(30 days)
The Palomar Erbium handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications:
- Skin resurfacing .
- Treatment of wrinkles .
- Epidermal nevi ◆
- Telangiectasia .
- Spider veins .
- Actinic chelitis .
- Keloids .
- Verrucae .
- Skin tags .
- Anal tags *
- Keratoses .
- Scar revision (including acne scars) ◆
- Debulking benign tumors .
- Debulking cysts .
- Superficial skin lesions .
The Palomar Erbium Handpiece attaches to the StarLux Pulsed Light and Laser System. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.
The provided text is a 510(k) summary for the Palomar Erbium Handpiece. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be answered based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully provided. The document states: "The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Erbium Handpiece is substantially equivalent to its predicate device." This is a general statement about equivalence and does not provide specific performance metrics or acceptance criteria for the new device. It implies that the new device performs similarly to the predicate, but the exact performance data and acceptance thresholds are not disclosed in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
* **Note:** The core of a 510(k) submission for substantial equivalence often involves demonstrating that the new device meets the same performance specifications as the predicate or that any differences do not raise new questions of safety and effectiveness. These specific performance metrics are typically included in the full submission but not in the public summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined. The summary does not mention any clinical study involving a "test set" with a specific sample size, data provenance, or study design (retrospective/prospective). The assessment appears to be based on technical characteristics and verification/validation, likely non-clinical.
3. 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)
- Cannot be determined. The summary does not describe a process for establishing ground truth using experts, as no clinical study or test set requiring such a process is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be determined. No adjudication method is mentioned because no clinical study 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. This device is a laser handpiece for surgical applications, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical instrument (laser handpiece), not an algorithm or software. It requires a human operator (surgeon/dermatologist) for its intended use. Performance is inherently "human-in-the-loop," as the device is a tool operated by a medical professional.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be determined (and likely not applicable in the way implied). For a medical device like a laser handpiece, "ground truth" related to its function would typically be based on engineering specifications, safety testing (e.g., power output, beam quality, tissue interaction in in-vitro or ex-vivo models), and potentially limited clinical observations for safety and efficacy endpoints (like wound healing, scar reduction, etc. as observed by clinicians). The summary does not detail these, instead relying on equivalence to a predicate.
8. The sample size for the training set
- Not applicable. This device is a physical instrument, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for a machine learning model, this question is not relevant to the device described.
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods that would be characteristic of a clinical validation study for a diagnostic device or an AI/ML product. The "Performance Data" section explicitly states that the determination is based on a "review of the technical characteristics, indications for use, mechanism of action, and verification and validation information," indicating a non-clinical evaluation for equivalence.
§ 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.