(87 days)
The intended use of the Candela Dynamic Cooling Device is:
- (1) cooling of the skin prior to laser treatment
- (2) reduction of pain during laser treatment
- (3) allows for use of higher laser fluences for laser treatments, such as for hair removal and vascular lesions
- (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions
Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (HFC 134a), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with a laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of HFC 134a just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.
This document is a 510(k) summary for the Candela Dynamic Cooling Device, which is a skin refrigerant used during laser treatments. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a de novo study with acceptance criteria and performance data.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from the given text. The document describes the device and its intended use, then asserts its substantial equivalence to predicate devices based on operating principles, materials, design, construction, methods of assembly, and other intended uses.
Based on the provided text, here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria or report performance metrics (e.g., cooling efficacy, pain reduction scores, side effect rates) from a study in the format typically seen for a new device claiming specific performance. Instead, it claims substantial equivalence to predicate devices, implying that their established performance is sufficient.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No new study data (test set, sample size, or provenance) is mentioned. The submission relies on the existing clearances and data of the predicate devices.
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)
- Cannot be provided. As no new test set or ground truth establishment process is described, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process is detailed in this 510(k) summary.
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
- Cannot be provided. This device is a cooling device for laser treatment, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This device is a mechanical cooling device, not an algorithm. Standalone performance as typically described for algorithms is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No specific ground truth establishment for a new performance claim is mentioned. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices.
8. The sample size for the training set
- Cannot be provided. This is not a machine learning or algorithm-based device, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable (see point 8).
Summary of available information related to "proof" of meeting criteria:
The document asserts the device meets its intended use and is safe and effective by demonstrating substantial equivalence to two predicate devices:
- Candela Dynamic Cooling Device (K951033): Cleared for "cooling of the skin prior to and reduction of pain during laser treatment."
- Epidermal Chiller tip accessory to Coherent, Inc.'s Versapulse Aesthetic Surgical Laser (K972347): Cleared for "protecting the dermis from thermal injury, which reduces possible side effects such as scabbing, scarring, and hyperpigmentation" and allowing "for the utilization of higher laser fluences for laser treatment."
The current device then claims:
- Substantial equivalence to K951033 for "use of higher laser fluences and reduction of potential side effects of laser treatments."
- Substantial equivalence to K972347 for "indications for use."
The "proof" is the assertion that the operating principles, materials, design, construction, methods of assembly, and other intended uses are the same as those for the predicate device K951033. The FDA's letter confirms their review and determination of substantial equivalence, allowing the device to proceed to the market.
In the context of a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as a legally marketed predicate device, and the "study" is the comparison and argument for substantial equivalence, rather than a new clinical trial with defined performance metrics against specific criteria.
§ 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.