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The TRANBERG®|Thermoguide 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 neurosurgery, for a wavelength of 1064nm.

When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton resonancefrequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to 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.

The TRANBERG®|Thermoguide Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. 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 analysis using the TRANBERG®|Thermoguide Therapy System.

The TRANBERG®|Thermoguide Therapy System is indicated for use in an MRI suite to perform soft tissue ablations under MRI guidance, it consists of three parts:

• 1. TRANBERG®|Mobile Laser Unit, cleared by K142216.
• 2. TRANBERG®|Laser applicator and introducer, cleared by K201466.
• 3. TRANBERG®|Thermoguide Workstation, article no. 1100-01, new in this submission.

The TRANBERG® Mobile Laser Unit includes a laser generator that operates at the wavelength of 1064nm, a continuous wave. The generated laser light is locally applied by means of a single use applicator kit (TRANBERG®)Laser applicator and introducer, cleared by K201466) through a minimally invasive surgical or percutaneous procedure. The energy from the laser generator is transmitted to tissue through the TRANBERG® Laser applicator and absorbed by the tissue surrounding the laser applicator, resulting in increased tissue temperature that necrotizes or coagulates soft tissue. The TRANBERG® Laser applicator is a 12m long optical fiber that allows the laser generator to be placed in the MRI control room. A workstation with software (TRANBERG®)Thermoguide Workstation) is used to extract temperature maps from magnetic resonance (MR) images and to calculate the thermal dose in treated tissue. Algorithms used in the system to calculate temperature maps and thermal dose in tissue are well established and described in scientific literature.

The TRANBERG® Mobile Laser Unit has safety systems to prevent the use of a malfunctioning unit, including self-testing at startup and continuous monitoring of software and components that are critical for the unit and laser emission to function optimally. All laser safety requirements are met according to IEC 60601-2-22:2019.

The TRANBERG® Laser applicator utilizes an RFID tag which limits the maximum power and time (per applicator type) that can be used. It also ensures that an expired fiber, a reused fiber, or a fiber programmed for a different use cannot be used as a treatment fiber.

The TRANBERG®|Thermoguide Workstation has an interface for control of the TRANBERG®|Mobile Laser Unit output through the computer interface port of the laser control). It controls power and time settings on the laser unit, and it can start and stop the laser control and safety as per medical laser equipment requirements are managed by the TRANBERG®|Mobile Laser Unit.

Mandatory conditions must be satisfied to enable the laser unit and run a treatment. When one of more of these conditions are not met, the laser will not allow emitting laser radiation until all conditions are fulfilled:

• Real time images from the scanner are received at least every 5s. If Thermoguide Workstation detects update rates longer than 5s the laser emission is automatically interrupted.
• Laser unit enabled and the connection is verified, any loss of communication within 1.5s between the Laser unit and Thermoquide workstation or data incoherency automatically stops the laser emission.
• The use of the RFID tag is a mandatory condition to run a treatment and limits the maximum power and time (per applicator type).
• Laser Applicator type confirmed and received by TRANBERG®Thermoguide Workstation, the information is read on the RFID tag belonging to the fiber.
• Minimum 1 ROI (monitoring or guard) has been set.
• Baseline temperature (e.g., core body temperature) is set and confirmed
• B0 drift compensation: Reference baseline ROI is set and confirmed
• Placement of the High temperature guard ROI.
• Test dose successful and confirmed

Safety guard functionality: TRANBERG®Thermoguide Workstation can be used to prescribe limits for the temperature at certain points (ROIs) in the image which can, in turn, be used to deactivate the laser if the limits are reached.

The given text is a 510(k) summary for the TRANBERG®|Thermoguide Therapy System. It describes the device, its intended use, and lays out the argument for its substantial equivalence to a predicate device (Visualase™ Thermal Therapy system, K181859). The document focuses on technological comparisons and performance data obtained through bench testing and a pre-clinical animal study. However, it explicitly states: "No clinical data was provided in support of this submission."

Therefore, based on the provided document, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria using clinical data or human evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the performance data submitted for FDA clearance, which here consists of bench testing and preclinical animal studies.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is explicitly stated as not present:

Acceptance Criteria and Device Performance (Based on available data)

Since no clinical study involving acceptance criteria for diagnostic performance (like sensitivity, specificity, accuracy) is mentioned for human use, the "acceptance criteria" discussed here are related to the successful operation and performance of the device's thermometry algorithm and safety features during non-human testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the explicit statement "No clinical data was provided in support of this submission," the following sections cannot be fully answered or are marked as not applicable based on the provided document.

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

• Sample Size:
  • Bench Testing: Not specified in terms of numerical "sample size" for data points, but described in terms of tests performed to verify compliance and functionality.
  • Pre-clinical Animal Study: The document mentions "a prospective preclinical animal study under GLP conditions." The exact number of animals or data points from this study is not specified.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the manufacturer is "Clinical Laserthermia Systems AB, Lund, Sweden."
  • Retrospective or Prospective: The animal study was "prospective." Bench testing is inherently prospective in nature (tests are performed on the device).

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 for the reported performance studies. The "ground truth" for technical performance was established through physical measurements (for thermometry algorithm accuracy) and defined specifications (for functional tests). For the animal study, the ground truth would be based on direct measurements and pathological assessment of ablated tissue, not human expert consensus on images.
• The device's Indications for Use state, "When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy." However, no study involving human interpretation of the device's output for establishing clinical ground truth is described.

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

• Not applicable. This typically refers to the process of resolving discrepancies among multiple human readers in a diagnostic study. Since no human reader studies are described, no adjudication method was used.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data was provided in support of this submission."

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

• Yes, in essence, the "Thermometry Algorithm Accuracy" and "Near Real-time Performance" evaluations described under bench testing are standalone performance assessments. These tests evaluated the algorithm's ability to accurately calculate and display temperature maps and thermal dose independent of a human operator making clinical decisions based on the output. The pre-clinical animal study also assessed the device's performance in generating accurate thermal data without human intervention in the data generation process itself.

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

• Physical Measurements: For the accuracy of the thermometry algorithm, the ground truth was based on physical measurements of temperature.
• Defined Specifications: For functional testing and compliance, the ground truth was the satisfaction of predefined engineering and safety specifications (e.g., proper communication, correct power output, safety interlocks).
• Pathology/Tissue Assessment: For the pre-clinical animal study, the ground truth for thermal damage would typically be established through histological examination of the ablated tissue, comparing the predicted thermal damage to the actual tissue necrosis.

8. The sample size for the training set

• Not applicable / Not specified. This submission is for a medical device that includes software for processing MR images to display temperature and thermal dose. The document describes the algorithms used as "well established and described in scientific literature," implying that they are based on known physical principles (Proton Resonance-Frequency shift analysis, CEM43 algorithm) rather than being a deep learning or AI model trained on a large dataset in the conventional sense. Therefore, there's no "training set" in the context of machine learning model development specified here.

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

• Not applicable / Not specified. As noted above, the device seems to rely on established physics-based algorithms rather than a trained AI/ML model that would require a ground-truth-labeled training set. If the algorithms involved any parameter tuning or classical machine learning components, that data and its ground truth are not detailed in this summary.

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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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The TRANBERG CLS/Diffusor 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, pulmonology, radiology, and urology, for wavelengths 980mm through 1064nm.

The TRANBERG45| Diffusor Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The diffusor laser fiber is designed with a core of 550 µm. The fiber length is 3 to 12m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The TRANBERGCS|Diffusor Laser fiber is delivered sterile and for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the TRANBERG CLS Diffusor Laser Fiber. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive human studies often required for new technologies or higher-risk devices.

Therefore, the document does not contain information about:

• Acceptance criteria in the context of clinical performance metrics like sensitivity, specificity, accuracy for an AI/algorithm-driven device.
• A test set size or its data provenance for an AI/algorithm.
• Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
• Adjudication methods for an AI/algorithm's test set.
• MRMC comparative effectiveness studies.
• Standalone performance for an AI/algorithm.
• Sample size for a training set.
• How ground truth for a training set was established.

The document primarily focuses on bench testing (non-clinical) to demonstrate that the device meets performance specifications and is substantially equivalent to its predicate.

Here's the information that can be extracted, framed within the context of a medical device submission, though it doesn't align with the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI/algorithm.

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

The document details performance testing for the device itself (laser fiber), not an AI algorithm. The "acceptance criteria" here are implied by the successful completion of specified engineering and bench tests, validating the device's physical and functional properties.

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

For the non-clinical bench testing:

• Sample size for ex vivo model: Not explicitly stated but mentions using "bovine cardiac tissue." The precise number of tissue samples or runs is not given.
• Data provenance: Ex vivo model. Implied to be lab-based, not patient-derived, and likely conducted in Sweden (location of the manufacturer). The document does not specify if it was retrospective or prospective, but as it's bench testing, it's generally a controlled, prospective experimental setup.

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

Not applicable for this type of device submission. Ground truth for the laser fiber's performance is established through physical measurements and observations during bench testing, not expert interpretation of image data.

4. Adjudication method for the test set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for bench testing of a laser fiber.

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. The device is a laser fiber for surgery, not an AI-assisted diagnostic tool. No MRMC study was conducted or relevant for this submission.

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

Not applicable. There is no algorithm to evaluate. The device is a physical instrument.

7. The type of ground truth used

For the bench testing, the ground truth was direct physical measurement and observation of the laser fiber's effects on ex vivo tissue and its adherence to engineering and safety standards (e.g., lesion size measurements, visual inspection for carbonization, results of standardized ISO tests for biocompatibility and sterilization).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; 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.

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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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