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The no!no! Skin™ is intended to provide phototherapeutic light and heat to the body and is generally indicated to treat dermatological conditions. It is specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

The no!no! Skin™ device is an over the counter device employing LHE® (Light & Heat Energy) phototherapy as a part of its fundamental characteristics to treat acne. It is a small, light, hand-held, portable, battery powered devices designed to treat individual acne pimples. The no!no! Skin™ device consist of an enclosure, a rechargeable battery, an electronic circuit and a low voltage halogen lamp. The treatment tip diameter of 8 mm covers an area of 0.5 cm². The energy delivered to the lesion is a combination of focused light emitted from the halogen lamp together and the heat accumulated in the tip placed over the acne lesion.

The provided document is a 510(k) summary for the Radiancy Ltd. no!no! Skin™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines technical specifications and intended use. Crucially, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through performance data.

Instead, the document states:

• "A series of safety and performance testing were performed to demonstrate that the modified no!no! Skin™ did not raise any new questions of safety and efficacy."
• These tests included: "Electrical Safety testing" and "Temperature Evaluation test."
• "Based on the risk analysis performed and these tests results, Radiancy Ltd. believes that the modified no!no! Skin™ device is substantially equivalent to the cleared no!no! Skin™ device and does not raise any new safety and/or effectiveness issues."

This indicates that the submission relies on demonstrating that changes made to an already cleared device (K082423) did not negatively impact its safety and effectiveness, rather than providing a de novo study with acceptance criteria and performance results for the device's clinical efficacy.

Therefore, for most of the requested points, the information is not available in the provided text.

Here's a breakdown of what can be answered and what cannot:

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

• Not available. The document states safety and performance tests were done (electrical safety, temperature evaluation) but does not provide specific acceptance criteria or reported performance results in a table format for these tests, nor for clinical efficacy. The submission focuses on substantial equivalence based on not raising new questions of safety and efficacy with changes made to a predicate device.

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

• Not available. The document does not describe a clinical study with a test set of human subjects, therefore, sample size and data provenance are not mentioned in this context. The "tests" mentioned are technical safety and performance tests of the device itself.

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 available. Since there is no described clinical study involving a test set of patients or medical images requiring ground truth establishment by experts, this information is not present.

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

• Not applicable/Not available. No clinical study with a 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/Not available. The device is not an AI-assisted diagnostic tool or an imaging device. It's a phototherapy device for acne. Therefore, an MRMC study is irrelevant in this context and none was performed or described.

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

• Not applicable/Not available. Again, this is a physical medical device, not an algorithm. Its performance is inherent in its operation and effect on the user/patient.

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

• Not applicable/Not available. No clinical efficacy study with ground truth for patient outcomes is described. The "tests" were likely engineering or bench tests for electrical and thermal safety.

8. The sample size for the training set

• Not applicable/Not available. As this is not an AI/machine learning device, there is no concept of a "training set."

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

• Not applicable/Not available. As above, no training set exists for this device.

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No! No! Skin is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Not Found

The provided text describes the FDA's decision to deem the "No! No! Skin™" device substantially equivalent for the treatment of mild to moderate acne based on a clinical trial. However, it does not explicitly state acceptance criteria in a quantitative table or the specific reported device performance values. It focuses more on the type of study and its outcome rather than numerical criteria and results.

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

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

• Note: The document does not provide specific numerical thresholds for "statistically and clinically significant improvement" or the exact performance metrics (e.g., mean time to resolution in days). It focuses on the conclusion drawn from the study.

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 for Test Set: Not explicitly stated. The document mentions "data from a randomized, sham-controlled, double-blinded, clinical trial," but the number of participants is not provided.
• Data Provenance:
  • Country of Origin: Radiancy (Israel) LTD. is the applicant, suggesting the study could have been conducted in Israel or elsewhere, but the document does not explicitly state the study's location.
  • Retrospective or Prospective: The study was a "randomized, sham-controlled, double-blinded, clinical trial," which by its nature is a prospective study.

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)

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The assessment was carried out by "blinded investigators." Their specific qualifications (e.g., dermatologists, medical professionals) are not detailed, but their role as "investigators" implies medical expertise in evaluating acne.

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

• The document mentions "blinded investigators" assessed the improvement and resolution of acne. The specific adjudication method (e.g., consensus, single reader, majority vote) is not specified.

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

• This device is not an AI-assisted diagnostic tool. It is a device for treating acne. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The study described is a clinical trial comparing the device's effectiveness to sham treatment.

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

• This question is not applicable as the device is a physical treatment device, not an algorithm. The "performance" in this context refers to its clinical efficacy in treating acne when used by individuals, not an algorithmic assessment.

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

• The ground truth was established by clinical assessment / outcomes data by blinded investigators. They assessed the "time to improvement and time to resolution of mild to moderate acne." This implies a subjective or semi-objective clinical evaluation of acne severity and progression by trained medical professionals.

8. The sample size for the training set

• The concept of a "training set" is not applicable here as this is a physical medical device undergoing a clinical trial for efficacy, not a machine learning algorithm that requires training data.

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

• As the concept of a "training set" is not applicable, this question is also not applicable.

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The Radiancy's Mistral® Device is intended to provide phototherapeutic light and heat energy to the body and is generally indicated to treat dermatological conditions. The Mistral is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, and mild to moderate psoriasis in patients with Fitzpatrick skin types I-VI.

Radiancy's Mistral Device is a Light and Heat Energy (LHE®) based multi-application device intended for the phototherapeautic treatment of: Hair Removal (HR), Skin Photo Rejuvenation (SPR), Acne Clearance (AC) and Psoriasis Care (PC), Mistral consists of a console, footswitch and interchangeable handpieces. It uses the same technology and has the same indications as the previously cleared SkinStation System.

The provided text is a 510(k) summary for the Radiancy Mistral Device. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not available in the provided document.

Here's a breakdown of the available and unavailable information:

1. Table of acceptance criteria and the reported device performance:

   • Not Available. The document does not describe specific acceptance criteria (e.g., minimum efficacy rates, safety thresholds) or quantitative performance metrics (e.g., specific percentages of hair reduction, lesion clearance, acne improvement) that the device had to meet. The submission is based on substantial equivalence, implying that its performance is expected to be similar to predicate devices, but no explicit performance data or criteria are listed.

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

   • Not Available. The document does not describe a specific clinical study with a test set, sample size, or data provenance (country of origin, retrospective/prospective). Substantial equivalence submissions often rely on existing data for predicate devices or bench testing, not necessarily new, separate clinical efficacy studies with independent test sets.

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

   • Not Available. Since no specific clinical efficacy study is described, there's no mention of experts establishing ground truth for a test set.

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

   • Not Available. For the same reason as above, no adjudication method is mentioned.

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 phototherapeutic light and heat energy system for dermatological conditions, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study or AI assistance is not relevant.

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

   • Not Applicable. This is a physical medical device, not a software algorithm.

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

   • Not Available. As no specific efficacy study is detailed, the type of ground truth for such a study is not specified.

8. The sample size for the training set:

   • Not Applicable/Not Available. The concept of a "training set" is typically for machine learning or AI models. This document describes a physical device, and while there would have been development and testing, it's not referred to as a "training set" in the context of AI. No performance or developmental data is provided that would involve specific sample sizes akin to a training set for an algorithm.

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

   • Not Applicable/Not Available. Again, the concept of "ground truth" for a "training set" does not apply here in the AI context.

Summary of what is available:

The document establishes substantial equivalence of the Radiancy Mistral Device to predicate devices (Radiancy SkinStation System, General Project's MED FLASH II, and McCue's Energist Ultra VPL) based on:

• Identical Intended Use and Indications for Use: Hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris, and mild to moderate psoriasis in patients with Fitzpatrick skin types I-VI.
• Identical Principles of Operation: It uses Light and Heat Energy (LHE®) technology.
• Similar Technological Characteristics: Consists of a console, footswitch, and interchangeable handpieces.

The basis for market clearance (510(k)) is that the differences between the Mistral and its predicate devices "do not raise new issues of safety and effectiveness." This means the FDA accepted that the device's performance would be equivalent to the already cleared predicate devices, without requiring new, specific clinical efficacy data to be presented in this summary document. Performance data for the predicate devices would have been previously reviewed.

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The ClearTouch Lite is intended to provide phototherapeutic light to the body. The ClearTouch Lite is generally indicated to treat dermatological conditions. The ClearTouch Lite is specifically indicated to treat mild and moderate inflammatory acne, which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-VI.

The ClearTouch Lite™ is a pulsed-light, manually controlled system designed to deliver light in a sequence of pulses to treat mild and moderate inflammatory acne.

The provided text is a 510(k) summary for the Radiancy ClearTouch Lite™ Acne Clearance System (K060411). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for the new device. As such, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states that the new device has "similar technical characteristics" and "the same intended use and the same indications for use" as the predicate. It also mentions a "minor difference" in energy delivery (lower intensity pulses in sequence vs. a single pulse) which does not raise new safety and effectiveness issues. However, specific quantitative acceptance criteria for acne treatment effectiveness (e.g., percentage reduction in lesions, success rates) and how the ClearTouch Lite performed against these criteria are not provided.

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

Not available. This 510(k) summary does not describe a new clinical trial for the ClearTouch Lite. It relies on the substantial equivalence to a previously cleared device (K032205, K051268). Therefore, there is no mention of a test set, its sample size, or data provenance for the ClearTouch Lite itself.

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

Not available. As no new test set is described, there's no information on experts or ground truth establishment for it.

4. Adjudication Method for the Test Set

Not available. No test set is described.

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

No. The document does not describe an MRMC study. It's a 510(k) for a physical medical device (pulsed light system), not typically an AI/software device that would undergo MRMC comparative effectiveness studies in the context of human reader improvement with AI assistance.

6. If a Standalone Performance Study Was Done

No, not explicitly for the ClearTouch Lite. The submission hinges on substantial equivalence to a predicate device (Radiancy Acne System with ClearTouch™ Light Unit Assembly) which had already demonstrated its safety and effectiveness. The focus is on the minor technical difference (sequence of lower intensity pulses vs. single pulse) not raising new issues. There's no description of a separate, standalone clinical performance study specifically for the ClearTouch Lite in this document.

7. The Type of Ground Truth Used

Not available/Applicable. Since no new clinical performance study for the ClearTouch Lite itself is presented, there's no discussion of ground truth establishment. For the predicate device, it would presumably involve clinical assessment of acne lesions and potentially photographic evidence, but this is not detailed for the ClearTouch Lite's submission.

8. The Sample Size for the Training Set

Not applicable. This device is a pulsed light system, not an AI/machine learning algorithm that requires a "training set" in the computational sense.

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

Not applicable. As above, the concept of a training set and its ground truth in this context is not relevant for this type of medical device submission.

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The Radiancy Facial SkinCare Device is intended for use in dermatology. The Facial SkinCare Device is specifically indicated to treat benign pigmented lesions, including, but not limited to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.

The Radiancy Facial SkinCare Device is a pulsed-light, manually controlled system designed to treat benign pigmented lesions.

This 510(k) summary (K052991) for the Radiancy Facial SkinCare Device does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on:

• Device Identification: Name, manufacturer, contact information.
• Predicate Devices: Identifying previously cleared devices with similar characteristics (Radiancy, Inc. SPR System K033181 and Danish Dermatologic Development A/S Ellipse IPPL ™ K043255).
• Device Description: A pulsed-light, manually controlled system for treating benign pigmented lesions.
• Intended Use/Indications for Use: Specifically for treating benign pigmented lesions (solar lentigines, ephilides (freckles), and mottled pigmentation) in Fitzpatrick skin types I-V.
• Technological Characteristics & Substantial Equivalence: Stating that the device has similar intended use, indications, principles of operation, and technological characteristics to its predicates, and that minor differences do not raise new safety and effectiveness issues, thus demonstrating substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because it is not present in the provided text.

The document is a regulatory submission for premarket clearance based on substantial equivalence to predicate devices, not typically a detailed report on clinical performance or specific testing against predefined acceptance criteria.

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The SkinStation® is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I-VI, and mild to moderate psoriasis in patients with Fitzpatrich skin types I-VI.

The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for the treatment of psoriasis in patients with Fitzpatrick skin types I - VI.

The provided text is a 510(k) Summary for the Radiancy SkinStation® with Modified Light Unit Assembly for Psoriasis Treatment. It describes the device, its intended use, and substantial equivalence to predicate devices, but does not contain a study or data proving the device meets specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document.

The document primarily focuses on demonstrating substantial equivalence to already cleared devices, a regulatory pathway that doesn't necessarily require new clinical studies with defined acceptance criteria to be submitted or summarized in the 510(k) application itself. The statement "The new psoriasis indication for use is based upon the indications for use for two already cleared predicate pulsed light device Systems" further supports this, suggesting reliance on prior approvals rather than new performance data for this specific 510(k).

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The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.

The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for hair removal in Fitzpatrick Skin Types V and VI.

The provided text is a 510(k) summary for the Radiancy SkinStation Photoepilation System with Modified Light Unit Assembly for Hair Removal. This document focuses on demonstrating substantial equivalence to predicate devices for a specific medical device. It does not include details about acceptance criteria, study designs, sample sizes for training or test sets, expert qualifications, or ground truth establishment in the manner typically associated with AI/ML device evaluations.

Therefore, most of the requested information cannot be extracted from this document because it describes a traditional medical device (a light-based hair removal system) and its regulatory submission, not a software as a medical device (SaMD) or an AI/ML-powered device. The study mentioned is a clinical data study to show the device's effectiveness for hair removal in specific skin types, not an "AI evaluation study."

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is typically found in the clinical study results section of a 510(k) submission when performance metrics are explicitly defined. The provided summary states: "Clinical data demonstrates that the Radiancy SkinStation removes unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI with only minor side effects."
However, it does not state specific quantitative acceptance criteria (e.g., "X% hair reduction required") or detailed performance metrics.

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 for Test Set: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary.
• Retrospective or Prospective: Not specified in the provided summary, but clinical trials for device approval are typically prospective.

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):

This question is not applicable to this type of device and study. The "ground truth" for a hair removal device is the actual hair reduction observed clinically, assessed by practitioners and potentially by patients, not by experts establishing a categorical ground truth like in AI/ML image analysis. No details about "experts" establishing ground truth are provided.

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

Not applicable. This concept is relevant for AI/ML studies where multiple human readers review cases to establish a consensus ground truth. For a hair removal device, performance is typically assessed by clinical observation of hair reduction and adverse events.

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 AI/ML specific study type. The device is a direct treatment device, not an AI assistant for human readers.

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

Not applicable. This device is a hardware-based system. "Standalone" performance generally refers to an algorithm's performance without human interaction, which doesn't fit a physical light-based hair removal system.

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

Based on the context of a hair removal device, the "ground truth" would implicitly be outcomes data related to hair reduction and adverse events observed clinically.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of AI/ML.

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

Not applicable. This device does not use a "training set" in the context of AI/ML.

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The Radiancy Acne System with ClearTouch™ Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes treatment of pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.

The ClearTouch LUA is mounted on the hand piece of Radiancy's SpaTouch Photoepilation System (the "SpaTouch"), or on the hair removal / acne hand piece of Radiancy's SkinStation (the "SkinStation"), in order to treat inflammatory acne (the "Radiancy Acne System"). The Radiancy Acne System consists of two green-coated flash lamps. The Radiancy Acne System produces a wavelength spectrum of 430 - 1100 nm with a pulse duration of 35 msec and has a spot size of 22 x 55 mm.

The provided text is a 510(k) summary for the Radiancy Acne System with ClearTouch™ Light Unit Assembly, intended for treating mild to moderate inflammatory acne. It makes a claim of substantial equivalence to a predicate device, the ClearLight Phototherapy System, Model CL 420. However, the document does not provide specific acceptance criteria for device performance or a detailed study description with the requested metrics.

The statement regarding a study is: "Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne which include pustular inflammatory acne in patients with Fitzpatrick skin types I-IV." This is a very high-level statement without any of the requested numerical details or methodological information.

Therefore, I cannot populate the table or provide the requested study details for the Radiancy Acne System based on the information given.

Here's what can be extracted and why other requested information is absent:

1. Table of acceptance criteria and reported device performance:

   • Not Available. The document states "Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne..." but does not specify quantitative acceptance criteria (e.g., a percentage reduction in lesion count) or report specific performance metrics (e.g., "75% reduction in inflammatory lesions").

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

   • Not Available. The document mentions "Clinical data" but gives no sample size, country of origin, or whether the data was retrospective or prospective.

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

   • Not Available. There is no mention of how ground truth was established or the involvement of experts.

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

   • Not Available. No information on adjudication is provided.

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 Available. The device is a "Light Unit Assembly," not an AI-driven image analysis system. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this type of device.

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

   • Not Applicable/Not Available. As mentioned above, this is a phototherapeutic light device, not an algorithm.

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

   • Not Available. The document does not specify how "treatment of mild and moderate inflammatory acne" was measured or validated as ground truth.

8. The sample size for the training set:

   • Not Applicable/Not Available. This device is a physical light therapy system, not a machine learning algorithm that requires a training set in that context.

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

   • Not Applicable/Not Available. As above, a training set for machine learning is not relevant to this device.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, principles of operation, and technological characteristics. It mentions "Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne," but crucially lacks any of the detailed quantitative or methodological information typically found in reports of studies proving performance against specific acceptance criteria. This type of detail is often found in the full clinical trial reports, which are not part of this 510(k) summary document.

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The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.

The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions. The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module.

The provided text is a 510(k) summary for the Radiancy (Israel) Ltd.'s SPR System.
A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed studies demonstrating device performance against specific acceptance criteria in the manner one might find for novel device approvals or software algorithms.

Based on the information provided in the text, it is not possible to complete the requested table and answer the questions related to acceptance criteria, study details, sample sizes, expert involvement, and ground truth.

Here's why and what information is available:

Key Takeaways from the document:

• Device Type: The SPR System is a pulsed light device.
• Intended Use: Providing light therapy to the body, specifically indicated for treatment of pigmented and vascular lesions.
• Substantial Equivalence: The submission asserts substantial equivalence to Radiancy's SkinStation® System (K030897). Crucially, the document states: "The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module."
• No Performance Data Presented: The document focuses on regulatory classification, contact information, and the claim of substantial equivalence. It does not contain any performance data, clinical study results, or specific acceptance criteria for treatment efficacy or safety.

Why the requested information cannot be found in the provided text:

• 510(k)s often rely on existing predicate devices and technological characteristics, especially for devices like light therapy systems where the mechanism of action is well-established and previous devices have cleared the regulatory hurdles. They typically do not involve the same level of detailed performance study reporting as a PMA (Pre-Market Approval) or a software as a medical device (SaMD) submission that requires extensive clinical validation metrics like sensitivity, specificity, or AUC against ground truth.
• The questions posed (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth) are highly relevant for diagnostic AI algorithms or novel therapeutic devices requiring extensive clinical trials to prove efficacy and safety. This document is for a pulsed light therapy device and demonstrates substantial equivalence to an already cleared device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided 510(k) summary.

The document states the device is "technologically identical" to its predicate for the relevant functions, suggesting that the basis for approval is primarily this equivalence rather than new performance data against numerical acceptance criteria.

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The SkinStation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.

The SkinStation is a pulsed light device intended for hair removal and treatment of pigmented and vascular lesions. When operated in the hair removal mode, the Skin Station is identical to the previously cleared SpaTouch, except that it is now housed with the SPR module for treating pigmented and vascular lesions. When operated in the pigmented and vascular lesions mode (i.e., using the SPR handpiece), the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the cleared Quantum, with a few exceptions which do not raise new issues of safety and effectiveness. In addition, the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the previously cleared MBC's Prolite and Palomar's EsteLux when operated in the SPR mode

I am sorry, but the provided text does not contain any information about acceptance criteria or a study to prove the device meets acceptance criteria. The document is a 510(k) summary for the Radiancy SkinStation™ System, primarily discussing its substantial equivalence to predicate devices for its intended use of hair removal and treatment of pigmented and vascular lesions. It does not detail specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment.

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