(155 days)
Quanta Systems Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta system equipped with SMA 905 connector.
Quanta Systems Surgical Laser Fibers are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode (with a compatible laser marketed for use in the desired application).
Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery. ENT/ololaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.
Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd;YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Quanta System Surgical Laser Fibers may be used in surgical specially or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.
The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetraffluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 800 and 1000 microns) are offered.
The Quanta System Surgical Laser Fibers are single-use sterile medical devices, supplied sterilized by Ethylene Oxide (EtO).
The provided text describes the 510(k) summary for Quanta System Surgical Laser Fibers, focusing on their substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.
However, I can extract information related to the performance and safety testing conducted to support the device's substantial equivalence.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for clinical performance that would typically be found in studies for diagnostic or AI devices (e.g., sensitivity, specificity thresholds). Instead, it refers to a "full plan of non-clinical performance tests" to demonstrate safety and effectiveness. The acceptance criteria for these tests would be compliance with the referenced standards and internal methods.
| Acceptance Criteria (based on compliance with standards/methods) | Reported Device Performance (demonstrated by testing) |
|---|---|
| Compliance with ISO 14971:2009 (Risk Management) | Full plan of non-clinical performance tests conducted |
| Compliance with ISO 10993-1:2008 & FDA Blue Book Memo G95-1 (Biocompatibility) | Biocompatibility testing performed |
| Compliance with ISO 11135-1:2007 & FDA Sterility Review Guidance K90 (EtO Sterilization) | First EtO sterilization validation performed |
| Compliance with ISO 11607-1:2009 & FDA Sterility Review Guidance K90 (Packaging) | Packaging validation performed |
| Compliance with ISO 17664:2004 & FDA MDUFMA Validation Data in 510(k) for Reprocessed single-use medical device (Reprocessing) | Re-processing validation performed |
| Visual, mechanical, and functional (optical) requirements per internal methods | Visual, mechanical and functional (optical) tests performed |
| Equivalence to predicate devices in components and technological characteristics | Fiber core/cladding made from silica (same as predicates), jacketed with ETFE (same as predicates), no technological differences compared to predicates, same intended use. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a "test set" of clinical data in the context of an AI or diagnostic device. The performance evaluation is based on non-clinical engineering and biological tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device's performance is established by compliance with recognized engineering, sterilization, and biocompatibility standards, not by expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. There is no clinical "test set" or adjudication process described.
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. This device is a surgical laser fiber, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" is defined by:
- International Standards: ISO 14971:2009, ISO 10993-1:2008, ISO 11135-1:2007, ISO 11607-1.2009, ISO 17664:2004.
- FDA Guidance Documents: FDA Blue Book Memo G95-1, FDA Sterility Review Guidance K90, FDA MDUFMA Validation Data in 510(k) for Reprocessed single-use medical device.
- Internal Methods: Visual, mechanical, and functional (optical) tests were conducted according to internal methods.
The overall "ground truth" for the 510(k) submission is that the device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device with a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned.
§ 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.