(165 days)
The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
The Exceed micro needling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless-steel nicro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece holder, Handpiece cover, Footswitch, Power supply
The control unit switches the device on and off and contains the power source (5.5-12 V, DC (150mA)). The control unit adjusts the frequency of the needle strom 100-150Hz using a digital display and a kevpad. The control unit receives power via a coaxial connector from a standard 100-240V, 50-60Hz, 1.2A wall socket transformer with an output of 15V. The handpiece contains a motor that moves the needles and a needle protrusion dial that allows the user to control the depth of the needle protrusion. The handpiece contains a scale that allows for the needle protrusion depth to be adjusted by the operator. The scale has a tolerance of +/-0.15 mm. The standard safety needle cartridge is a 6-stainless steel micro needle plate of 1.5 mm length. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use only. This standard safety needle cartridge is used for microneedling only. The length of needles is 1.5 mm. In combination with the handpiece needle protrusion can be adjusted between 0.0 mm (min) and 1.5 mm (max).
This document is a 510(k) summary for the Exceed Microneedling device, demonstrating its substantial equivalence to a predicate device. It includes information on the device's intended use, technological characteristics, and results from non-clinical and clinical performance testing. However, it does not explicitly define acceptance criteria as a standalone table with numerical thresholds for performance metrics. Instead, the "acceptance criteria" are implied by the clinical study's objective: to assess effectiveness by demonstrating a "clinically meaningful result" (defined as a >1 grade improvement on the Lemperle scale) in specific facial areas, and to assess safety by monitoring adverse events.
Here's an attempt to structure the information based on your request, inferring "acceptance criteria" from the study's stated goals and results:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Inferred Acceptance Criteria) | Reported Device Performance (Results) | Conclusion |
|---|---|---|
| Effectiveness: Clinically meaningful improvement in wrinkles (defined as ≥1 grade improvement on Lemperle scale) in specific facial areas. | Glabella Frown Lines: 41/48 (85.4%) subjects showed ≥1 grade improvement. Mean change >1 grade. (Statistically significant) | Met for Glabella Frown Lines |
| Periorbital Lines: 42/48 (87.5%) subjects showed ≥1 grade improvement. Mean change >1 grade. (Statistically significant) | Met for Periorbital Lines | |
| Cheek Folds: 43/48 (89.6%) subjects showed ≥1 grade improvement. Mean change >1 grade. (Statistically significant) | Met for Cheek Folds | |
| Horizontal Forehead Lines, Nasolabial Folds, Upper Lip Lines: Did not demonstrate a clinically meaningful improvement at day 150. | Not met for these areas (but not part of the primary treated areas stated) | |
| Safety: Device is not associated with an unacceptable rate of severe adverse events and expected post-treatment responses are temporary and manageable. | Adverse Events: 13/48 (27%) subjects reported adverse events. 9 (18.75% of total subjects) were device-related and mild (8 Herpes Simplex Labialis (HSL) outbreaks, 1 dry skin). No severe adverse events reported. HSL outbreaks in predisposed individuals were managed with prophylactic antiviral therapy, with no further outbreaks. | |
| Erythema: 100% subjects experienced erythema immediately after treatment, physician-graded as minor (70%) or moderate (30%). Resolved largely by Day 8 (81% reported no erythema). | ||
| Pain: 100% experienced some pain. Mean pain score 5.2 (0-10 scale) during treatment, decreasing to ~0.1 by Day 8. | ||
| Discomfort: 100% experienced some discomfort. Mean discomfort score 1.3 (0-10 scale) during treatment, decreasing by Day 8. | ||
| Skin Peeling: 100% experienced peeling from Day 3, peaking at Day 4 (3.4 on 0-10 scale), still reported in 65% by Day 8. | Met – AE rates managed, all reported AE were mild, and expected side effects were transient. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study/Test Set): 48 subjects were recruited for the study and 48 subjects completed the study.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data in "human-readable" form. However, the submitter's address is listed as "Gustav-Krone-Str. 3, 14167 Berlin, Germany," implying the study could have been conducted in Germany or overseen by the German entity. The study was conducted at a "single center." The study appears to be prospective as it involves recruitment of subjects, a treatment protocol, and follow-up assessments over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Three (3) physicians.
- Qualifications of Experts: They are described as "physicians" who independently analyzed randomized digital images using the Lemperle (2001) grading scale. No further specific qualifications like years of experience or specialization are provided in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: The digital images were randomized and "analyzed independently by 3 physicians." The document does not specify an adjudication method like 2+1 or 3+1 if there were discrepancies in grading. It reports the results as aggregate percentages (e.g., "Subjects graded as having a ≥1 grade improvement"). It seems the consensus of the three reviewers was used, or the average/majority was taken, but the exact arbitration process is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This study evaluates the effectiveness and safety of a microneedling device itself, not an AI system. The "multi-reader" aspect refers to the three independent physicians assessing patient outcomes after treatment with the device, not assessing AI performance or AI-assisted human performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a medical device (microneedling device), not an algorithm or AI. Therefore, no standalone algorithm performance was evaluated.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for effectiveness was established by expert consensus (independent grading by 3 physicians using the validated Lemperle (2001) grading scale based on digital images). For safety, the ground truth was based on physician-reported adverse events and patient-reported outcomes (erythema, pain, discomfort, skin peeling).
8. The Sample Size for the Training Set
- Not applicable. This device is hardware for a procedure, not an AI model that requires a training set. The clinical study described served as a validation/test set for the device's performance in humans.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI device requiring a training set.
§ 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.