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510(k) Data Aggregation
(91 days)
The Collagen P.I.N. (Percutaneous Induction Needling system is indicated for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older.
The Collagen P.I.N. consists of a handheld device that creates microinjuries into the skin, by virtue of a 1 A DC motor that rapidly reciprocates (7000 - 9000 rpm) an array of 35 gauge (SWG) stainless steel microneedles. The device handpiece motor body is comprised of aluminum alloy, with a dial mechanism that controls the depth of penetration of the microneedle array from 0.0 mm to a maximum of 3.0 mm. The Collagen P.I.N. disposable needle cartridge is designed in a single configuration - a 36-pin array in a radial arrangement. The needles, which are 3.0 mm long, are composed of medical grade stainless steel, with a 1.0 mm conical taper to needle array is housed in a cartridge housing that prevents liquids from entering the handpiece motor body via the inside lumen of the cartridge. The needle cartridge is composed of a polycarbonate outer shell and piston, which houses the microneedle array. The microneedle array is attached to the polycarbonate shell using a silicone boot, which acts as spring mechanism which facilitates the microneedling mode of action. Each lot of disposable microneedle cartridges are individually packaged and sterilized by ethylene oxide gas ("EtO"). The device contains a rechargeable lithium-ion battery. The device is to be operated only cordlessly, and not used while the device is plugged into the wall charging station.
This document describes a 510(k) premarket notification for the "Collagen P.I.N. (Percutaneous Induction Needling) System". This device is a microneedling system indicated for improving the appearance of facial acne scars. The provided text outlines the performance data, including non-clinical and clinical studies, to demonstrate substantial equivalence to a predicate device.
Based on the provided text, the device itself is a mechanical microneedling device, not an AI/algorithm-based device. Therefore, acceptance criteria, study design elements, and performance metrics typically associated with AI/ML-driven devices (like those in sections 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt, pertaining to AI performance, expert ground truth, multi-reader studies, training sets, etc.) are not applicable here.
The document primarily focuses on demonstrating the safety and efficacy of a medical device (microneedling system), not an AI algorithm. Its acceptance criteria and study designs are therefore geared towards verifying the mechanical function, sterility, biocompatibility, and clinical outcome for physical treatment, rather than the performance of an algorithm performing a diagnostic or predictive task.
However, I can extract the relevant performance data and acceptance criteria for this physical medical device as described in the document.
Here's a summary of the acceptance criteria and the study results for the Collagen P.I.N. device, focusing on what is available in the provided text:
Preamble:
The Collagen P.I.N. device is a microneedling system. The studies described are to demonstrate its safety and effectiveness for improving the appearance of facial acne scars, and to establish its substantial equivalence to a predicate device (Crown Aesthetics' SkinPen Precision System). There is no mention of AI or algorithmic components in this device or its testing. Therefore, the requested information pertaining to AI/ML device testing (e.g., sample size for test/training sets for AI, ground truth establishment for AI, MRMC studies, standalone AI performance) is not applicable here.
The evaluation focuses on the device's physical properties, biocompatibility, sterilization, and clinical outcomes based on human assessment.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single, consolidated table of "acceptance criteria" alongside "reported device performance" for each criterion in the way an AI/ML device submission might. Instead, it describes various tests and their successful outcomes. I will synthesize this information into a table format based on the detailed performance data provided.
| Criterion Category / Test | Specific Acceptance Criteria | Reported Device Performance / Test Result | Conclusion |
|---|---|---|---|
| Biocompatibility - In Vitro Cytotoxicity (ISO 10993-5) | Qualitative: Grade < 2 (non-cytotoxic) Quantitative: > 70% viability (non-cytotoxic) | Qualitative: No change in morphology (Grade 0). Quantitative: Viability ranged from 91.30% - 97.95%. | PASS |
| Biocompatibility - Intracutaneous Reactivity (ISO 10993-10) | Avg Graded Score should be minimal/low (implied, as score of 0 was target). No mortality/morbidity. | Avg Graded Score = 0. No mortality or morbidity. Increase in body weight observed. Difference of mean skin reaction scores for test item extracts and vehicle control was zero. | PASS |
| Biocompatibility - Skin Sensitization (ISO 10993-10) | Positive control gives clear positive results. No response in negative control. No evidence of sensitization by test item. | No mortality or morbidity observed. All animals showed increase in body weight. No evidence of sensitization. | PASS |
| Biocompatibility - Acute Systemic Toxicity (ISO 10993-11) | No significantly greater biological reactivity than solvent control. No significant body weight loss in control. No mortality/abnormal behavior in control. | Control animals showed no biological reactions. All animals showed increase in body weight. No signs of ill health or overt toxicity. No animals dead/moribund. | PASS |
| Biocompatibility - Material Mediated Pyrogenicity (ISO 10993-11) | Control temperature variation < 1°C. Test animal temperature < 39.8°C. No individual body temperature increase of 0.5°C or more compared to control. | Control temperature variation < 1°C. Control temperatures < 39.8°C. No individual temperature increases of 0.5°C or more. | PASS |
| Cleaning/Disinfection Method Validation | 3-log10 (99.9%) reduction of specified microorganisms: S. aureus, P. aeruginosa, E. coli, K. pneumoniae, M. terrae. | Achieved microbial load reduction performance criteria for each microorganism (3-log10 reduction). | PASS |
| ETO Sterilization Validation (ISO 11135:2014) | Sterility Assurance Level (SAL) of 10^-6 (6-log10 reduction). EtO residuals below 0.5 µg/lens. ECH residuals below 2 µg/lens. | Achieved 6-log10 reduction. EtO residuals not detectable (<0.5 µg/lens). ECH residuals not detectable (<2 µg/lens). | PASS |
| Shelf Life Testing Validation | Conformance to specified packaging integrity standards (visual inspection, internal pressure/bubble test, seal strength, dye penetration) after accelerated aging. | All aged samples passed visual inspection, internal pressure, seal strength, and integrity-dye penetration tests at both 1-year and 2-year simulation time points. | PASS (2-year shelf life validated for microneedle cartridges) |
| Transport Simulation Testing (ISTA 2A, ISO 11607-1) | No adverse effects on device integrity/packaging after transport simulation (visual inspection, internal pressure/bubble test, seal strength, dye penetration). | No visible changes for conditioning/vibration. No irreversible changes for compression. Needle cartridges passed visual inspection, internal pressure, seal strength, and integrity-dye penetration tests. | PASS |
| In Vitro Study - Needle Length, Penetration, Cross-Contamination | Visible needle length within 3.0 mm specification. Max skin penetration depth within 2.5 mm specification. Max puncture duration within 0.180 seconds specification. No leakage or backflow. | Visible length: 1.959 mm to 2.833 mm (within 3.0 mm spec). Max penetration depth: 2.866 mm (±0.047) (within 2.5 mm spec). Max puncture duration: 0.180 seconds (within 0.180 sec spec). No evidence of leakage or backflow. | Meets specifications |
| Clinical Study - Efficacy (Clinician Global Aesthetic Improvement Assessment - CGAIS) | Proportion of subjects with "CGAIS success" (grade 1-3) at Visit 5 (Day 150). | Investigator (live assessment): 100% success for facial acne scars (n=23). Non-investigator panel (photographs): 47.8% (non-investigator 1) and 60.9% (non-investigator 2) success for facial acne scars (mITT population). | Met (Investigator), Varies (Panel) |
| Clinical Study - Subject-Reported Efficacy (SSIS, SGAIS, Satisfaction) | Improvement in appearance as reported by subjects. | SSIS: 91.3% reported at least 25% improvement at Day 150. SGAIS: 82.6% reported at least improvement at Day 150. Subject Satisfaction: 91.3% satisfied or very satisfied at Day 150. | Met |
| Clinical Study - Safety (Adverse Events) | Acceptable incidence and severity of Adverse Events (AEs), Treatment-Related AEs (TRAEs), Serious AEs (SAEs), Unexpected Adverse Device Effects (UADEs). | 11 (22%) subjects experienced TEAEs. 6 (24%) subjects with facial scars experienced TRAEs (all post-inflammatory pigment change, mild/mod severity, in Fitzpatrick skin type IV-VI). No SAEs, no UADEs. No study discontinuation due to AEs. | Acceptable safety profile |
| Clinical Study - Safety (Tolerability Assessments) | Acceptable levels of dryness, roughness, tightness, erythema, edema, itching, burning. | Most assessments (dryness, roughness, itching, burning) were none/mild for ≥ 94% post-treatment. Tightness: none/mild (60-84%), moderate (up to 38%), severe (2%). Erythema: none/mild (34-64%), moderate (up to 58%), severe (up to 11%). Edema: none/mild (62%), moderate (up to 38%), severe (up to 4%). | Acceptable tolerability profile with expected, mostly mild, transient skin responses. |
2. Sample size used for the test set and the data provenance
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Clinical Study Test Set (Efficacy & Safety):
- Sample Size: 50 subjects initially entered the study. 47 (94%) completed the study.
- Primary Efficacy Population (mITT): 48 subjects (all who received at least one treatment and had at least one post-treatment evaluation).
- Facial Acne Scars Efficacy Sub-group: 25 subjects (from the mITT group, 23 with complete efficacy data (CGAIS)).
- Non-facial Scars Safety Sub-group: 25 subjects.
- Data Provenance: The document explicitly states "Induction Therapies sponsored a clinical study... single-arm, two-site study". The locations of the sites are not specified by country, but the submission is to the U.S. FDA, implying a U.S. or internationally accepted clinical trial. The study was prospective.
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Non-Clinical Test Sets: Sample sizes vary by test (e.g., 1000 aged samples for shelf-life, with 900 being the 36-needle cartridge; 2 pig specimens for animal study, 8 skin samples; specific numbers for biocompatibility tests are standard for those protocols, but not explicitly stated as "sample size" in this summary).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
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Clinical Study (CGAIS - for efficacy ground truth):
- Investigator Assessment (Live): Performed by the study Investigator. Their qualifications are not explicitly stated, but they are implied to be medical professionals conducting the study.
- Non-Investigator Panel Assessment (Photographs): A panel of 2 board-certified dermatologists (non-investigators) graded the CGAIS post-final visit using photographs. Their years of experience are not specified.
-
Animal Study (Histopathology):
- Morphological analysis performed by unstated "experts." No specific number or qualifications are given, but usually implies qualified pathologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Clinical Study - CGAIS by Non-Investigator Panel:
- The document states "graded by a panel of 2 board-certified dermatologists". It then reports separate success rates for "non-investigators 1 and 2" (47.8% and 60.9% respectively). This indicates that their assessments were reported individually and potentially averaged or reported as a range, rather than strict adjudication like 2+1 or 3+1 consensus. There is no mention of an explicit adjudication method if their assessments differed.
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
- Not Applicable. This is a medical device (microneedling system), not an AI-assisted diagnostic or imaging device. The "readers" in this context (dermatologists) are providing a clinical assessment of a physical outcome, not interpreting images with or without AI assistance. Therefore, an MRMC comparative effectiveness study with AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical microneedling system, not an algorithm. There is no "standalone algorithm" performance to report.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Clinical Study:
- Efficacy: Primarily expert assessment (investigator and independent dermatologists) based on visual appearance and photographic evidence (CGAIS), and patient-reported outcomes (SSIS, SGAIS, Subject Satisfaction).
- Safety: Clinician assessment of adverse events and tolerability (Investigator Tolerability Assessments), and patient-reported outcomes (Common Treatment Responses in Diaries).
- Animal Study: Pathology (histopathology from pig specimens) for morphological analysis.
- Non-Clinical Material Tests: Ground truth is established by universally accepted standardized test methods (ISO, ASTM standards), which define test conditions and expected results for material properties, sterility, and biocompatibility.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no AI/ML training set, there is no ground truth establishment for it.
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