(381 days)
The INTRALASE® FS Laser is an ophthalmic surgical laser with the following indications for use:
- In patients undergoing surgery or other treatment requiring intial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of the corneal ring segments
- In lamellar keratoplasty and corneal harvesting
- In the creation of a corneal flap in patients undergoing LASIK 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 and in the creation of a penetrating cut/incision for penetrating keratoplasty
The INTRALASE FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar and full thickness or penetrating corneal resections. The cutting action of the INTRALASE FS 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 is a 510(k) summary for the INTRALASE FS Laser, which is a medical device for ophthalmic surgery. This document primarily focuses on establishing substantial equivalence to predicate devices for expanded indications for use. It does not contain information about explicit acceptance criteria or a study designed to prove the device meets specific performance metrics in the way modern AI device submissions do.
Instead, the submission relies on the fact that the technological characteristics of the INTRALASE FS Laser were already cleared for a primary indication (corneal harvesting under K002890) and that the design, materials, and characteristics of the laser are the same regardless of the indication. The "study" mentioned implicitly is essentially a comparison to predicate devices, asserting equivalent performance based on existing safety standards and the device's inherent characteristics.
Therefore, many of the requested categories cannot be directly answered from the provided text, as they pertain to a different type of performance validation (e.g., for AI or diagnostic devices).
Here's an attempt to answer as much as possible based on the provided text, with clear indications where information is not present:
Acceptance Criteria and Device Performance Study (K041893: INTRALASE FS Laser)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Equivalence to Predicate Devices for Corneal Resections: The device must perform equivalently to predicate devices (K981063 Automated Corneal Trephine, K013151 ASMOTOM Automated Corneal Trephine) with respect to the creation of partial or full thickness corneal resections for lamellar keratoplasty and penetrating keratoplasty. | The INTRALASE FS Laser was found to perform "equivalently" to the predicate devices with respect to the creation of partial or full thickness corneal resections for lamellar keratoplasty and penetrating keratoplasty. The submission states, "Thus, the INTRALASE FS Laser and the predicate device have similar safety, effectiveness and performance profiles." |
| Safety Standards Compliance: The device must have undergone testing in accordance with applicable safety standards. | The INTRALASE FS Laser "has undergone testing in accordance with applicable safety standards." (Specific standards or results not detailed in this summary). |
| Technological Characteristics Equivalence: For the expanded indications, the technological characteristics of the device must be the same as those cleared under its original 510(k) (K002890 for corneal harvesting). | The technological characteristics of the INTRALASE FS Laser are "already been cleared under K002890 for corneal harvesting. The design, materials, and characteristics of the laser keratome are the same irrespective of the indication for use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not provided. The submission describes nonclinical testing and comparison to predicates, not a clinical study with a specified "test set" in the context of AI or diagnostic device evaluation.
- Data Provenance: Not applicable/Not provided. The evaluation is based on technical characteristics and equivalence, not patient data from specific countries or retrospective/prospective studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not provided. This type of evaluation (expert consensus for ground truth) is not relevant for this device's 510(k) submission, which focuses on substantial equivalence of a physical surgical laser tool.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. This concept is typically relevant to clinical studies involving human observers or diagnostic assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not conducted as this is a surgical laser device, not a diagnostic imaging device or an AI-assisted interpretation tool. The submission does not mention human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a surgical laser, not an algorithm. The concept of "standalone performance" for an algorithm is not applicable here.
7. The Type of Ground Truth Used
- Equivalence/Performance to Predicate Devices and Safety Standards: The "ground truth" implicitly used for this submission is the established performance and safety of legally marketed predicate devices, along with compliance with applicable safety standards for the device itself. The assessment relies on the device's ability to perform the same surgical cuts as the predicates and its adherence to safety requirements.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided. This device is 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.