(84 days)
Schwartz Electro-Optics, Inc. is not requesting any additional indications or changing the indications as previously cleared in K954013 received 1/31/96. As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 will be indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Specialties are: General Surgery, Plastic Surgery, Podiatry, Urology, Gynecology, Pulmonary Surgery, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic Surgery, Oral and Maxiliofacial Surgery. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated laser. Schwartz Electro-Optics, Inc. seeks no new indications for the CLR 2940 and is only requesting a modification.
From a technology perspective, theory of operation the predicate device is the same as the Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase. The laser mediums are the same, the systems are similar both mechanically and electronically. Schwartz Electro-Optics, Inc. believes that the technological characteristics of the TriLase 2940 Erbium Laser are similar to the predicate device (Premier Centauri Erbium). The Premier Centauri Erbium has the ability to deliver laser energy at 2.94 microns (2940nm), average power of 5 watts at repetition rates of up to 50 pulses per second. These characteristics are very similar to the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser.
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided document, the device described, the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser (referred to as CLR 2940 elsewhere), is being submitted for 510(k) clearance based on substantial equivalence to a predicate device, not through a performance study against specific acceptance criteria in the traditional sense of a clinical trial for a novel device.
The core of the submission relies on demonstrating that the new device has "similar" technological characteristics and that "slight differences in the performance characteristics of these devices raises no concerns." This is a key aspect of 510(k) submissions where a direct comparison to a legally marketed predicate device is made rather than de novo clinical studies establishing specific performance metrics.
Therefore, many of the requested categories for a new device's acceptance criteria and study information are not explicitly present in this type of submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by 510(k) Equivalence) | Reported Device Performance (Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser) |
|---|---|
| Delivery of laser energy at 2.94 microns (2940nm) | Ability to deliver laser energy at 2.94 microns (2940nm) |
| Average power of 5 watts | Similar to predicate device (Premier Centauri Erbium), which has 5 watts |
| Repetition rates of up to 50 pulses per second | Similar to predicate device (Premier Centauri Erbium), which has up to 50 pulses per second |
| Similar mechanical and electronic systems | Identified as similar to predicate device |
| Same laser mediums | Identified as the same as predicate device |
| No new indications for use | No new indications requested; aligns with predicate device's cleared indications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/not provided. The submission is based on a comparison to a predicate device's specifications and existing indications for use, not a clinical study on a test set.
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)
This information is not applicable/not provided. Ground truth in this context would refer to the established performance characteristics and safety profile of the predicate device, which is already legally marketed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There was no test set requiring adjudication in the context of this 510(k) submission.
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
This information is not applicable/not provided. This device is an erbium laser for surgical procedures, not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the established safety and effectiveness profile and performance characteristics of the legally marketed predicate device (Premier Centauri Erbium and CRL 2940 Erbium CrystaLase), as determined by their prior FDA clearance. The company asserts that the new device's characteristics are "similar" to these predicate devices, making them substantially equivalent.
8. The sample size for the training set
This information is not applicable/not provided. There was no "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
§ 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.