(136 days)
The Horus Laser Keratome is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
The Horus Laser Keratome is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Horus Laser Keratome is achieved through precise individual mirco-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vaccum.
The provided text does NOT contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for the Horus Laser Keratome, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results with specific acceptance criteria.
However, I can extract the available information and indicate where data is missing.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify acceptance criteria for the Horus Laser Keratome in a numerical or categorical format with corresponding performance results. It broadly states:
| Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence | "The Horus Laser Keratome was found to perform equivalently to the predicate device, the Hansatome Microkeratome, with respect to the creation of cornea resections." |
| Safety Standards | "The Horus Laser Keratome has been designed and tested to applicable safety standards." |
| Intended Use | The device is indicated for "creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea." This implies it successfully creates such flaps. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance (country of origin, retrospective/prospective): Not specified.
- The study is described as "extensive ex-vivo studies," suggesting it was conducted on excised tissue (likely animal or cadaveric) rather than live human patients.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Not specified.
4. Adjudication method for the test set
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study is not mentioned. The study described is an "ex-vivo" comparison to a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is a surgical laser, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" is not applicable in the way it would be for an AI diagnostic device. The performance mentioned ("creation of cornea resections") refers to the device's physical action.
7. The type of ground truth used
- The text describes "extensive ex-vivo studies" comparing the device's performance in "creation of cornea resections" to a predicate device. The "ground truth" implicitly would be the physical characteristics and quality of the corneal resections created by both the Horus Laser Keratome and the predicate device, as evaluated by expert assessment (though the number and qualifications of experts are not specified). It is not pathology, expert consensus in a diagnostic sense, or outcomes data from human patients.
8. The sample size for the training set
- This device is not an AI algorithm that undergoes a "training set." It is a physical medical device.
9. How the ground truth for the training set was established
- Not applicable, as it's not an AI algorithm.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.