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The reVive Light Therapy® Wrinkle and Acne LED Device is intended for treatment of wrinkles and mild to moderate inflammatory acne.

The reVive Light Therapy® Wrinkle and Acne LED Device is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne, as defined in 21 CFR § 878.4810. The reVive Light Therapy® Wrinkle and Acne LED Device components include the device containing the LED module. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.

The provided text is a 510(k) summary for the reVive Light Therapy® Wrinkle and Acne LED Device. It details the device's characteristics, its intended use, and its substantial equivalence to predicate devices. However, this document primarily focuses on regulatory approval based on equivalence rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria.

The information sought in your request (acceptance criteria, specific study details like sample size, expert involvement, and ground truth establishment) is typically found in clinical study reports or performance testing reports, which are separate from a standard 510(k) summary focused on substantial equivalence.

Based on the provided text, here's what can be extracted and what is missing:

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

• Mentioned in text:
  • The document states: "Testing confirmed that the performance of the reVive Light Therapy® Wrinkle and Acne LED Device meets the product system requirements, which is based on the predicate devices."
  • And, "The Testing confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices."
• Missing from text: Specific quantitative acceptance criteria (e.g., X% reduction in wrinkles, Y% clearance of acne lesions) and the actual numerical performance results against these criteria are not provided. The document focuses on equivalence rather than a direct performance claim with specific metrics.

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

• Missing from text: The document does not describe a clinical test set in the traditional sense for evaluating clinical efficacy. It refers to "software was tested and validated" and general "Testing" to confirm modifications and performance relative to predicate devices. There is no mention of human subjects, data provenance (country, retrospective/prospective), or numbers of patients/treatments.

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

• Missing from text: Given that no human-in-the-loop clinical efficacy study or test set with specific ground truth establishment is described, this information is not present.

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

• Missing from text: Not applicable, as no such test set or ground truth establishment process is detailed.

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

• Missing from text: This is an LED device for direct patient use, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and not discussed.

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

• Missing from text: This is a physical LED device, not a standalone algorithm. The mention of "software was tested and validated" refers to the device's internal operational software, not an AI or diagnostic algorithm providing standalone performance.

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

• Missing from text: Not applicable, as detailed clinical efficacy testing with specific ground truth data is not described in this 510(k) summary. The "ground truth" for this submission appears to be the performance characteristics of the predicate devices and confirmation that the new device's modifications do not negatively impact those.

8. The sample size for the training set

• Missing from text: Not applicable. This document refers to the validation of device software and confirms equivalence to predicate devices, not the training of a machine learning model.

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

• Missing from text: Not applicable, as no machine learning training set is mentioned.

In summary:

The provided 510(k) summary (K223482) is a regulatory document focused on demonstrating substantial equivalence to previously cleared predicate devices (K210965 and K210968) for the reVive Light Therapy® Wrinkle and Acne LED Device. It asserts that the device performs "as well as" or "the same as" the predicate devices and that modifications (primarily software and associated hardware) were correctly implemented.

However, it does not contain the detailed clinical study information often associated with performance evaluation of AI or diagnostic devices, which would typically include specific acceptance criteria, sample sizes of test sets, details on expert ground truth establishment, or specific efficacy metrics from clinical trials. For a device like this, the primary evidence for 510(k) clearance is often bench testing, electrical safety, EMC compatibility, and demonstration that its operating parameters (wavelengths, irradiance, treatment area, time) are similar to those of devices already deemed safe and effective. Any clinical data presented for such devices in a 510(k) would be to support the efficacy claims, but this summary primarily relies on the predicate devices' established performance.

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The reVive Light Therapy LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.

The reVive Light Therapy® LED Cleansing System is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne, as defined in 21 CFR § 878.4810. In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material. The reVive Light Therapy® LED Cleansing System components include the device containing the LED module, USB power cord, and power adapter. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

This document describes a 510(k) premarket notification for the reVive Light Therapy® LED Cleansing System (K221430). It establishes substantial equivalence by comparing the new device to two predicate devices (K180445 and K180447).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for clinical performance (e.g., specific reduction percentages for wrinkles or acne severity scores). Instead, it relies on demonstrating that the modified device performs "as well as the legally marketed devices" and meets "product system requirements, which is based on the predicate devices."

The table below summarizes the comparison of technological characteristics between the new device and its predicates, which forms the basis of the performance claim.

Study Proving Acceptance Criteria:

The document describes a study that aimed to confirm that the modifications made to the device were "correctly implemented and that the device performs as well as the legally marketed devices." The study focused on software testing and validation:

• Study Name/Description: The specific name of the study is not given, but it is described as "Testing" in Section 6.
• Methodology: The "reVive Light Therapy® LED Cleansing system software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
• Conclusion: The testing "confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices."

Important Note: This submission is a 510(k) for a modified device, leveraging existing predicates. Clinical studies demonstrating efficacy for wrinkles and acne are implied to have been conducted for the original predicate devices, not extensively for this specific modification, which primarily involves updated software and associated hardware while maintaining the fundamental scientific technology and parameters.

Here's the breakdown for the additional information requested, based on the provided text:

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

• Sample Size: Not specified. The document states "The reVive Light Therapy® LED Cleansing system software was tested and validated..." but does not provide details on the number of test cases, subjects, or data points used during this software testing and validation.
• Data Provenance: Not specified. There is no mention of the origin (e.g., country) of any data used for testing, nor whether it was retrospective or prospective. Given it's a software validation for a hardware modification, it's likely internal testing without external patient data.

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 specified. The document describes software testing and validation for a device modification, not a clinical study requiring expert ground truth for diagnostic or therapeutic outcomes on patients. The "ground truth" here would likely be defined by engineering and software requirements.

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

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms by multiple experts. This documentation focuses on software and hardware verification against established design specifications and predicate performance.

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. A multi-reader, multi-case comparative effectiveness study (MRMC) was not conducted or reported in this document. This device is an LED therapy system for direct use, not an AI-assisted diagnostic tool that would involve human readers.

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

• This is not an AI algorithm in the context of diagnostic or interpretive tools; it's an LED therapy device with software controls. The "standalone" performance here refers to the device's functional integrity as a light therapy system. The document states that "Testing confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices." This implies testing of the device's operational parameters (light output, timing, power, etc.) in a standalone capacity.

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

• For the software testing and validation mentioned, the "ground truth" would be the design specifications and functional requirements of the device's software and hardware, as well as the established performance of the predicate devices. It is not clinical ground truth like pathology or patient outcomes for this specific submission, but rather adherence to engineering and safety standards.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI algorithm in the context of a "training set." The device is a physical light therapy product.

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

• Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this submission.

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The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

The reVive Light Therapy® Essentials is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm blue. The reVive Light Therapy® Essentials components include the device containing the LED module. There are no user settings or adjustments required. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.

The provided text describes the regulatory clearance of the "reVive Light Therapy® Essentials" device. While it details performance testing conducted for safety and functionality, it does not include information about clinical studies proving the device's efficacy in treating mild to moderate inflammatory acne against specific acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, intended use, and safety testing (electrical, EMC, biocompatibility, software validation, and usability). It explicitly states: "The conclusions drawn from nonclinical tests demonstrate that the device is safe, as effective, and performs as well as the legally marketed devices." This implies that clinical efficacy, such as a reduction in acne severity, was not a primary part of this submission for demonstrating substantial equivalence, but rather inferred from the predicate devices.

Therefore, for the aspects of your request related to clinical efficacy and performance against specific acceptance criteria for treatment outcomes (e.g., reduction in inflammatory lesions), the provided text does not contain the necessary information. I will fill in what is available and state when information is not present.

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

Acceptance Criteria and Device Performance Study (as described in the document):

The document does not detail acceptance criteria related to a specific clinical efficacy outcome (e.g., percentage reduction in acne lesions) nor does it present results from a clinical study proving such efficacy for the new device. Instead, the "Performance Testing and Standards" section focuses on safety and functionality.

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

Since no clinical efficacy acceptance criteria are presented, this table will focus on the non-clinical performance and safety criteria mentioned.

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

• Sample Size for Usability Study: 16 participants.
• Data Provenance: Not specified in terms of country of origin or whether it was retrospective/prospective for the usability study. The document is an FDA submission for a US market, suggesting US relevance, but this is not explicitly stated for the data collection.

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

• Applicability: This question is typically relevant for studies involving expert interpretation of data (e.g., medical images).
• In this context: For the usability study, there wouldn't be "ground truth" established by experts in the same way. The performance was measured by participant actions. For the functional/safety testing, compliance was assessed against recognized standards, implying expert evaluation by the testing body, but specific numbers and qualifications are not provided here.

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

• Applicability: This is typically for studies where multiple annotators establish ground truth for complex data.
• In this context: Not applicable to the usability study or the stated safety/functional testing.

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

• Applicability: This is for AI-assisted diagnostic devices.
• In this context: Not applicable. The "reVive Light Therapy® Essentials" is a light therapy device for acne, not an AI diagnostic tool. No MRMC study was mentioned.

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

• Applicability: This is for AI/algorithm performance directly.
• In this context: Not applicable. This device is a direct treatment device, not an algorithm.

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

• For Usability Study: The "ground truth" was predefined correct procedures for device preparation and usage, against which participants' actions were evaluated.
• For Safety/Functional Testing: Compliance with specified international and national standards (e.g., IEC 60601 series, ISO 10993 series, USP chapters). The ground truth is the performance specification defined by these standards.

8. The sample size for the training set

• Applicability: This is for AI/machine learning models.
• In this context: Not applicable. No AI/ML model for which "training data" would be used is described for this device.

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

• Applicability: This is for AI/machine learning models.
• In this context: Not applicable. No AI/ML model for which "training data" would be used is described for this device.

Summary of what the document focuses on for "proving the device meets acceptance criteria":

The core of the submission, as per the text, relies on substantial equivalence to legally marketed predicate devices, combined with comprehensive non-clinical safety and functional testing. The rationale is that since the new device has "similar technical characteristics," "same control mechanism, same operating principle, and energy type," and the "same method of operation" as already cleared predicate devices for the same intended use (mild to moderate inflammatory acne), and it passes all safety and functional tests, it is deemed safe and effective. The minor changes in size were also assessed and found not to introduce new risks.

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The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of writkles.

The reVive Light Therapy® Essentials is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles. The device uses four types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The reVive Light Therapy® Essentials components include the device containing the LED module. There are no user settings or adjustments required. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.

The provided FDA 510(k) summary for the reVive Light Therapy® Essentials does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of clinical efficacy (e.g., wrinkle reduction).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, safety testing, and usability, which are common for 510(k) submissions for Class II devices.

Here's what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not report specific acceptance criteria for clinical effectiveness (e.g., wrinkle reduction) nor does it provide performance metrics related to such an outcome study. The performance testing mentioned is primarily related to safety, functionality, and software.

Missing Information (for clinical efficacy study):

• Specific clinical acceptance criteria (e.g., a certain percentage reduction in wrinkle count, or a statistically significant improvement on a wrinkle severity scale).
• Quantitative results demonstrating the device's performance against clinical acceptance criteria.

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

• For Usability Study:
  • Sample size: 17 participants.
  • Data provenance: Not specified, but generally, usability studies are prospective and often conducted in research facilities. The country of origin is not mentioned.
• For Clinical Efficacy Study:
  • Sample size: Not applicable/not provided, as no clinical efficacy study is detailed.
  • Data provenance: Not applicable.

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

• For Usability Study: The "ground truth" here is objective observation of user actions. No external experts are mentioned for establishing ground truth; the performance was assessed by the study administrators.
• For Clinical Efficacy Study: Not applicable/not provided.

4. Adjudication Method:

• For Usability Study: Not explicitly stated as "adjudication," but the results indicate clear observation (100% correct demonstration). This implies direct observation and assessment by the study team.
• For Clinical Efficacy Study: Not applicable/not provided.

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

• No such study was mentioned in the provided document. The device is a direct-to-consumer light therapy device, not a diagnostic imaging AI algorithm typically subjected to MRMC studies.

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

• Not applicable. This device is a physical light therapy device, not an AI algorithm. "Standalone performance" in this context typically refers to the device's physical output and safety, which were tested and found to conform to standards.

7. The Type of Ground Truth Used:

• For Usability Study: Observed user behavior against predefined correct procedures.
• For Clinical Efficacy Study: Not applicable/not provided.

8. The Sample Size for the Training Set:

• Not applicable/not provided. The document describes a physical medical device (LED light therapy) and does not mention any machine learning or AI components requiring a "training set" in the context of typical AI algorithm development.

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

• Not applicable/not provided. See point 8.

In summary: The provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence and safety/functionality for a light therapy device. It does not include a detailed clinical efficacy study with specific acceptance criteria, clinical performance metrics, or ground truth establishment relevant to an AI/diagnostic imaging context. The "study" mentioned is a usability study with 17 participants, assessing correct device operation, not clinical outcome.

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The dpl® Faceware is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.

The dpl® Faceware is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses five types of LEDs: 605nm amber, 630nm red, 880nm infrared, and 415 blue. The dpl® Faceware components include the device containing the LED module, USB power cord, and power adapter. The treatment time is controlled by the user. There are no user settings or adjustments required. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.

The provided text is a 510(k) summary for the dpl® Faceware device. It describes the device, its intended use, and its comparison to predicate devices, along with performance testing conducted to demonstrate safety and effectiveness. However, it does not explicitly contain a table of acceptance criteria and reported device performance in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC).

Instead, the performance testing described primarily relates to:

• Functional performance testing
• Software validation
• User safety testing
• Compliance with international consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10)
• Usability study

The device is an LED-based device for treating wrinkles and mild to moderate inflammatory acne—it is not an AI/algorithm-based diagnostic or prognostic device that would typically have acceptance criteria such as sensitivity, specificity, or AUC based on ground truth established by experts.

Therefore, many of the requested points related to AI/algorithm performance (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to the information provided in this 510(k) summary.

Based on the provided text, here's what can be extracted:

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

The document does not provide a table of acceptance criteria for device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC), as this is an LED therapy device, not a diagnostic AI. The "performance" described is centered around safety, functionality, and user aBility.

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

• Test set for Usability Study: 15 participants.
• Data Provenance: Not explicitly stated, but assumed to be from a prospective study conducted for regulatory submission in the US.

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

Not applicable for this type of device. The "ground truth" for a usability study is subjective user experience and objective task completion.

4. Adjudication method for the test set

Not applicable for a usability study of this nature. The results are reported as percentages of participants completing tasks.

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 an LED therapy device, not an AI-assisted diagnostic tool.

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

Not applicable. This device does not involve a standalone algorithm for diagnostic performance. Its "performance" is its therapeutic effect.

7. The type of ground truth used

For the usability study, the "ground truth" was simple task completion and demonstration, observed directly. For safety and functional testing, the "ground truth" was compliance with established engineering and biocompatibility standards.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set in the machine learning sense.

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

Not applicable for this device.

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The dpl® SpotLite is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

The dpl® SpotLite is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs, 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® SpotLite components include the unit containing the LED module. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

Here's an analysis of the provided text regarding the acceptance criteria and study information for the dpl® SpotLite device:

Based on the provided text, the submission focuses on substantial equivalence to a predicate device rather than demonstrating the device meets pre-defined acceptance criteria through a specific clinical study for efficacy. The performance testing mentioned is primarily for safety, functional performance, software validation, and usability, not clinical effectiveness.

Therefore, the requested information elements (especially those related to clinical effectiveness studies, sample sizes for test/training sets, expert ground truth, adjudication, and MRMC studies) are largely not present in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size (for clinical effectiveness/efficacy): Not applicable. The document does not describe a clinical effectiveness study with a test set for efficacy.
• Test Set Sample Size (for usability study): 16 participants.
• Data Provenance: Not specified for the usability study (e.g., country of origin). The study is described as a "Usability Study," implying it was prospective for that purpose.

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

Not applicable. No experts were used to establish ground truth for a clinical effectiveness test set because such a study is not described. The usability study's "ground truth" would be the successful completion of tasks by the participants itself, not an expert panel reviewing outcomes.

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

Not applicable. No clinical effectiveness test set or complex judgment of outcomes requiring adjudication 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 device is an LED therapy device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or described.

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

Not applicable. This device is a direct-treatment device, not an algorithm.

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

• For safety and functional testing: Ground truth is conformity to established international consensus standards (IEC, ISO).
• For software validation: Ground truth is adherence to FDA guidance for software in medical devices.
• For usability study: Ground truth is the direct observation of participants' ability to successfully perform specified tasks (demonstrating light sensitivity test, using the device successfully).

8. The sample size for the training set

Not applicable. No clinical effectiveness study is described, and thus no training set for an algorithm is mentioned.

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

Not applicable. As no training set is discussed, the method for establishing its ground truth is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (reVive Light Therapy® LED Cleansing System K180447) rather than a de novo clinical study proving effectiveness against specific acceptance criteria.

The "study" component consists of:

1. Functional Performance Testing: Confirmed the device's operational capabilities. The details or results are not explicitly provided beyond stating that it was conducted.
2. Software Validation: Tested and validated in accordance with FDA guidance, ensuring its proper functioning.
3. User Safety Testing: Demonstrated conformity to various international consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). These tests cover electrical safety, electromagnetic compatibility, cytotoxicity, intracutaneous reactivity, and skin sensitization.
4. Usability Study: Conducted with 16 participants. The study proved that 100% of participants could successfully demonstrate the light sensitivity test and use the device.

The overall conclusion is based on comparing the dpl® SpotLite's intended uses, technological characteristics (wavelengths, irradiance source, treatment time, class, output, treatment regimen, materials), and safety performance to the predicate device. The manufacturer asserts that the device is "as effective" and "performs as well as the legally marketed devices" because "no significant differences exist between the subject device and predicate, and no different questions of safety and effectiveness arise." This indicates that the primary "proof" of meeting efficacy criteria is through the established safety and efficacy of the predicate, to which the dpl® SpotLite is deemed substantially equivalent.

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reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne.

The reVive Light Therapy® LED Cleansing system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The reVive Light Therapy® LED Cleansing System components include the unit containing the LED module, USB power cord, and power adapter. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC). It is intended for users 13 years or older.

The provided FDA 510(k) summary for the reVive Light Therapy® LED Cleansing System (K180447) does not contain a typical acceptance criteria table with reported device performance metrics in the way a clinical study for diagnostic or prognostic devices would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Clear Bi-Light K153081) through comparison of technological characteristics and performance testing related to safety and functionality. The "acceptance criteria" can be inferred from the comparisons made to the predicate device and the pass/fail nature of the safety and usability tests.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since there isn't a direct table in the document, I will construct one based on the information provided, inferring acceptance criteria from the comparisons to the predicate and the documented test results.

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

• Usability Study Test Set: 15 participants.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This was a usability study, often conducted in a controlled environment, likely in the US where the submitter is located.

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

This type of information is not applicable to the studies presented for this device.

• For the usability study, "ground truth" was about successful execution of tasks and demonstrating light sensitivity, not clinical diagnosis. The performance was measured by participant action, not expert judgment.
• For the safety and functional performance testing, "ground truth" was established by adherence to international standards (e.g., IEC, ISO) and internal testing protocols, not by expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The usability study involved observing participants' actions (e.g., "100% of the participants were able to demonstrate the light sensitivity test."). Safety and performance tests against standards have pass/fail criteria, not adjudication.

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

No. This type of study is for diagnostic devices where human readers interpret medical images or data. The reVive Light Therapy® LED Cleansing System is a direct treatment device, not a diagnostic tool requiring human interpretation with or without AI assistance.

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

Yes, in a sense. The "performance testing" described (functional performance testing, software validation, safety testing, thermal performance testing) essentially represents standalone performance of the device's physical and software aspects against defined specifications and standards, without real-time human intervention influencing its core operation during the test.

7. The Type of Ground Truth Used

• Usability Study: User performance metrics (ability to demonstrate a test, successful device use).
• Safety and Functional Testing: Adherence to established international consensus standards (IEC, ISO) and internal performance specifications (e.g., thermal limits, software functionality).
• Substantial Equivalence: Comparison to the technological characteristics, intended use, and treatment parameters of a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is an LED therapy system, not an AI/machine learning algorithm that requires a training set in the typical sense. The software validation is likely for operational logic and safety features, not for learning from data.

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

Not applicable, as there is no training set for this device.

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The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating wrinkles.

The reVive Light Therapy® LED Cleansing System is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles. The device uses four types of LEDs: 605nm amber, 630nm red, and 880nm infrared. In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material. The reVive Light Therapy® LED Cleansing System components include the device containing the LED module, USB power cord, and power adapter. The treatment time is controlled by the user. There are no user settings or adjustments required. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

The provided text describes a 510(k) premarket notification for the "reVive Light Therapy LED Cleansing System," an Over-the-Counter (OTC) LED device intended for treating wrinkles and cleansing. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific clinical performance against acceptance criteria for a novel AI/software medical device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for a complex AI/software medical device, such as a table of performance metrics (sensitivity, specificity, AUROC), sample sizes for AI model training/testing, expert adjudication, MRMC studies, and detailed ground truth establishment, are not applicable to this specific 510(k) submission.

This submission is for an LED light therapy device, not an AI or software-driven diagnostic or therapeutic device that requires performance validation against specific clinical endpoints like identifying disease. The "performance testing" mentioned is primarily focused on safety, functional performance, software validation (for basic control software), and biocompatibility, not clinical efficacy measured by common AI metrics.

However, I can extract the relevant information regarding the device's validation and "acceptance criteria" as presented in this 510(k) summary, interpreting "acceptance criteria" in the context of device safety and functional performance for this type of device.

Acceptance Criteria and Device Performance for ReVive Light Therapy LED Cleansing System

Based on the provided 510(k) summary, the "acceptance criteria" for this device are primarily related to safety, functional performance, and substantial equivalence to legally marketed predicate devices, rather than the diagnostic or therapeutic accuracy metrics typically associated with AI/ML medical devices.

1. Table of "Acceptance Criteria" (interpreted as demonstrated compliance with standards and successful functional tests) and Performance:

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

• Software Validation/Functional Performance/Safety Testing: No specific numerical sample size (e.g., number of test cases run) is provided, but it's stated that "Testing... included functional performance testing, software validation, testing, and user safety testing," confirming these tests were conducted.
• Biocompatibility Testing: The number of biological samples or subjects for the biocompatibility tests are not explicitly stated, but the summary refers to "test cell culture" and "test subject(s)."
• Usability Study: 15 participants.
• Data Provenance: Not specified, but generally, these types of tests are conducted in a controlled laboratory environment (e.g., in-house or by contract research organizations) and are not clinical data from patients in a specific country. This is a pre-market submission, not a clinical trial report.

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

• For Biocompatibility Tests: The "ground truth" (e.g., toxicity, reactivity, sensitization) is established by standard laboratory methods and read/interpreted by qualified personnel in the testing lab according to the specified ISO standards. The number and specific qualifications of these experts are not provided in this summary.
• For Usability Study: The "ground truth" for usability is based on direct observation of user performance. No "experts" in the sense of adjudicators are mentioned, as the criteria (e.g., "100% were able to demonstrate...") are objective.
• For Electrical/EMC Standards: Compliance is determined by testing against the specified standards, likely by qualified engineers. No mention of "experts" establishing a "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set:

• Not applicable in the context of clinical AI performance. The tests described are compliance-based, functional, and usability assessments, not clinical data adjudication for diagnostic accuracy.

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

• No. This type of study (comparing human readers with and without AI assistance for interpretation) is not relevant to an LED light therapy device. The device's "effectiveness" is in treating wrinkles, which is stated as being "substantially equivalent" to predicate devices, implying similar efficacy without detailed comparative studies of human interpretive performance.

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

• Not applicable. This device does not involve a diagnostic algorithm or AI that operates "standalone" in a clinical diagnostic sense. Its software controls the LED function and has no independent diagnostic or interpretive function.

7. The Type of Ground Truth Used:

• Functionality/Safety: Compliance with established engineering and safety standards (e.g., IEC standards, physical measurements of light output).
• Biocompatibility: Results of standardized in-vitro (cytotoxicity) and in-vivo (intracutaneous reactivity, skin sensitization) biological tests as per ISO 10993 standards.
• Usability: Direct observation of user interactions and task completion (e.g., demonstrating light sensitivity test, using the device successfully).

8. The Sample Size for the Training Set:

• Not applicable. This device does not utilize AI/ML, and therefore, there is no "training set" for an algorithm.

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

• Not applicable. As there is no AI/ML training set, this question does not apply.

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The dpl® IIa Panel is an Over-the Counter (OTC) device intended for use in treating wrinkles, and treatment of mild to moderate inflammatory acne.

The dpl® IIa Panel system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses five types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared, and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® IIa Panel system components include the panel unit containing the LED module, power supply, goggles, and storage case. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

The provided text describes a 510(k) premarket notification for the dpl® IIa Panel, an over-the-counter LED device intended for treating wrinkles and mild to moderate inflammatory acne.

Based on the provided information, the document does not contain acceptance criteria or a study proving the device meets performance criteria in the way typically expected for a medical device efficacy study against specific clinical endpoints. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving independent efficacy against predefined performance metrics.

Here's an analysis based on the structure of the request, highlighting what is and isn't available in the text:

1. A table of acceptance criteria and the reported device performance:
   The document does not present a table of specific acceptance criteria for clinical performance (e.g., X% reduction in wrinkle count, Y% clearance of acne lesions). Instead, it primarily focuses on comparing the technological characteristics of the dpl® IIa Panel to predicate devices. The "reported device performance" in this context refers to its operational parameters rather than clinical outcomes.

   Characteristic	dpl® IIa Panel (Reported Performance - Technological)	Predicate Device (Example: dpl® II Panel, K171390)
   Intended Use	Treatment of wrinkles, mild to moderate inflammatory acne	Treatment of wrinkles, mild to moderate inflammatory acne
   Wavelengths	605nm amber, 630nm red, 660nm red, 880nm infrared, 415nm blue	605nm, 630nm, 660nm, 880nm
   Irradiance source	LED	LED
   Treatment Area	415 cm²	415 cm²
   Treatment Time	3 minutes per treatment daily	3 minutes per treatment daily
   Type/Class	OTC	OTC
   Output (mW/cm²)	Similar to predicate devices	Not specified, but implied similar
   Treatment Duration	Similar to predicate devices (180 seconds)	Similar to predicate devices (180 seconds)

   The document states: "The dpl® IIa Panel system has the same intended uses, with similar technological characteristics as predicate devices. The system performs as intended and does not raise any new safety or effectiveness issues." This implies that the 'acceptance criteria' for substantial equivalence are met by demonstrating these similarities and conforming to safety standards, rather than proving clinical efficacy.

2. Sample size used for the test set and the data provenance:
   The document mentions a "Usability Study" with 16 participants. No other test set data for clinical efficacy is reported. The provenance of these participants (e.g., country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no clinical efficacy test set with ground truth established by experts is described. The usability study involved participants using the device, but no expert assessment of clinical outcomes.

4. Adjudication method for the test set:
   Not applicable, as no clinical efficacy test set requiring adjudication 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 device is a light therapy panel, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a standalone light therapy device, not an algorithm. Its performance is inherent in its operation.

7. The type of ground truth used:
   For the usability study, the "ground truth" was whether participants could "demonstrate the light sensitivity test" and "use the device successfully." This is a user performance metric, not a clinical ground truth like pathology or expert consensus on disease state.

8. The sample size for the training set:
   Not applicable. The document describes a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable.

In summary, the provided FDA 510(k) submission focuses on demonstrating substantial equivalence of the dpl® IIa Panel to existing predicate devices based on shared intended use, similar technological characteristics, and compliance with safety standards. It does not present a clinical study with detailed acceptance criteria for efficacy or related performance data against a defined clinical ground truth. A usability study with 16 participants confirmed user interaction success but not clinical outcomes.

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The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.

The reVive® Perioral LED Light Therapy system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device uses four types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required. The reVive® Perioral LED Light Therapy system components include the device containing the LED module, USB charging cord, and a storage bag. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over The Counter (OTC).

This submission discusses the "reVive® Perioral LED Light Therapy system," an over-the-counter device intended for the treatment of fine lines and wrinkles and to increase circulation in the perioral region. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance data for a standalone device.

Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria (especially regarding efficacy in reducing wrinkles or increasing circulation) is not fully detailed in this document. The document focuses on demonstrating safety and comparable technical characteristics to predicate devices.

However, based on the provided text, here's what can be extracted and inferred regarding performance and safety, framed within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" tied to specific clinical efficacy endpoints (e.g., a certain percentage reduction in wrinkle depth) are not provided in the same way they would be for a de novo or PMA submission. Instead, the "acceptance criteria" are implied by demonstrating equivalence to predicate devices and meeting safety standards.

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

The document describes a "Usability Study" as the primary user-facing test.

• Sample Size: 15 participants.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, usability studies are generally prospective.

The performance characteristics cited (e.g., wavelengths, energy levels) are inherent design parameters of the device, not results from a "test set" in the context of clinical efficacy demonstration here.

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

This information is not provided in the document. The Usability Study likely involved observers or researchers assessing participant interactions, but the document does not specify experts establishing ground truth for efficacy. For the safety tests (IEC, ISO, UL), the "ground truth" is adherence to those established international standards.

4. Adjudication Method for the Test Set

This information is not provided. For the Usability Study, it's not clear if there was any formal adjudication beyond observation of task completion.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically associated with diagnostic imaging devices evaluating human reader performance with and without AI assistance, which is not applicable to an LED light therapy device for wrinkle reduction.

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

This concept is not directly applicable to this device. The reVive® Perioral LED Light Therapy system is a physical therapy device; it does not involve an "algorithm only" component or human interpretation of outputs in the way an AI diagnostic tool would. Its performance is its direct physical output (light therapy). The "Usability Study" evaluates human interaction with the physical device, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

For the safety and performance characteristics, the "ground truth" is adherence to:

• Established international and national consensus standards (IEC, UL, ISO) for electrical safety, electromagnetic compatibility, battery safety, and biocompatibility.
• The manufacturer's design specifications for parameters like wavelength, energy level, and treatment time.
• For the Usability Study, the "ground truth" implicitly was the successful completion of tasks (light sensitivity test, device usage) by participants.

There is no mention of "expert consensus, pathology, or outcomes data" as ground truth for clinical efficacy in this 510(k) summary. The submission relies on substantial equivalence to legally marketed devices for efficacy claims.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. A "training set" typically refers to data used to train an artificial intelligence or machine learning algorithm. This device is a hardware-based light therapy system, not an AI/ML product.

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

This information is not provided and is not applicable for the reasons stated above (not an AI/ML product).

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