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The Candela Smoothbeam Laser is indicated for the following uses: For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, New indication: Treatment of Sebaceous Hyperplasia

The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used in dermatology for the treatment of wrinkles. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output produces circular beams on the skin. The Dynamic Cooling Device, provides a short burst of cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operations. Users of the device, make selections from a control panel to regulate operation during the laser treatment.

The provided document, K041242 for the Candela Smoothbeam Laser System, describes the device and its intended uses, including a new indication for the treatment of sebaceous hyperplasia. However, it does not include detailed information regarding specific acceptance criteria, a clinical study design with performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods for the new indication.

The document primarily focuses on establishing substantial equivalence to a predicate device (Candela Smoothbeam 1450 nm Diode Laser System, K013825, K030834) for the expanded indication. It states: "Published clinical data, using t he predicate Smoothbeam Laser, cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser is safe and effective for the expanded indication, - the treatment of sebaceous hyperplasia." This suggests that the substantial equivalence hinges on existing clinical data from the predicate device rather than a new standalone study for this specific 510(k) submission.

Therefore, many of the requested details about acceptance criteria and study particulars for this specific submission are not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text for the new indication of sebaceous hyperplasia. The document states that "Published clinical data, using the predicate Smoothbeam Laser, cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser is safe and effective for the expanded indication." This implies that the acceptance criteria for "safety and effectiveness" for sebaceous hyperplasia were met by the existing data from the predicate device, but the specific quantitative criteria (e.g., percentage reduction in lesion size, number of lesions cleared, etc.) are not detailed.

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

Not explicitly stated for the sebaceous hyperplasia indication in this document. The document refers to "Published clinical data" from the predicate device, but does not provide details of that specific study, including its sample size or data provenance (e.g., country of origin, retrospective/prospective nature).

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

Not explicitly stated. Ground truth for the published clinical data of the predicate device is not described in this submission.

4. Adjudication method for the test set

Not explicitly stated. Adjudication method for the published clinical data of the predicate device is not described in this submission.

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. The Candela Smoothbeam Laser System is a physical medical device, not an AI-assisted diagnostic or imaging system involving human readers. Therefore, an MRMC study with AI assistance is not relevant to this submission.

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

Not applicable. This is a physical medical laser device, not an algorithm.

7. The type of ground truth used

Not explicitly stated for the sebaceous hyperplasia indication. For a laser treatment, ground truth in clinical data would typically involve clinical assessment (e.g., visual grading, photographic assessment of lesions by dermatologists, possibly histology from biopsies if performed). The document only broadly refers to "results that demonstrate that the Smoothbeam Laser is safe and effective."

8. The sample size for the training set

Not applicable. The device is a physical laser system, not a machine learning algorithm that requires a training set in this context. The "training" in this context would refer to physician training on using the laser, which is not what this question is asking.

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

Not applicable, as it's not an AI system with a machine learning training set.

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The Candela Smoothbeam Laser System is indicated for the treatment of mild to moderate inflammatory acne vulgaris.

The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment

The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used in the Candela Smoothbeam Laser System. The Candela Smoothbeam Laser System is comprised of a laser, delivery system, software control system and Dynamic Cooling Device. The laser energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device functions to cool the skin during the laser treatment by spraying cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment and reducing pain associated with laser treatment.

The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.

The provided text is a 510(k) summary for the Candela Smoothbeam Laser System (K030834). Despite mentioning a "controlled clinical study" for safety and effectiveness, the document does not provide any specific acceptance criteria or detailed results of that study (such as performance metrics, sample sizes, or ground truth methods) that would allow for the completion of the requested table and comprehensive description.

The summary focuses on:

• Substantial equivalence: The primary claim is that the device is identical to a previously cleared predicate device (K022884) in terms of operating principles, materials, mechanism of action, and design.
• Regulatory compliance: Conformance to laser performance standards (21 CFR 1040) and electrical safety standards (UL 2601, EN 60601-1-2) is stated.
• General statement on clinical study: "A controlled clinical study, using a device that has been cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser System is safe and effective for the treatment of mild to moderate inflammatory acne vulgaris."

Therefore, based on the provided text, it is not possible to fill in the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or expert details. The summary simply states that a study was done and confirmed safety and effectiveness, without providing the details required for this request.

Here's what can be extracted and what cannot:

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

   • Acceptance Criteria: Not specified in the document.
   • Reported Device Performance: Not specified in the document beyond a qualitative statement that "the Smoothbeam Laser System is safe and effective for the treatment of mild to moderate inflammatory acne vulgaris." No quantitative metrics (e.g., percentage improvement, lesion count reduction) are provided.

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

   • Sample Size (Test Set): Not specified.
   • Data Provenance: Not specified (country, retrospective/prospective). While it says a "controlled clinical study" was done, it doesn't offer details about the data used in that study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This is a laser 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 is a laser device, not an algorithm. The "clinical study" would have involved the device's application to patients.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For acne treatment, this might typically involve clinical assessment scores, lesion counts, or patient-reported outcomes, but the document does not elaborate.

8. The sample size for the training set: Not applicable/specified. This is not an AI/algorithm-based device in the sense of requiring a "training set." The clinical study evaluated the device's effect directly.

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

In summary, the provided 510(k) summary is a regulatory filing focused on substantial equivalence and regulatory compliance, not a detailed scientific report of a clinical trial. It does not contain the granular data requested for performance metrics, acceptance criteria, sample sizes, or ground truth establishment.

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The Candela Smoothbeam Laser System is indicated for use in the treatment of facial wrinkles.

The Diode laser is a continuous wave, diode medical laser, controlled by an embedded processor, to be used for use in dermatology for treatment of periorbital wrinkles. The laser system operates with a Dynamic Cooling Device, which provides a short burst of cryogen spray during the laser treatment. The laser output energy is delivered via an optical fiber to a hand piece, which produces a circular beam on the skin. The cryogen is delivered via a hose to a nozzle located in the hand piece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment.

The Candela Smoothbeam system is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device.

The Candela Smoothbeam Laser is equipped with safety interlock systems to protect patients and operators. Users of the device make selections from a control panel to regulate operation during treatment.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Candela Smoothbeam System, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not contain information about a specific clinical study with a test set for the new indication of "treatment of facial wrinkles." The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new clinical study data for this specific claim. Therefore, information about sample size and data provenance for a test set is not available in this document.

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

Since no new clinical study data is presented for the "treatment of facial wrinkles" indication, no information is available regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

As no new clinical study data is presented for the "treatment of facial wrinkles" indication, no information is available regarding adjudication methods.

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

No MRMC comparative effectiveness study was done as part of this 510(k) submission. The submission focuses on substantial equivalence to predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical laser system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable.

7. Type of Ground Truth Used

For the new indication of "treatment of facial wrinkles," the "ground truth" implicitly used for the substantial equivalence claim is the demonstrated effectiveness and safety of the predicate devices (Cool Touch Laser for fine lines and wrinkles, and Candela Smoothbeam for periorbital wrinkles and atrophic acne scars). The assumption is that because the new device operates on identical/similar principles and design, it will achieve similar outcomes. No new, independent ground truth (e.g., pathology, outcomes data from a new trial) was established for this specific 510(k).

8. Sample Size for the Training Set

There is no information about a "training set" as this 510(k) submission is for a physical medical device (laser system), not an AI/machine learning algorithm that requires training data.

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

As there is no training set for an AI/machine learning algorithm, this question is not applicable.

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The Smoothbeam Laser System is indicated for the treatment of Atrophic Acne Scars.

The Smoothbeam Laser is comprised of the following main components:

• a laser system console (including software and control electronics)
• a control and display panel
• a fiberoptic-coupled handpiece
• a skin cooling device integrated into the laser (cryogen is delivered via a hose to a nozzle in the handpiece)
• a safety interlock system

The provided text describes a 510(k) summary for the Candela Smoothbeam Laser System. However, it does not include detailed acceptance criteria or a specific study that quantifies device performance against those criteria in the typical format requested.

The document primarily focuses on establishing substantial equivalence to a predicate device and states that a clinical study was performed, but it lacks the granular details required to fully address your request in the structured format.

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

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

The document does not specify quantitative acceptance criteria. It only states: "A clinical study was performed that produced results that indicate that the Smoothbeam Laser System is effective for the treatment of Atrophic Acne Scars." and "The Smoothbeam Laser is effective for the treatment of Atrophic Acne Scars."

Therefore, a table cannot be constructed with specific numeric acceptance criteria and reported performance values.

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

• Sample Size (Test Set): Not specified. The document only mentions "A clinical study was performed."
• Data Provenance: Not specified (e.g., country of origin).
• Retrospective or Prospective: Not specified, but clinical studies for 510(k) clearances 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)

Not specified. The document does not detail how the results of the clinical study were assessed or who assessed them.

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

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

Not applicable. This device is a laser system, not an AI-powered diagnostic imaging tool that would involve human readers interpreting images with or without AI assistance. The study described is a clinical effectiveness study for a therapeutic device.

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

Not applicable. This is a therapeutic laser system, not an algorithm.

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

The implied "ground truth" would be clinical improvement in "Atrophic Acne Scars" as assessed in a clinical study. However, the specific methodology (e.g., physician global assessment, patient-reported outcomes, objective scoring systems) is not described in detail. It would fall under "outcomes data" but further specifics are missing.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

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

Not applicable. This is a physical device, not a machine learning algorithm.

Summary of available information:

The available text primarily focuses on the device's intended use, its substantial equivalence to a predicate device, and the general statement that a clinical study was performed demonstrating its effectiveness for treating Atrophic Acne Scars. It lacks the detailed methodological information, specific acceptance criteria, and performance metrics typically found when describing studies for diagnostic algorithms or more complex medical devices.

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The Candela Smoothbeam Laser System is indicated for use for the treatment of back acne.

The Diode laser is a diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of back acne. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device provides multiple bursts of cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.

The Candela Smoothbeam Laser System (K014128) is indicated for the treatment of back acne. The provided documents describe that "Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of back acne." However, the documents do not provide specific acceptance criteria or detailed study results (such as metrics, sample sizes, or ground truth establishment) to demonstrate how the device meets these criteria.

Therefore, I cannot populate the requested table or answer most of the questions fully based on the provided text.

Here's a breakdown of what can be extracted and what information is missing:

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: Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). While clinical trials are mentioned, details are absent.

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

• Number of experts: Not provided.
• Qualifications of experts: Not provided.

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

• Adjudication method: Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• This device is a laser system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

• This device is a laser system, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

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

• Type of ground truth: Not specified. For a treatment device, this would likely involve clinical outcomes, but the specific methodology is not described.

8. The sample size for the training set:

• Training set sample size: Not applicable and not provided. The device is a physical laser system, not a machine learning model that requires a training set in the conventional sense. The "clinical trials" mentioned would be for evaluating the device's efficacy, not for training it.

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

• Ground truth for training set: Not applicable and not provided, as this is a physical device, not an AI model.

In summary, the provided documents indicate that clinical trials were performed and "produced results that the Smoothbeam Laser System is effective in the treatment of back acne." However, no specific details about the methodology, acceptance criteria, sample sizes, or ground truth establishment for these clinical trials are included within the given text.

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The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles.

The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment

The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of periorbital wrinkles. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.

The provided text describes a 510(k) premarket notification for the "Candela Smoothbeam Laser System" for the treatment of periorbital wrinkles. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.

The document primarily focuses on regulatory approval based on substantial equivalence to predicate devices (Laser Aesthetics CoolTouch K003715 and Candela 1450 nm Diode laser K002421). It confirms that "Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of periorbital wrinkles," but it doesn't elaborate on the methodology, sample sizes, ground truth establishment, or specific quantitative performance metrics.

Therefore, I cannot provide a complete answer to your request in the specified format from the given text.

Here's what I can extract and what is missing based on your request:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated in quantitative terms. The primary acceptance criterion appears to be "substantial equivalence" to predicate devices and demonstration of "effectiveness in the treatment of periorbital wrinkles."
• Reported Device Performance: "effective in the treatment of periorbital wrinkles." No quantitative metrics (e.g., percentage reduction in wrinkles, physician global assessment scores, patient satisfaction scores) are provided.

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

• Sample Size for Test Set: Not specified. The document only mentions "Clinical trials."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• 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:

• Not applicable/Not mentioned. This device is a laser system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable/Not mentioned. This is a medical device for direct treatment, not an algorithm.

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

• Implied to be clinical outcomes related to "treatment of periorbital wrinkles." The specific method (e.g., blinded physician assessment, photographic analysis, patient questionnaires) is not detailed.

8. The sample size for the training set:

• Not applicable/Not mentioned for a laser treatment device. This concept is typically relevant for machine learning algorithms.

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

• Not applicable/Not mentioned.

In summary: The provided document is a regulatory submission focused on demonstrating substantial equivalence and does not contain the detailed clinical study data, acceptance criteria, and performance metrics typically found in scientific publications or more comprehensive clinical study reports.

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