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510(k) Data Aggregation
(215 days)
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The semiconductor laser therapeutic device is mainly composed of a host, the treatment handle, foot switch, power cord, and accessories. The host consists of a control panel, cooling system, circuit control system, semiconductor laser power supply, etc.
The provided document is a 510(k) clearance letter for a Diode Laser Hair Removal Machine (QDTM-02), not a study report. It states that "No clinical study is included in this submission," and therefore, it does not contain the detailed information requested regarding acceptance criteria and a study proving device performance against those criteria.
However, based on the information available in the 510(k) summary, I can infer some aspects related to the intent of testing and acceptance criteria for demonstrating "substantial equivalence."
Inferred Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The submission aims to demonstrate substantial equivalence to predicate devices, meaning the acceptance criteria are implicitly tied to matching or falling within acceptable ranges of the predicate devices' specifications and performance, and complying with recognized safety standards.
1. Table of Acceptance Criteria and Reported Device Performance (Inferred)
| Feature/Parameter | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (as per K242951) |
|---|---|---|
| Intended Use | Permanent hair removal/reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction in regrowing hairs at 6, 9, and 12 months post-treatment. | Intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. (Matches predicate indication) |
| Laser Type | Class IV Diode Laser (as per predicates K192735, K180353) | Class IV Diode Laser |
| Wavelength | 808nm (as per predicates K192735, K180353) | 808nm |
| Frequency | Within range of predicates (e.g., 1-20 Hz for K180353) | 1-20Hz (Matches Predicate Device 2, K180353) |
| Pulse Duration | Within range of predicates (e.g., 50-400ms for K192735, 10-400ms for K180353) | 10-200ms (Falls within ranges of both predicates) |
| Small Spot Handpiece Size | 1.44 cm² (as per Predicate Device 2, K180353) | 1.44 cm² (Identical to Predicate Device 2) |
| Large Spot Handpiece Size | Within acceptable range, possibly similar to Predicate Device 1 (2.4 cm²) or reference device Eneka Pro (4.75 cm²) | 4 cm² (Differs from Predicate 1, but similar to reference device Eneka Pro; deemed safe/effective) |
| Biocompatibility | Compliance with ISO 10993 series standards. | Test results comply with ISO 10993 series standards (ISO 10993-5, -10, -23 cited). |
| Electrical Safety & EMC | Compliance with relevant IEC standards (e.g., IEC 60601-1, IEC 60601-1-2) | Meets IEC 60601-1 (2005), IEC 60601-1-2 (2014), IEC 60601-2-22 (2019), IEC/TR 60601-4-2. |
| Laser Safety | Compliance with IEC 60825-1 | Meets IEC 60825-1 (2014). |
2. Sample size used for the test set and the data provenance:
- The document explicitly states: "No clinical study is included in this submission."
- Therefore, there is no information on a "test set" in the context of clinical performance data for hair removal.
- The testing mentioned (biocompatibility, electrical safety, EMC, laser safety) would involve samples of the device components or the entire device, tested in a laboratory setting. This is not performance data on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set for performance evaluation is reported.
- For the non-clinical tests (biocompatibility, safety standards), the "ground truth" is defined by the requirements of the standards themselves, not by expert consensus on clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set for performance evaluation requiring expert adjudication is reported.
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 hair removal machine, not an imaging diagnostic device or AI software that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests conducted, the "ground truth" is compliance with established international standards (IEC for electrical and laser safety, ISO for biocompatibility). There is no "outcomes data" or "pathology" cited in the context of device performance on patients.
8. The sample size for the training set:
- Not applicable, as "training set" typically refers to data used to train an algorithm or AI model. This is a physical laser device.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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(159 days)
The Q Switched Nd: YAG Laser machine (QNHF-01) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers laser at a wavelength 1064nm or 532nm. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device: the Q Switched Nd:YAG Laser machine (QNHF-01). This type of document is a notification of intent to market and not a detailed study report providing acceptance criteria and performance data for an AI/ML-driven device, particularly not in the format requested.
Therefore, I cannot provide the requested information as the document does not contain details about:
- Acceptance criteria table and reported device performance for an AI/ML component.
- Sample sizes for test sets or their provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Details of multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
The document explicitly states: "No clinical study is included in this submission." This further confirms that it does not contain the kind of performance data usually required to demonstrate AI/ML device capabilities against pre-defined acceptance criteria.
The submission focuses on demonstrating substantial equivalence to a predicate device (K163123) based on technological similarities and non-clinical performance testing against recognized safety and performance standards (e.g., IEC 60601-1, ISO 10993 series for biocompatibility). This is typical for a traditional medical device, not an AI/ML device that requires complex evaluation of predictive accuracy or clinical utility improvements due to AI assistance.
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