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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)

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.

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.

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