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510(k) Data Aggregation
(156 days)
LERNER MEDICAL DEVICES, INC.
The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75 Phototherapy System is intended for use on all skin types (I -VI).
Not Found
The provided 510(k) summary for the LH-75 Phototherapy System does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria.
The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring formal clinical trials with pre-defined acceptance criteria and reported performance metrics in the same way a PMA (Premarket Approval) would.
Therefore, many of the requested details about acceptance criteria, study sample sizes, expert involvement, and ground truth establishment are not typically found in a 510(k) submission for a device like this.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document describes the device and its intended use, but does not list specific performance metrics with acceptance criteria and corresponding reported performance from a study. 510(k)s for this type of device often rely on electrical safety, EMC, and photometric output testing to demonstrate substantial equivalence, rather than clinical performance metrics with defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. No clinical performance study is described that would have a test set.
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/Not provided. Since no clinical performance study with a test set is described, there's no mention of experts or ground truth establishment for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical performance study with a test set 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
- Not applicable/Not provided. This device is a phototherapy system, not an AI-assisted diagnostic device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware device for phototherapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. No clinical performance study requiring ground truth is described in the 510(k) summary. The "ground truth" for a phototherapy device would generally relate to its ability to emit specific UV dosages and wavelengths, and its safety, rather than diagnostic accuracy.
8. The sample size for the training set
- Not applicable/Not provided. This device is a physical phototherapy system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set is relevant for this type of device.
Summary based on the 510(k) Document:
The 510(k) summary for the LH-75 Phototherapy System focuses on demonstrating substantial equivalence to predicate devices (TheraLight, Inc. UV1 20-2 UVA / UVB Phototherapy System, Lerner Medical Devices, Inc. LH-75T Phototherapy System, Daavlin Distributing Co. 3 Series Phototherapy Cabinet, Daavlin Distributing Co. Flex Controlled Phototherapy Equipment).
The "study" implied by a 510(k) is the comparison to predicate devices, focusing on technological characteristics, indications for use, and safety/performance data (often non-clinical, such as electrical safety, EMC, and photometric output testing) to show that the new device is as safe and effective as the predicate. The document does not detail specific acceptance criteria or results from a dedicated clinical performance study with human subjects, as would be expected for a PMA or for certain novel devices requiring such evidence.
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(42 days)
LERNER MEDICAL DEVICES, INC.
The LH-75T Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75T Phototherapy System is intended for use on all skin types (I -VI).
The LH-75T Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 mm) light for use in phototherapy and allows delivery of controlled doses!
The LH-75T consists of a Console that contains the electronics and a Handpiece that contains the lamp and the ballast. The console and handpiece are connected with an electrical cable. A Spot Treatment Attachment (LP-3) jand a Fiber-optic Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Attachment (LB-10) are connected to the handpiece for selective treatment of skin lesions without exposure of adjacent, healthy tissues. The desired dose is selected using controls on the panel of the console and activated with either a switch on the panel or foot-switch. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
The LH-75T Phototherapy System is an ultraviolet light source and energy delivery system designed for UVB phototherapy. The study supporting its substantial equivalence focuses on its spectral output and technological specifications compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spectral Output: The device must emit UV-B light within the spectral band of 290 - 320 nm. | The LH-75T Phototherapy System "is between 290 and 320 nm." |
| Technological Specifications: The device's technological specifications should be similar to those of legally commercialized predicate devices. | "Other performance data included in the application show that the technological specifications are similar to those of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly mention a "test set" in the context of a clinical study with real patient data. The performance evaluation seems to be based on engineering and technical data comparing the device to predicate devices rather than a human-centric outcome study. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
As there is no mention of a clinical test set requiring expert ground truth establishment, this information is not provided.
4. Adjudication Method for the Test Set:
Given the nature of the evaluation (spectral output and technological specifications), an adjudication method for a clinical test set is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported in this 510(k) summary, as the performance data focuses on technical characteristics and not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The LH-75T Phototherapy System is a hardware device for light therapy, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. Type of Ground Truth Used:
The ground truth for the device's performance is based on engineering measurements and technical specifications (e.g., spectral analysis to confirm UV-B output, comparison of hardware configurations with predicate devices). It is not based on expert consensus, pathology, or outcomes data in a clinical trial setting.
8. Sample Size for the Training Set:
Since this is a hardware device and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI algorithm, this information is not applicable.
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(31 days)
LERNER MEDICAL DEVICES, INC.
The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The Levia Phototherapy System is intended for use on all skin types (I -VI).
The Levia Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 nm) light for use in phototherapy and allows delivery of controlled doses. The desired dose is selected using controls on the panel of the Light Source and activated with a switch on the panel or remotely by a foot switch. A Spot Handpiece and a Fiber-optic Brush allow for selective treatment of skin lesions without exposure to neighboring, healthy tissues. The Spot Handpiece and Fiber-optic Brush connect to Light Source with a flexible Light Guide. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
The provided text describes a 510(k) premarket notification for the Levia Phototherapy System, a device intended for UVB phototherapy. The submission aims to establish substantial equivalence to predicate devices, rather than presenting a study proving performance against defined acceptance criteria in the way a clinical trial for a novel AI device might.
Therefore, the requested information elements (1-9) which are typically associated with AI/software device studies demonstrating performance against acceptance criteria, are largely not applicable or cannot be extracted from this documentation for the Levia Phototherapy System. The document focuses on demonstrating substantial equivalence to existing, legally marketed devices.
Here's an analysis based on the provided text, highlighting what is present and what is not:
Acceptance Criteria and Study Details for Levia Phototherapy System
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Spectral output within UVB range of 290-320 nm | "The Levia Phototherapy System emits UVB light within the spectral band of 290 -320 nm similar to that of the predicate device Panosol II UVB-206 device." |
| "Performance data were submitted as part of the 510(k) application to confirm that the spectral output of the Levia System is between 290 and 320 nm..." | |
| Similar technological specifications to predicate devices | "Other performance data included in the application show that the technological specifications are similar to those of the claimed predicate devices." |
| Indications for Use (treatment of specific dermatologic conditions and all skin types I-VI) | The "Indications for Use" section states: "The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The Levia Phototherapy System is intended for use on all skin types (I -VI)." This aligns with the conditions that predicate UVB phototherapy systems are indicated for, implying similar efficacy for these conditions. |
| Safety and Effectiveness (no new questions raised by differences from predicate) | "Lerner Medical Devices, Inc. believes that this difference [Fiber-optic Brush] is an added convenience and does not raise new questions about safety or effectiveness." This is a statement of belief, not empirical data from a study. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is based on engineering and performance characteristics comparing the device to predicates, not a clinical study with a test set of patients or data samples. The "Performance Data" mentioned refers to engineering measurements of spectral output and technological specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert ground truth establishment for a test set is described.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method 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:
- Not applicable. This is a hardware medical device (phototherapy system), not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a phototherapy system and does not involve an algorithm with standalone performance.
7. The type of ground truth used:
- Not applicable, or inferred. The "ground truth" for this device's submission is effectively the established performance and safety profile of the predicate devices. The Levia System's spectral output and technological specifications are compared to these known and accepted benchmarks.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth establishment for a training set is relevant.
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