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510(k) Data Aggregation
(69 days)
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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(50 days)
The Candela Family of Pulse Dye Laser Systems Pigmented Lesion Handpiece Accessory is indicated for the Treatment of Benign Epidermal Pigmented Lesions
The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses: The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams or elliptical beams on the skin.. The Pigmented Lesion Handpiece Accessory attaches to the standard handpiece and replaces the standard distance gauge for the treatment of benign epidermal pigmented lesions The Candela Family of Pulsed Dye Laser Systems is equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment. The pigmented lesion handpiece accessory is designed for use with the Candela Pulsed Dye Laser handpiece, for the treatment of Benign Epidermal pigmented Lesions
The provided text is a 510(k) Summary for a medical device (Candela Family of Pulsed Dye Lasers Pigmented Lesion Handpiece Accessory) and does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of acceptance criteria for a clinical study measuring device performance (e.g., lesion clearance rates, skin reaction scores). Instead, it refers to regulatory compliance and safety standards.
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| CDRH Laser Performance Standard (21 CFR 1040) | The Candela Family of Pulsed Dye Laser Systems conforms to this standard. |
| Electrical Safety Standard (IEC 60601-1) | The Candela Family of Pulsed Dye Laser Systems conforms to this standard. |
| Biocompatibility (ISO 10993-1) | All materials contacting the patient conform to the requirements of this standard for biocompatibility. |
| Substantial Equivalence to Predicate Devices | The device is deemed substantially equivalent to K043251, K040200, and K001746 based on "similarities in key design aspects, intended uses and materials." |
| Indication for Use | "Treatment of Benign Epidermal Pigmented Lesions." No specific performance metrics for this indication are provided in this summary. |
2. Sample Size for Test Set and Data Provenance:
The document does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the clinical performance of the pigmented lesion handpiece accessory. The "Testing" section focuses on regulatory compliance for laser and electrical safety, and biocompatibility, rather than clinical efficacy/safety studies for the accessory's intended use.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. As there's no mention of a clinical study with a test set that required ground truth establishment, these details are absent.
4. Adjudication Method for the Test Set:
This information is not provided in the document, as there is no mention of a clinical test set that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported in this document. The focus is on regulatory clearance through substantial equivalence, not on comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not conducted or reported. This device is a laser accessory, not an AI algorithm.
7. Type of Ground Truth Used:
This information is not provided as no specific clinical study data requiring ground truth for efficacy assessment is presented. The "ground truth" for regulatory clearance is based on adherence to established safety and performance standards for laser products and materials, and comparison to predicate devices.
8. Sample Size for the Training Set:
This information is not applicable/not provided. The device is a physical laser accessory, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reason as above.
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