(136 days)
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.
| Parameter Tested (Implicit Acceptance Criteria: Meets Specification) | Reported Device Performance |
|---|---|
| Engineering Comparative Temperature Testing | Shows ability to necrotize/coagulate soft tissue. |
| Lesions size (in ex vivo bovine cardiac tissue) | Achieved 4.6 cm³ at 2min/15W (compared to predicate's 0.8 cm³ at 1min/8W; 2.7 cm³ at 2min/8W) |
| Occurrence of carbonization | Studied, but specific performance details not quantified here. |
| Integrity of the laser fiber | Studied, but specific performance details not quantified here. |
| Biocompatibility Testing (ISO 10993-1, -5, -10) | Performed to specification (implies acceptable biocompatibility profile) |
| Sterilization/Shelf Life Testing (ISO 11135-1, 10993-7, 11607-1, -2) | Performed to specification (implies device is sterile and stable over shelf life) |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.