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The TRANBERG CLS Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology, at a wavelength of 1064nm.

The TRANBERG CLS Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The laser fiber is an optical fiber with a core of 550 mic and radial diffusor. The length is 3m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The material in contact with human tissue is biocompatible. The TRANBERG CLS Laser fiber is delivered sterile and for single use only.

The provided document describes a 510(k) premarket notification for the TRANBERG CLS Laser Fiber, which is a medical device used for necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, the demonstration of substantial equivalence relies on comparing the device's technological characteristics and performance (as assessed through bench testing) to a legally marketed predicate device. The performance is assessed against general safety and performance standards rather than specific numerical criteria.

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set with human subjects. The testing described is non-clinical bench testing.
• Data Provenance: The document does not specify the country of origin for the non-clinical bench testing data, but the manufacturer is Clinical Laserthermia Systems, AB, in Lund, Sweden. The testing appears to be retrospective in the sense that it was conducted before the 510(k) submission to demonstrate equivalence.

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

Not applicable. This was a non-clinical bench study. There was no "ground truth" derived from expert review of data in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process for clinical or image data is mentioned.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There are no animal or clinical data submitted with this Notification." This type of study would involve human readers and AI assistance, neither of which is relevant to the data submitted.

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

Yes, in a conceptual sense, a "standalone" performance assessment of the device was done, but not in the context of an AI algorithm. The device itself (the laser fiber) was tested on a benchtop to ensure it met performance specifications and was substantially equivalent to its predicate. This is a standalone assessment of the physical device's functionality.

7. The Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" was established by engineering measurements and compliance with industry standards. For example, lesion volume was measured and compared to the predicate's reported lesion volume. Biocompatibility was assessed against established standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser fiber, not an AI/ML 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 an AI/ML algorithm, no ground truth was established for it.

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The Tranberg 65 Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The TRANBERGCSS|Thermal Therapy System consists of three parts:

• TRANBERGCSS|Mobile Laser
• TRANBERGCLS|Temperature Sensor ●
• Applicator Kit (The Applicator kit is not included)
  The mobile laser unit is provided with a laser generator operating at the wavelength 1064 nm. The generated laser light is locally applied by means of a single use applicator kit through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature. Tissue heating and lesion formation is controlled by a tissue temperature feedback system integrated into the TRANBERGCS | Thermal Therapy System.

The document describes the TRANBERG® CLS Thermal Therapy System and its substantial equivalence to a predicate device, the PhoTex 30 Diode Laser Series (K092197). The device is a laser surgical instrument for soft tissue ablation, vaporization, excision, incision, and coagulation.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance & Equivalence:

The document doesn't present "acceptance criteria" in the typical format of a threshold to be met, but rather compares the technological characteristics of the TRANBERG® CLS Thermal Therapy System with its predicate device to demonstrate substantial equivalence. The "Acceptance Criteria" here are implicitly the predicate device's existing characteristics and performance, which the new device aims to match or exceed for safety and effectiveness.

Study Proving Acceptance Criteria (Substantial Equivalence):

The study to prove the device meets the acceptance criteria is a non-clinical bench testing comparison to a legally marketed predicate device (K092197: BioTex, Inc.; PhoTex30 Diode Laser).

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

• Sample Size: Not explicitly stated as a numerical sample size. The "test set" for this type of submission typically refers to the testing conducted on the device itself against various standards and specifications. It does not involve a human patient data test set in the way a clinical study would.
• Data Provenance: The testing was non-clinical bench testing, meaning it was conducted in a lab environment. The document does not specify a country of origin for the data beyond "Non-clinical bench performance testing." It is implied to be from a controlled lab environment. The testing is prospective in the sense that it evaluates the new device's performance against predefined standards and the predicate.

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

This information is not applicable to this type of submission. Ground truth, in the context of expert consensus, pathology, or outcomes data, is relevant for AI/ML device evaluations or diagnostic devices where human interpretation or definitive medical findings are being compared. For this laser device, the "ground truth" is defined by established engineering and safety standards (e.g., ISO, IEC, FDA) and the functional characteristics of the predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions or interpretations, typically in clinical evaluations or ground truth establishment for diagnostic algorithms. Since no expert panel was used for ground truth for this non-clinical submission, no adjudication method was needed.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or imaging devices where human readers interpret cases, and AI assistance is being assessed. This submission is for a surgical laser device based on substantial equivalence to an existing device through non-clinical testing.

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

Yes, in essence, standalone performance (non-clinical bench testing) was done. The device's performance characteristics (e.g., wavelength, output power accuracy, operating modes, safety features) were evaluated directly through engineering bench tests to ensure they meet applicable standards and are comparable to the predicate. There is no "algorithm" in the sense of AI/ML, but the device's operational parameters were tested without human intervention in the loop of the device's core function during these bench tests.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Established engineering standards: Applicable ISO, IEC, and FDA safety and performance standards.
• Predicate device characteristics: The established and legally marketed characteristics and performance of the PhoTex 30 Diode Laser Series (K092197).
• Product Requirement Specifications: The device was tested against its own documented design and functional requirements.

8. The Sample Size for the Training Set:

This information is not applicable. This is a medical device clearance based on substantial equivalence, not an AI/ML algorithm requiring a training set. The device manufacturing processes and designs would undergo validation, but there isn't a "training set" in the machine learning context.

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

This information is not applicable as there is no training set for an AI/ML algorithm.

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The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.

When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase analysis.

The Visualase Thermal Therapy System comprises four devices: a laser energy source, a cooled laser applicator, a pump for circulating coolant through the applicator, and a computer workstation with magnetic resonance imaging (MRI) analysis software for determination and visualization of relative changes in tissue temperature during therapy.

The four components have themselves been previously cleared for marketing via 510(k) notifications with the new device bringing these four components into a single portable cart for use in MR-guided laser thermal therapy procedures. In practice, all of the devices are used according to their approved indications for use. That is, the laser applicator is introduced into the tissue to be destroyed and connected to both the laser energy source and the cooling pump. The cooling pump and laser are operated as normal to deliver energy and cause tissue ablation. Since the laser applicator is MR-compatible, the laser ablation procedure may be carried out inside of an MRI magnet. In this case, appropriate MR imaging can be performed during the treatment, and the MR analysis software can be used to evaluate the thermal changes in the target tissue.

The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or the methodology typically associated with evaluating AI/software performance as requested in the prompt.

The document K071328 is a 510(k) summary for the Visualase® Thermal Therapy System, describing it as a combination of four previously cleared devices: a laser energy source, a cooled laser applicator, a pump, and MRI analysis software. The summary focuses on the substantial equivalence of this combined system to its predicate devices, emphasizing that the individual components' functions and performance remain unchanged.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics. It rather states that "Performance and technical data for each of the components of the Visualase Thermal Therapy System are unchanged from those listed in the original submissions." This implies that the individual components met their respective acceptance criteria in prior 510(k) clearances, and the combination as a system is not introducing new performance parameters that require a new set of criteria.

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

Not applicable. The submission is a 510(k) for a system combination, not a new device requiring a performance study with a test set of data.

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

Not applicable. No new test set or ground truth establishment is described for this 510(k).

4. Adjudication method for the test set:

Not applicable.

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 predates the common application of AI in this context and is a combination of existing cleared components. The MR analysis software provides "passive monitoring" and "information that may be useful," but explicitly states "Patient management decisions should not be made solely on the basis of Visualase analysis," indicating it's not designed for standalone diagnostic or decision-making. No MRMC study is mentioned.

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

The document indicates the Visualase MRI analysis software is for "passive monitoring" and processing "images to determine relative changes in tissue temperature during therapy." It provides "information that may be useful in the determination or assessment of thermal therapy" but explicitly states "Patient management decisions should not be made solely on the basis of Visualase analysis." This suggests it is not intended for standalone decision-making, and no standalone performance study is mentioned.

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

Not applicable. There is no new performance study described in this 510(k) that would require establishing a ground truth for a test set. The individual components would have had their own validation data during their initial clearances.

8. The sample size for the training set:

Not applicable. The document describes a combination of existing cleared devices. There is no mention of a new "training set" for the MRI analysis software in this context. The software processes images based on physical principles (proton resonance-frequency shift analysis), not machine learning requiring a training set in the modern sense.

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

Not applicable. See point 8.

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