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The IPL HAIR REMOVAL Device (Model: TFDA06S-A ) is an over-the-counter device 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 re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.

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The provided FDA 510(k) clearance letter and associated Indications for Use document for the "IPL Hair Removal" device (K220927) do not contain detailed information regarding acceptance criteria, specific study designs, or performance metrics from clinical trials.

FDA 510(k) clearances typically establish substantial equivalence to a predicate device, which means the new device is as safe and effective as a legally marketed device. While a 510(k) submission includes documentation of performance testing, the public clearance letter usually summarizes the outcome rather than providing the granular data often found in premarket approval (PMA) applications or detailed clinical study reports.

Therefore, I cannot extract the specific information requested in your prompt (Table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types for test/training sets, and training set size).

The document states:

• Device Name: IPL HAIR REMOVAL (Model: TFDA06S-A)
• Indications for Use: Over-the-counter device for the removal of unwanted hair and permanent reduction in hair regrowth (defined as long-term, stable reduction measured at 6, 9, and 12 months after treatment regime completion) for adults.
• Regulatory Class: Class II

To obtain the detailed information you are requesting about specific acceptance criteria and study data, one would typically need to:

1. Access the full 510(k) Summary: While not included in this document, a 510(k) Summary often contains more details about the performance data presented to the FDA. These are publicly available through the FDA's 510(k) database.
2. Review the actual 510(k) submission: This document (which is usually proprietary and not publicly available in its entirety) would contain the complete study protocols, raw data, statistical analyses, and reports.
3. Consult relevant publications or manufacturer's technical documentation: If the device manufacturer has published clinical data or provided more detailed technical specifications, that information would be found outside of the FDA clearance letter.

In summary, based only on the provided text, none of the specific study details you've asked for (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone, ground truth info) are present. The document confirms the device's clearance based on substantial equivalence for the stated indications.

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The IPL HAIR REMOVAL Device (Model: TFDA06S) 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 REMOVAL, Model: TFDA06S, a portable device, is a prescription home-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 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 regimen. Emission activation 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 260g, and the size is 185.4 x 68.5 x 41.4mm (HWD). The device adopts the international photonic beauty 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 Removal device (Model: TFDA06S). It details the device's substantial equivalence to predicate devices, primarily through non-clinical testing. It does not involve a study proving the device meets acceptance criteria related to AI/ML performance, human reader improvement, or complex ground truth establishment as would be present in an AI/ML-driven medical device submission.

Therefore, many of the requested points are not applicable to this document. I will answer the applicable points and explicitly state when information is not present.

Acceptance Criteria and Device Performance for IPL Hair Removal Device (Model: TFDA06S)

This submission primarily relies on comparing the subject device to legally marketed predicate devices through non-clinical testing to establish substantial equivalence, rather than a clinical study demonstrating performance against specific acceptance criteria for diagnostic accuracy or human-AI interaction.

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

The "acceptance criteria" here are implicitly the safety and performance characteristics of the predicate devices. The "reported device performance" is the demonstration of similar characteristics and compliance with relevant safety standards.

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

This document states: "Clinical testing: No clinical trial is necessary in the submission." Therefore, there is no "test set" in the context of clinical data for performance evaluation as would be seen for an AI/ML device. The "testing" refers to bench testing for electrical safety, EMC, biocompatibility, and software V&V. The provenance of this bench testing data is not specified beyond being "evaluated... by lab bench testing."

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)

Not applicable. As no clinical trial or AI/ML performance study was conducted, there was no need for expert-established ground truth for a test set.

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

Not applicable. No clinical test set requiring adjudication was used.

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 is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

Not applicable in the context of clinical accuracy for an AI/ML device. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the specifications outlined in the referenced IEC and ISO standards.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that would require a "training set."

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

Not applicable. There is no training set for this device.

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