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Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Intense pulsed light therapy apparatus is an over-the-counter, home-use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device includes 12 model: FDA01, FDA02, FDA03, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S), the model name with an "S" indicates that the model has a cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and the device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses.

The provided FDA 510(k) Summary for the "Intense pulsed light therapy apparatus" describes the device's technical characteristics and how it compares to predicate devices to establish substantial equivalence. However, it does not present acceptance criteria or a study that proves the device meets specific performance acceptance criteria related to its efficacy (e.g., hair removal effectiveness) in the format of a clinical study with a test set, ground truth, expert adjudication, or MRMC studies.

The "Performance Data" section primarily focuses on non-clinical performance data (biocompatibility, electrical safety, EMC, eye safety, software V&V, and usability testing), which are crucial for safety but do not assess the primary clinical function (hair removal efficacy).

Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and a study proving clinical efficacy, as that type of study is not detailed in this document.

However, I can extract and state what is provided regarding the safety and non-clinical performance, and explicitly mention what is missing per your request.

Based on the provided K241120 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to predicate devices through similar technological characteristics and adherence to safety standards, rather than proving performance against specific quantitative clinical acceptance criteria for hair removal efficacy.

2. Sample size used for the test set and the data provenance:

• Clinical Efficacy Test Set: Not mentioned or detailed. The document primarily focuses on non-clinical/safety testing and comparison to predicates.
• Safety Testing (e.g., Biocompatibility, Electrical Safety): These involve laboratory sample sizes specific to the tests (e.g., cell cultures, test circuits), not human subjects for efficacy. Data provenance is implied to be from laboratory testing conducted for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• For Clinical Efficacy: Not applicable, as a clinical efficacy study with human subjects requiring ground truth establishment is not described in the provided text.
• For Safety/Technical Data: The "experts" would be the engineers, toxicologists, and quality control personnel performing the specified lab tests and evaluations. Their qualifications are implicit in their ability to perform and interpret these standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• For Clinical Efficacy: Not applicable, as a clinical efficacy study is not described.

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 IPL hair removal apparatus, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to its stated function or the type of data presented in this summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a hardware device for treatment, not a standalone algorithm.

7. The type of ground truth used:

• For Clinical Efficacy: Not applicable, as a clinical efficacy study is not described.
• For Safety/Non-Clinical Data: Ground truth is established by regulatory standards and established laboratory test methods (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). Passing these tests constitutes meeting the safety "ground truth."

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its software components are primarily for device control, safety interlocks, and user interface, verified via standard software V&V methods rather than machine learning training.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI/ML algorithm is mentioned.

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The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.

IPL Hair Removal Device (Model: PB1, PB2, PB3, PB4, TM002), is an over-the-counter, homeuse and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The indications for use, performance, structure design and operation of these five models of the device are basically the same, there is only a minor difference in appearance and physical dimension. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product is equipped with a skin sensor to detect appropriate skin contact, if the flash window of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

The provided text describes the FDA 510(k) clearance for an IPL Hair Removal Device. However, it does not contain the information necessary to describe acceptance criteria for an AI/CADe device, nor a study proving it meets those criteria.

The document discusses:

• The FDA clearance process for a medical device (specifically, an IPL hair removal device).
• Comparison of the device to predicate devices based on technical specifications (e.g., energy density, wavelength, power supply).
• Non-clinical performance data, primarily focusing on safety testing such as biocompatibility, electrical safety, electromagnetic compatibility (EMC), eye safety, software verification and validation, and usability.

There is no mention of an AI/CADe component in this device, nor any study or data related to diagnostic performance, ground truth, expert readers, or statistical measures like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/CADe device meets those criteria based solely on the provided text. The document pertains to a physical IPL hair removal device and its safety/performance testing, not an AI-powered diagnostic tool.

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IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.

The IPL Hair Removal 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. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains Xenon Lamp to emit light and skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot trigger a pulse. The IPL Hair Removal includes two models, W-1095 and W-1098. The two models are the same in intended use, working principle, the main differences are appearance and output parameters.

The provided text is a 510(k) Summary for an IPL Hair Removal device. It does not describe an AI/ML powered device, but rather a physical medical device. Therefore, much of the requested information regarding acceptance criteria and study data for an AI/ML model (e.g., sample size for test set, ground truth experts, MRMC study, training set details) is not applicable or present in this document.

However, I can extract the relevant information regarding the device's "performance" and the non-clinical tests performed to demonstrate safety and effectiveness, which serve as the acceptance criteria from a regulatory perspective for this type of device.

Here's a breakdown of the available information based on your request, with an emphasis on what is present and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the typical sense of a target metric for an AI model (e.g., AUC > X, sensitivity > Y). Instead, the "acceptance criteria" are implied by the compliance with recognized standards for medical devices and the demonstrated substantial equivalence to predicate devices. The "reported device performance" is primarily in terms of meeting these technical and safety standards.

Similar but different values: Energy density (W-1095: 1.674.46 J/cm², W-1098: 1.162.79 J/cm² vs. Predicates: 1.3-4.5 J/cm²), Spot size (W-1095: 2.69cm², W-1098: 4.3cm² vs. Predicates: 2.0-4.5cm²), Pulse duration (4-13ms vs. Predicates: 3-15ms), Output intensity levels (W-1095: 5 levels, W-1098: 3 levels vs. Predicates: 5 levels).

Different: Dimensions, Weight, Materials of skin-contacting components (ABS, PS vs Plastic, metal, ABS, PC, Aluminium alloy). |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83. | The device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83. |
| Photobiological Safety | Compliance with IEC 62471. | The device complies with IEC 62471. |
| Biocompatibility | Compliance with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization). | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. |
| Software Verification & Validation | Compliance with FDA guidance "Guidance for Pre Market Submissions and for Software Contained in Medical Devices." | Software verification and validation test performed according to FDA guidance. |
| Usability Evaluation | Compliance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." | Usability evaluation performed according to FDA guidance. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For a physical device like this, "test set" and "data provenance" as described for an AI/ML model are not typically relevant. The testing is based on engineering validation and adherence to safety standards rather than a clinical dataset for algorithmic performance.

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)

This information is not applicable/provided. There is no "ground truth" in the diagnostic sense for this type of device, as it's not performing a diagnostic task where expert interpretation is needed to label data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are relevant for resolving discrepancies in expert labeling of ground truth data, which is not the context here.

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

This information is not applicable/provided. An MRMC study is specific to evaluating the impact of AI on human reader performance in diagnostic tasks. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/provided. As explained, there is no "ground truth" of this nature for a hair removal device. The "ground truth" for regulatory clearance is that the device is safe and effective when used as intended, demonstrated by meeting engineering standards, biocompatibility, and substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as understood in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable/provided. There is no "training set" or "ground truth" for it in this context.

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