(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 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 |
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.