(88 days)
Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications, including dermatology and plastic surgery, discectomy, gastroenterological/ gastrointestinal surgery, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology surgery.
The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium: YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 um and up to 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.
The provided text is a 510(k) Summary for the Trimedyne Holmium Laser System. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a standalone study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the format typically associated with performance evaluations for AI/Machine Learning devices or novel medical devices requiring de novo clearance.
Here's a breakdown of why the requested information isn't available in this document:
- Type of Device: The Trimedyne Holmium Laser System is a physical medical device (a laser) from 1999, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The regulatory requirements and testing methodologies for such devices are very different.
- Regulatory Pathway (510(k)): The 510(k) pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. This means the manufacturer primarily demonstrates that their new device has the same intended use, technological characteristics, and safety and effectiveness profile as an already approved device. It does not typically involve extensive new clinical trials or the setting of quantitative acceptance criteria in the way an AI algorithm might have for its performance metrics (e.g., sensitivity, specificity).
- Lack of Performance Metrics: The document describes the device's technical specifications (wavelength, pulsewidth, power output) and its intended uses. It concludes that "The Trimedyne Holmium: YAG Laser System can be used for the proposed indications," which is a general statement of equivalency, not a specific performance metric. There are no mentions of sensitivity, specificity, AUC, or other quantitative performance measures.
- No "Ground Truth": For a physical laser, the "ground truth" concept as applied to AI models (e.g., expert consensus on image interpretation, pathology results) isn't relevant. Its effectiveness is based on its physical properties and how those properties are used in surgical procedures, often evaluated through bench testing, animal studies, and limited human clinical experience in the context of equivalency to existing technology.
- No AI Component: There is no AI or machine learning algorithm described, nor any human-in-the-loop component.
To directly answer your request based on the provided text, while acknowledging its limitations for this type of query:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document for specific performance metrics. | The Trimedyne Holmium: YAG Laser System can be used for the proposed indications, demonstrating substantial equivalence to predicate devices (Coherent VersaPulse Select Dual Wavelength Surgical Laser, Trimedyne Optilase® Model 1000-100 Nd: YAG Laser System, Nortech Autolith Lithotriptor Electro-Hydraulic System). |
| Technological Equivalence Criteria (Implied by 510(k) process): | Met (Implied by FDA Clearance): |
| - Deliver pulsed infrared laser energy with a wavelength of 2.1 um | Wavelength: 2.1 um (near infrared) |
| - Maximum pulsewidth up to 350 microseconds | Maximum pulsewidth: 350 microseconds |
| - Maximum output of 100 watts of power (for OmniPulse™-MAX) | Maximum output power: 100 watts |
| - Menu-driven control options for pulse repetition rate, output energy, and lasing duration | Menu-driven control options allow users to select pulse repetition rate, output energy, and lasing duration. |
| - Intended Use: Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications (as detailed in the "Indications for Use" section). | Demonstrated substantial equivalence to predicate devices for these intended uses. |
2. Sample sized used for the test set and the data provenance
- Not Applicable / Not Provided: The document does not describe a "test set" in the context of an algorithm's performance evaluation. The substantial equivalence determination would have been based on a comparison of device specifications, bench testing results, and potentially pre-existing clinical data or literature relating to the predicate devices, rather than a new, defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: The concept of "ground truth" for expert consensus is not relevant to this medical device type or its regulatory pathway as described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set or adjudication method is 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 Done: This is a physical laser device, not an AI-assisted diagnostic tool. There are no "human readers" or AI assistance components to evaluate in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Done: This is a physical laser device. There is no algorithm to evaluate in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: The concept of "ground truth" as it applies to the evaluation of AI models or diagnostic devices is not relevant or described for this physical laser device. Equivalence for a laser is typically established through engineering specifications, bench testing on tissue phantoms, and comparison of outcomes data for similar predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided: The device is a physical laser, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no AI model or training set, this information is not relevant.
§ 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.