(52 days)
For photocoagulation during ophthalmic surgery. To be used with (specified equipment).
For photocoagulation and illumination during ophthalmic surgery. This Indications for Use: r or photoougaliation, as well as 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 Illuminating 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 for laser delivery and acrylic fiber for illumination with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
The provided text does not contain detailed information about acceptance criteria or a study proving the device meets those criteria. Instead, it is a 510(k) premarket notification summary for the "Innovatech Illuminating Laser Probe," primarily focused on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use.
Here's what can be extracted and what is not available based on your request:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not specify quantitative acceptance criteria or provide performance data from a study. It focuses on comparing physical and functional specifications to predicate devices.
2. Sample sized used for the test set and the data provenance
- Not available. No test set or study data is presented. The submission relies on a comparison to predicate devices rather than a performance study of the Innovatech device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not available. Since no test set or performance evaluation study is described, there's no mention of experts establishing ground truth.
4. Adjudication method for the test set
- Not available. No adjudication method is mentioned as there is no test set described.
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
- Not applicable/Not available. This device is an ophthalmic laser probe, not an AI-assisted diagnostic or imaging system involving human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available. This is a hardware device for surgical procedures, not an algorithm.
7. The type of ground truth used
- Not available. No ground truth is mentioned because no performance study is detailed. The "ground truth" for this submission is effectively the established performance and safety of its predicate devices, implying that if the new device is sufficiently similar, it should perform equivalently.
8. The sample size for the training set
- Not applicable/Not available. This is a physical device, not a machine learning model, so there is no training set in the context of AI.
9. How the ground truth for the training set was established
- Not applicable/Not available. As above, this is not an AI/ML device.
Summary of available information related to equivalence, which is a form of "acceptance" for 510(k):
The submission demonstrates "Substantial Equivalence" by comparing the Innovatech Illuminating Laser Probe to three predicate devices: Peregrine Illuminated Laser Probe (PD600.10, K031023), HGM Illuminating Laser Probe (K931784), and Peregrine Straight Laser Probe (PD600.00, K024061).
Table of Comparison (from the document):
| Feature/Criterion | Innovatech Illuminating Laser Probe | Peregrine Illuminated Laser Probe | HGM Illuminating Laser Probe | Peregrine Straight Laser Probe |
|---|---|---|---|---|
| Primary Function | Illumination and Light transmission for photocoagulation | Illumination and Light transmission for photocoagulation | Illumination and Light transmission for photocoagulation | Light transmission for photocoagulation |
| Connector Material | Aluminum connector | Aluminum connector | Aluminum connector | Aluminum connector |
| Handpiece Material | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| Fiber Type | Optical Fiber (Glass - Silica Core) | Optical Fiber (Glass - Silica Core) | Optical Fiber (Glass - Silica Core) | Optical Fiber (Glass - Silica Core) |
| Fiber Diameter | .008" (200 microns) | .008" (200 microns) | .008" (200 microns) | .008" (200 microns) |
| Jacket Material | PVC Jacket | PVC Jacket | Teflon Jacket | PVC Jacket |
| Length | 101 inches | 101 inches | 96 inches | 101 inches |
| Needle Material | 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle |
| Needle Gauge | 20 Gauge | 20 Gauge | 20 Gauge | 20 Gauge |
| Max Power Output | 1 watt | 1 watt | 1 watt | 1 watt |
| Illumination | Illumination (Acrylic Optical fiber) | Illumination (Acrylic Optical fiber) | Illumination (Acrylic Optical fiber) | No illumination (N/A) |
"Study" Proving Acceptance (Substantial Equivalence):
The "study" here is a design and materials comparison between the Innovatech device and multiple legally marketed predicate devices. The acceptance is based on the argument that because the Innovatech Illuminating Laser Probe shares the same indications for use, fundamental technological characteristics, and similar materials and design specifications (e.g., fiber type, diameter, maximum power output, connector, handpiece, needle material and gauge) with its predicates, it is substantially equivalent and therefore presumably as safe and effective. The minor differences (like jacket material from Teflon to PVC in one comparison, and the inclusion of illumination compared to a non-illuminating predicate) are implied to not raise new questions of safety or effectiveness.
Sterilization: The device will be ETO Sterilized, and the method used to validate the sterilization cycle is the AAMI Overkill Method, which is a standard method. This is a crucial aspect of safety and effectiveness that is mentioned.
In summary, for a 510(k) submission like this, "acceptance criteria" are generally met by demonstrating that the new device does not raise new questions of safety and effectiveness compared to predicate devices, rather than through a direct performance study with quantitative metrics against predefined thresholds.
§ 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.