(90 days)
The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in:
-Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
-Treatment of wrinkles, rhytides, furrows, fine lines;
-Pigmented lesions;
-Textural irregularities;
-Vascular dyschromia.
The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of:
- Actinic and seborrheic keratoses;
-Chelitis;
-Cutaneous horns;
-Hemangiomas;
-Keloids;
-Nevi, including spider, epidermal and protruding;
-Rhinophyma;
-Syringomas;
-Warts;
-Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.
The Fraxel re:pair Laser System consists of a CO2 laser source and three delivery handpieces for resurfacing, incision and debulking procedures. Each handpiece attaches to an articulating arm. Additional device accessories include interchangeable resurfacing treatment tips, incisional handpiece spatulas, and debulking handpiece spatulas.
The provided text is a 510(k) summary for the Fraxel re:pair (Fraxel III SR) Laser System and Accessories. It focuses on establishing substantial equivalence to previously marketed devices (K063038, K071051, K022060, K030147) rather than presenting a study with specific acceptance criteria and detailed performance metrics for this particular device.
Therefore, the information required to populate the tables and answer the questions regarding acceptance criteria and a study proving the device meets those criteria is largely not present in the provided document. The document describes clinical performance data from "Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece," but it does not provide details of these studies, such as specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
It states: "Substantial equivalence for the Fraxel re:pair Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications for use statements and equivalent performance specifications." This indicates that the device's clearance is based on its similarity to existing cleared devices, not on a new, independent study with defined acceptance criteria for this specific iteration.
However, I will extract any relevant information that might vaguely touch upon the requested points, even if it doesn't fully fulfill the criteria.
Acceptance Criteria and Reported Device Performance
As noted, the document does not define specific, quantifiable acceptance criteria or provide a table of performance metrics for this new device's clinical performance. The substantial equivalence argument relies on the predicate devices having "equivalent performance specifications."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in this document for the new device | The document states "Substantial equivalence for the Fraxel re:pair Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications for use statements and equivalent performance specifications." This implies that the performance of the new device is considered equivalent to the predicate devices, which are already deemed safe and effective for their indications. |
Study Information (Based on available text)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document mentions "Non-Significant Risk and Investigational Device Exemption studies," suggesting prospective clinical studies, but no details are given.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified in the provided document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the provided document.
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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/Not mentioned. This is a medical device (laser system) for dermatological procedures, not an AI-assisted diagnostic device typically subject to MRMC studies comparing human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not mentioned. This is a laser system, not an AI algorithm. Its performance is inherent to the device's physical operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the provided document. For clinical studies supporting laser systems, ground truth often involves clinical assessments, photographic documentation, and patient-reported outcomes related to the treated conditions (wrinkles, lesions, etc.).
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The sample size for the training set
- Not applicable/Not mentioned. This is a hardware medical device, not an AI model that requires a training set in the conventional sense.
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How the ground truth for the training set was established
- Not applicable/Not mentioned.
Summary of what is available in the document regarding studies:
The document briefly states: "Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece." This confirms that clinical studies were performed, but the 510(k) summary itself does not provide the detailed study results, acceptance criteria, methodologies, or sample sizes of these studies. The substantial equivalence argument relies on the existence of these studies for the predicate device, or implicitly, for this device's performance being similar to the predicates.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.