Search Results
Found 2 results
510(k) Data Aggregation
(88 days)
The PhotoGenica ER laser is used for skin resurfacing in the treatment of wrinkles and for the incision, excision ablation or vaporization of soft bodily tissues.
The PhotoGenica ER Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 20 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 20 watts.
The provided FDA 510(k) summary for the Cynosure PhotoGenica ER Laser states "Clinical Performance Data: none" and "Nonclinical Performance Data: none". This indicates that the submission did not include specific acceptance criteria or a study demonstrating the device meets such criteria in the traditional sense of a clinical trial or performance study with quantified metrics.
Instead, the FDA determined substantial equivalence primarily based on the device's technical characteristics being comparable to a legally marketed predicate device (Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser) and the intended use. The 510(k) process for this type of device focuses on demonstrating that the new device is as safe and effective as a predicate device, often without requiring new clinical data if technological characteristics are sufficiently similar.
Therefore, the requested information cannot be fully provided as it pertains to a type of performance study that was not part of this 510(k) submission. However, I can infer what the "acceptance criteria" for the 510(k) itself were, which primarily revolved around demonstrating substantial equivalence.
Here's an attempt to answer based on the provided document, acknowledging the lack of a clinical performance study:
1. A table of acceptance criteria and the reported device performance
Since no clinical or nonclinical performance data was provided or required for this 510(k) submission, there are no explicit acceptance criteria for a performance study. The "acceptance criteria" for the 510(k) process in this case were met by demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Inferred for 510(k) Submission) | Reported Device Performance (Inferred for 510(k) Submission) |
|---|---|
| Criterion: Device is substantially equivalent to a legally marketed predicate device in terms of intended use and technological characteristics. | Performance: "The PhotoGenica ER Laser is substantially equivalent to the Continuum Biomedical CB Erbium / 2.94™ Er: YAG Laser in terms of treatment wavelength, pulse duration, pulse energy, and biological effects." |
| Criterion: Intended use is consistent with the predicate device. | Performance: Intended for "Skin resurfacing in the treatment of wrinkles" and "incision, excision, ablation or vaporization of soft bodily tissues," similar to the predicate. |
| Criterion: Device is safe and effective for its intended use. | Performance: "The PhotoGenica ER Laser is another safe and effective way to remove or reduce wrinkles, and to ablate or excise tissue." (Conclusion reached by the submitter and accepted by FDA through substantial equivalence.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No clinical or nonclinical test set was used for performance evaluation as part of this 510(k) submission.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a test set was established as no clinical or nonclinical performance study was conducted.
4. Adjudication method for the test set
- Not applicable.
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 interpretation tool. 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 physical laser system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was used for a performance study. The ground for substantial equivalence was based on comparison to an existing, legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Ask a specific question about this device
(59 days)
The PhotoGenica Er laser is used for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.
Typical applications include dermatology, plastic surgery, urology, gastrocnterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.
The PhotoGenica Er Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 20 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 20 watts.
This document pertains to a 510(k) premarket notification for a medical laser system, specifically the PhotoGenica Er Laser by Cynosure, Inc. The core of this submission is to demonstrate substantial equivalence to a predicate device, not to establish new safety and efficacy criteria through clinical trials. As such, the information you've requested regarding acceptance criteria and performance studies for a new device's clinical performance, ground truth, and expert evaluation is largely not applicable in this context.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are not typically performance metrics demonstrating new clinical safety and efficacy. Instead, the acceptance criteria are met by demonstrating the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing:
- Same intended use.
- Same technological characteristics, or if different, that the differences do not raise new questions of safety and effectiveness and that performance data (non-clinical or clinical) demonstrate the device is as safe and effective as the predicate.
- Reported Device Performance:
Since this is a 510(k) for substantial equivalence, clinical performance data demonstrating novel safety and efficacy was not provided and not required. The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." The device's performance is assumed to be substantially equivalent to the predicate.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (as demonstrated for 510(k)) |
|---|---|
| Same Intended Use as Predicate Device | Yes, stated Intended Use for PhotoGenica Er Laser is "Skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues," which is implied to be the same as the predicate Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser. |
| Same Technological Characteristics as Predicate Device | The PhotoGenica Er Laser is compared to the predicate in terms of "treatment wavelength, pulse duration, pulse energy, and biological effects," implying substantial similarity. |
| Differences in Technology Do Not Raise New Questions of Safety and Effectiveness | Explicitly stated: "The PhotoGenica Er Laser is substantially equivalent to the Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser in terms of treatment wavelength, pulse duration, pulse energy, and biological effects." |
| Performance Data (if technological differences exist) | None provided; the submission relies on the substantial equivalence of technological characteristics and intended use, rather than new performance data. |
Regarding the other points you've asked for, they are largely not applicable to this 510(k) submission:
2. Sample Size Used for the Test Set and the Data Provenance
- Not Applicable. No test set was used for a de novo clinical study in this 510(k). The submission relies on the established safety and efficacy of the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. No new ground truth was established by experts for a test set for this 510(k).
4. Adjudication Method for the Test Set
- Not Applicable. No test set existed that required adjudication.
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 interpretation tool. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device (a laser), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No new ground truth was established or used for a clinical study within this 510(k) submission. The "ground truth" for a 510(k) is essentially that the predicate device is already recognized as safe and effective, and the new device is equivalent.
8. The Sample Size for the Training Set
- Not Applicable. There was no training set for an AI algorithm or a clinical trial in this 510(k). This is a hardware submission.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there was no training set (see point 8), no ground truth for it was established.
In summary: The provided document is a 510(k) premarket notification for a laser system. This regulatory pathway primarily focuses on demonstrating "substantial equivalence" to a previously cleared device. It does not typically require new clinical studies, performance data, or AI-related metrics like those you've inquired about, unless significant technological differences exist that could raise new safety and effectiveness questions, which was not the case here. The FDA concluded that the PhotoGenica Er Laser is "another safe and effective laser" based on its substantial equivalence to the predicate device.
Ask a specific question about this device
Page 1 of 1