Percutaneous Lumbar Disc Decompression/Discectomy in soft, cartilaginous, and bony tissue, including: foraminoplasty
Percutaneous Cervical Disc Decompression/Discectomy in soft tissue, in patients with: Uncomplicated ruptured or herniated discs; Neck pain with radiation down the arm; Symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep tendon reflexes; MRI. CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms; Positive electromyography and/or nerve conduction studies; No improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)
Percutaneous Thoracic Disc Decompression/Discectomy in soft tissue, in patients with: Uncomplicated ruptured or herniated discs; Thoracic and intercostal intractable pain; Paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myelography; MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms; No improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)

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 enerqy with a wavelength of 2.1 µm and 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 document is a 510(k) summary for the Trimedyne Holmium Laser Systems, which describes the safety and effectiveness of a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, pre-defined acceptance criteria with explicit performance metrics and comprehensive study results akin to a clinical trial for a novel drug or a software-as-a-medical-device (SaMD).

Therefore, the requested information, particularly regarding acceptance criteria, study design for meeting those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this type of regulatory document for this device. The regulatory pathway here is a 510(k), which typically relies on comparisons to already marketed "predicate" devices and existing scientific literature/data.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

No explicit acceptance criteria with performance metrics are stated. The 510(k) process focuses on demonstrating "substantial equivalence" to a predicate device, not on meeting specific, quantitative performance targets for a novel functionality.
No specific device performance metrics are reported in this summary. The document describes the technological characteristics of the laser system (wavelength, pulsewidth, maximum output) but doesn't provide data on its performance against any pre-defined acceptance criteria for its intended use.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable/Not provided. The document states that "Animal data and human clinical data from published literature were included." This indicates a reliance on existing, retrospective data rather than a newly conducted, primary clinical study with a defined test set. The exact sample sizes or provenance (country of origin, retrospective/prospective) of this published literature are not detailed in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable/Not provided. Since a specific "test set" and a process for establishing its ground truth are not described (as reliance is on published literature), there is no information on experts for this purpose.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. No "test set" requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done or reported. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key aspect. The Trimedyne Holmium Laser System is a surgical instrument.

6. Standalone (Algorithm Only) Performance:

Not applicable. The Trimedyne Holmium Laser System is a physical surgical laser device, not an algorithm or software. Its performance is intrinsically linked to its operation by a human user.

7. Type of Ground Truth Used:

Not explicitly defined for a new study. The document refers to "Animal data and human clinical data from published literature." For a surgical device, "ground truth" in efficacy and safety would typically come from clinical outcomes, histological analysis of ablated/treated tissue, or direct observation of the surgical effect. However, the document does not elaborate on how ground truth was established within the cited literature for the purpose of this 510(k).

8. Sample Size for the Training Set:

Not applicable/Not provided. As this is a hardware device relying on existing literature for safety and effectiveness, there is no "training set" in the context of machine learning or AI.

9. How Ground Truth for the Training Set Was Established:

Not applicable/Not provided. (See point 8).

Summary of Device Acceptance Criteria and Study:

Based on the provided K013974 510(k) summary, the device's "acceptance criteria" and "proof of meeting them" are framed within the context of the substantial equivalence pathway.

Acceptance Criteria (Implied by 510(k)): The device must be deemed "substantially equivalent" to legally marketed predicate devices in terms of its intended use, technological characteristics, and demonstrated safety and effectiveness for its proposed applications.
Study That Proves the Device Meets Acceptance Criteria:
- The study consists of a comparative analysis against existing "standard surgical instruments, such as knives and forceps" (the predicate device) as well as relying on a review of "Animal data and human clinical data from published literature."
- The submission outlines the technological characteristics of the Trimedyne Holmium Laser System (2.1 µm wavelength, 350 microseconds pulsewidth, 100 watts max power) and asserts that these are comparable or suitable for the stated indications.
- The intended uses for incision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications, specifically percutaneous cervical, lumbar, and thoracic disc decompression/discectomy, are supported by the literature review to be safe and effective.

In essence, the "study" is a compilation and synthesis of existing scientific evidence from published literature, used to argue that the Trimedyne Holmium Laser System performs similarly or adequately for its intended use compared to established methods and devices, thereby demonstrating "substantial equivalence." There are no explicit performance metrics, custom test sets, or dedicated expert reviews described for a novel performance goal within this 510(k) summary.

Summary

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SEP 23 2002

K 013974

510(k) Summary of Safety and Effectiveness Information Trimedyne Holmium Laser Systems

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.15091 Bake ParkwayIrvine, CA 92618
Contact person:	Laurie CartwrightManager, Regulatory AffairsOrGlenn YeikExecutive Vice President
Summary Date:	June 24, 2002

ll. Device Name

Proprietary: Trimedyne Holmium Laser System, including:

Trimedyne OmniPulse™ Holmium Laser System (Model 1210) �
Trimedyne OmniPulse MAX™ Holmium Laser System (Model 1210-� VHP)
Trimedyne OmniPulse Jr. ™ Holmium Laser System (Model 1230-30) �
Model 1500-A Holmium Laser System �
Common: Holmium: Yttrium Aluminum Garnet (Holmium:YAG) Laser

Classification: Laser-Powered Instrument

III. Predicate Device

Standard surgical instruments, such as knives and forceps.

IV. Device Description

V. Intended Use

The Trimedyne Holmium:YAG Laser System is intended for incision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications. The applications addressed in this premarket notification include percutaneous cervical. lumbar, and thoracic disc decompression/discectomy.

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VI. Technological Characteristics

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

VII. Animal Data and Human Clinical Data

Animal data and human clinical data from published literature were included in this premarket notification to demonstrate that the Trimedyne Holmium Laser Systems are safe and effective for the specified indications.

VIII. Conclusion

The Trimedyne Holmium:YAG Laser System is substantially equivalent to the predicate device described in this premarket notification. Furthermore, the non-clinical and clinical data submitted demonstrated the safety and effectiveness of the device for the proposed applications. Therefore, upon clearance of this submission, the Trimedyne Holmium:YAG Laser System will be marketed for the proposed expanded indications.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central emblem. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2002

Ms. Laurie Cartwright Manager, Regulatory Affairs Trimedyne, Inc. 15091 Bake Parkway Irvine, CA 92618

Re: K013974

Trade/Device Name: Trimedyne Holmium Laser Systems: OmniPulse™ Holmium Laser System, Model 1210 OmniPulse MAX™ Holmium Laser System, Model 1210-VHP OmniPulse Jr.TM Holmium Laser System, Model 1230-30 Model 1500-A Holmium Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 24, 2002 Received: June 25, 2002

Dear Ms. Cartwright:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Laurie Cartwright

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N Millkerson

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

Enclosure

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Indications Page

This indications page includes only the indications statement affected by this premarket Note: notification submission.

510(k) Number (if known): K013974

Device Name:

Trimedyne Holmium Laser Systems, including:

. OmniPulse™ Holmium Laser System, Model 1210
OmniPulse MAX™ Holmium Laser System, Model 1210-VHP ●
OmniPulse Jr.™ Holmium Laser System, Model 1230-30 .
Model 1500-A Holmium Laser System .

Indications for Use:

Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

Percutaneous Lumbar Disc Decompression/Discectomy in soft, cartilaginous, and bony tissue, . including:
- foraminoplasty .
Percutaneous Cervical Disc Decompression/Discectomy in soft tissue, in patients with: .
- Uncomplicated ruptured or herniated discs .
- Neck pain with radiation down the arm .
- Symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or . decreased deep tendon reflexes
- MRI. CT, myelogram, or discogram findings of disc herniation consistent with patient signs . and symptoms
- Positive electromyography and/or nerve conduction studies .
- No improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed . rest, exercises, and medication)
Percutaneous Thoracic Disc Decompression/Discectomy in soft tissue, in patients with: .
- Uncomplicated ruptured or herniated discs .
- . Thoracic and intercostal intractable pain
- Paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-. myelography
- . MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms
- . No improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K013974
Prescription Use _
OR Over-the-Counter Use _

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.