(90 days)
The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used to deliver: frequency doubled, Q-switched frequency doubled, and Q-switched Nd:YAG; Q-switched Alexandrite:YAG laser energy for use in surgical applications requiring the photothermolysis (photocoagulation) of soft tissue; and Er: Y AG laser energy for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
Coherent VersaPulse Aesthetic Surgical Lasers are comprised of the following main components:
- · a laser console and tower;
- · a counterbalanced articulated arm and delivery systems;
- · a fiber port and delivery systems;
- · control and display panels;
- · footswitch and handswitch delivery controls;
- · a remote control unit; and
- · a variety of delivery device accessories (articulated arm and fiber handpieces, scanners, and epidermal cooling devices).
This submission is a 510(k) Summary Statement for a medical device (Coherent VersaPulse Aesthetic Surgical Lasers) and does not contain the detailed study information typically found in a clinical trial report or a comprehensive regulatory submission. The document explicitly states it's a "Rationale for Substantial Equivalence," meaning the primary argument for approval is that the device is similar enough to already marketed devices. Therefore, a formal study with acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies is not described in the provided text.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This approach to regulatory clearance (510(k)) often relies on comparing device features and performance to existing, legally marketed devices, rather than conducting new, elaborate clinical trials to establish de novo safety and effectiveness with specific performance metrics and acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy percentages) are provided in the document, nor are specific performance metrics like "sensitivity" or "specificity" reported. The acceptance criteria essentially revolve around demonstrating equivalence in design, function, and intended use to predicate devices, and demonstrating acceptable physical test results and biocompatibility.
| Acceptance Criteria (Inferred from Substantial Equivalence Logic) | Reported Device Performance (Summary) |
|---|---|
| Indications for Use: Same as predicate devices | Shares the same indications for use as predicate devices. Intended for photothermolysis of soft tissue (532 nm, 1064 nm, 755 nm) and excision, incision, ablation, vaporization, and coagulation of soft tissue (2940 nm). |
| Design Features: Similar to predicate devices | Similar design features (control system, wavelengths, beam quality, laser tube configuration, active medium, cooling system, controls and displays). |
| Functional Features: Similar to predicate devices | Similar functional features (power, repetition rate, energy, spot sizes, treatment areas). |
| Laser Energy Equivalence: Equivalent to currently marketed surgical lasers | In-vivo testing performed to demonstrate that the laser energy provided is equivalent to that provided by currently marketed surgical lasers. (No specific metrics or thresholds reported). |
| Biocompatibility: New delivery device materials are biocompatible | Testing performed to establish the biocompatibility of new delivery device materials that could potentially contact patient tissue. (No specific metrics or thresholds reported). |
| Safety and Effectiveness: Assumed equivalent to predicate devices | Found to be substantially equivalent to similar currently marketed surgical laser devices. Physical test results demonstrated acceptable performance characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "In-vivo testing" and "Testing is performed to establish biocompatibility," but it does not provide any details on the number of subjects, animals, or test cases involved in these tests.
- Data Provenance: Not specified. It's highly likely this was internal company testing, but no country of origin is mentioned. The description "In-vivo testing" suggests prospective testing, but without further detail, it's impossible to confirm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. Given the nature of a 510(k) for a laser device, "ground truth" as it would be understood in an AI/diagnostic study (e.g., expert consensus on image interpretation) is not directly applicable. The "ground truth" here would likely relate to objective measurements of laser output and observed tissue effects, or standard biocompatibility assessments, rather than expert judgment on complex cases.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. There's no indication of any expert adjudication process for the "in-vivo testing" or biocompatibility assessments mentioned. These typically involve objective measurements and established scientific protocols rather than subjective consensus.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human interpretation (e.g., AI for radiology). This device is a surgical laser, and its primary function is to deliver energy for therapeutic purposes, not to provide diagnostic information or assist human "readers." Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device's regulatory submission as described.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This device is a physical surgical laser, not a software algorithm. Its "performance" is inherent in its physical output and functional capabilities (e.g., laser power, wavelength, tissue effects). Its operation requires a human operator, so an "algorithm-only" or "standalone without human-in-the-loop" performance is not a relevant concept for this type of device.
7. The Type of Ground Truth Used
- For "in-vivo testing" to demonstrate laser energy equivalence, the ground truth would likely be objective measurements of laser parameters (e.g., power output, energy density, pulse duration) and possibly observed tissue effects (e.g., depth of photocoagulation, ablation rates) against established benchmarks or the performance of predicate devices.
- For "biocompatibility testing," the ground truth would be established through standardized testing protocols (e.g., ISO standards for cytotoxicity, irritation, sensitization) which involve specific assays and observational criteria to determine if a material is biologically compatible.
- The document does not explicitly state these, but these are the standard "ground truths" for such tests.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device is a hardware surgical laser, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI development. The device's design and engineering are based on established physics and medical knowledge, rather than being "trained" on data.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided for the same reasons as point 8. There is no training set for this type of 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.