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510(k) Data Aggregation
(69 days)
AdvaTx
The ADVATx at 589 nm is indicated for use for dermatologic treatment of benign cutaneous vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, periorbital wrinkles, facial and leg telangiectasia, rosacea, cherry angiomas, port wine stains, hemangiomas and venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucae/warts, scars, striae, psoriasis and the treatment of benign pigmented lesions.
The ADVATx at 1319 nm is indicated for treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild and moderate inflammatory acne vulgaris.
The AdvaTx is non-ablative laser with two wavelengths: 1319nm and 589nm. There are multiple indications for use that are specific to each wavelength. The AdvaTx consists of a console, a handpiece that has a scanner and a distance guide. The laser is activated using a trigger that is located on the handpiece.
The AdvaTx produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. Laser use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable of absorbing energy from the specific light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak. The working basis of the laser rests on the principle of selective photothermolysis, in which thermally mediated radiation damage is confined to chosen epidermal and/or dermal pigmented targets at the cellular or tissue structural levels.
The provided text is a 510(k) Clearance Letter for the AdvaTx Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a diagnostic AI device would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of regulatory submission for a therapeutic laser system. There is no information provided regarding:
- A table of acceptance criteria and reported device performance (in terms of specific clinical outcomes or AI metrics).
- Sample size used for a test set, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
- Ground truth used or how it was established for training or test sets.
The relevant information from the document is summarized below based on the nature of the device and the submission.
Summary of AdvaTx Laser System Regulatory Submission (K250189)
The AdvaTx Laser System (K250189) received 510(k) clearance based on demonstrating substantial equivalence to predicate and reference devices, rather than a clinical study establishing performance against pre-defined acceptance criteria for a new and unique clinical outcome. The clearance specifically addresses the addition of an indication for "treatment of benign pigmented lesions" at 589nm, and an increased fluence (up to 60 J/cm2) for the 1319nm wavelength.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a therapeutic laser device seeking 510(k) clearance by demonstrating substantial equivalence, specific "acceptance criteria" in terms of clinical performance metrics, as would be seen for a diagnostic device with an AI component, are not provided in the document. Instead, the "performance" demonstrated is through engineering and safety testing, and comparison of technical characteristics to legally marketed predicate devices.
| Characteristic / Requirement | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (AdvaTx K250189) |
|---|---|---|
| Indications for Use (589nm) | Substantially equivalent to predicate/reference devices for dermatologic treatment of benign cutaneous vascular lesions. Addition of "benign pigmented lesions" must be supported. | Met: Indicated for: wrinkles, periocular/periorbital wrinkles, facial/leg telangiectasia, rosacea, cherry angiomas, port wine stains, hemangiomas, venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucae/warts, scars, striae, psoriasis, AND treatment of benign pigmented lesions. |
| Indications for Use (1319nm) | Substantially equivalent to predicate/reference devices. | Met: Indicated for: treatment of fine lines and wrinkles, atrophic acne scars, mild and moderate inflammatory acne vulgaris. |
| Wavelengths | Match or be substantially equivalent to predicate/reference. | Met: 589nm and 1319nm. (Compared to 589nm predicate, 595nm reference, 1320nm reference, stating 589/595nm and 1319/1320nm are substantially equivalent). |
| Spot Size | Safe and effective, potentially smaller than predicate. | Met: 1.0 mm (Subject device spot size is smaller than predicates, but deemed safe with no additional risks). |
| Pulse Width (589nm) | Match or be within acceptable range of predicate/reference. | Met: 20-950 ms |
| Pulse Width (1319nm) | Match or be within acceptable range of predicate/reference. | Met: 20-200 ms |
| Fluence (589nm) | Match or be within acceptable range of predicate/reference. | Met: Up to 100 J/cm2 |
| Fluence (1319nm) | Increased fluence must be safe and effective, and within range of reference devices. | Met: Up to 60 J/cm2 (This is an increase from the predicate's 40 J/cm2 but is the same as a reference device, implying safety/efficacy is established by the reference). |
| Repetition Rate | Match or be within acceptable range of predicate/reference. | Met: 0.67 - 1.0 Hz |
| Electrical Safety (IEC 60601-1 Ed 3.2) | Compliance with standard. | Met: Test performed and deemed compliant. |
| EMC (IEC 60601-1-2:2014) | Compliance with standard. | Met: Test performed and deemed compliant. |
| Laser Specific Safety (IEC 60601-2-22:2012) | Compliance with standard. | Met: Test performed and deemed compliant. |
| Biocompatibility (ISO 10993-1:2018) | Compliance with standard. | Met: Biological Evaluation performed. |
| Software V&V | Documentation provided as recommended by FDA guidance. | Met: Verification and validation testing conducted and documentation provided. |
| Safety and Effectiveness Conclusion | Safe and effective as the predicate device, with no new concerns from changes. | Met: Concluded AdvaTx is "as safe and effective as the predicate device" and that "The addition of the higher fluence does not present any new concerns for safety or efficacy." |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not applicable/not provided in the context of this 510(k) submission for a therapeutic laser system. The submission relies on technical comparisons and established safety standards. There is no mention of a "test set" in the sense of a dataset for validating an algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/not provided. There is no "test set" for which ground truth would be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable/not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable/not provided. The AdvaTx is a laser system, not a software algorithm.
7. The Type of Ground Truth Used
This information is not applicable/not provided. Clinical performance for specific indications is demonstrated implicitly by the substantial equivalence to predicate devices, which would have had their own evidence for clearance. The safety and technical performance are demonstrated via engineering standards and comparisons.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The AdvaTx is a physical laser device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided.
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(206 days)
ADVATX
The ADVATx at 589nm is indicated for use for dermatologic treatment of benign cutaneous vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, periorbital wrinkles, facial and leg telangiectasia, rosacea, cherry angiomas, port wine stains, hemangiomas and venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucae/warts, scars, striea, and psoriasis.
The ADVATx at 1319nm is indicated for treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild and moderate inflammatory acne vulgaris.
The ADVATx Laser System is a Nd:YAG laser delivering 589nm @-switched pulsed light and 1319nm continuous wave light. This laser system was developed specifically for dermatological treatments. The laser light is delivered to the patient either through a scanner or a hand piece.
This document is a 510(k) summary for the AdvaLight ApS ADVATx surgical laser. It describes the device's intended use, technological characteristics, and claims of substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with machine learning or diagnostic device studies.
The "Performance Data" section solely mentions electrical and laser safety testing, and general system/software validation, which are compliance checks, not performance studies as requested in the prompt.
Therefore, most of the requested information cannot be extracted from this document because the provided text concerns regulatory approval of a medical laser device, not a study evaluating its diagnostic or AI-driven performance against specific clinical acceptance criteria.
However, I will extract what I can based on the prompt's categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-22. |
| Laser Safety | Complies with IEC 60825-1. |
| System and Software Validation | Performs as intended and meets its specifications. |
| Laser Output Spectrum and Power Stability | Stable over a single treatment session and long term. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document describes safety and system validation tests, not a clinical performance study with "test sets" in the context of device effectiveness for its intended use or AI algorithms.
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. This document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This document does not describe a study involving adjudication of a test set.
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 document does not describe an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document pertains to a physical laser device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the tests mentioned are regulatory standards (e.g., IEC standards for safety), not clinical outcomes or expert consensus on medical conditions.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not an algorithm that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is mentioned or relevant to the content of this document.
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