(477 days)
The PICOHI is indicated for the following at the specified wavelength:
- · 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
- · 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
- · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
The PICOHI is a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in the range of 275-300ps. The laser system contains one 1064nm (Nd:YAG) laser head which is used to create the 1064nm picosecond wavelength which can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be colinear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 1064nm or 532nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.
The provided text is a 510(k) summary for the PICOHI laser device. It does not present any clinical study data or acceptance criteria for AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (PICOWAY) primarily through non-clinical testing and a comparison of technological characteristics.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, specifically regarding AI/ML performance, because the document explicitly states:
"8. Clinical tests submitted - 807.92(b)(2) No clinical performance testing was performed." (Page 7)
And the entire document is about a laser surgical instrument, not an AI/ML device.
To address your prompt based on the provided document:
The acceptance criteria and study proving the device meets them, as presented in this 510(k) submission, are centered on non-clinical performance and a comparison to a predicate device, not on AI/ML.
Here's a breakdown of what the document does provide regarding the device's acceptance (which is substantial equivalence through non-clinical means):
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):
The acceptance criteria are implied by the standards and characteristics the device must meet to be deemed substantially equivalent to the predicate. The "reported device performance" is essentially that the device passed these non-clinical tests and exhibits comparable technological characteristics.
| Acceptance Criteria (Implied by Standards/Comparison) | Reported Device Performance |
|---|---|
| Basic Safety & Essential Performance: Compliance with IEC 60601-1:2012 | Evaluated in accordance with IEC 60601-1:2012. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014 | Evaluated in accordance with IEC 60601-1-2:2014. |
| Laser Product Safety: Compliance with IEC 60825-1:2014 | Evaluated in accordance with IEC 60825-1:2014. |
| Usability: Compliance with IEC 60601-1-6:2013 and IEC 62366:2007 | Evaluated in accordance with IEC 60601-1-6:2013 and IEC 62366:2007. |
| Low Intensity Laser System Basic Safety & Essential Performance: Compliance with IEC 60601-2-22:2012 | Evaluated in accordance with IEC 60601-2-22:2012. |
| Risk Management: Compliance with ISO 14971:2007 (implied as risk management is "recorded") | Recorded in the reference of ISO 14971:2007. |
| Software Verification & Validation: Compliance with IEC 62304:2006 (moderate level of concern) | Verified and validated in accordance with its moderate level of concern. Evaluated according to IEC 62304:2006. |
| Technological Characteristics Comparability to Predicate (PICOWAY K191685): | - Laser Source: Nd:YAG (Same) |
- Wavelength: 532/1064 nm (Same)
- Max. Fluence: 16.00 J/cm² (PICOHI) vs. 12.5 J/cm² (PICOWAY) - Different, but deemed acceptable for substantial equivalence.
- Pulse Width: 275-300 ps (PICOHI) vs. 375-450 ps (PICOWAY) - Different, but deemed acceptable for substantial equivalence.
- Max. Repetition: 10 Hz (Same)
- Spot Size: 1.5-13 mm (PICOHI) vs. 2-10 mm (PICOWAY) - Different, but deemed acceptable for substantial equivalence.
- Rated Input: 220-240 VAC, 50/60 Hz, 20 A (PICOHI) vs. 200-240 VAC, 50/60 Hz, 30 A (PICOWAY) - Different, but deemed acceptable for substantial equivalence. |
| Intended Use & Indications for Use: Same as/similar to predicate. | Same intended use; similar indications for use, with PICOHI having a slightly narrower range of indications (e.g., no 730/785nm wavelengths, no acne scar or wrinkle treatment indications as listed for predicate). |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not applicable in the traditional sense of a clinical trial or AI/ML test set. The "test set" for this device's acceptance consists of the device itself undergoing various laboratory and engineering tests (bench testing, electrical safety, EMC, software V&V, etc.). No patient samples were used for performance evaluation for this 510(k).
- Data Provenance: Not applicable as no clinical or patient data was used for performance testing. The "data" comes from the results of the non-clinical engineering and safety tests conducted on the device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Experts: Not applicable. Ground truth, in the context of an AI/ML device, is established by human experts or definitive diagnostic tests. For this laser device, the "ground truth" for its safety and performance is established by its adherence to recognized engineering standards and a comparison of its physical and operational characteristics to a legally marketed predicate device.
- Qualifications: Not specified, as it's not a human-data-driven evaluation. The experts performing the non-clinical tests would be engineers, physicists, and quality assurance personnel with expertise in medical device safety and performance testing.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There's no human interpretation or disagreement on results to adjudicate in the context of the non-clinical tests described. The results are quantitative measurements against defined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, there was no MRMC comparative effectiveness study, as this is not an AI/ML device, and no clinical data was submitted for performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the Loop) Performance:
- Standalone Performance: Not applicable. This is a physical laser device, not an AI/ML algorithm.
7. Type of Ground Truth Used:
- Ground Truth: For this type of device and submission, the "ground truth" for acceptance is successful completion of non-clinical engineering and safety standards (e.g., IEC standards) and a demonstration of substantial equivalence in technological characteristics and intended use to a predicate device.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no AI/ML training set.
§ 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.