(158 days)
Intended Use: The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.
Indications for Use: The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Accent Pixel RF Tips include cleanable, sterilizable, multiple use radiofrequency (RF) energy delivery devices (accessory) intended for use with the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite]. These Pixel RF Tips are also available as single use, disposable products. The Accent Pixel RF Tips are comprised of the following main components: Pixel Stationary Tip, Pixel Roller Tip.
The provided text is a 510(k) Summary for the Alma Lasers Accent Pixel RF Tips. It describes the device and its intended use, and argues for substantial equivalence to predicate devices, supported by animal and human clinical data. However, the document is a regulatory submission for substantial equivalence rather than a detailed study report proving the device meets specific acceptance criteria.
Therefore, direct answers to many of your questions, particularly those related to detailed study methodologies, sample sizes for training/test sets, ground truth establishment methods, expert qualifications, adjudication, and MRMC studies, are not explicitly stated or available in the provided text.
Here's an analysis of what can be extracted and what is missing:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" in this document is primarily centered around demonstrating substantial equivalence to existing predicate devices. This means the device performs similarly to devices already cleared by the FDA for similar indications. The document doesn't outline specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet against a predefined threshold. Instead, the "performance" discussed relates to the device's functional characteristics and its ability to achieve the stated indications for use.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category (Implied by Substantial Equivalence Review) | Reported Device Performance (Summary from Document) |
|---|---|
| Intended Use (Same or similar to predicates) | Match: "Intended for use in dermatologic and general surgical procedures." This aligns with the intended use of predicate devices. |
| Indications for Use (Same or similar to predicates) | Match: "Indicated for dermatological procedures requiring ablation and resurfacing of the skin." This aligns with specific indications of predicate devices (e.g., Matrix RF Applicator, EndyMed FSR applicator). Also "non-invasive treatment of wrinkles and rhytids" when used with Unipolar and Bipolar handpieces. |
| Device Operation (Similar to predicates) | Similar: "Shares the same or similar... device operation..." (General statement). |
| Overall Technical and Functional Capabilities (Similar to predicates) | Similar: "Shares the same or similar... overall technical and functional capabilities..." (General statement). Illustrated by comparable RF power ranges, tip matrix, treatment area, handpiece dimensions, and materials in the comparison tables. |
| Safety and Effectiveness (Demonstrated through data) | Demonstrated: "Animal and human clinical data were submitted to substantiate product performance." (General statement, no specific metrics provided). |
| Substantial Equivalence Conclusion | Achieved: "The Accent Pixel RF Tips were found to be substantially equivalent to the predicate devices." |
Study Information (Based on available text):
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Sample size used for the test set and the data provenance:
- Not explicitly stated for either animal or human clinical data. The document only mentions "animal and human clinical data were submitted." The exact numbers of subjects or cases in these studies are not provided.
- Data Provenance: Not specified (e.g., country of origin). "Animal histology data - section 19 - and human clinical data - section 20" are referenced as supporting the indications for use, suggesting prospective collection for the purpose of the submission, but details are absent from this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not stated. The document refers to "animal histology data" and "human clinical data." For clinical data, the assessment of "ablation and resurfacing" or "wrinkles and rhytids" would typically involve expert assessment (e.g., dermatologists, plastic surgeons), but the number or qualifications of these experts are not provided in this summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not stated. The methods for evaluating the clinical data (e.g., how efficacy was determined, or how disagreement among evaluators, if any, was resolved) are not detailed.
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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 device is an energy delivery system (RF tips), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to "human readers improving with AI" would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As noted above, this device is a medical instrument (RF tips) used in dermatological procedures, not an algorithm. Performance is assessed through its physical effects on tissue and clinical outcomes, not through an algorithm's standalone output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred: For the "animal histology data," the ground truth would typically be pathology (histopathology from tissue samples). For the "human clinical data," the ground truth would likely be clinical assessment / outcomes data by medical professionals, potentially supported by photographic evidence or other objective measurements of skin ablation, resurfacing, or wrinkle reduction.
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The sample size for the training set:
- Not applicable/Not stated. This device does not use machine learning in the conventional sense where a "training set" of data is used to teach an algorithm. The "data" mentioned (animal and human clinical data) is for validation or substantiation of the device's performance, not for training a model.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence. It confirms that animal histology and human clinical data were submitted to support the device's performance and indications for use, but it does not provide the detailed study protocols, participant numbers, or specific methodological information that would be found in a clinical study report.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.