(112 days)
The vela® XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The vela® XL is thulium laser system, which emits laser radiation with a wavelength of approximately 1.9 µm. The laser power transfers an optical application fiber. The indications are dissection, ablation, resection and coagulation of tissue. The laser system consists of: - laser system including control panel (user interface) - foot switch - application fiber
The provided document is a 510(k) summary for the StarMedTec vela® XL laser system. It details the device's intended uses and provides information about performance testing. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) or comparative effectiveness from a multi-reader, multi-case study.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific accuracy thresholds, rates of success for procedures). Instead, the performance testing described focuses on compliance with established standards and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety and Effectiveness | Substantial equivalence to predicate device (Lisa Laser Products – Revolix 120 Laser System, K070476) for various surgical procedures (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue). | "The vela® XL is as effective and save as the predicate device. The vela® XL is substantially equivalent to the cited legally marked predicate device." |
| Design Specifications | Met all design specifications. | "Laboratory testing was conducted to verify and validate that the vela® XL met all design specifications..." |
| Standards Compliance | Compliance with specified international and European standards. | "The vela® XL is tested according to following standards: IEC 60601-1:1988 + A1:1991 + A2:1995, IEC 60601-1-2:2005, IEC 60601-1-4: 1996 (First Ed.) + Am.1: 1999 (Consolidated 1.1 Ed.) for use with IEC 60601-1 (1988), Amts 1 (1991) and 2 (1995) 60601-1-6, IEC 60601-2-22:2005, IEC 60825-1:2007, IEC 62366:2007, IEC 62304:2007. The device also complies with European Medical Device 93/42/EEC + Amendment 2007/47/EC." |
| Clinical Data | No clinical information required for submission. | "No clinical information is required." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical information is required." This means there was no clinical "test set" of patients or cases used for performance evaluation in the context of this 510(k) submission. The evaluation was based on laboratory testing and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical test set was required or used for performance evaluation in this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was required or used for performance evaluation in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No MRMC comparative effectiveness study was reported in this document. The submission states that "No clinical information is required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The vela® XL is a laser surgical instrument, an active device used by a human practitioner. It's not an "algorithm only" device in the sense of AI-driven diagnostic software. Its performance is intrinsically linked to its operation by a human user during surgical procedures. The performance evaluation focuses on the device's technical specifications and safety rather than independent algorithmic performance.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by demonstrating its compliance with technical standards and its substantial equivalence to an already legally marketed predicate device (Lisa Laser Products – Revolix 120 Laser System, K070476). This relies on:
- Engineering and laboratory test data confirming design specifications.
- Regulatory assessment of the similarities and differences between the new device and the predicate device, with respect to indications for use, technological characteristics, and safety/effectiveness profiles.
8. The Sample Size for the Training Set
Not applicable. As this is a medical device approval based on substantial equivalence and laboratory testing, there is no "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in this context.
§ 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.