(35 days)
The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.
MeDioStar XT Laser System is a pulsed diode laser with a wavelength of 808µm. It consists a laser enclosure and optic delivery system (fiber bundle and handpiece).
The provided text is a 510(k) summary for the Asclepion Laser Technologies GmbH MeDioStar XT Laser System. It is a premarket notification to the FDA for a new medical device, aiming to demonstrate substantial equivalence to a predicate device. This type of document does not typically contain detailed acceptance criteria or a study proving that the device meets specific performance metrics in the way a clinical trial report would.
Here's an analysis based on the provided text, highlighting what's missing and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to MeDioStar H Laser System | Claimed substantial equivalence |
| Same principles of operation as predicate | Same principles of operation confirmed |
| Same wavelength as predicate | Same wavelength (808µm) confirmed |
| Essentially the same power range as predicate | Essentially the same power range confirmed |
| Safety and effectiveness for unwanted body hair removal | Deemed safe and effective (by FDA K050900 letter) |
| Safety and effectiveness for vascular lesion treatment | Deemed safe and effective (by FDA K050900 letter) |
Explanation:
The document does not state explicit, quantitative acceptance criteria for performance parameters such as hair reduction percentage, number of treatments, or lesion clearance rates. Instead, the "acceptance criteria" here are implied by the 510(k) process, which focuses on demonstrating substantial equivalence to a predicate device. The performance is "reported" by stating that the device is substantially equivalent and therefore safe and effective for its stated indications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no new test set of data (clinical or nonclinical) was generated or used for this 510(k) submission to demonstrate performance a new.
- Data Provenance: Not applicable, as no new data was submitted or analyzed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Since no new clinical or non-clinical performance data was generated or analyzed for this submission, there was no need for experts to establish ground truth from such data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As no test set data was provided, no adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: None."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, this device is a physical laser system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant or mentioned.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for performance data related to the MeDioStar XT itself. The "ground truth" for the 510(k) submission relies on the established safety and effectiveness of the predicate device (MeDioStar H Laser System). The new device is claimed to be safe and effective because it is substantially equivalent to the predicate, not based on new, direct evidence from the MeDioStar XT itself.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This document does not describe the development or training of an algorithm, but rather the regulatory submission for a physical laser device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. No algorithm training set is mentioned or relevant to this type of device submission.
In Summary:
The provided 510(k) summary is for a device seeking market clearance based on substantial equivalence to an already approved predicate device. For such submissions, detailed performance studies with acceptance criteria and clinical data are often not required if the new device can demonstrate very close similarity in design, function, and intended use to an existing device. The FDA's acceptance of this 510(k) indicates their agreement that the MeDioStar XT Laser System is substantially equivalent to the MeDioStar H Laser System and is therefore safe and effective for its intended uses without new clinical data.
§ 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.