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510(k) Data Aggregation
(245 days)
The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age.
The Rejuvapen is a handheld instrument that contains a Single Use micro needle cartridge containing 12 stainless steel microneedles in a circular arrangement with an adjustable microneedle depth of up to 2.5 mm. The needles create very small punctures in the epidermal and dermal layers of the skin. The device is powered by a medical grade wall plug-in supply. An adjustment is provided for a variable speed motor that controls the frequency of the puncture process with a
Here's an analysis of the acceptance criteria and study findings based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with quantitative thresholds for effectiveness as a primary endpoint. Instead, the effectiveness is demonstrated through a clinical study where improvement in periorbital wrinkles is observed. The acceptance criteria for safety are primarily qualitative observations and adherence to international standards.
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Safety - Biocompatibility | ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, USP 40 part 151, ISO 10993-12 | Biocompatibility evaluation performed, indicating compliance with standards. (Implied successful given broader conclusion of substantial equivalence). |
| Safety - Sterilization | ISO11135-1:2007, ISO/TS11135-2:2008, ISO11737-1:2006 | Shelf life (2 years) verified; sterilization validation reports in accordance with standards. |
| Safety - Reprocessing | Cleaning and low-level disinfection validation, use of protective sleeve required. | Cleaning and low-level disinfection validations performed. |
| Safety - Electrical | IEC / ES60601-1, IEC60601-1-2, IEC60601-1-6 | EMC testing and electrical safety testing performed, complying with standards. |
| Performance - Needle Protrusion Accuracy | Maximum needle protrusion setting of 2.5 + 0.25 mm. | Bench testing demonstrated accuracy of needle penetration depth and maximum permissible depth within set tolerance (± 0.25mm) at depths of 0.5mm and 2.5mm. Device maintained functional integrity with aged cartridges and devices. |
| Performance - Puncture Frequency Accuracy | Maximum puncture frequency of 110 Hz + 2%. | Bench testing demonstrated accuracy of puncture rate within set tolerance (± 2%) at frequencies of 80 Hz and 110 Hz. Device maintained functional integrity with aged cartridges and devices. |
| Performance - Cross-Contamination | Safety features to protect against cross-contamination (e.g., fluid ingress protection, safety membrane). | Testing of the safety membrane/seal under worst-case scenario (maximum puncture rate and needle penetration depth) did not result in penetration of viral particles, protein, or hemoglobin markers. |
| Effectiveness (Periorbital Wrinkles) | Not explicitly stated as a quantitative threshold in the provided text, but implied as significant improvement. | Physician Assessment: For 37 subjects with consistent grading, mean improvement in Lemperle scale was 0.57. 19 out of 45 subjects (42%) had at least a one-grade improvement according to both assessors. Subject Assessment: 37/46 (80%) of subjects graded their treatment response as "slight to somewhat noticeable improvement in periorbital wrinkles." |
| Adverse Events | Not explicitly stated as a quantitative threshold or maximum allowed percentage, but events should be mild and self-limiting. | 20 adverse events in 12/52 subjects (23%), all judged mild, self-limiting, and requiring no intervention. 14/20 (70%) were bruising, 2/20 (10%) swelling, 1/20 (5%) blotchy skin/bruising, 1/20 (5%) 'watery eyes'/allergic response. |
| Erythema (Physician) | Not explicitly stated as a quantitative threshold; generally expected to be mild/moderate and transient. | Immediately post-treatment: predominantly minor or mild (83-93% across treatments), with 2-10% moderate. No severe erythema was observed. |
| Erythema (Subject) | Not explicitly stated as a quantitative threshold; generally expected to be transient. | Immediately post-treatment: 26% severe, 52% moderate, 22% mild/minor. One day post-treatment: 11% severe. By evening Day 3: 96% mild, minor, or absent. By Day 8: 96% none, 4% minor, 2% mild. |
| Pain/Discomfort (Subject) | Not explicitly stated as a quantitative threshold; generally expected to be low and transient. | Mean pain score during treatment: 2.1 (range 0-7) on a 0-10 scale. Mean discomfort score during treatment: <1 (range 0-7) on a 0-10 scale. By evening Day 2: mean pain score 0.5; mean discomfort score <1. By Day 4: mean pain score 0. |
2. Sample Size Used for the Test Set and the Data Provenance
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Sample Size for Test Set:
- Clinical Study (Effectiveness & Safety): 52 healthy volunteers recruited.
- Effectiveness Analysis (Physician): 37 subjects for whom both physicians gave the same grade improvement, out of 45 subjects evaluated by both assessors.
- Safety Analysis (Physician & Subject): 52 subjects initially, with 46 subjects completing all treatments and follow-up.
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Data Provenance: The clinical study was conducted at a single center. The document does not specify the country of origin of the data, but the submission is to the U.S. FDA, implying the data was likely collected in the U.S. or recognized by U.S. standards. The study design (recruitment, interventions, follow-up) indicates it was a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: 2 physicians.
- Qualifications of Experts: The document states they were "2 physicians" who used the Lemperle grading scale (periorbital region) and were "blinded evaluators." No further specific qualifications (e.g., years of experience, specialization like dermatology or plastic surgery) are provided.
4. Adjudication Method for the Test Set
- The effectiveness results are reported based on instances where the two blinded evaluators gave the same grade improvement (37 out of 45 subjects). This implies an approach where agreement was prioritized or a subset with agreement was analyzed, rather than a formal adjudication method like 2+1 or 3+1 for resolving disagreements. The document mentions "For the 37 subjects for whom the two physicians gave the same grade improvement the mean improvement was 0.57." This suggests that cases where the physicians disagreed might have been excluded from the primary effectiveness metric presented, or an averaging/adjudication was not explicitly detailed for disparate readings.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical trial evaluating the standalone effectiveness and safety of the Rejuvapen NXT device itself on patients, not comparing human reader performance with or without AI assistance. The device is a microneedling device, which is a physical skin treatment, not an AI-powered diagnostic or interpretive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the context of the Rejuvapen NXT. The Rejuvapen NXT is a physical microneedling device, not an algorithm or software. The "standalone" performance tested was the device's ability to mechanically deliver treatments (e.g., needle penetration, puncture rate accuracy) and its clinical effectiveness when used by a human operator.
7. The Type of Ground Truth Used
- Clinical Study (Effectiveness): The ground truth for effectiveness was established through expert consensus (2 blinded physicians using the Lemperle grading scale) and subject-reported outcomes (grading their own improvement).
- Clinical Study (Safety): The ground truth for safety was based on physician assessments of erythema and adverse events, and subject-reported assessments of erythema, pain, discomfort, and peeling.
- Bench Testing (Performance): The ground truth for mechanical performance (e.g., needle protrusion, puncture rate, fluid ingress) was established through direct measurements and laboratory testing against predefined technical specifications.
8. The Sample Size for the Training Set
- This question is not applicable as the Rejuvapen NXT is a physical medical device, not a machine learning or AI algorithm that requires a training set. The study describes a clinical trial and bench testing for device validation.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as the Rejuvapen NXT is a physical medical device, not a machine learning or AI algorithm that requires a training set.
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