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The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

The ID-510 iRestore Elite is a low-level laser/light system operating at 680 ± 10, 655 ± 10, and 625± 10 nanometers. The physical configuration is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The device helmet is constructed of an ABS type plastic. The system operates on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any heads of non-toxic silicone pads. The helmet contains 300 units of five-millwatt-diode lasers and 200 units of fivemilliwatt, super luminescent diodes, that emit red light. This system delivers fixed laser emission levels, measured to be 2500 total millwatts per 12 minute treatment session, which cannot be altered by the operator.

The provided text describes a 510(k) premarket notification for the ID-510 iRestore Elite device, which is an infrared lamp for promoting hair growth. The document focuses on demonstrating substantial equivalence to a predicate device (ID-500 iRestore Hair Growth System) rather than providing specific acceptance criteria and detailed study results for the ID-510 iRestore Elite itself.

The document lists non-clinical performance data (e.g., cytotoxicity, electrical safety, software verification) that were performed to support substantial equivalence. However, it does not detail a clinical study with acceptance criteria for device performance based on hair growth outcomes in human subjects, nor does it refer to an AI algorithm that would typically have the detailed study requirements you've requested.

Therefore, I cannot provide the information you asked for regarding:

• A table of acceptance criteria and reported device performance related to hair growth.
• Sample size used for a test set, data provenance, or expert involvement for ground truth, as these typically relate to the validation of a diagnostic or AI-driven device's performance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth on a test set.
• MRMC comparative effectiveness study results or effect sizes for human readers with/without AI assistance.
• Standalone (algorithm-only) performance.
• Detailed type of ground truth beyond the general claim of "safety and effectiveness" through non-clinical tests.
• Sample size for the training set or how ground truth for a training set was established, as this implies a machine learning model, which is not described.

The information provided solely pertains to the non-clinical tests performed to demonstrate the ID-510 iRestore Elite's safety and effectiveness for substantial equivalence, not its direct clinical efficacy against quantified hair growth metrics under specific acceptance criteria.

The document states:

• "To demonstrate safety and effectiveness of ID-510 iRestore Elite and to show substantial equivalence to the predicate device, Remax Medi-Tech (Shenzhen) Corporation completed the following non-clinical tests."
• "Results confirm that the design inputs and performance specifications for the device are met."
• "The ID-510 iRestore Elite passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:"

The tests listed are:

• Cytotoxicity testing per ISO 10993-5: Passed
• Sensitization testing per ISO 10993-10: Passed
• Electrical safety testing per ANSI AMMI 60601-1: Passed
• Electromagnetic Disturbance (EMC) testing per IEC 60601-1-2: Passed
• Software verification and validation per FDA Guidance: Compliant
• Lifetime Testing: Supports lifetime of five years
• Transportation Testing per ASTM D4169: Demonstrates package integrity maintained

This means the acceptance criteria detailed are for these non-clinical engineering and biocompatibility tests, not for a clinical outcome like hair growth percentage or density, and there is no mention of an AI component requiring a "test set" or "training set" in the context of machine learning.

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ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.

The ID-500 iRestore Hair Growth System are two low-level laser/light systems operating at different wavelengths. The ID-500 iRestore Hair Growth System consists of laser and LED operating at 655 ± 10 nanometers. The physical configuration of the device is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The systems operate on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any head shape by means of non-toxic silicone pad. The helmet contains 5-millwatt-diode lasers and 5-milliwatt, super luminescent diodes, that emit red light.

The provided text describes the ID-500 iRestore Hair Growth System and its substantial equivalence to a predicate device, the iRestore Professional 282. However, it does not include detailed acceptance criteria for a device performance study in terms of clinical outcomes (e.g., hair count increase) or a study proving the device meets those clinical criteria. Instead, the document focuses on non-clinical performance data demonstrating safety and electrical/laser compliance.

Therefore, many of the requested elements for a clinical performance study (like sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not available in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

The document primarily discusses acceptance criteria related to safety and engineering standards, not clinical efficacy.

2. Sample size used for the test set and the data provenance:
This information is not provided as there is no description of a clinical performance study with a test set of human subjects. The "test set" here refers to the samples used in the non-clinical tests (e.g., cytotoxicity tests would use cell cultures or animal models, electrical safety tests would use the device itself). The document does not specify details about these samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there is no mention of a human-centric performance study where experts would establish a ground truth for clinical outcomes like hair growth. The "ground truth" for the non-clinical tests would be defined by the standards themselves (e.g., a cytotoxicity assay result being below a certain threshold).

4. Adjudication method for the test set:
This information is not applicable for the same reasons as above.

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. The device described is a low-level laser/light therapy system for hair growth, not an AI-powered diagnostic tool requiring human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the harmonized standards (ISO, ANSI, IEC, ASTM) and FDA guidance documents that the device was tested against. For example:

• Safety standards: Passing specific thresholds for electrical leakage, laser emission limits, or biocompatibility responses.
• Software compliance: Adherence to defined software development and validation practices.
• Lifetime/Transportation: Meeting predefined engineering specifications for durability and package integrity.

8. The sample size for the training set:
This information is not applicable as the device is a hardware product, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.

Summary of the Study:

The document describes a non-clinical performance study focused on demonstrating the safety and engineering compliance of the ID-500 iRestore Hair Growth System. The study involved testing the device against various national and international standards related to biocompatibility, electrical safety, electromagnetic compatibility, home use environment, laser safety, software validation, product lifetime, and transportation durability. The results of these tests confirmed that the device met the design inputs and performance specifications required by these standards, supporting its safety and effectiveness from an engineering and manufacturing perspective, and its substantial equivalence to the predicate device. No clinical efficacy study or AI-related performance study is detailed in this document.

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The iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, males who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The iRestore Professional 282 consists of 82 red visible light, diode lasers and 200 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down. by emitting an audible beep pattern.

The provided document describes the acceptance criteria and study for the iRestore Professional 282 device, primarily focusing on its suitability for Over-the-Counter (OTC) sale rather than clinical efficacy against a disease endpoint. The core of the "study" is a usability test to confirm consumer comprehension and safety handling, and then establishing substantial equivalence to a predicate device for clinical performance.

Here's a breakdown of the requested information:

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

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

• Sample Size: 30 subjects
• Data Provenance: The document does not explicitly state the country of origin or whether it was retrospective or prospective. Given the nature of a usability test for OTC readiness, it is most likely a prospective study conducted in the United States (implied by FDA submission) at the time of the submission.

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

This document primarily describes an OTC usability study and relies on substantial equivalence for clinical efficacy.

• For the OTC Usability Test: The "ground truth" was established by the "interviewer" who filled in the responses. The document does not specify the number or qualifications of the interviewer(s), but implies they were conducting a structured interview based on the questions provided. Given the nature of this usability test, the "ground truth" isn't a medical interpretation by experts, but rather the objective correctness of the user's answers to predefined questions.
• For Clinical Efficacy: No new clinical ground truth was established. The device's "efficacy" acceptance is based on its substantial equivalence to a predicate device (iRestore Hair Growth System K151662), which presumably had its efficacy established in a prior submission.

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

• For the OTC Usability Test: None. The judgment was based on whether the subject answered "all questions correctly" (Pass) or "any questions incorrectly" (Fail). There was no mention of multiple reviewers or an adjudication process for the subject's answers. The interviewer directly assessed the correctness of the answers.
• For Clinical Efficacy: Not applicable, as no new clinical study was performed.

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

No MRMC comparative effectiveness study was done. This device is a therapeutic device (for hair growth), not an AI-assisted diagnostic or assistive device that would typically involve human "readers" or an MRMC study.

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

Not applicable. This is a light-based therapeutic device, not an algorithm.

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

• For the OTC Usability Test: The ground truth was based on pre-defined correct answers to questions about the product packaging and manual. The "correctness" of these answers served as the ground truth for user comprehension and self-selection.
• For Clinical Efficacy: The clinical efficacy of the iRestore Professional 282 is implicitly derived from the established efficacy of its predicate device (iRestore Hair Growth System K151662) based on the argument of substantial equivalence. This would mean the predicate device likely had its efficacy proven through outcomes data (e.g., hair count, observer assessment, subject self-assessment) in its own clinical trials. The current submission did not generate new clinical outcomes data.

8. The sample size for the training set

Not applicable. This submission describes a medical device, not an AI/algorithm that requires a training set. The "study" here is a usability test and a comparison to a predicate device.

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

Not applicable, as there is no training set for an algorithm.

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The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I- II, males who have Norwood-Hamilton Classifications of IIa- V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The iRestore Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

The iRestore Hair Growth System (Model ID-500) is indicated to promote hair growth in females with Ludwig-Savin Classifications of I-II and males with Norwood-Hamilton Classifications of IIa-V, for individuals with Fitzpatrick Classification of Skin Phototypes I to IV. The device is for Over-The-Counter Use.

The provided document indicates that "No clinical performance data was produced for this submission because the iRestore is an IDENTICAL device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the igrow." Therefore, the acceptance criteria and study detailed below refer to those used for the predicate device, the igrow Hair Growth System, as the iRestore is considered substantially equivalent based on these prior studies.

1. Table of Acceptance Criteria and the Reported Device Performance (based on predicate device, igrow):

Note: The specific numerical acceptance criteria (e.g., minimum percentage increase in hair count) are not explicitly stated in this document but are implied to be met by the positive study findings compared to placebo.

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

• Males: 41 subjects in the active device group and 42 in the placebo group.
• Females: 29 subjects in the active device group and 29 in the placebo group.
• Data Provenance: The studies were published in "Lasers in Surgery and Medicine" and do not explicitly state the country of origin. The studies were described as "clinical trials" which implies prospective data collection.

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

The document does not specify the number of experts or their qualifications for establishing ground truth, beyond the mention of "clinical testing." However, the studies were published in a peer-reviewed journal ("Lasers in Surgery and Medicine").

4. Adjudication method for the test set:

The document does not describe a specific adjudication method beyond the general description of clinical trials.

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 is not applicable as the device is a therapeutic hair growth system, not an AI diagnostic tool involving human readers.

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

This is not applicable as the device is a therapeutic hair growth system, not an algorithm.

7. The type of ground truth used:

The ground truth used was clinical outcome data, specifically hair count, assessed in "clinical trials." The studies compared the active device against a placebo.

8. The sample size for the training set:

There is no mention of a "training set" as this device is not an AI/ML algorithm. The sample sizes referenced are for the clinical trials that established the efficacy of the predicate device.

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

This is not applicable as there is no "training set" for this type of device. The efficacy of the predicate device (iGrow) was established through controlled clinical trials involving male and female subjects with androgenetic alopecia, using objective measurements of hair count change from baseline compared to a placebo group. These studies were peer-reviewed and published.

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