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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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