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The VAPORMAX II is intended for surgical use including: incision, vaporization, vaporization, in ablation, and coagulation of soft tissue.

The VAPORMAX II is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

The VAPORMAX II is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.

The provided document K053457 describes a 510(k) premarket notification for the VAPORMAX™ II Side Firing Fiber. It explicitly states that no nonclinical data and no clinical tests were submitted. Instead, the device's substantial equivalence was established by comparing its technological characteristics to a predicate device. Therefore, a study demonstrating the device meets acceptance criteria as typically understood in a clinical or performance study context was not performed or submitted.

Here's a breakdown based on your requested information, highlighting what is not applicable due to the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

• Test Set Sample Size: Not applicable. No test set was used for a performance study.
• Data Provenance: Not applicable. No clinical or non-clinical study data were provided.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

• Not applicable. No test set was used, and therefore no ground truth was established by experts in the context of a performance study.

4. Adjudication method for the test set

• Not applicable. No test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human improvement with vs. without AI assistance

• Not applicable. This device is a laser fiber and does not involve AI or human-in-the-loop performance measurement.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

• Not applicable. This device is a laser fiber and does not involve an algorithm.

7. The type of ground truth used

• Not applicable. No ground truth in the context of a performance study was established. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. This device is a physical medical device (laser fiber) and does not involve machine learning or a training set.

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

Summary of the Study (as presented in the 510(k)):

The "study" in this context is a substantial equivalence comparison to predicate devices, not a performance study with clinical or non-clinical data generation.

• Predicate Devices:

  • VAPORMAX™ Side Firing Fiber (K050412)
  • UROLASE® Right Angle Laser Fiber (K944204, K954597, K970422)

• Methodology: The submission relies on demonstrating that the VAPORMAX™ II Side Firing Fiber has the "same technological characteristics" and "intended use" as the predicate devices.

  • Technological Characteristics: The VAPORMAX™ II shares most of its design characteristics and all materials with its VAPORMAX™ predicate. It emits laser energy at an approximately 90-degree angle by way of direct reflection, like the UROLASE® predicate. This allows it to be used with up to 100 watts of laser power, consistent with its predicate.
  • Intended Use: The intended use for incision, excision, ablation, vaporization, and coagulation of soft tissue with cleared Holmium:YAG lasers is the same as for its predicates.

• Conclusion: Based on this comparison, it was concluded that the VAPORMAX™ II performs as intended and has acceptable mechanical properties when used in accordance with its labeling, implying that it is as safe and effective as the legally marketed predicate devices. No new performance data was generated to prove specific acceptance criteria for the new device itself.

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The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.

The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.

Due to the nature of the provided document, which is a 510(k) premarket notification summary for a medical device (VAPORMAX™ Side Firing Fiber), the information requested about acceptance criteria and a study proving the device meets those criteria is not present in the document.

Here's why and what can be extracted based on your request:

• No Acceptance Criteria or Performance Study: This document states explicitly in sections "VII. Nonclinical Data" and "VIII. Clinical Data" that "No nonclinical data were submitted in this Premarket Notification" and "No clinical tests were submitted in this Premarket Notification."
• Predicate Device Equivalence: The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive de novo acceptance criteria and performance data for a new technology. The VAPORMAX™'s submission focuses on its technological characteristics (increased power handling) compared to existing Trimedyne side firing fibers and the Lumenis DUOTOME SIDELITE™.
• Intended Use Statement: The "Conclusions Drawn From Testing" (Section IX) simply states, "The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling." This is a general statement, not a detailed report of specific performance metrics against defined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth as this information was not part of this 510(k) submission.

Summary based on available information:

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Superficial 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, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures
• Gastroenterological/Gastrointestinal Surgery
• General Surgery of soft tissue
• Genitourinary Surgery/Urology
• Gynecological Surgery during open and endoscopic procedures
• Lithotripsy and Percutaneous Urinary Lithotripsy
• Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints
• Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue
• Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy

Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstitial applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.

The OmniPulse" Mini Laser System Model 2120 is a pulsed solid-state Holmium:YAG laser system is designed to deliver infrared laser energy with a wavelength of 2.1 um and a nominal pulse width of 350 microseconds. Menu driven control options allow the operator to select the pulse energy, the pulse repetition rate or frequency, and one of three exposure modes (continuous, single burst or repetitive burst).

The provided document is a 510(k) summary for the Trimedyne OmniPulse™ Mini, Model 2120, a Holmium:Yttrium Aluminum Garnet (Ho:YAG) Laser System. It outlines the device's technical characteristics, intended use, and its substantial equivalence to predicate devices. However, this document clearly states that "No nonclinical data was submitted in this Premarket Notification" and "No clinical data was submitted in this Premarket Notification."

Therefore, based on the provided information, there is no study detailed that proves the device meets specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems) based on similar technological characteristics and intended use.

Consequently, most of the requested information (acceptance criteria, reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from this document as no such studies were submitted or referenced.

Here's a breakdown of what can and cannot be stated based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as this was a substantial equivalence submission relying on predicate devices, not a de novo clearance requiring novel performance thresholds.
• Reported Device Performance: No performance data from new studies are reported in this document. The device's technological characteristics such as wavelength, pulse width, pulse energy range, and pulse repetition rates are described, but these are specifications, not performance metrics against acceptance criteria from a study.

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

• Sample Size: Not applicable, as no test set or clinical study was submitted.
• Data Provenance: Not applicable.

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

• Experts and Qualifications: Not applicable, as no test set requiring ground truth establishment was submitted.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no test set was submitted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No MRMC comparative effectiveness study was mentioned or submitted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Standalone Performance Study: Not applicable, as this is a laser device, not an AI algorithm. No standalone performance study was mentioned or submitted.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable, as no studies requiring ground truth were submitted.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable, as this is a laser device, not a machine learning model requiring a training set. No study involving a training set was mentioned or submitted.

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of what can be extracted:

The submission for the OmniPulse™ Mini, Model 2120, based its clearance on demonstrated substantial equivalence to existing predicate devices (Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems). This means the FDA concluded that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

The document describes the technological characteristics of the OmniPulse™ Mini, including:

• Wavelength: 2.1 µm
• Nominal Pulse Width: 350 microseconds
• Pulse Frequencies: 7, 10, 15, and 20 Hz
• Pulse Energies: 0.2 to 2.0 Joules (range depends on frequency)
• Exposure Modes: Continuous, single burst, or repetitive burst

Its intended use covers a broad range of applications in various surgical specialties, identical to the predicate devices. The key argument for acceptance was that "All of the characteristics of the OmniPulse Mini fall with the previously cleared ranges for the predicate devices." This implies that the 'acceptance criteria' were met by demonstrating that the new device's specifications and capabilities were within the established safe and effective parameters of the predicate devices, rather than through new performance studies specific to this device model.

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

1. Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, 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), COLIS, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization
2. Gastroenterological/Gastrointestinal Surgery, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder 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, telangiectasias of the Osler-Weber-Rendu disease
3. General Surgery of soft tissue, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, hemiorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilodidal cyst removal and repair, debridement of statis ulcer, biopsy
4. Genitourinary Surgery/Urology, including: superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, lesions of the external genitalia, bladder, urethral and ureteral tumors, condylomas, urethral and penile hemangioma, bladder neck obstructions, holmium laser incision, excision, resection, ablation, hemostasis, vaporization, and enucleation in the treatment of benign prostatic hyperplasia (BPH)
5. Gynecological Surgery during open and endoscopic procedures, including: condyloma acuminata
6. Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, fragmentation of kidney calculi, treatment of distal impacted fragment of steinstrasse when guide wires cannot be passed
7. Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, debridement of the degenerative knee, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, capsulectomy in the knee, chondroplasty in the knee, chondromalacia ablation
8. Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g., turbinectorny), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrostomy, frontal sinusotomy, sphenoidotomy
9. Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following: Percutaneous Lumbar Disc Decompression/Discectorny in soft, cartilaginous, and bony tissue, including: foraminoplasty; Percutaneous Cervical Disc Decompression/Discectorny 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/Discectorny 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-myclography, 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)

Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstital applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.

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 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.

This document is a 510(k) premarket notification for the Trimedyne Holmium Laser System. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies, based solely on the text provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not report any specific acceptance criteria or performance metrics for the Trimedyne Holmium Laser System in relation to clinical or non-clinical studies. Instead, it states that:

• "No non-clinical data were submitted in this Premarket Notification."
• "No clinical tests were submitted in this Premarket Notification."

The basis for this 510(k) clearance is "substantial equivalence" to a predicate device, not fulfillment of specific performance criteria demonstrated through new testing.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable. No new clinical or non-clinical data/tests were submitted.
• Data provenance: Not applicable. No new clinical or non-clinical data/tests were submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No new clinical or non-clinical data/tests were submitted, and therefore no ground truth was established by experts for such tests.

4. Adjudication method for the test set:

• Not applicable. No new clinical or non-clinical data/tests were submitted.

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. This device is a medical laser system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a medical laser system, not an algorithm.

7. The type of ground truth used:

• Not applicable. No new clinical or non-clinical data/tests were submitted for which ground truth would be established. The document relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

• Not applicable. This document is for a medical device (laser system), not a machine learning or AI algorithm that would require a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, this document is not for an AI/ML algorithm.

Conclusion from the Document:

The Trimedyne Holmium Laser System received clearance based on substantial equivalence to an already legally marketed predicate device (also referred to as "Trimedyne Holmium Laser System"). This means the manufacturer demonstrated that the new device has the same intended use and technological characteristics as the previously cleared device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. As such, the submission did not include any new non-clinical or clinical data/tests to prove performance against specific acceptance criteria.

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The Side Firing Needle with Vent Sheath is intended for superficial or interstitial incision. excision, resection, ablation, vaporization, coagulation and hemostasis and may be used with any cleared Holmium laser that has a compatible connector.

Superficial and interstitial incision, excision, ablation, vaporization, and coagulation.

The Side Firing Needle with Vent Sheath is a single use, disposable fiberoptic energy delivery device for use with the Omni™ Multiuse Handpiece and Fiber Assembly. The device consists of a near-contact laser fiber enclosed in a stainless steel pointed needle assembly. The device includes a luer connector assembly that connects the irrigation channel to an irrigation fluid source via an external line, as well as a vent sheath with proximal exhaust ports that terminates just proximal to the beam exit point. The Side Firing Needle with Vent Sheath is attached to the Omni Multiuse Handpiece through a quick-connect mechanism.

The provided text describes a medical device, the Trimedyne Side Firing Needle with Vent Sheath, and its 510(k) submission to the FDA. It does not include information about acceptance criteria or a study using the device with acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity, which is typically found for AI/ML or diagnostic devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and nonclinical testing.

Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth, experts, and MRMC studies are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the provided text, indicating where information is present or absent:

1. A table of acceptance criteria and the reported device performance

Note: The acceptance criteria are inferred from the "Conclusions Drawn From Testing" and the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to previously cleared devices. Specific numerical performance targets are not provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. The submission states "No clinical tests were submitted in this Premarket Notification." The nonclinical data involved "verification and validation tests, including performance and tissue affect studies," but specific sample sizes or provenance for these tests are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. No clinical data was submitted, and thus no expert-adjudicated ground truth for a test set is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. No clinical data or test set requiring adjudication 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. This device is a laser fiber accessory, not an AI or diagnostic device that would involve human readers or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. Given the lack of clinical studies, no "ground truth" in the diagnostic sense was established. The nonclinical "tissue affect studies" would have relied on direct observation of the laser's interaction with tissue, but details are not provided.

8. The sample size for the training set

• Not Applicable. As a physical device, there is no "training set" in the context of machine learning or AI models. The device was likely designed and optimized through engineering and bench testing.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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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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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

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.

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The OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium: YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation.

The OmniTip Side Firing Switchable Tip with Suction/Irrigation is a fiber optic energy delivery device consisting of a near-contact laser fiber enclosed in a needle assembly of a capillary tube and an external stainless steel shaft. The device is attached to the Omni Multiuse Handpiece through a quick-connect mechanism. A luer connector assembly installed at the proximal end of the device connects the suction/irrigation channel to a pump via an external line.

This document describes the Trimedyne® OmniTip™ Side Firing Switchable Tips with Suction/Irrigation, a laser fiber device. The primary focus of the provided text is the device's substantial equivalence to predicate devices and its intended use, rather than detailed acceptance criteria and a specific study proving those criteria.

Based on the provided information, the device is considered substantially equivalent for its intended use, which is with any pulsed Holmium:YAG 2.1 micrometer laser for incision, excision, ablation, vaporization, and coagulation.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria with corresponding performance metrics in a tabular format. The conclusion states: "The device is biocompatible, performs as intended, and has acceptable mechanical properties when used according to its labeling." This is a general statement of compliance rather than a detailed breakdown of acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document mentions "simulated clinical testing using heart tissue" but does not specify a sample size for this testing. It also references "a series of tests, including mechanical, biological, and performance studies," but again, no sample sizes are provided.
• Data Provenance: Not specified. It's likely the testing occurred at the manufacturer's location in the USA (Trimedyne, Inc., Irvine, CA). Whether the data was retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document states: "A physician's feedback is also used to validate the use of the device in a clinical setting."

• Number of Experts: "A physician" suggests one expert, but it's not explicitly stated.
• Qualifications of Experts: The term "physician" is a general qualification; specific experience or specialty is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The clinical validation involved "a physician's feedback," which doesn't describe a formal adjudication process typically seen in studies involving multiple reviewers for ground truth establishment.

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. This device is a laser fiber, not an AI diagnostic or assistance tool, so an MRMC study comparing human readers with and without AI assistance is not relevant. The document does not mention any MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (laser fiber), not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "simulated clinical testing," the ground truth was implicitly based on the observed performance during these tests and the "physician's feedback." This would likely involve visual assessment of the tissue effects (incision, ablation, coagulation) and mechanical function, but a formal "ground truth" definition (like pathology) is not explicitly stated.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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