(47 days)
The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I. II, III and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types 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 XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainlesssteel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.
This document is a 510(k) premarket notification letter from the FDA regarding the XCELLARISPRO TWIST microneedling device. It clarifies that this device is not an AI/ML powered device, and therefore, the acceptance criteria and study information requested would not be present in this type of document. The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and adherence to general and special controls, rather than human-in-the-loop or standalone AI performance studies.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance, cannot be extracted from the provided text.
The closest relevant sections in the document that discuss performance and criteria are under "Non-Clinical Performance Testing" on pages 8-10. These sections outline special controls and non-clinical tests conducted to demonstrate the device's safety and effectiveness without involving AI.
Summary of available information related to device performance in the provided text (not AI-related):
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related):
The document does not present a formal table of acceptance criteria and reported performance in the way typically seen for AI/ML devices. Instead, it lists "special controls" that the device must meet through non-clinical performance data. These are more akin to design and function requirements than performance metrics in an AI context.
| Acceptance Criteria (Special Controls) | Reported Device Performance (as implied or stated) |
|---|---|
| 1. Technical specifications and needle characteristics identified (needle length, geometry, puncture rate, max protrusion depth). | Identified. Needle length: 2.5 mm. Puncture frequency range: 50-150 per second. Max recommended needle penetration depth: 1.5 mm. Max needle protrusion depth: 2.5 mm. Needle cushion: 6 stainless steel microneedles in squared arrangement. |
| 2. Non-clinical performance data demonstrate device performs as intended under anticipated conditions of use. | - Accuracy of needle protrusion depth and puncture rate: Tested in pig skin with high-speed camera measurements. (Specific values not provided in this summary, but stated to be demonstrated). |
- Safety features (cross-contamination, fluid ingress): Due to a bellows. (Demonstrated).
- Maximum safe needle protrusion depth: Identified in pig skin with high-speed camera measurement. (Demonstrated). |
| 3. Performance data demonstrate sterility of patient-contacting components (ISO 11737-2, ISO 11135). | Demonstrated for sterile, single-use needling module (Ethylene oxide sterilized). |
| 4. Performance data supports shelf life (sterility, package integrity, functionality per ISO 11607-1). | Demonstrated. |
| 5. Performance data demonstrate electrical safety and electromagnetic compatibility (EMC) per IEC 60601-1 and IEC 60601-1-2. | Demonstrated. |
| 6. Software verification, validation, and hazard analysis. | Conducted. (The device has a control unit and adjustable settings, indicating software or firmware for operation, but this is not an AI/ML software). |
| 7. Patient-contacting components biocompatible (cytotoxicity, irritation, sensitization, acute systemic toxicity, material pyrogenicity per ISO 10993-1). | Demonstrated. |
| 8. Cleaning and disinfection validations for reusable components. | Performed for surfaces of the control unit and handpiece. |
| 9. Labeling includes required information (operation, technical parameters, reprocessing, disposal, shelf life). | Included. |
| 10. Patient labeling includes required information (operation, risks/benefits, post-operative care). | Included. |
Regarding the AI/ML specific questions:
- Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML device. Performance testing involved pig skin for physical measurements.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a microneedling device's physical performance typically relies on instrumental measurements and engineering specifications, not expert human interpretation of data/images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical performance tests mentioned, the ground truth would be based on validated objective measurements (e.g., high-speed camera measurements for needle protrusion and puncture rate, laboratory tests for sterility, biocompatibility, electrical safety).
- The sample size for the training set: Not applicable (no AI training set).
- How the ground truth for the training set was established: Not applicable (no AI training set).
Conclusion: The provided FDA 510(k) summary is for a traditional medical device (microneedling device) and focuses on demonstrating substantial equivalence through non-clinical performance and adherence to established regulatory controls, rather than on AI/ML algorithm performance. Therefore, the specific questions related to AI/ML acceptance criteria, study design, and ground truth establishment are not addressed in this document. The document explicitly states: "No clinical studies were performed to test the XCELLARISPRO TWIST microneedling device." This further confirms the absence of human "expert" involvement in establishing performance for this particular device submission beyond standard engineering and lab testing.
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.