(99 days)
The Pitanga is indicated for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superfícial benign pigmented lesions.
The Pitanga is a device that is used for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions. The Pitanga treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage pigmented and vascular lesions without damaging the surrounding tissues.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Pitanga device.
Key Observation: The provided document is a 510(k) summary (and the FDA's acceptance letter) for the Pitanga device, not a detailed study report. As such, it does not contain the specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes, ground truth establishment methods, or expert qualifications that would typically be found in a clinical study report.
The document's primary purpose is to establish "substantial equivalence" to predicate devices, meaning it does not pose new safety or effectiveness concerns. This regulatory pathway often relies on demonstrating that the new device has similar technological characteristics and performs comparably to existing, legally marketed devices, rather than a full de novo clinical effectiveness study with quantitative performance metrics.
Therefore, many of the requested details cannot be extracted from this document.
1. Table of Acceptance Criteria and Reported Device Performance
- Cannot be provided from this document. The 510(k) summary states that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit." This is a general statement of equivalence, not a presentation of specific acceptance criteria (e.g., "sensitivity > 90%") or detailed performance results (e.g., "sensitivity = 92%").
2. Sample size used for the test set and the data provenance
- Cannot be provided from this document. The document does not mention any specific test set, its sample size, or its provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided from this document. There is no mention of a test set, ground truth establishment, or experts involved in such a process.
4. Adjudication method
- Cannot be provided from this document. There is no mention of an adjudication method, as no specific test set or expert evaluation is described.
5. 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
- No, an MRMC comparative effectiveness study was not done (or at least not reported here). This device is an aesthetic medical device (hair removal, skin lesion treatment), not an AI-powered diagnostic tool, so an MRMC study related to AI assistance for human readers is not relevant to its regulatory submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. Its "performance" refers to its efficacy in treating patients, not the performance of a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided from this document. The term "ground truth" is not used, and no specific method for validating clinical outcomes or performance against a gold standard is detailed. The submission relies on substantial equivalence to predicate devices, implying that their established safety and effectiveness serve as the basis.
8. The sample size for the training set
- Not applicable / Cannot be provided from this document. This device is hardware-based, not an AI model, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided from this document. As there is no AI training set, this question is not relevant.
Summary of what the document does provide:
The document primarily provides:
- Device Name: Pitanga family of products
- Indications for Use: Hair removal on all skin types; treatment of superficial benign vascular lesions (Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma); treatment of superficial benign pigmented lesions.
- Predicate Devices: Aurora DS (K021149), Aurora SR (K022266) by Syneron Medical Ltd.; Lumenis family of IPL and IPL/Nd:YAG laser systems (K020839) by Lumenis Inc.
- Regulatory Pathway: 510(k) Pre-market Notification, establishing "substantial equivalence" to predicate devices.
- Conclusion: The manufacturer believes "no significant differences exist" and "the Pitanga should raise no new issues of safety or effectiveness" when compared to predicate devices.
In conclusion, this 510(k) summary is not a clinical study report and therefore does not contain the detailed quantitative performance metrics, sample sizes, and ground truth information typically associated with establishing acceptance criteria and proving performance through a clinical trial. Its purpose is to demonstrate substantial equivalence to already approved devices.
§ 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.