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The TRANBERG® Laser Applicator 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, for wavelengths 980nm through 1064nm.

The TRANBERG® Laser Applicator is used to transfer laser energy from the laser unit to the location for the treatment. The laser Applicator is designed with a core of 550 μm. The fiber length is 3 and 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The Laser Applicator is used with an introducer and both (fiber and introducer), are delivered sterile and for single use only. The introducer consists of an introducer stylet and introducer catheter with a fiber lock.

The provided document, a 510(k) summary for the TRANBERG® Laser Applicator, describes a medical device and its substantial equivalence to a predicate device. It primarily focuses on the device's technical specifications and non-clinical performance testing.

It is crucial to note that the document does not include information on acceptance criteria, clinical studies to prove device performance against those criteria, or details regarding AI/algorithm performance. The document explicitly states: "There are no clinical data submitted with this Notification."

Therefore, I cannot provide the requested information regarding acceptance criteria, AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment for a test set, as this information is not present in the provided text.

However, I can extract the information that is present and indicate what is missing:

Device: TRANBERG® Laser Applicator

Type of Review: 510(k) Premarket Notification (for substantial equivalence, not full clinical efficacy or AI performance).

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, explicit performance acceptance criteria are not defined, nor is there a table of reported device performance against such criteria. The document focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and non-clinical (bench) testing.

The "performance" described is about meeting safety and design specifications, not clinical efficacy or diagnostic accuracy.

• Determined through engineering testing to support substantial equivalence.
• Showed the Tranberg® Laser Applicator to meet applicable ISO, IEC and FDA safety and performance standards. |

2. Sample Size and Data Provenance

• Test Set Sample Size: Not applicable/Not provided. The document describes non-clinical (bench) engineering testing to meet safety and performance standards, not a "test set" of clinical data or images for an algorithm.
• Data Provenance: The document does not specify the origin of any data (e.g., country) as it discusses engineering and design parameters, not clinical data sets. The manufacturer is Clinical Laserthermia Systems, AB, located in Lund, Sweden.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable/Not provided. The document does not describe any expert-established ground truth for a test set, as it does not involve clinical data or diagnostic/AI performance evaluation.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. No adjudication method is mentioned as there is no clinical test set requiring ground truth establishment through expert consensus.

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

• No. The document explicitly states: "There are no clinical data submitted with this Notification." Therefore, no MRMC study was conducted or reported here.

6. Standalone (Algorithm Only) Performance

• No. This device is a laser applicator, a hardware medical device, not a software algorithm. Therefore, "standalone (algorithm only) performance" is not relevant to this submission.

7. Type of Ground Truth Used

• Not applicable/Not provided. The document describes a hardware device and its physical/engineering characteristics. There is no mention of "ground truth" in terms of clinical outcomes, pathology, or expert consensus, as this is not a diagnostic device or AI algorithm being validated against such benchmarks.

8. Sample Size for Training Set

• Not applicable/Not provided. As this is a hardware device and not an AI/ML algorithm, there is no "training set" in the computational sense.

9. How Ground Truth for Training Set Was Established

• Not applicable/Not provided. As there is no AI/ML algorithm or training set, this information is not relevant or available.

In summary, the provided FDA 510(k) document is for a physical medical device (laser applicator) seeking substantial equivalence, not a diagnostic device or an AI/ML product. Consequently, it does not contain the information typically associated with validation studies for AI/ML algorithms, such as acceptance criteria against clinical performance metrics, test set characteristics, expert ground truth establishment, or multi-reader studies. The focus is on technical specifications and non-clinical safety/performance testing to demonstrate equivalence to an existing device.

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