(121 days)
The FemTec™ Laser Microkeratome 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 FemTec Laser Microkeratome is intended for use in the creation of a corneal flap by producing short bursts of laser pulses, with each laser pulse having a duration on the order of 500 to 1000 femtoseconds ("fs", 10-15 seconds). Microscopic gas bubbles, which form as a result of the laser induced optical breakdown (LIOB), arc created adjacent to each other at a pre-determined depth in the cornea. It is this continuous layer of gas bubbles that create the lamellar corneal dissection plane just like a mechanical microkeratome blade. The FemTec Laser Microkeratome creates a flap under very low vacuum (250 mbar), and delivers the laser energy directly to the stromal layer of the cornea through a disposable PMMA contact lens, referred to as the Patient Interface (PI).
Here's an analysis of the provided text regarding the FemTec™ Laser Microkeratome, structured to address your specific questions about acceptance criteria and the supporting study:
The provided document is an Amendment to 510(k) K033354 for the FemTec™ Laser Microkeratome, cleared in 2004. It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study reports or comprehensive acceptance criteria tables for novel device performance. Therefore, some of the requested information may not be explicitly present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen in clinical study reports. It relies on demonstrating equivalence to predicate devices. The primary "performance" mentioned is that the device was "found to perform equivalently to the Hansatome Microkeratome with respect to the creation of a corneal flap in an ex vivo study."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document only mentions an "ex vivo study."
- Data Provenance: "Ex vivo study." The country of origin is not mentioned, but the submitter (20/10 Perfect Vision GmbH) is based in Heidelberg, Germany, suggesting the study might have taken place there or in a related European location. It is by nature a prospective study on ex vivo tissue.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For an ex vivo study comparing flap creation, the "ground truth" (e.g., quality of flap, thickness, smoothness) would typically be assessed by ophthalmic specialists or researchers, but no details on their number or qualifications are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. 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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a surgical instrument (microkeratome), not an AI diagnostic tool that assists human readers.
- Effect Size of AI: Not applicable, as this is a device for creating corneal flaps, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an AI algorithm. The device itself (FemTec™ Laser Microkeratome) performs the laser microkeratome procedure. Its "standalone" performance would refer to its ability to create a corneal flap, which was assessed in the ex vivo study. The study implies that the device, functioning independently, achieved equivalent results to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies the ground truth for the ex vivo study was based on objective assessment of corneal flap creation characteristics (e.g., consistency, smoothness, depth) in comparison to the Hansatome Microkeratome. This would likely involve measurements and visual inspection, potentially by experts, but the specific methodologies are not detailed. It's not pathology, or outcomes data in the sense of patient follow-up, as it was an ex vivo study.
8. The sample size for the training set
This information is not applicable as the FemTec™ Laser Microkeratome is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the FemTec™ Laser Microkeratome is a physical device, not a machine learning algorithm.
Summary of Device Performance (Based on available text):
| Performance Aspect | Reported Device Performance (FemTec™ Laser Microkeratome) | Acceptance Criteria (Implicit/Explicit) | Study Type |
|---|---|---|---|
| Corneal Flap Creation | Found to perform equivalently to the Hansatome Microkeratome with respect to the creation of a corneal flap. | Equivalence to predicate device (Hansatome Microkeratome) in corneal flap creation. | Ex vivo study |
Study Details:
- Test Set Sample Size: Not specified.
- Data Provenance: Ex vivo study.
- Number of Experts for Ground Truth: Not specified.
- Qualifications of Experts: Not specified.
- Adjudication Method: Not specified.
- MRMC Comparative Effectiveness Study: No (not applicable for this device type).
- Standalone Performance (in AI context): Not applicable. The device's "standalone" performance in creating flaps was the subject of the ex vivo study.
- Type of Ground Truth: Objective assessment of corneal flap characteristics, likely via measurements and visual inspection in comparison to a predicate device.
- Training Set Sample Size: Not applicable (not an AI algorithm).
- Ground Truth for Training Set: Not applicable (not an AI algorithm).
In conclusion, the document provides a 510(k) summary demonstrating substantial equivalence primarily through technological characteristics and a single ex vivo study comparing flap creation to a predicate device. It lacks the detailed quantitative acceptance criteria and specific study methodology (e.g., sample sizes, expert details, adjudication) typically found in comprehensive clinical study reports for devices undergoing more rigorous novel technology review.
§ 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.