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The MEP-90 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Medically prescribed use for the treatment of androgenic alopecia in females: The treatment of androgenic alopecia in females by promoting hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV.

The MEP-90 is a stationary low-level laser device that promotes hair growth and provides treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp. The MEP-90 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+.76%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.

The MEP-90 Hair Growth Stimulation System, identified by 510(k) number K091496, is indicated for the treatment of androgenic alopecia in females with specific Ludwig and Savin Hair Loss Scale classifications (I to II) and Fitzpatrick Skin Typing (I to IV), by promoting hair growth.

Here's an analysis of the provided information regarding acceptance criteria and the study that supports it:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined "acceptance criteria" as a set of quantified thresholds that needed to be met for device approval. Instead, it describes "therapeutic results standards" and "statistical significance." However, based on the performance data presented, we can infer the device's efficacy targets related to hair count increase and stabilization of hair loss.

2. Sample Size and Data Provenance for the Test Set

• Sample Size Used for the Test Set: While the exact number of subjects for the study is not explicitly stated, the document consistently refers to "subjects" and "subject population" in singular. However, given the percentages mentioned (e.g., 92% of subjects, 57% demonstrating an increase), it implies a reasonable number of participants to make these percentages meaningful, suitable for statistical analysis. It is described as a "multi-phased experimental study."
• Data Provenance: The study was "performed with Institutional Review Board (IRB) preapproval and oversight, in accordance with all applicable references of the Food and Drug Cosmetic Act and Title 21; Code of Federal Regulations." This indicates a prospective clinical study designed to evaluate the device. The country of origin for the data is implicitly the USA, given the FDA submission and compliance with US regulations.

3. Number of Experts and Qualifications for Ground Truth

The document pertains to a clinical efficacy study for a medical device that promotes hair growth. The "ground truth" here is the actual biological response to the treatment, measured by hair count and observed changes in alopecia. This is a direct physiological outcome rather than an interpretation task requiring expert consensus on images.

• Number of Experts: Not applicable in the traditional sense of image review or diagnosis confirmation. The "ground truth" is established by direct measurement of hair count and self-reported patient perceptions.
• Qualifications of Experts: The study indicates that "Androgenic alopecia in women is a chronic medical condition requiring diagnosis, treatment, and monitoring by a licensed medical physician." This implies that initial diagnosis and potentially evaluations were performed by licensed medical professionals, but this isn't explicitly described as an "expert consensus" process for establishing ground truth within the efficacy measurements themselves.

4. Adjudication Method for the Test Set

Not applicable. The study measures objective physiological changes (hair count) and subjective patient reports. There's no indication of a diagnostic "test set" requiring adjudication by multiple experts in the context of image interpretation or complex diagnostic calls. The data likely comes from direct clinical measurements and patient questionnaires.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study typically evaluates diagnostic performance (e.g., radiologists reading images) with and without AI assistance. The MEP-90 study is a direct clinical efficacy study of a therapeutic device designed to stimulate hair growth.

6. Standalone (Algorithm Only) Performance

Yes, a standalone study was done in the sense that the clinical efficacy described is the algorithm (device) only performance, without human-in-the-loop assistance for diagnosis or treatment application. The device, the MEP-90 Hair Growth Stimulation System, is a standalone therapeutic device that applies laser light. The study directly measures its effectiveness in promoting hair growth in human subjects when used as prescribed.

7. Type of Ground Truth Used for the Test Set

The ground truth used for the test set was a combination of:

• Objective Biophysical Measurements: Hair count increases at specified intervals (10-weeks and 18-weeks) compared to baseline. The report mentions "linear trend plotting for all subjects of their Initial, 10-Week, and 18-Week hair counts," confirming direct measurement.
• Patient-Reported Outcomes/Observations: Self-reported stabilization of hair loss, perception of treatment effectiveness, slowed loss rate, and reduction in the visible area of alopecia (bald spot).

8. Sample Size for the Training Set

The document describes a single "multi-phased experimental study" conducted on human subjects to determine the efficacy of the MEP-90. There is no mention of a separate "training set" in the context of machine learning. The clinical study is the evaluation of the device's performance, not the training of an AI algorithm on data for later validation. Therefore, this concept is not applicable here as the device itself is a physical light therapy system, not an AI diagnostic tool.

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

As mentioned above, there is no "training set" in the context of an AI algorithm. The MEP-90 is a physical device, and its design and parameters (like wavelength, power output, treatment duration) are based on the established scientific understanding of biostimulation and predicate devices, rather than being "trained" on a dataset in a machine learning sense. The clinical study was to confirm the efficacy and safety of the already designed device.

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The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a Siemens Medical Systems 1.5 Tesla MRI Scanner with Total imaging matrix (Tim) option.

SV Brain Array, Model# 1500SV-SMS64

The provided document is a 510(k) clearance letter from the FDA for the SV Brain Array, Model # 1500SV-SMS64. This type of document declares substantial equivalence to a predicate device and permits marketing. It is not a study report or clinical trial documentation, and therefore does not contain the detailed information required to answer the prompt regarding acceptance criteria, device performance, and study specifics.

The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was deemed substantially equivalent based on comparisons to a predicate device, not necessarily extensive new clinical studies with defined acceptance criteria and performance metrics as might be found in a PMA (Premarket Approval) application or a detailed clinical study report.

Therefore, I cannot provide the requested information from this document. To answer your prompt, I would need access to the actual 510(k) submission document or any underlying performance studies referenced within that submission.

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The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the anatomy of head and brain. This device is used in association with a General Electric 1.5T Signa MRI System and is currently cleared for use with the PROBE (Proton Brain Exam) option.

Special Procedures II Head Coil, Model #1400GE-64

I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a medical device (Special Procedures II Head Coil, Model #1400GE-64).

This letter primarily focuses on:

• Substantial Equivalence Determination: The FDA's finding that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: The device's regulation number, regulation name, regulatory class, and product code.
• General Controls: Information about the general controls provisions of the Act (registration, listing, GMP, labeling, misbranding, adulteration).
• Contact Information: For specific advice on labeling regulations.
• Indications for Use: A brief statement outlining what the device is intended for.

The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

The acceptance criteria and detailed study data (including specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) are generally part of the 510(k) submission itself, which is not fully provided in these excerpts. The letter only confirms that such a submission was reviewed and deemed acceptable for market clearance based on substantial equivalence to a predicate device. It does not contain the detailed study results or explicit acceptance criteria.

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Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and Proton Spectroscopy of the pediatric head, body and extremities. This device is used in conjunction with a General Electric 1.5 Tesla MRI System. Proton Spectroscopy is used in conjunction with the PROBE (Proton Brain Exam) option.

Model 1300GE-64 - Pediatric Positioner. Compatible with GE Signa 1.5T MRI Systems. MRI Accessory.

The provided text describes a 510(k) summary for the "Model 1300GE-64 - Pediatric Positioner." This document focuses on demonstrating substantial equivalence to predicate devices, primarily through safety and imaging performance parameter comparisons. It does not describe a study performed to establish acceptance criteria for the device itself or analyze its diagnostic performance.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance (beyond "no change" relative to predicate).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or effect size.
• Standalone performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

Based on the provided text, the device is a "Pediatric Positioner" intended for use with a GE Signa 1.5T MRI System. The "study" described is essentially a comparison to legally marketed predicate devices to establish substantial equivalence concerning safety and imaging performance.

Here's an analysis of what can be extracted or inferred:

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

The acceptance criteria are implicitly that the device should not change the performance or safety parameters of the MRI system when compared to using legally marketed predicate devices.

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

• Sample Size: Not applicable/not provided. This is a comparison to predicate devices' specifications, not a study involving a test dataset of patient images.
• Data Provenance: Not applicable/not provided.

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

• Not applicable. Ground truth for diagnostic performance is not established as this is a device accessory comparison.

4. Adjudication method (e.g., 2+1, 3+1, none) 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:

• No, an MRMC comparative effectiveness study was not done. This device is a passive pediatric positioner, not an AI or diagnostic imaging algorithm.

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

• Not applicable. This is a passive medical device accessory, not an algorithm.

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

• Not applicable for diagnostic performance. The "ground truth" for this submission is the established safety and performance parameters of the GE Signa 1.5T MRI System when used with legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm.

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

• Not applicable. This is not an AI/algorithm.

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