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The Xtrallux Alpha, Super Plus, Turbo Pro, and Extreme RX are intended to treat Androgenetic Alopecia (AGA) and promote hair growth in males who have Norwood-Hamilton Classifications of hair loss and, females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The Xtrallux devices are non-invasive, low level laser therapy (LLT) devices containing red, visible light diode lasers operating at 650 nm wavelength. The maximum power output of each diode is 5 mW. The diodes are configured within a cap, enclosed between the outer shell and inner liner. They deliver non-thermal energy to hair follicles via photostimulation of the scalp and are intended to stimulate hair growth. Xtrallux has developed four models: Xtrallux Alpha, Xtrallux Super Plus, Xtrallux Turbo Pro, Xtrallux Extreme RX.

This FDA 510(k) summary (K222364) for the Xtrallux devices does not include a clinical study with acceptance criteria and reported device performance in the way typically expected for an AI/ML medical device.

The document indicates that the Xtrallux devices are Low-Level Laser Therapy (LLLT) devices intended to treat Androgenetic Alopecia (AGA) and promote hair growth. The FDA clearance is based on the devices being substantially equivalent to predicate devices (CapillusX & CapillusX+ and HairMax Laser).

Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those specific acceptance criteria, as this type of study was not conducted or presented in this 510(k) summary.

Instead, the summary focuses on non-clinical testing to demonstrate safety and substantial equivalence to existing devices.

Here's a breakdown of the requested information based on the provided document:

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

   • Not applicable / Not provided. The 510(k) relies on substantial equivalence to predicate devices, not on a standalone performance study against specific acceptance criteria for efficacy. The non-clinical tests performed were for safety (biocompatibility, electromagnetic compatibility, electrical safety, usability, and laser safety) to ensure the device is as safe as legally marketed predicate devices.

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

   • Not applicable. There was no clinical "test set" in the context of an AI/ML medical device performance study described. The non-clinical tests are on the device itself, not on data from patients.

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. There was no clinical "test set" requiring expert ground truth in this submission.

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

   • Not applicable. No clinical test set requiring adjudication was 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

   • No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in interpreting medical images or data. The Xtrallux devices are therapeutic LLLT devices, not diagnostic AI.

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

   • Not applicable. The Xtrallux devices are hardware-based therapeutic devices, not AI algorithms.

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

   • Not applicable. There was no clinical performance study requiring ground truth in this submission. The "ground truth" for the non-clinical tests would be the established safety standards and regulatory requirements.

8. The sample size for the training set

   • Not applicable. No AI model was trained for this device.

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

   • Not applicable. No AI model was trained for this device.

In summary, the provided document describes a 510(k) submission for Low-Level Laser Therapy devices based on substantial equivalence to predicate devices, primarily demonstrating safety through non-clinical testing rather than clinical efficacy studies with specific performance metrics and acceptance criteria.

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Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications of I-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV.

The LaserCap Family of Lasers, models 300, 224, 120 and 80 contains the listed number of diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The LaserCap models are powered by a lithium-ion battery pack that contains an embedded controller chip.

The provided text is a 510(k) summary for the LaserCap Family of Lasers, models 300, 224, 120, and 80, seeking Over-The-Counter (OTC) clearance for devices previously cleared for prescription-use. The core argument for substantial equivalence relies on the fact that the proposed OTC devices are identical to the previously cleared prescription-use predicate devices in their design, function, and performance. Therefore, no new clinical performance data or testing was performed for this submission.

This means that the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, because such studies were deemed unnecessary due to the device's substantial equivalence to already cleared devices.

The document explicitly states:

• "No clinical performance data was produced for this submission because the LaserCap Family of Lasers, Models, 300, 224, 120 and 80 are the same device as the Predicates..." (Page 4)
• "No OTC testing was performed for this submission because the User Manual and packaging contents for the predicates and reference devices, are substantially equivalent to the Reference Devices." (Page 5)
• "Biocompatibility, electrical safety and EMC testing is not needed in this submission because the subject device is identical to the predicate devices in these aspects." (Page 6)

In summary, the provided text does not include the details of a study that proves the device meets acceptance criteria in the way typically expected for a new or novel device. Instead, it relies on the established safety and efficacy of its identical predicate devices. Therefore, I cannot construct the requested table or answer most of the questions, as the information is not present in the provided context.

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The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopeda who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.

The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. 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 is a 510(k) premarket notification for a medical device called "Hair Boom 69". It aims to demonstrate substantial equivalence to a previously cleared predicate device, also named "Hair Boom 69" (K182562), for Over-the-Counter (OTC) use.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Key Takeaway: The submission argues for substantial equivalence primarily based on the identity of the device itself (the new Hair Boom 69 is physically identical to the previously cleared prescription-use Hair Boom 69) and specific testing for OTC use, rather than a clinical performance study demonstrating efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance metrics (like sensitivity, specificity, or improvement in a clinical outcome) for this specific submission. Instead, the "acceptance criteria" for this 510(k) revolve around establishing substantial equivalence, particularly for an Over-the-Counter (OTC) indication.

The performance data presented is focused on demonstrating safety and usability for OTC use, given the device's technical identity with its predicate.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 30 female and male subjects were used for Over-the-Counter (OTC) Testing.
• Data Provenance: The document does not specify the country of origin for the OTC testing data. It is a prospective test, as it was "performed for this proposed submission."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies assessing diagnostic accuracy, especially for image-based AI. For this submission, the "ground truth" for the OTC testing was established by observing and evaluating the subjects' performance in tasks related to "Self-Selection, Usability and Hazards & Precautions." No expert readers of medical images were involved.

4. Adjudication Method for the Test Set

The document does not describe an "adjudication method" in the context of expert review for medical decision-making. For the OTC testing, the results likely involved pass/fail criteria assessed by the researchers or observers conducting the usability study, rather than expert adjudication of conflicting interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical performance data was produced for this submission because the Hair Boom 69 is an identical device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the Hair Boom 69." (Page 4).

This means there was no study comparing human readers' (e.g., clinicians') performance with and without AI assistance, as "Hair Boom 69" is a physical device (an infrared lamp) and not an AI algorithm assisting human interpretation.

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

This question is not applicable. "Hair Boom 69" is a physical device, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

For the OTC testing, the "ground truth" was established based on the performance and understanding of the subjects themselves in relation to the device's instructions for use, self-selection criteria, and safety precautions. It's direct observation and evaluation of user interaction, not clinical outcomes or expert consensus on a medical diagnosis.

For the efficacy claim (hair growth), the ground truth is implicitly tied to the previous clinical data submitted for the predicate device (K182562) for its prescription use. This current submission leverages the substantial equivalence argument to inherit the efficacy claim from the predicate.

8. The Sample Size for the Training Set

The document does not mention a "training set" for an algorithm. There is no AI component described in this device submission.

9. How the Ground Truth for the Training Set Was Established

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

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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 Hair Boom 69 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 Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. 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 a 510(k) premarket notification for the "Hair Boom 69" device. The submission asserts substantial equivalence to a predicate device, the "HairMax Laser 80," rather than presenting a new study with acceptance criteria and device performance. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available because the submission is based on demonstrating substantial equivalence to a predicate device, not on a new clinical study with specific acceptance criteria that the device's performance was measured against.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No new clinical test set was used for the Hair Boom 69 as part of this 510(k) submission. The device's equivalence is based on its technological characteristics and the predicate device's existing clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. No new ground truth was established for a test set for the Hair Boom 69 in this submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC comparative effectiveness study was not done as part of this 510(k) submission.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a hardware product (laser helmet) and does not involve an algorithm with standalone performance.

7. Type of Ground Truth Used:

Not applicable to the Hair Boom 69 itself in this submission. The "ground truth" for its efficacy relies on the prior clearance of the predicate device, HairMax Laser 80, which presumably established its efficacy through its own studies.

8. Sample Size for the Training Set:

Not applicable. No training set was used for this device as it's a hardware device demonstrating equivalence, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the K182562 Submission for Hair Boom 69:

The document focuses on establishing substantial equivalence of the "Hair Boom 69" to the "HairMax Laser 80" (K180885). This means the Hair Boom 69 did not undergo a new clinical trial to define and meet specific acceptance criteria. Instead, its safety and effectiveness are inferred from the predicate device's prior clearance based on similar intended use and technological characteristics.

Key points from the submission regarding "performance":

• No clinical performance data was produced for this submission because the Hair Boom 69 is an equivalent device in optical, electronic, and mechanical function, as well as recommended clinical treatment regime, to the predicate device.
• The Hair Boom 69 was tested to internationally recognized non-clinical standards (IEC, AAMI/ANSI, ISO standards for laser safety, basic safety, EMC, home use, software, risk management, and biological evaluation). These standards demonstrate the device's safety and quality manufacturing, but do not directly assess clinical efficacy in terms of hair growth.
• The submission highlights that both devices use Class IIIa/3R laser systems (by IEC standard) and have similar adverse event profiles.
• The only ergonomic design distinction mentioned is that the Hair Boom 69 is a helmet design, while the HairMax Laser 80 is a cap design, which the sponsor believes does not affect therapeutic value or safety.
• Both devices share the same treatment regime: 30 minutes, every other day, on non-consecutive days, or three times per week for 16 weeks.

In essence, the "study" proving the device meets acceptance criteria (in this context, substantial equivalence to the predicate) is the comparison chart and the assertion that "the Hair Boom 69, is substantially equivalent to the HairMax Laser 80 and based upon the equivalent technological designs of the compared devices." The acceptance criteria for this type of submission are legal and regulatory (meeting the requirements for substantial equivalence to a legally marketed predicate) rather than specific clinical performance metrics for the new device.

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