(52 days)
For photocoagulation during ophthalmic surgery. This device delivers laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
The Innovatech Straight Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber with PVC jacket, a Delrin handpiece and a 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
The Innovatech Straight Laser Probe is an ophthalmic laser delivery device, and its acceptance criteria and the study proving it meets these criteria are outlined in the provided text, primarily through a substantial equivalence comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Innovatech Straight Laser Probe are implicitly defined by its substantial equivalence to predicate devices, meaning its performance characteristics are comparable to those already legally marketed. The table below summarizes the key features and their performance (or characteristics) for the Innovatech device and its primary predicate, the Peregrine Straight Laser Probe (Product: PD600.00, 510(k): K024061).
| Acceptance Criteria (Characteristic) | Innovatech Straight Laser Probe Performance | Peregrine Straight Laser Probe Performance (Predicate) |
|---|---|---|
| Intended Use | Light transmission for photocoagulation | Light transmission for photocoagulation |
| Connector Material | Aluminum connector | Aluminum connector |
| Handpiece Material | Delrin Handpiece | Delrin Handpiece |
| Optical Fiber Type | Optical Fiber Glass - Silica Core | Optical Fiber Glass - Silica Core |
| Optical Fiber Diameter | .008" (200 microns) | .008" (200 microns) |
| Jacket Material | PVC Jacket | PVC Jacket |
| Length | 101 inches | 101 inches |
| Needle Material | 304 Stainless Needle | 304 Stainless Needle |
| Needle Gauge | 20 Gauge | 20 Gauge |
| Max Power Output | 1 watt | 1 watt |
| Sterilization Method | ETO Sterilized | (Implied equivalent for ETO sterilized devices) |
| Sterilization Validation | AAMI Overkill Method | (Implied equivalent for devices validated by AAMI) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a specific "test set" in the context of clinical or performance testing with human subjects or a defined dataset for AI evaluation. The substantial equivalence claim is based on a comparison of device specifications and intended use against existing predicate devices. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there is no mention of a "test set" in the context of clinical performance or AI evaluation, there is no information provided on the number of experts or their qualifications used to establish ground truth.
4. Adjudication Method for the Test Set
As there is no described test set involving expert review, there is no adjudication method mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. The submission focuses on device characteristics and substantial equivalence, not comparative effectiveness with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a physical ophthalmic laser probe, not an artificial intelligence algorithm. Therefore, no standalone (algorithm only) performance study was conducted or is relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on engineering specifications and functional characteristics being substantially equivalent to legally marketed predicate devices. This is a technical and regulatory comparison, not a clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense of diagnostic or treatment efficacy studies.
8. The Sample Size for the Training Set
Since this is a physical medical device and not an AI algorithm, there is no concept of a "training set" as understood in machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 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.