(17 days)
The AccuTrac Laser Fibers are intended for use in laser-based surgical applications, including, but not limited to, endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue. The AccuTrac Laser Fibers are designed for use with Ho:YAG lasers with a standard SMA-905 connector that have been cleared for surgical use.
The AccuTrac Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA-905 connector, strain relief, and a silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE). The AccuTrac fibers are equipped with a polished and reinforced ball-shaped TracTip. These fibers may be used in a variety of laser based surgical cases as an integral part of laser systems.
The provided text describes a 510(k) summary for the Boston Scientific AccuTrac Laser Fiber, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria and proving device performance against them as might be done for a novel device or a significantly modified device requiring de novo authorization.
Therefore, the document does not contain the kind of detailed information typically found in a clinical study report proving a device meets specific acceptance criteria. This submission is for a Class II device and relies on showing it is "as safe, as effective, and performs as well as the predicate devices".
However, I can extract the available information related to performance testing and present it.
Acceptance Criteria and Device Performance Study for AccuTrac Laser Fiber
The AccuTrac Laser Fiber, a Class II device, gained 510(k) clearance by demonstrating substantial equivalence to predicate devices (AccuMax™ and Flexiva™ Laser Fibers). The submission focuses on showing that the new device, particularly its "polished and reinforced ball-shaped TracTip," performs equivalently to the predicate devices which have a "polished flat tip."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tip Fracture Resistance: Equivalent to predicate devices. | Performance testing results "demonstrate equivalence of the AccuTrac to the predicate AccuMax and Flexiva laser fibers." |
| Scope Testing: Equivalent to predicate devices. | Performance testing results "demonstrate equivalence of the AccuTrac to the predicate AccuMax and Flexiva laser fibers." |
| Power Rating/Output Efficiency Testing: Equivalent to predicate devices. | Performance testing results "demonstrate equivalence of the AccuTrac to the predicate AccuMax and Flexiva laser fibers." |
| Aiming Beam Testing: Equivalent to predicate devices. | Performance testing results "demonstrate equivalence of the AccuTrac to the predicate AccuMax and Flexiva laser fibers." |
| Safety and Effectiveness: "As safe, as effective, and performs as well as the predicate devices." | The AccuTrac fibers are considered safe and effective for their intended use based on the demonstrated equivalence in the performance tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "samples aged at T=0 and T=13 months accelerated aging," suggesting a laboratory-based bench test with a limited number of physical samples.
- Data Provenance: The study was a "Performance Testing (Bench and User Evaluation)" conducted by Boston Scientific. This indicates internal, company-sponsored testing, likely in a laboratory setting. No country of origin for data or retrospective/prospective nature is specified as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: This was a bench study, not a clinical study requiring expert consensus or ground truth establishment in a clinical context. Performance metrics were likely objective measurements from laboratory equipment.
4. Adjudication Method for the Test Set
- Not Applicable: As a bench study with objective measurements, an adjudication method in the context of human expert review is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: An MRMC comparative effectiveness study was not conducted. The submission relied on bench testing to show equivalence to predicate devices, not on assessing human reader improvement with AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a physical laser fiber, not an algorithm or AI software. Therefore, the concept of standalone algorithm performance is not relevant. The "performance testing" described is for the physical device itself.
7. The Type of Ground Truth Used
- Objective Bench Test Measurements: The "ground truth" for this type of submission typically consists of objective, quantifiable measurements of physical properties and performance (e.g., laser power output, fiber integrity under stress, aiming beam accuracy) against predefined engineering specifications or in direct comparison to predicate device performance. It is not based on expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not Applicable: This device is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for an AI/ML model, this question is not relevant.
§ 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.