(71 days)
The Twister™ Side Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope. urethroscope, or any other viewing scope.
The Biolitec Medical Devices, Inc. Twister™ Side-Fire Fiber Optic Delivery System contains equivalent components and identical patient-contact materials as the cleared Biolitec Inc. Megabeam Lateral/ Side Fire Fiber Optic Delivery Systems.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria. Instead, it describes a 510(k) submission for a medical device (Twister™ Side-Firing Fiber Optic Delivery System) and states that no specific performance testing was included because its performance on soft tissue is "well established and documented."
Therefore, most of the requested information cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document explicitly states: "Since the performance of the Twister™ Side-Fire Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission." This indicates that no new performance data or acceptance criteria for this specific submission were presented or needed due to relying on prior established performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No new test set data was included in this submission.
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)
- Cannot be provided. No new test set data was included in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No new test set data was included in this submission.
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
- Cannot be provided. This device is a fiber optic delivery system, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a fiber optic delivery system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No new performance study generating ground truth was conducted for this submission. The submission relies on "well established and documented" performance of similar predicate devices, implying that any ground truth would have been established during the development and clearance of those previous devices.
8. The sample size for the training set
- Cannot be provided. This device is a physical delivery system, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Cannot be provided. Same as above, no training set applies.
Summary from the provided text:
The submission for the Twister™ Side-Firing Fiber Optic Delivery System is based on substantial equivalence to existing predicate devices (Megabeam® Lateral/ Side Fire Fiber Optic Delivery System). The core argument is that the Twister system has "equivalent components and identical patient-contact materials" and its "performance... on soft tissue is well established and documented." Therefore, no new performance testing or specific studies were included in this submission to demonstrate acceptance criteria for this particular device. The acceptance criteria are implicitly met by its substantial equivalence to previously cleared devices whose performance was already deemed acceptable.
§ 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.