(128 days)
The PiXel8-Reveal contains two handpieces, each of which has its own indications for use.
The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
The Er.Y AG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion. and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The PiXel8-Reveal system is a multi-function laser and radiofrequency system intended for dermatologic and general surgery purposes. The system is comprised of a single console with two handpieces:
- PiXel8-RF - a bipolar radiofrequency microneedling handpiece with disposable tips
- Er:YAG - an Erbium:Yag single wavelength light-based handpiece.
The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.
Based on the provided text, the device in question, PiXel8-Reveal, is an electrosurgical cutting and coagulation device, and a powered laser surgical system. The document is an FDA 510(k) premarket notification clearance letter, which determines substantial equivalence to legally marketed predicate devices, rather than a clinical study proving the device meets specific performance acceptance criteria for diagnostic or clinical tasks.
Therefore, the information requested in the prompt, such as acceptance criteria, statistical performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance, are not explicitly present or relevant to this type of device clearance document.
This document focuses on demonstrating substantial equivalence to existing predicate devices (PINXEL-RF system (K180654) and MultiLaser System (K123777)) through technical specifications comparison and non-clinical performance testing (e.g., electrical safety, EMC, thermal testing).
However, I can extract and structure the information that is available related to the device's technical specifications and the testing performed to support its clearance:
Summary of Device Clearance Information for PiXel8-Reveal
This device obtained FDA 510(k) clearance based on demonstrating substantial equivalence to predicate devices, not on a clinical study proving diagnostic or clinical performance against acceptance criteria typically seen for AI/CADe devices.
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" here refers to demonstrating that the new device's technical specifications and performance are comparable to the predicates, addressing any differences. The document does not define quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity thresholds) as it's not a diagnostic device clearance based on clinical performance.
Instead, the "performance" is demonstrated through comparison of specifications and non-clinical testing.
Comparison of Key Technical Specifications and Performance Aspects:
| Feature/Metric | Acceptance/Comparison Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (PiXel8-Reveal) | Comparison/Justification |
|---|---|---|---|
| PiXel8-RF Handpiece | |||
| System Type | Bipolar Radiofrequency (Predicate) | Bipolar Radiofrequency | Same |
| RF Frequency | 2MHz (Predicate) / 4MHz (Reference Device) | 4MHz | Different from Predicate 1 (2MHz), Same as Reference Device (4MHz). Thermal testing performed to show performance is substantially equivalent and raises no new concerns regarding safety or effectiveness. The Test Device showed "somewhat milder thermal damage". |
| Max Power | 25W @ 500ohm (Predicate) | 25W @ 500ohm | Same |
| Total Power delivered per treatment | 25W (Predicate) | 25W | Same |
| Power per pin | 25W (Predicate) | 25W | Same |
| RF Duration | 50ms-950ms (Predicate) | 50ms-1000ms | Different. The difference is stated as "not large enough to impact safety or effectiveness." |
| Tips | 25 and 64 pin microneedle electrodes (Predicate) | 25, 49 and 64 pin microneedle electrodes | Addition of one new electrode (49 pins). Justified by stating it's mid-way between existing sizes, does not impact needle depth, and is included in the reference device. Dimensions are the same. |
| Needle Insert Depth | 0.5-3.5mm (Predicate) | 0.5-3.5mm | Same |
| Er:YAG Handpiece | |||
| Wavelength | 2940nm (Predicate) | 2940nm | Same |
| Max Power | 2.4W (Predicate) | 2.4W | Same |
| Max Fluence | Up to 8J/cm2 (Predicate) | Up to 10J/cm2 | Different. The difference is stated as "not large enough to impact the safety or effectiveness of the device." |
| Pulse Width | 300 μs (Predicate) | 300 μs | Same |
| Repetition Rate | Up to 10 pulses/second (Predicate) | Up to 5 pulses/second | Different. No explicit justification for impact on safety/effectiveness is given for this specific difference, but the overall conclusion is substantial equivalence. |
| Spot Size | 1.5mm, 3mm, 6mm, 9mm (Predicate) | 1.5mm, 3mm, 6mm, 9mm | Same |
| Other Performance Testing (Non-Clinical) | |||
| Electrical Safety, EMC, Software, Biocompatibility | Compliance with relevant IEC standards. | IEC 60601-1:2005+Corr.1:2006+A1:2012, IEC 60601-1-2:2014+A1:2020, IEC 60601-2-2:2017, IEC 62304:2006+A1:2015. Software V&V conducted per FDA guidance. Biocompatibility materials deemed acceptable from prior clearance (K180654). | Compliant. |
| Thermal Testing | Comparable thermal damage profile to Predicate at 2MHz RF. | Test Device (4MHz RF) showed "somewhat milder thermal damage (moderately smaller CMZs)" than 2MHz Predicate. Consistent thermal damage profiles were achieved, "comparable to the profiles produced by the Predicate Device". | Indicates safer nature, while achieving comparable treatment effect. This test directly addresses the primary difference in RF frequency to demonstrate substantial equivalence in practical effect. |
2. Sample sizes used for the test set and the data provenance
The document describes non-clinical performance testing, specifically thermal testing for the RF handpiece.
- Test Sample: The thermal testing was conducted using three tissue types (ex vivo kidney, liver, and skin). The document does not specify a "sample size" in terms of number of cases or patients, as it was ex vivo tissue testing, not a clinical study.
- Data Provenance: The data is generated from ex vivo tissue testing. Origin (country) is not specified but the context implies it was part of the device manufacturer's internal testing as submitted to the FDA for US market clearance. This was an experimental/testing process, not retrospective or prospective clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device clearance. The "ground truth" for the thermal testing was the direct measurement of thermal damage profiles in the ex vivo tissues using the devices, not expert human interpretation or labeling of clinical data. There were no experts establishing ground truth in the sense of clinical diagnosis or interpretation for this specific clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No human interpretation requiring adjudication was involved in the thermal or other non-clinical performance testing.
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 device is not an AI/CADe system for diagnostic interpretation. The document explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm, but a physical medical device. Standalone performance as typically described for AI/CADe was not assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the thermal testing, the "ground truth" was the physically measured thermal damage profiles (CMZs - Coagulation Measurement Zones) in the ex vivo tissues. This is a direct measurement of the device's biophysical effect, not a clinical diagnosis or patient outcome.
8. The sample size for the training set
Not applicable. This device clearance is not based on an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no AI model/training set was part of this clearance process.
In summary, the FDA clearance for the PiXel8-Reveal was based on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications, rather than a clinical study evaluating diagnostic or treatment performance against pre-defined acceptance criteria, as would be typical for AI-enabled diagnostic devices.
§ 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.