(162 days)
The LYRA Series Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
The LYRA Laser systems are intended to be semi-portable systems which target the office and small out-patient surgery markets. The laser output characteristics and fiber optical beam delivery method of these LYRA systems are very similar to the Laserscope "Orion" though physically they are much more similar to the Laserscope "Aura" systems. The LYRA systems are based on the same chassis, bezel and user interface as the "Aura" laser systems. The LYRA Systems described herein are capable of delivering laser energy equivalent to the systems Laserscope currently has in commercial distribution and will operate in the following modes: ·1 to 50 Joule StarPulsed and StarPulsedQ 1.064 micron wavelength laser output at frequencies from single shot to 100 HZ.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Laserscope Lyra Surgical Laser System, submitted to the FDA in 1999. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way modern AI/ML device submissions do.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document relies on the predicate device's established safety and efficacy, not a new study.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or a corresponding "reported device performance" from a new study as would be seen for an AI/ML device. Instead, the "performance" demonstrated is substantial equivalence to a predicate device.
| Aspect | Acceptance Criteria (Explicitly Stated for this Device) | Reported Device Performance (from a New Study) |
|---|---|---|
| Safety and Effectiveness | Substantially equivalent to predicate device (Laserscope Orion lasers). Conformity with federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. | Not applicable; based on predicate device. |
| Technological Characteristics | Matching or appropriately similar to predicate device (Laserscope Orion lasers) regarding wavelength, pulse characteristics, delivery systems, and power densities. | The Lyra specifications (Wavelength, Max Energy per Pulse, Max Repetition rate, Pulse width, etc.) are provided as descriptive, not as performance metrics against acceptance criteria from a new study. |
| Indications for Use | Aligned with the predicate device's cleared indications for use. | Not applicable; based on predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No new test set data was used for a performance study.
- Data Provenance: Not applicable. The demonstration of substantial equivalence relies on the established safety and efficacy of the predicate device (Laserscope Orion lasers), which would have had its own historical data. The document does not specify the provenance of that historical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No new test set requiring expert ground truth was established for this submission.
4. Adjudication Method for the Test Set
Not applicable. No new test set was established.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission predates the common application of such studies for AI/ML device clearances and relies on substantial equivalence to an existing laser system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Lyra Surgical Laser System is a physical medical device, not an algorithm, and its performance is inherently human-controlled.
7. The Type of Ground Truth Used
Not applicable in the context of a new performance study. The "ground truth" for the Lyra system's clearance is its substantial equivalence to the predicate device, the Laserscope Orion lasers, which have already demonstrated safety and efficacy for the stated indications.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
§ 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.