(84 days)
The Sphinx laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The Sphinx system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
This submission focuses on establishing substantial equivalence for a surgical laser system (Sphinx) to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria for a new AI/CAD device. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI performance is not applicable or cannot be extracted from this document.
Here's what can be inferred and stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a new device's function. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to existing predicate devices. This means proving that the Sphinx laser system has the same intended use, indications for use, and similar design/functional features as the predicate devices.
- Reported Device Performance: The document does not provide quantitative performance metrics for the Sphinx laser system such as power output accuracy, beam stability, or tissue ablation rates against specific benchmarks. It describes the device's capabilities (ablation, coagulation, dissection, resection of soft tissue) and its intended applications across various medical specialties.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (as described in the document) |
|---|---|
| Same Intended Use as Predicate Devices | Surgical laser system for ablation, coagulation, dissection, and resection of soft tissue. |
| Same Indications for Use as Predicate Devices | Broad range of surgical procedures in Urology, Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, and General Surgery. |
| Similar Design Features as Predicate Devices | Surgical laser system operating at 2.1 micron, delivery via standard silica laser fibers, handpiece or endoscopic instrument guidance. |
| Similar Functional Features as Predicate Devices | Provides laser power for soft tissue modification. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This submission is not based on a clinical performance study using a test set of patient data to evaluate an AI/CAD device's diagnostic or predictive performance. It's a regulatory submission affirming substantial equivalence based on technical specifications and intended use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. As there is no "test set" in the context of an AI/CAD device's performance, there were no experts used to establish ground truth for such a set. The "ground truth" here would be the established safety and efficacy of the predicate devices.
4. Adjudication Method for the Test Set:
- Not Applicable. No test set or adjudication process for AI/CAD performance is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This document does not mention an MRMC study. It is a submission for a surgical laser device, not a diagnostic imaging AI.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device (laser system), not an algorithm.
7. The Type of Ground Truth Used:
- Not Applicable / Implied Equivalence: The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and efficacy of the predicate devices (Lumenis - Holmium VersaPulse Power Suite Holmium Laser and Trimedyne - OmniPulse Max 80 Watt Holmium Laser System). The "proof" for the Sphinx system is its demonstration of substantial equivalence to these legally marketed devices, implying that if it is sufficiently similar, it can be considered safe and effective for the stated indications.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
§ 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.