the corneal surface.
In addition, the FEMTO LDV Z6 Surgical Laser is intended for use in patients undergoing cataract surgery for the creation of single-plane, multi-plane, partial thickness and full thickness cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Corneal dissection with the FEMTO LDV Z6 Femtosecond Surgical Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical pulses which are delivered through an applanation window assembly while fixating the eye under a vacuum.
The provided text describes the submission of a 510(k) summary for the FEMTO LDV Z6 Femtosecond Surgical Laser but lacks detailed information regarding specific acceptance criteria, study methodologies, and performance metrics typically found in a comprehensive clinical or non-clinical study report.
Based on the information provided, here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The document states that "Results of the software validation and the in-vitro validation show that the design changes made to the device are substantially equivalent." And specifically, that "An in-vitro validation was performed that demonstrated the accuracy and precision of the new incisions."
However, no specific quantitative acceptance criteria or reported performance values (e.g., specific accuracy percentages, precision ranges, or success rates) are provided within the given text. The document broadly states that the validation "demonstrated the accuracy and precision," but does not detail what those demonstrated values were or against what specific benchmarks they were measured.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Demonstrated accuracy and precision (no quantitative values provided) |
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "an in-vitro validation was performed." This implies a test set was used, but the sample size for this test set is not provided.
- Data provenance is not explicitly stated, but "in-vitro" suggests a laboratory-based study rather than data from human subjects. This would typically mean no specific country of origin, and it is by nature a prospective design for the experimental setup.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Since the validation was "in-vitro" and focused on "accuracy and precision of the new incisions," the ground truth would likely be established through precise metrological measurements (e.g., using calipers, microscopy, or other optical measurement tools) against pre-defined design specifications, rather than expert human interpretation. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not relevant here.
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Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation where there might be disagreement among readers. For an in-vitro validation of accuracy and precision, the measurements performed would be objective and rely on verified instruments and procedures, not human adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The provided text does not describe an MRMC comparative effectiveness study. The device is a surgical laser, and the validation described is an "in-vitro validation" of its physical performance (accuracy and precision of incisions), not a diagnostic AI system requiring evaluation of human reader performance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The "in-vitro validation" focusing on the accuracy and precision of incisions produced by the laser itself, without human intervention in the cutting process (beyond initial setup and operation), can be considered analogous to a standalone performance evaluation of the device's cutting capabilities. There is no AI algorithm being evaluated for diagnostic performance, but rather the physical output of the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the "in-vitro validation" of incision accuracy and precision would have been pre-defined engineering specifications or physical measurements from a highly accurate reference system (e.g., specific dimensions, depths, or shapes of the incisions as intended by the device design).
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The sample size for the training set:
- Not applicable / Not specified. This device is a surgical laser, and the validation described is for its mechanical/optical performance. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "software changes" mentioned relate to the control software for the laser, which would undergo traditional software validation and verification, not machine learning training.
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How the ground truth for the training set was established:
- Not applicable / Not specified. As there is no AI/ML training set in the context of this device and validation, the concept of establishing ground truth for a training set does not apply.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.