(160 days)
The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
The V-Laser is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The V-Laser consists of the main body, optical fiber cable, user-undetachable laser handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered to the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.
The provided document is a 510(k) Premarket Notification for the V-Laser system. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria, device performance metrics, or a study proving the device meets acceptance criteria in the context of clinical outcomes or diagnostic accuracy.
The "Clinical Test Summary" section explicitly states: "No clinical studies were considered necessary and performed." This means the device's performance was not evaluated through clinical trials for human use, and therefore, there are no reported device performance metrics against acceptance criteria related to clinical efficacy or safety from such studies.
Instead, the submission focuses on bench tests to verify that the device meets design specifications and complies with non-clinical standards related to electrical safety, electromagnetic compatibility, laser safety, and software validation. It also includes biocompatibility testing for materials that may come into contact with the body.
Here's an attempt to answer your questions based only on the provided document, acknowledging the significant limitations:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no acceptance criteria or reported device performance for clinical efficacy or diagnostic accuracy because "No clinical studies were considered necessary and performed."
The "acceptance criteria" discussed are primarily compliance with international and national standards for medical electrical equipment, electromagnetic compatibility, laser safety, and biocompatibility. The "reported device performance" is that the device "met all design specifications" and "complies with the following standards."
| Acceptance Criteria (Non-Clinical Standards) | Reported Device Performance |
|---|---|
| Electrical Safety & Essential Performance: Compliance with AAMI ES60601-1 (Edition 3.1, 2012) | "Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with... AAMI ES60601-1" |
| Electromagnetic Compatibility: Compliance with IEC 60601-1-2 (Edition 3, 2007) | "Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with... IEC 60601-1-2" |
| Particular Requirements for Laser Equipment: Compliance with IEC 60601-2-22 (Edition 3.1, 2012) | "Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with... IEC 60601-2-22" |
| Safety of Laser Products: Compliance with IEC 60825-1 (Edition 3, 2014) | "Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with... IEC 60825-1" |
| Software Validation: Designed and developed according to a software development process, verified and validated (for a MODERATE level of concern software), and in accordance with FDA guidance "The content of premarket submissions for software contained in medical devices, on May 11, 2005." | "The V-Laser contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005." |
| Biocompatibility: Compliance with ISO 10993-1 and FDA Blue Book Memo #G95-1, specifically passing: Cytotoxicity (ISO 10993-5:2009), Intracutaneous (intradermal) reactivity (ISO 10993-10:2010), and Skin sensitization (ISO 10993-10:2010) tests for materials in contact with the body. | "According to the recommendations of ISO 10993-1 and FDA Blue Book Memo #G95-1, the following tests were performed: -Cytotoxicity test according to ISO 10993-5:2009 -Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010 -Skin sensitization test according to ISO 10993-10:2010" (Implied "passed" as part of demonstrating substantial equivalence). |
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 and therefore not provided, as "No clinical studies were considered necessary and performed." The "test set" for non-clinical bench testing would typically refer to the specific laser units, components, or materials tested, not a patient cohort. The document does not specify the number of units or samples subjected to each bench test.
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 and therefore not provided, as "No clinical studies were considered necessary and performed." Ground truth established by medical experts is relevant for studies involving human diagnosis or treatment outcomes, which were not conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided, as "No clinical studies were considered necessary and performed." Adjudication methods are used in clinical trials or diagnostic accuracy studies involving human interpretation.
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 such study was done. The device is a laser system for surgical and aesthetic applications, not an AI-powered diagnostic or assistive tool. "No clinical studies were considered necessary and performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the V-Laser system, as it is a physical laser device, not a standalone AI algorithm. "No clinical studies were considered necessary and performed."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable as "No clinical studies were considered necessary and performed." For the non-clinical tests, the "ground truth" would be the specifications and requirements outlined in the various engineering and biocompatibility standards.
8. The sample size for the training set
This information is not applicable. Training sets are relevant for machine learning algorithms. The V-Laser is a hardware device. "No clinical studies were considered necessary and performed."
9. How the ground truth for the training set was established
This information is not applicable. "No clinical studies were considered necessary and performed."
Summary of the Study that Proves the Device Meets the Acceptance Criteria (Non-Clinical):
The "study" in this context refers to a series of non-clinical bench tests and validations. The document states:
"Verification and validation activities were conducted to establish the performance and safety characteristics of the V-Laser. The results of these activities show that there are no any new safety and effectiveness issues. Therefore, the V-Laser is considered substantially equivalent to the predicate."
These activities included:
- Electrical Safety, Electromagnetic Compatibility, and Performance Bench Tests: These tests verified that the device met all design specifications and complied with AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards.
- Software Validation: The software, identified as having a MODERATE level of concern, was designed, developed, verified, and validated according to a software development process and FDA guidance.
- Biocompatibility Testing: Tests were performed according to ISO 10993-1 and FDA Blue Book Memo #G95-1, covering cytotoxicity, intracutaneous reactivity, and skin sensitization for materials in contact with the body.
The "proof" that the device meets these non-clinical "acceptance criteria" is the statement that the tests were conducted and the device "complies" with the listed standards and its design specifications. No detailed results, specific measurements, or pass/fail thresholds beyond the general statement of compliance are provided in this summary.
§ 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.