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Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.

The Intense Pulse Light Therapeutic Apparatus 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 Intense Pulse Light Therapeutic Apparatus is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are IPL-1 PRO, IPL-1, IPL-12, and IPL-17 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, size are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

The provided FDA 510(k) summary does not contain information on the acceptance criteria and study proving device performance as typically understood for AI/ML-driven medical devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and standard safety and performance testing.

Here's a breakdown of why the requested information is absent and what is provided:

No AI/ML Performance Study Details:
The document does not describe an AI/ML component, nor does it detail a study proving specific performance metrics (like accuracy, sensitivity, specificity) against a clinical ground truth, which would typically involve acceptance criteria, test sets, expert adjudication, or MRMC studies.

The device, "Intense Pulse Light Therapeutic Apparatus," is a physical device for hair removal and does not appear to incorporate AI or machine learning. The section titled "Software Verification and Validation" primarily addresses the software aspect within the context of electrical safety and general device functionality, classifying it as "moderate level of concern" software, which is typical for embedded control systems in medical devices, not necessarily AI.

What the Document Does Provide Regarding Performance and Equivalence:

1. Acceptance Criteria (Implicit via Substantial Equivalence):

   • The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices (K230097 and K220669). This means the device must have the same intended use, fundamental technological characteristics, and be as safe and effective as the predicate device(s).
   • Specific parameters compared (and found to be similar or within acceptable ranges) are listed in the tables. These implicitly act as performance criteria for demonstrating substantial equivalence. For example, energy density (Max 4.92 J/cm² for the subject vs. Max 5.0 J/cm² for predicate K230097), wavelength range, spot size, and output energy levels are compared.

2. Study Proving Device Meets Criteria (Safety and Performance Testing):
   The document outlines the following standard safety and performance tests performed to demonstrate safety and effectiveness, supporting the claim of substantial equivalence:

   • Biocompatibility Safety:

     • Tests performed: ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Irritation).
     • Result: Passed.

   • Electrical Safety and EMC:

     • Tests performed: IEC 60601-1-2 (EMC), IEC 60601-1 (Basic Safety and Essential Performance), IEC 60601-1-11 (Home Healthcare Environment), IEC 60601-2-83 (Home Light Therapy Equipment).
     • Result: Passed.

   • Eye Safety:

     • Test performed: IEC 62471 (Photobiological safety of lamps and lamp systems).
     • Result: Not explicitly stated as "passed" but grouped with other passed tests under "Performance Data."

   • Software Verification and Validation:

     • Description: "Software documentation consistent with moderate level of concern was submitted... System validation testing... demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This suggests internal V&V activities rather than a clinical performance study.

Addressing the Specific Questions (where information is available or can be inferred):

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

   Acceptance Criterion (Implicit for SE)	Reported Device Performance (Subject Device)	Predicate Device K230097
   Intended Use	Removal of unwanted body hair (OTC)	Same
   Mode of Action	IPL	Same
   Applicable Skin Type	Fitzpatrick Skin Type I-V	Same
   Wavelength range	510~1200nm	470~1200nm
   Energy density	Max 4.92 J/cm²	Max 5.0J/cm²
   Spot size	3.3 +/- 0.25 cm²	3.0 cm² +/- 0.5 cm²
   Output energy	Level 1: 6.0J to Level 5: 12.5J (±20%)	Range in 5~12.5J (±20%)
   Output energy level	1 to 5 level	5 level
   Pulse duration	5.84~9.24ms	4~10ms
   Biocompatibility	Met ISO 10993-5, -10, -23	Not explicitly detailed but implied similar for SE
   Electrical Safety/EMC	Met IEC 60601-1-2, -1, -11, -2-83	Not explicitly detailed but implied similar for SE
   Eye Safety	Met IEC 62471	Not explicitly detailed but implied similar for SE

2. Sample size used for the test set and the data provenance: Not applicable. This refers to a clinical or AI/ML performance test set, which is not detailed here. The tests mentioned are laboratory safety and performance tests for the physical device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth or expert review is described.

4. Adjudication method for the test set: Not applicable.

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. The device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Safety and performance tests against recognized standards are used, not clinical ground truth in the AI/ML sense.

8. The sample size for the training set: Not applicable. There is no mention of an AI/ML training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical Intense Pulse Light device, not an AI/ML medical device. Therefore, the detailed AI/ML performance study criteria requested are not present in this submission. The "performance data" section refers to standard electrical, biocompatibility, and eye safety testing necessary for the physical device's regulatory clearance.

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

IPL Hair Removal Device is a personal, light-based, home-use hair reduction device intended to be sold over-the-counter. The device provides hair reduction by 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 (100-240V, 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the light outlet of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

The device includes JP1, JR3, JR9 four models. There is difference in product appearance, physical product dimension, indicator display, spot size and output energy, but their intended use, performance, structure design and operation are basically identical.

This FDA 510(k) summary describes the substantial equivalence of the "IPL Hair Removal Device" to predicate devices, focusing on the safety and efficacy for its intended use. It does not contain information about acceptance criteria and performances of an AI/ML powered device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI component.

The document primarily addresses:

• Device Description: An over-the-counter IPL device for hair removal.
• Comparison to Predicate Devices: Demonstrates similar intended use, technology, and operational characteristics to previously cleared devices.
• Performance Data (Non-Clinical):
  • Biocompatibility Testing: Conducted in accordance with ISO 10993 standards (ISO 10993-5, ISO 10993-10, ISO 10993-23) to assess cytotoxicity, irritation, and skin sensitization. All tests were passed.
  • Electrical Safety and EMC: Tested against IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83 standards. All tests were passed.
  • Eye Safety: Tested against IEC 62471.
  • Software Verification and Validation: Submitted documentation consistent with a moderate level of concern, demonstrating that all software requirements are met and hazards mitigated.
  • Usability: Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."

The conclusion states that based on this non-clinical data, the device is as safe and effective as the legally marketed predicate devices.

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

The Intense pulsed light device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G twelve models. All have adopted the same structure design, consisting of Intense pulsed light device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly product size, appearance, sapphire, skin color recognition function and enclosure color, DE01A series means without sapphire and skin color recognition function. DE01B series means with sapphire, but without skin color recognition function. DE01C series means with sapphire and skin color recognition function. DE02A series means without sapphire and skin color recognition function. DE02B series means with sapphire, but without skin color recognition function. DE02C series means with sapphire and skin color recognition function. Letter -B the enclosure color is blue, letter -G is green, which do not affect the intended use.

The provided text is a 510(k) summary for an Intense Pulsed Light (IPL) device intended for over-the-counter hair removal. It details the device's characteristics, comparison with predicate devices, and performance data submitted to support substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of advanced AI/ML performance metrics (e.g., accuracy, sensitivity, specificity). The performance data shared are related to:

1. Biocompatibility Testing: Ensuring the device materials are safe for human contact.
2. Electrical Safety and EMC: Verifying the device meets electrical safety and electromagnetic compatibility standards.
3. Eye Safety: Confirming the device is safe for eye exposure.
4. Software Verification and Validation: Demonstrating that software meets requirements and mitigates hazards.
5. Usability: Evaluating and verifying the product's usability.

These are standard regulatory requirements for medical devices, particularly for consumer-grade devices like the IPL hair removal system. They are not AI/ML performance metrics.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about a study proving this in the context of an AI-driven device, because the provided text is for a physical IPL device and does not mention any AI/ML components or associated performance studies. The request's questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are specific to the evaluation of AI/ML algorithms in medical imaging or diagnostics, which is not the subject of this 510(k) submission.

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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: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108), is an over-the-counter, home-use and personal device for hair reduction by using 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 device is only powered by the external power adapter (a.c.100~240V 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the Light Outlet of the device is not in full contact with the skin, the device cannot trigger a light pulse. The device have six models and these models share the same performance, structure and operation, the only difference is their enclosure color.

The provided document does not contain information about specific acceptance criteria related to clinical performance metrics (e.g., hair reduction percentage, adverse event rates) or a detailed study demonstrating the device meets such criteria. Instead, it focuses on non-clinical studies for safety and functional equivalence to predicate devices.

Therefore, the following information cannot be extracted from the document:

• A table of acceptance criteria and the reported device performance regarding hair removal efficacy.
• Sample size used for a test set (clinical or performance efficacy).
• Data provenance for a clinical test set.
• Number of experts used to establish ground truth for a clinical test set and their qualifications.
• Adjudication method for a clinical test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
• The sample size for the training set (as no AI/algorithm performance study is described).
• How the ground truth for the training set was established.

However, the document does describe non-clinical studies conducted to demonstrate substantial equivalence, focusing on safety and technical performance.

Here's a summary of the non-clinical studies and their conclusions as presented:

Acceptance Criteria and Reported Device Performance (Non-Clinical):

The document states that non-clinical tests were conducted to verify that the IPL Hair Removal Device meets all design specifications and complies with various safety standards. While specific numerical acceptance criteria for each test are not explicitly detailed (e.g., current limits, specific temperature ranges), compliance with the listed standards serves as the acceptance criterion for these non-clinical aspects.

Study Details:

The non-clinical studies were conducted to support the conclusion of Substantial Equivalence (SE) to predicate devices. These are laboratory-based tests rather than clinical trials with human subjects for efficacy.

1. Sample size used for the test set and the data provenance: Not applicable in the context of clinical efficacy; these were non-clinical, laboratory-based tests on the device itself.
2. 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 ground truth in this context refers to compliance with established technical and safety standards, not clinical diagnoses or outcomes. The tests were performed by a "reliable third-party lab" for biocompatibility.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical compliance testing.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No (not an AI/algorithm device in this context).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, the "ground truth" is adherence to the specifications and requirements set forth by the cited international and national standards (e.g., ISO, IEC, ANSI AAMI).
7. The sample size for the training set: Not applicable, as no AI/machine learning algorithm requiring a training set is described in relation to clinical efficacy.
8. How the ground truth for the training set was established: Not applicable.

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

The IPL 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. 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 a Xenon Quartz Lamp Tube to emit light and a 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 emitting.

The IPL Hair Removal Device includes: AP10, AP20, AP32 four models. Their intended use, performance, structure design and operation, are essential the same for the device models, with main differences being product appearance, display contents, physical product dimension, treatment area (spot size), output energy and power supply.

The provided text is an FDA 510(k) summary for an IPL Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and non-clinical studies performed to demonstrate substantial equivalence. However, this document does not contain information about studies proving the device meets acceptance criteria related to its clinical efficacy (e.g., hair reduction percentage, number of treatments for efficacy). The non-clinical studies focus on electrical safety, photobiological safety, and biocompatibility, as well as software validation, which are all important for safety and performance but do not address the clinical effectiveness of hair removal.

Therefore, for aspects related to the clinical performance criteria (like hair reduction), the information requested in your prompt (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be extracted from this document as it does not describe clinical trials for efficacy. The document primarily focuses on demonstrating equivalence to predicate devices based on technical characteristics and safety standards.

Here's what can be extracted and what cannot:

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

• Cannot be extracted for clinical efficacy: The document does not state clinical acceptance criteria such as a required percentage of hair reduction or number of treatments. Instead, it focuses on non-clinical performance standards.
• For non-clinical performance (safety):

  Acceptance Criteria (Standard Conformance)	Reported Device Performance
  ANSI AAMI ES 60601-1 (Basic Safety and Essential Performance)	Meets standard
  IEC 60601-1-2 (Electromagnetic Disturbances)	Meets standard
  IEC 60601-1-11 (Home Healthcare Environment)	Meets standard
  IEC 60601-2-83 (Home Light Therapy Equipment)	Meets standard
  IEC 62471 (Photobiological Safety)	Meets standard
  ISO 10993-5 (In Vitro Cytotoxicity)	Meets standard
  ISO 10993-10 (Irritation and Skin Sensitization)	Meets standard
  FDA Guidance for Pre Market Submissions and for Software Contained in Medical Devices (Software Verification and Validation)	Meets requirements

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

• Cannot be extracted for clinical efficacy: Not mentioned as no clinical efficacy study is described.
• For non-clinical testing: Sample sizes are not specified for the safety and performance tests (e.g., how many devices were tested for electrical safety). Data provenance is implicitly from the manufacturer or third-party labs contracted by the manufacturer (Shenzhen Yangyi Technology Co., Ltd. in China). These are non-clinical tests, not human data.

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)

• Cannot be extracted: No clinical trial involving expert assessment of outcomes is described. Ground truth for non-clinical tests is established by adherence to documented test procedures and standards.

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

• Cannot be extracted: Not applicable as no clinical trial with human assessment is 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

• Cannot be extracted: Not applicable. This document describes an IPL hair removal device, not an AI-assisted diagnostic device.

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

• Cannot be extracted: Not applicable. This refers to the performance of a diagnostic algorithm, not a therapeutic device. The device itself is "standalone" in that it performs the therapy.

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

• Cannot be extracted for clinical efficacy: No clinical efficacy data is presented.
• For non-clinical testing: Ground truth is established by the specified international and national performance and safety standards (e.g., IEC, ISO, ANSI AAMI ES). Compliance with these standards indicates the "ground truth" of the device's technical safety and performance.

8. The sample size for the training set

• Cannot be extracted: No machine learning model is being trained for clinical decision-making or diagnosis. The device has "Software/Firmware/Microprocessor Control? Yes," and "Software verification and validation test" was done, but this refers to the internal operating software, not an AI trained on a large dataset.

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

• Cannot be extracted: Not applicable, as no external training set for an AI/ML model for clinical application is mentioned. Ground truth for internal software validation would be derived from functional requirements and test specifications.

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