Search Results
Found 1 results
510(k) Data Aggregation
(153 days)
The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).
The MCL 29 Dermablate laser is an erbium: YAG of power at 2.94um.
This looks like a 510(k) premarket notification for a medical device, specifically a laser system for soft tissue ablation. In the context of 510(k) submissions, the “acceptance criteria” and “study that proves the device meets the acceptance criteria” often refer to the demonstration of substantial equivalence to a predicate device, rather than a clinical trial with specific performance metrics like sensitivity and specificity for an AI algorithm.
Here's an analysis based on the provided text, addressing your questions where applicable within this regulatory framework:
1. Table of Acceptance Criteria and Reported Device Performance
For 510(k) applications demonstrating substantial equivalence, the "acceptance criteria" are typically that the new device shares basic features, intended use, and similar technological characteristics with a legally marketed predicate device, and does not raise different questions of safety and effectiveness.
In this document, the "performance" is assessed by comparing the specifications and intended use of the MCL 29 Dermablate laser with two predicate devices.
| Specification | Acceptance Criteria (Similar to Predicate) | Reported Device Performance (MCL 29 Dermablate Laser) |
|---|---|---|
| Intended Use | Same or similar to predicate devices: coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery, oral and maxillofacial surgery, and ophthalmology. | Meets this criterion. The stated intended use is identical (coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral and maxillofacial surgery, and ophthalmology (oculoplasty)). |
| Type of laser | Er: YAG | Er: YAG |
| Power | Similar to predicate (e.g., within a reasonable range of 5W max or 1 J/pulse max) | 6 Watts maximum (compared to TriLase's 5W max and Multilite's 30 mJ min, 1 J max - this is presented as a comparable characteristic) |
| Wavelength | 2.94 um | 2.94 um |
| Pulse width | Similar to predicate (e.g., 300 usec, 100-400 usec) | 350 usec |
| Frequency | Similar to predicate (e.g., 5-20 Hz, 1-10 Hz) | 5-15 Hz |
| Spot size | Comparable to predicate (e.g., focusing handpiece) | 1.6mm, 3mm, 5mm |
| mJ energy | Similar to predicate (e.g., 1 J/pulse maximum, 30 mJ min, 1 J max) | 100-800 mJ |
| Beam delivery | Articulated arm | Articulated arm |
| Cooling | Internal heat exchanger | Water/air heat exchanger (presented as comparable) |
| Aiming beam | Similar to predicate (e.g., 3 mW, red helium neon, 635 nm diode < 1 mW) | 635 nm diode, 1 mW |
| Power requirements | Similar to predicate | 220-240V, 50/60 Hz; 100-120V, 50-60 Hz |
Summary of Device Performance: "The specifications and intended uses of the MCL 29 Dermablate laser are the same or very similar to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "None. Because of this, performance data were not required." This indicates that no separate "test set" of empirical data (clinical or otherwise) was used to evaluate the device's performance in the way one would for an AI algorithm. The demonstration of substantial equivalence relies on a comparison of characteristics with predicate devices already on the market.
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)
Not applicable, as no performance data based on a test set requiring expert ground truth was generated or submitted for this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no performance data based on a test set requiring adjudication was generated or submitted.
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
Not applicable. This device is a laser system, not an AI-assisted diagnostic or therapeutic tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior marketing clearance. The new device is deemed safe and effective if it doesn't raise new questions of safety and effectiveness compared to these predicates.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
In summary, for K964128, the "study that proves the device meets the acceptance criteria" is the detailed comparison of its specifications and intended use against two legally marketed predicate devices. The acceptance criteria essentially boil down to demonstrating that the new device is "substantially equivalent" to these predicates, meaning it does not raise new questions of safety or effectiveness. The document explicitly states, "Because of this, performance data were not required," indicating that a clinical trial or empirical performance study was not deemed necessary by the FDA for this particular submission.
Ask a specific question about this device
Page 1 of 1