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

IPL Hair Remover Device (Model: G993, G996, G998 and G885), is an over-the-counter use device for removal of unwanted body and/or facial hair based on Intense Pulsed Light (IPL) treatment. The device package includes IPL DEVICE, Power supply and User manual. It is supplied by AC power supply (Input 100-240 V AC). The weight of the device is 215.1g, and the size is 188 x 76 x 49mm. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device is equipped with a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Remover Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered for pulse emitting. The device can be used for large areas on legs, arms, back and abdomen. The product can flash for 100,000 times.

The provided text is a 510(k) Pre-Market Notification for an IPL Hair Remover device. It details the device's technical specifications, comparison to predicate/reference devices, and compliance with standards.

However, it explicitly states, "Clinical performance is not deemed necessary." and "As the modification of subject device ... results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device (legally existing device) are suitable for use in the assessment of the subject devices. As there have been no changes to the performance of the subject device from the predicate device, this submission leverages performance and electrical testing provided in previous submission."

This means the submission does not include a new study proving the device meets acceptance criteria for its performance. Instead, it relies on the substantial equivalence principle, arguing that since the device's technological characteristics haven't changed from a previously cleared predicate device, and its intended use is similar to a cleared reference device (just changing from Prescription Use to Over-The-Counter use with a usability study for the new user base), a new clinical performance study is not required.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because the document explicitly states such studies were not conducted for this particular 510(k) submission.

To directly address your request based on the provided text, the answer is that a study proving the device meets acceptance criteria as typically understood for new performance claims (e.g., efficacy in hair removal) was not performed for this submission. The device's "performance" in this context is established through its similarity to a legally marketed predicate device, its compliance with electrical safety and biocompatibility standards, and a usability study for the OTC use.

Here's what can be inferred or explicitly stated from the document regarding the closest relevant points, acknowledging the absence of a direct performance study:

Acceptance Criteria and Device Performance (Inferred from Submission Strategy - Not a Direct Performance Study)

Since no clinical performance study was conducted for this specific submission, there are no reported device performance metrics against acceptance criteria related to hair removal efficacy. Instead, the "acceptance criteria" are effectively met by demonstrating substantial equivalence to predicate devices.

Key aspects not found in the document, as no new performance study was undertaken as part of this 510(k):

1. Sample sized used for the test set and the data provenance: Not applicable for a performance study. A usability study for OTC use was mentioned, but details on sample size or provenance are not provided.
2. Number of experts used to establish the ground truth... and qualifications: Not applicable, as no clinical performance ground truth was established for this submission.
3. Adjudication method: Not applicable.
4. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
5. Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not applicable (this is a hardware device, not an AI algorithm).
6. The type of ground truth used: Not applicable for a performance study in this submission.
7. The sample size for the training set: Not applicable (no AI/ML algorithm involved, no 'training set').
8. How the ground truth for the training set was established: Not applicable.

What was done (explicitly stated):

• Reliance on Predicate Device Data: The submission explicitly states it leverages performance and electrical testing data from the predicate device (K211368) because there have been no changes to the performance of the subject device.
• Usability Study: A usability study was performed to verify the device's suitability for over-the-counter (OTC) use by lay persons, given the change in its intended use from a prescription device. Details of this study (sample size, methodology) are not provided in this summary.
• Biocompatibility: Assessed by demonstrating material identicality to the predicate device, which was already deemed biocompatible.
• Compliance with Standards: The device complies with specified IEC and ISO standards for electrical safety, EMC, and biocompatibility.

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The IPL Hair Remover Device, Model: G993, G996, G998 and G885 is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.

IPL Hair Remover, Model: G993, G996, G998 and G885 is a small prescription-use device for the permanent reduction of hair growth 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. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE. Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 215.1g, and the size is 188 x 76 x 49mm (HWD). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

This document is a 510(k) summary for an IPL Hair Remover device, asserting its substantial equivalence to previously cleared devices. It describes the device's technical specifications and compares them to predicate devices. However, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance evaluation using metrics like accuracy, specificity, or sensitivity, or information about clinical trials, ground truth establishment, or expert adjudications.

The document primarily focuses on explaining why a full clinical efficacy study was not deemed necessary for this 510(k) submission, by demonstrating substantial equivalence through technical specifications and adherence to safety standards.

Therefore, I cannot extract the requested information from the provided text.

Summary of missing information based on the prompt's request:

• Acceptance Criteria & Reported Performance Table: Not provided. The document states "No clinical trial is necessary in the submission" and relies on comparisons to predicate devices for safety and effectiveness.
• Sample Size and Data Provenance for Test Set: Not applicable/not provided, as no clinical test set appears to have been used for performance evaluation in the context of AI/algorithm performance.
• Number/Qualifications of Experts for Ground Truth: Not applicable/not provided.
• Adjudication Method: Not applicable/not provided.
• MRMC Comparative Effectiveness Study: Not performed/not described.
• Standalone (algorithm-only) Performance: Not applicable/not described, as this is a physical device, not an AI algorithm.
• Type of Ground Truth Used: Not applicable/not provided.
• Sample Size for Training Set: Not applicable/not provided (no AI/algorithm training mentioned).
• How Ground Truth for Training Set was Established: Not applicable/not provided.

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