(86 days)
The COMPACT-KTP-laser-is-intended-for-the-coagulation, ablation- vaporization, incision, excision, and/or cutting of soft tissue in dermatology.
Examples of applications include:
- Benign Vascular Lesions Port Wine Stains Erythrosis Couperosis Facial Telangiectasias Leg Veins - Micro-varicosities Benign Pigmented Lesions Senile Lentigo
- The examples are not intended to be exhaustive or complete but-to serve as a general guide to surgeons.
The COSMOS Medical Technology COMPACT KTP laser emits a beam of coherent light at 532 nanometers as do the predicate devices.
The provided document describes a 510(k) summary for the COSMOS Medical Technology COMPACT KTP laser. It does not contain information about acceptance criteria or a dedicated study proving device performance in the way typically expected for medical device evaluations that involve quantitative performance metrics, such as accuracy, sensitivity, or specificity.
Instead, the submission relies on substantial equivalence to predicate devices. This means that performance data were not required because the specifications and indications for use of the COSMOS Medical Technology COMPACT KTP laser were deemed "the same or very similar" to those of legally marketed predicate devices.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable to this specific submission.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for quantitative performance metrics. The underlying acceptance criterion for this 510(k) was substantial equivalence to predicate devices in terms of specifications and indications for use. | The device's specifications (e.g., emits a beam of coherent light at 532 nanometers) and indications for use (coagulation, ablation, vaporization, incision, excision, or cutting of soft tissue in dermatology) were found to be the same as or very similar to the predicate devices. This similarity was considered sufficient to establish substantial equivalence without new performance data. |
2. Sample size used for the test set and the data provenance
- Not Applicable. No dedicated test set or study validating the device's performance against specific metrics was conducted or reported in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no test set with ground truth was established for this device's performance evaluation, this information is not relevant.
4. Adjudication method for the test set
- Not Applicable. No adjudication method was employed for a test set as no such study was conducted for 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
- Not Applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical laser instrument for surgical procedures, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No specific ground truth was used for performance validation of this device, as its substantial equivalence was based on comparison to predicate devices, not on new performance data demonstrating accuracy against a ground truth.
8. The sample size for the training set
- Not Applicable. This 510(k) submission does not describe a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This 510(k) submission does not describe a machine learning algorithm; therefore, a training set and its associated ground truth are not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is a comparative analysis of specifications and indications for use against legally marketed predicate devices. The document states:
- "The specifications of and indications for the COSMOS Medical Technology COMPACT KTP laser are the same as or very similar to those of the claimed predicates."
- "Because of this, performance data were not required."
- Conclusion: "Based on the similarities of specifications and indications for use, COSMOS Medical Technology believes that the COMPACT KTP laser described in this notification is substantially equivalent to the cited legally marketed predicate devices."
The FDA, through the letter dated November 25, 1998, concurred with this assessment, stating, "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Therefore, the "proof" is the demonstration of substantial equivalence through a direct comparison with existing, legally marketed devices, rather than a prospective study with quantitative 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.