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.

Device Description

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.

AI/ML Overview

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.

Summary

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OCT 2 9 1999

K992574

510(k) Summary of Safety and Effectiveness Information

Trimedyne® Holmium Laser System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I.	Submitter Information:	Trimedyne, Inc.P.O. Box 57001Irvine, CA 92619-7001
	Contact person:	Susan H. GambleVice President, Regulatory Affairs and Quality
	Summary Date:	July 29, 1999

II. Device Name

Trimedyne Holmium Laser System, including: Proprietary:

Trimedyne OmniPulse™ Holmium Laser System (Model 1210) +
Trimedyne OmniPulseTM-MAX Holmium Laser System (Model 1210-VHP) ◆
Model 1500-A Holmium Laser System �

Holmium: Yttrium Aluminum Garnet (Holmium: YAG) Laser Common:

Classification: Laser-Powered Instrument

III. Predicate Device

The predicate devices are:

Coherent VersaPulse Select Dual Wavelength Surgical Laser. 1.
Trimedyne Optilase® Model 1000-100 Nd: YAG Laser System. 2.
Nortech Autolith Lithotriptor Electro-Hydraulic System. 3.

IV. Device Description

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V. Intended Use

The Trimedyne Holmium:YAG Laser System is intended for 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.

VI. Technological Characteristics

The laser system is a Holmium: YAG laser which emits light at a wavelength of 2.1 um (near infrared) and a maximum pulsewidth of 350 microseconds. The laser has the capability of attaining a maximum output of 100 watts of power.

VII. Conclusions Drawn from Testing

The Trimedyne Holmium: YAG Laser System can be used for the proposed indications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1999

Ms. Susan H. Gamble Vice President, Regulatory Affairs and Quality Trimedyne, Inc. 2801 Barranca Road P.O. Box 57001 Irvine, California 92619

Re: K992574

Trade Name: Omni Pulse™ Holmium Laser System, Model 1210 Omni Pulse™ MAX Holmium Laser System, Model 1210-VHP Model 1500-A Holmium Laser System

Regulatory Class: II Product Code: GEX Dated: July 29, 1999 Received: August 2, 1999

Dear Ms. Gamble:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or

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Page 2 – Ms. Susan H. Gamble

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free_ number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Munell H. Sager

Sur Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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9925'74

Page 1 of 2 (revised)

510(k) Number (if known):
Device Name:	Trimedyne Holmium Laser System, including:
	OmniPulse™ Holmium Laser System, Model 1210
	OmniPulse™-MAX Holmium Laser System, Model 1210-VHP
	Model 1500-A Holmium Laser System
Indications for Use:	Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/ Gastrointestinal Surgery, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
	Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
	Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), corns, papillomas, and basal cell carcinomas.
	General Surgery of soft tissues, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablation.
	(Continued on page 2)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-the-Counter Use
------------------	----	----------------------

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number ____________________________________________________________________________________________________

. .

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Indications - continued

Genitourinary Surgery, including: superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.

Gynecological Surgery during open and endoscopic procedures.

Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi.

Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectorny, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, and debridement of the degenerative knee.

Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocystorhinostomy (DCR).

Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.

Regulation Number and Section

§ 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.