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510(k) Data Aggregation
(70 days)
Shenzhen IONKA Medical Technology Co., Ltd.
Hand-held IPL device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The IPL Home Use Hair Removal Device is composed of a hand-held applicator and an external power supply. The spot size (treatment area) in the IPL Home Use Hair Removal Device is 3cm². The device contains a lamp, a skin proximity sensor. If the IPL Home Use Hair Removal Device is not properly applied (in full contact with the skin), the device will not trigger a pulse.
The IPL Home Use Hair Removal Device includes FZ-608, FZ-608G, FZ-100, and FZ-200 four models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance, energy output range and its equipped power supply model. The model difference is embodied in: #1) energy output level of model FZ-608 and FZ-608G has 9 levels, corresponding to an output range of 4.16J10J; model FZ-100 has 9 levels, corresponding to an output range of 5.7J16.26J, and model FZ-200 has 6 levels, corresponding to an output range of 4.6J~13,5J; #2) the main unit FZ-608 and FZ-608G can be supplied by the power adaptor (model: SHCSP2402000FUS), and the main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.
The provided document is a 510(k) summary for an IPL Home Use Hair Removal Device (K230739). It outlines the device's substantial equivalence to predicate devices, focusing on safety and efficacy for over-the-counter (OTC) use.
However, the document does not contain information related to an AI/algorithm-driven device or a study involving ground truth, expert consensus, MRMC studies, or training/test sets for AI models. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the regulatory requirements for a medical device's safety and effectiveness for its intended use, not an AI algorithm's performance against specific metrics established by expert review.
The performance testing mentioned is for the physical device itself (electrical safety, EMC, biocompatibility, and usability/self-selection for OTC use), not for an AI's diagnostic or analytical capabilities.
Therefore, I cannot populate the requested table and answer the specific questions about AI acceptance criteria, ground truth, expert adjudication, or MRMC studies for this device based on the provided text.
The relevant "study" mentioned in the document is a usability study for OTC use, not an AI performance study.
Here's a breakdown of what is available in the document regarding the device's acceptance and testing:
Device Acceptance Criteria and Performance (Based on Usability Study for OTC Use)
The document states that a usability study was conducted to demonstrate that the device is safe and effective for over-the-counter (OTC) use by lay users. The "acceptance criteria" here are implied regulatory requirements for OTC medical devices, specifically regarding user comprehension and safe application.
| Acceptance Criterion (Regulatory Implication for OTC Device) | Reported Device Performance (from Usability Testing) |
|---|---|
| Self-selection: Lay users can determine if they are appropriate candidates for the device based on external labeling. | The study demonstrated that "the lay user can self-select themselves as being appropriate users of this device by the external box labeling." |
| Safe and Correct Application: Lay users can apply the treatment safely and correctly following the instructions for use. | The study demonstrated that "the lay user can apply the treatment safely and correctly according to the instructions for use." |
| Comprehension of Labeling: Lay users understand indications, contraindications, warnings, and precautions, and can identify if they are in a contraindicated group. | The study demonstrated that "the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual." |
Detailed Information Not Applicable to an AI Study:
Since this is a physical medical device (IPL hair removal) and not an AI/algorithm, the following points outlined in your request are not addressed or are not relevant in the provided text:
- Sample size for the test set and data provenance:
- Test set sample size: 24 subjects (for the usability/OTC study).
- Data provenance: Not explicitly stated, but likely prospective given it's a usability study involving direct interaction with subjects. Country of origin not specified, but the applicant company is Shenzhen, China.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth for an IPL device's usability doesn't involve expert medical image review.
- Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert review settings (e.g., radiology). For a usability study, the "adjudication" would be whether users successfully completed tasks or understood information.
- MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone (algorithm only) performance: Not applicable. There is no AI algorithm.
- Type of ground truth used: For the usability study, the "ground truth" would be the successful demonstration of user comprehension and safe device operation, assessed by usability researchers, not medical experts interpreting data like pathology or outcomes.
- Sample size for the training set: Not applicable. There is no AI model to train.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device. While it includes "performance testing," this refers to electrical safety, biocompatibility, and OTC usability, not the performance of an AI algorithm against clinical ground truth.
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(147 days)
Shenzhen IONKA Medical Technology Co., Ltd.
IPL home use hair removal device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL home use hair removal device is also intended for permanent reduction in unwanted hair. 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 regimen.
The device is used for adults with Fitzpatrick skin types I - IV.
The Hand-held IPL device are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photosynthesis in which optical energy is used to disable hair growth. The Hand-held IPL device devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Hand-held IPL device devices is 3 cm², The device contains a lamp, a skin proximity sensor. If the Hand-held IPL device is not properly applied (in full contact with the skin) , the Hand-held IPL device will not trigger a pulse.
The main unit FZ-608 and FZ-608G can only be supplied by the power adaptor (model: SHCSP2402000FUS), The main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.
FZ-608 and FZ-608G are identical except for model No. and enclosure colour.
The patient is an intended operator.
The provided document is a 510(k) Premarket Notification for a Hand-held IPL device (IPL Home Use Hair Removal Device). This document is primarily concerned with demonstrating substantial equivalence to predicate devices, not with establishing acceptance criteria for a new and novel device, nor does it detail a study proving the device meets specific acceptance criteria related to efficacy beyond showing similarity to already cleared devices.
Therefore, the information required to answer your prompt thoroughly, particularly regarding a multi-reader multi-case (MRMC) comparative effectiveness study, human expert involvement in ground truth, sample sizes for training/test sets for a novel AI algorithm, and quantitative metrics of device performance against specific acceptance criteria, is not present in this type of regulatory submission.
The document discusses performance data in a general sense, focusing on:
- Biocompatibility testing: Cytotoxicity, Sensitization, Irritation. These are related to safety of materials in contact with the skin.
- Electrical safety and electromagnetic compatibility (EMC) testing: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-2-83, and IEC 60601-1-2. These relate to electrical safety and electromagnetic interference.
- Software Verification and Validation Testing: Standard V&V for software, with a "Moderate" level of concern.
- Bench Testing: Verification of parameters like wavelength, pulse duration, output energy, and maximum fluence against design specifications and comparison to predicate devices. This is to show the device operates as intended and is similar to predicates.
The "Performance Data" section (Section 7) describes general testing conducted to support substantial equivalence, but it does not provide the kind of detailed study data (like sensitivity, specificity, or improvement over human readers) that would be expected for an AI/ML-based medical device. The "Indications for Use" section focuses on permanent hair reduction, defined by hair regrowth measurements at 6, 9, and 12 months, but the document does not present clinical study results to demonstrate this. Instead, it relies on the predicate devices having similar indications and technology.
Based on the provided document, here's what can be inferred or explicitly stated, with limitations:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., specific hair reduction percentages) and reported device performance against those criteria. The "acceptance criteria" discussed are largely compliance with electrical safety, EMC, and biocompatibility standards, and demonstrating similar technical parameters to predicate devices.
The closest to "acceptance criteria" are the parameters verified by bench testing and their similarity to predicate devices. However, these are not clinical performance metrics.
| Parameter (Bench Testing) | Subject Device 1# (FZ-608 & FZ-608G) | Subject Device 2# (FZ-100) | Subject Device 3# (FZ-200) | Predicate Devices (Range) | Note/Remark |
|---|---|---|---|---|---|
| Wavelength (nm) | 510 - 1200 | 510 - 1200 | 510 - 1200 | 475 - 1200 | Similar |
| Spot size (cm²) | 3 | 3 | 3 | 3 - 3.3 | Similar |
| Max fluence (J/cm²) | 3.33 | 5.43 | 4.5 | 4.5 - 6 | Note 2# |
| Energy output (J) | 4.16 - 10 | 5.7 - 16.26 | 4.6 - 13.5 | 7 - 20 (max) | Similar |
| Energy density range (J/cm²) | 1.4 - 3.3 | 1.9 - 5.4 | 1.5 - 4.5 | 2.1 - 6 | Similar |
| Pulse duration (ms) | 0.5 - 0.8 | 0.5 - 0.8 | 0.5 - 0.8 | 0.5 - 10 | Similar |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of an AI/ML device or a performance study with human participants. The testing mentioned (biocompatibility, electrical safety, bench testing) does not involve human sample sizes for a clinical performance evaluation of hair reduction efficacy. Data provenance is not applicable here as it's not a data-driven AI/ML model for diagnosis/prognosis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There's no mention of experts establishing ground truth for a test set, as this is not a diagnostic/AI device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There's no mention of a test set requiring 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 an Intense Pulsed Light (IPL) device for hair removal, not an AI-assisted diagnostic or image interpretation tool. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail the establishment of "ground truth" for clinical efficacy of hair removal. For the device's stated purpose, "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 regimen." However, the 510(k) submission relies on substantial equivalence to predicate devices for this claim, rather than presenting a de novo clinical study with measured outcomes. The "ground truth" for the technical parameters is primarily the design specifications and measurements from the predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or "ground truth" for machine learning.
In summary: This 510(k) submission for a Hand-held IPL device focuses on demonstrating substantial equivalence to already cleared predicate devices through technical comparisons, safety testing (biocompatibility, electrical safety, EMC), and software validation. It does not contain the detailed clinical performance study data that would be required for a novel AI/ML device, nor does it define or report against explicit clinical acceptance criteria using specific patient sample sizes or expert ground truth methods. The "performance data" refers to technical and safety compliance, not clinical efficacy metrics from a human study.
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