(89 days)
The NuvoLase 720 Laser System is intended for use in retinal and macular photocoagulation, trabeculoplasty, and iridotomy.
The NuvoLase Model 720 is a continuous wave argon ion laser system, emitting a maximum of 2.5 watts, primarily at 488 nm and 514.5 nm wavelengths. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 720 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected by fiber optic.
The provided text is a 510(k) summary for the NuvoLase 720 Laser System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with predefined acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found in a 510(k) summary for a device like the NuvoLase 720 Laser System.
510(k) submissions primarily compare the new device's technological characteristics and intended use to a predicate device. The "study" in this context is a comparison of specifications and intended uses, not a clinical trial proving performance against acceptance criteria in the way you've described.
Here's an explanation of why the requested information is absent and what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
- Not applicable for a 510(k) of this nature. The NuvoLase 720 Laser System is an ophthalmic laser. For such devices, substantial equivalence is typically based on comparing technical specifications (e.g., wavelength, power output, exposure times, aiming beam) and intended uses with predicate devices, rather than clinical performance metrics like sensitivity, specificity, or reader improvement.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No test set or clinical study described. The 510(k) regulatory pathway does not mandate clinical trials for all devices, especially when substantial equivalence can be demonstrated through technological comparison. There is no mention of a test set, data provenance, or retrospective/prospective studies.
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)
- No ground truth establishment described. Since no clinical test set or study is detailed, there's no mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No adjudication method described. Again, without a clinical test set, adjudication methods are irrelevant to this submission type.
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 laser system, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study, especially concerning AI assistance, would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware laser system, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- No ground truth discussed. As explained, the 510(k) focuses on technological equivalence, not clinical performance against a ground truth.
8. The sample size for the training set
- No training set described. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- No training set or ground truth described.
Information that can be extracted from the document relevant to a "device comparison" which serves as the "study" for this 510(k) submission:
"Acceptance Criteria" (Implied from Predicate Comparison) and "Reported Device Performance" (Specifications):
For a 510(k), the "acceptance criteria" are implicitly met if the new device's specifications and performance fall within the established safe and effective parameters of the predicate devices, or if any differences do not raise new questions of safety or effectiveness.
| Feature | Implicit "Acceptance Criteria" (from Predicates) | NuvoLase 720 Reported Performance |
|---|---|---|
| Laser Type | Argon Ion Laser | Argon Ion Laser |
| Plasma Tube | BeO plasma tube (Nidek AC2200) or Tungsten disc plasma tube (Coherent Ultima 2000) | BeO plasma tube |
| Wavelengths | Primarily 488 nm (blue) and 514.5 nm (green) | Primarily 488 nm and 514.5 nm |
| Blue Wavelength Sup. | Ability to suppress the blue portion of the output by filtering | Ability to suppress blue by filtering |
| Max Output Power | 2.0 Watts (Nidek AC2200) and 1.5 Watts (Coherent Ultima 2000) - The NuvoLase 720 is higher at 2.5W, but this difference was deemed not to raise new questions regarding safety or effectiveness, likely due to physician control over power settings. | 2.5 Watts |
| Aiming Beam Source | Red diode laser | Red diode laser |
| Beam Delivery | Via fiber optic | Via fiber optic (Rodenstock RO 5000 LS slit lamp) |
| Exposure Times | Comparable discrete and continuous exposure times (specifics for predicates not given, but implied to be similar or within acceptable range) | 0.02, 0.05, 0.1, 0.25, 0.5, 1.0 seconds, and continuous |
| Intended Use | Retinal and macular photocoagulation, trabeculoplasty, and iridotomy (based on predicate indications or general ophthalmic laser applications for which predicates are used). | Retinal and macular photocoagulation, trabeculoplasty, and iridotomy |
| Safety Features | Implied to have warnings, cautions, and precautions substantially the same as predicate devices, and manufactured under Good Manufacturing Practice requirements (21 CFR Part 820). | "warnings, cautions, and precautions are all substantially the same" |
| Materials/Design | Implied to be substantially the same as predicate devices to ensure safety and effectiveness. | "materials, design... are all substantially the same" |
The "Study" (Comparison for Substantial Equivalence):
The "study" for this 510(k) is the direct comparison of the NuvoLase 720 Laser System with two predicate devices:
- AC 2200 Argon Laser Photocoagulator (Nidek, Inc.)
- Ultima 2000 Argon Laser Photocoagulator (Coherent, Inc.)
This comparison is documented under the "Technological Characteristics/Device Comparison" section. The conclusion states that the NuvoLase 720 is substantially equivalent based on matching materials, design, intended use, method of manufacture, warnings, cautions, and precautions.
Summary Conclusion from 510(k) Context:
The NuvoLase 720 Laser System met the "acceptance criteria" of being substantially equivalent to legally marketed predicate devices by demonstrating that its technological characteristics and intended uses were sufficiently similar, and any differences did not raise new questions of safety or effectiveness. This determination was made through a comparative analysis rather than a clinical study with performance metrics.
§ 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.