(193 days)
The KARL STORZ Urological Laser Accessories are used with laser fibers during urological endoscopic procedures.
The KARL STORZ Urological Laser Accessories include Sheaths, Obturators, Working Elements, Guiding Probes, Telescope Bridge, Working Insert, and LUER-Lock Tube Connectors and Adaptor.
This FDA 510(k) summary describes Karl Storz Urological Laser Accessories. Based on the provided text, there are no specific AI/ML components mentioned or evaluated through a study. Therefore, the questions related to AI/ML acceptance criteria, performance, and study design are not applicable.
The acceptance criteria and supporting studies focus on traditional medical device performance, biocompatibility, and reprocessing validation.
Here's a breakdown of the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Adherence to Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, -2, -5, -10, -11, -12, -18, -23 | Device complies with listed ISO 10993 standards, demonstrating biocompatibility. |
| Reprocessing Validation | Compliance with ISO 14937, ISO 17665-1, AAMI TIR 30:2011, ASTM F3208-17, ISO 15883-5 | Reprocessing data submitted complies with the listed standards, ensuring effective cleaning and sterilization. |
| Bench Performance | Device meets design specifications, substantial equivalence to predicate. These are tested through: |
- System Interlocking Test
- Flow Test (comparative)
- Bending Force Test | Additional bench testing was performed to ensure the device met its design specifications and is substantially equivalent to its predicate device. Specific quantitative results are not provided in this summary but the conclusion states they were met. |
| Technological Characteristics | The device's technological characteristics (dimensions, components, irrigation method) are compared to the predicate device to confirm substantial equivalence. | Similar system components, continuous flow irrigation/aspiration. - Sheath: Diameter: 23.5-27.6Fr., Length: 216.5-239mm (Predicate: 21-24Fr., 235-260.5mm)
- Obturator: Diameter: 19.9-21Fr., Length: 249.5-311.7mm (Predicate: 17.9-21.15Fr., 246.5-377.8mm)
- Laser Guide Probe: Length: 342.7-345.7mm (Predicate: N/A)
- Working Element: Diameter: 1x 4.4mm, 1x 2.5mm; Length: 2x 4.4mm (Predicate: N/A)
- Telescope Bridge: Number of channels: 1 (Predicate: 1-2) |
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: Not explicitly stated as this is a non-clinical evaluation. The "sample size" would refer to the number of devices or components tested for biocompatibility, reprocessing, and bench performance. The summary only states that tests were performed.
- Data Provenance: Not applicable in the context of clinical data. For non-clinical testing, it's generally conducted by the manufacturer or accredited labs, and the location is not specified in this summary. The studies are prospective in the sense that they are conducted specifically for regulatory submission, but they are not clinical studies on human subjects.
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. This device does not involve expert interpretation for ground truth establishment. Its performance is evaluated through objective, non-clinical tests based on established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This device does not involve human readers or interpretation of diagnostic images requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical accessory, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance evaluation was not done. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's evaluation is defined by adherence to recognized international and industry standards for biocompatibility, reprocessing, and engineering design specifications. For example:
- Biocompatibility: ISO 10993 series.
- Reprocessing: ISO 14937, ISO 17665-1, AAMI TIR 30:2011, ASTM F3208-17, ISO 15883-5.
- Bench Performance: Internal design specifications and comparative testing against the predicate.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning and therefore has 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, 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.