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ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.

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Here's an analysis of the provided information, focusing on the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a hair removal device. Notably, it does not explicitly state specific numerical acceptance criteria (e.g., "X% hair reduction"). Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a previously legally marketed device.

Therefore, the acceptance criteria here are implicitly:

• Demonstrating similar clinical effectiveness (hair removal) as predicate devices.
• Demonstrating similar safety profile (adverse effects) as predicate devices.

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

• Sample Size for the Test Set: Not explicitly stated. The document mentions "A multi-center study was conducted," but the number of patients included in this study ("test set") is not provided in this summary.
• Data Provenance:
  • Country of Origin: Not explicitly stated. Multi-center studies could involve various locations.
  • Retrospective or Prospective: Not explicitly stated, but the phrasing "A multi-center study was conducted to examine..." suggests a prospective study where data was collected specifically for this purpose.

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

• This information is not provided in the summary. For hair removal studies, "ground truth" often involves visual assessments by clinicians or photographic documentation, but the details of who performed these assessments and their qualifications are not included.

4. Adjudication Method for the Test Set

• This information is not provided in the summary.

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

• No, a MRMC comparative effectiveness study was not explicitly stated or implied. The study focused on the performance of the IPL device for hair removal on skin type VI patients compared to existing data/predicate devices for skin types I-V. There's no mention of human readers evaluating cases with and without AI assistance (as AI is not the primary focus here, rather it's a device).

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

• Yes, in a sense, the study describes a standalone device performance. This is an Intense Pulsed Light (IPL) device, not an AI algorithm. The device operates independently to deliver treatment, and the study evaluated its clinical effect directly. There is no "human-in-the-loop" component in the context of an AI algorithm interacting with human interpretation.

7. The Type of Ground Truth Used

• The ground truth for effectiveness would likely be based on:
  • Clinical observation/assessment of hair clearance (reduction in hair count or density) by trained personnel.
  • Adverse event reporting for safety.
  • This is inferred as the study "documented the clearance rate and the adverse effects."

8. The Sample Size for the Training Set

• Not applicable / not provided. This device is an IPL device, not an AI/machine learning model that typically requires a "training set." The clinical study evaluated the device's performance directly.

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

• Not applicable / not provided. As this is not an AI/ML device, there isn't a "training set" in the conventional sense that would require establishing ground truth for machine learning. The data from the multi-center study would serve as the "test set" to confirm the device's performance against the implicit acceptance criteria of substantial equivalence.

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EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.

The provided text is a 510(k) summary for the EpiLight® and PhotoDerm® HR devices, which are electro-optical medical devices for hair removal. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Based on the information given, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) for a new device's performance. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through technical comparisons and clinical trials.

The primary performance claim for the EpiLight® and PhotoDerm® HR is:

• Permanent hair reduction: Defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

The document states that a technical comparison and clinical trials were performed to establish substantial equivalence. However, no specific performance metrics resulting from these studies are provided in this summary.

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

The document mentions "clinical trials were performed by ESC Medical Systems," but it does not provide any details about:

• The sample size of the test set (number of participants or observations).
• The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not provide any information regarding experts used to establish ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The devices described are medical devices for hair removal, not AI-assisted diagnostic tools requiring reader interpretation. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

This question is not applicable. The devices are physical medical devices for hair removal, not AI algorithms.

7. The Type of Ground Truth Used

Given the nature of the device (hair removal), the "ground truth" for "permanent hair reduction" would most likely be based on clinical observation and measurement of hair regrowth over time following a treatment regime. However, the document does not explicitly state the method for establishing this ground truth (e.g., photographic assessment, hair count, patient self-reporting, etc.).

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device, not an AI algorithm that undergoes training.

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

This question is not applicable.

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The ESC Diode Laser System is intended for the treatment of vascular and pigmented lesions including leg veins.

The ESC Diode Laser System is a semiconductor diode laser system operating at the 830nm wavelength

This 510(k) premarket notification for the ESC Diode Laser System does not contain the detailed information necessary to complete the requested table and study description. This document focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and intended use, rather than presenting a performance study with acceptance criteria and results for the device itself.

Here's why the requested information cannot be fully provided from the given text:

• No specific acceptance criteria are defined or reported. The document states the device "conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems," but these are general safety and performance standards, not specific clinical or technical acceptance criteria with measurable metrics (e.g., specific treatment success rates, lesion clearance percentages, etc.) that would typically be found in a performance study.
• No performance study is detailed. The document does not describe any clinical or technical study conducted to evaluate the ESC Diode Laser System against specific performance metrics or acceptance criteria. It primarily focuses on comparing the device to existing predicate devices based on general characteristics.
• The document is a 510(k) summary and FDA letter, not a clinical study report. These types of documents aim to demonstrate equivalence for regulatory approval, not to present the results of a dedicated clinical trial or performance evaluation with all the requested details.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria, study design, sample sizes, expert involvement, adjudication, or ground truth establishment. These elements are not provided in the supplied 510(k) documentation.

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The PhotoDerm® HR is intended for the removal of unwanted hair.
The PhotoDerm® HR is used for the removal of unwanted hair.

PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal.

This document describes a 510(k) premarket notification for the PhotoDerm® HR device, which is an electro-optic medical device designed for the photothermal treatment and removal of unwanted hair. The submission asserts substantial equivalence to several predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in a quantitative or qualitative manner (e.g., "hair reduction of X% after Y treatments"). Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices. The performance data presented refers to general outcomes without numerical targets.

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

• Sample Size: Not explicitly stated. The text mentions "a multi-center clinical study," but the number of subjects or test cases is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the clinical study. However, the submitter, ESC Medical Systems, Ltd., is based in Yokneam, ISRAEL.
  • Retrospective or Prospective: Not explicitly stated, but clinical studies for 510(k) submissions are typically prospective.

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 study described focuses on "clearance rates and adverse effects," which would typically be assessed by clinical investigators or medical professionals, but their specific number, role in establishing ground truth, or qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. The text does not describe any specific adjudication process for evaluating the clinical outcomes.

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 section is not applicable. The PhotoDerm® HR is an electro-optic medical device for hair removal, not an AI or imaging device designed to be read by human readers. Therefore, an MRMC study and
assessment of AI assistance for human readers were not performed.

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

This section is not applicable. The PhotoDerm® HR is a physical medical device (an electro-optic system), not a software algorithm. Its performance is inherent to its operation in interaction with a patient, not a standalone algorithmic output.

7. The Type of Ground Truth Used

The ground truth used for assessing the PhotoDerm® HR's performance was primarily based on:

• Clinical Outcomes (Clearance Rates): The effectiveness of the device in removing unwanted hair.
• Safety Data (Adverse Effects): The occurrence and nature of any negative side effects.

These are clinical endpoints directly observed and measured during the multi-center clinical study.

8. The Sample Size for the Training Set

This information is not applicable. The PhotoDerm® HR is a physical device, and the submission describes clinical validation, not the training of a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

This information is not applicable for the same reasons as point 8.

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The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.

The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength of 1064 nanometers. The device is operated by the PhotoDerm® system and emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2. The Nd: YAG laser accessory is a hand held device that replaces the standard optical treatment head used in the PhotoDerm® machines.

The provided document is a 510(k) Premarket Notification for the PhotoDerm® Nd:YAG Accessory. It primarily focuses on demonstrating substantial equivalence to existing devices and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against such criteria. The "Performance Standards" section only states conformity with federal regulations for medical laser systems (21 CFR 1040.10 and 1040.11), which are general safety and performance standards for laser products, not specific clinical acceptance criteria for the intended use.

Therefore, most of the requested information cannot be extracted from this document, as it is not a clinical study report.

Here's an attempt to answer based on the available information, with many points being "Not Applicable" or "Not Provided":

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

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 provided.
• Data provenance: Not provided. This document does not describe a clinical 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)

• Not applicable. No ground truth establishment for a test set is described.

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

• Not applicable. No test set or adjudication process 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

• No. This is a laser device, not an AI-assisted diagnostic tool. An MRMC study is 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. This is a laser device, not an algorithm.

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

• Not applicable. No ground truth for device performance in a clinical context is described in this document. The "ground truth" for substantial equivalence is based on comparison to predicate devices' technical specifications and intended use.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model that would require a training set.

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

• Not applicable. See point 8.

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The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissuc.

The Derma™ K is a surgical laser system that produces laser (infrared) energy at wavelengths of 2.94 and 10.6 microns which is directed to soft tissue through an articulated arm system with removable handpieces.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) summary for the Derma™ K laser system, issued in 1997. It describes the device, its intended use, and its technological characteristics in comparison to predicate devices, to establish substantial equivalence.

Specifically, under section 9, "Clinical and Non-clinical Performance Data," the document states: "None submitted." This indicates that no performance data, clinical or non-clinical, was provided as part of this submission for the Derma™ K laser system. Therefore, details regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are absent.

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The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.

DermaScan™ Surgical Laser Scanner is a microprocessor controlled device that converts a surgical laser device into an advanced aesthetic surgery tool for a variety of cosmetic procedures. The device uses motorized mirrors to deflect a laser beam over a specified area in a uniform and controlled manner. Using a sophisticated interface the user can specify a large number of parameters to achieve a scanning procedure that is tailored to the individual needs of the patient. The scanner then controls the actual tissue ablation process to achieve a uniform removal of tissue over the entire area. An aiming beam is used to outline the treated area

The provided text is a 510(k) Premarket Notification for the DermaScan™ Surgical Laser Scanner. This document does not describe acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it's a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily focusing on device description, intended use, and comparison to existing products. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," indicating that no performance studies were conducted or submitted for this device.

Therefore, I cannot provide the requested information from this document. The sections on acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and MRMC studies are not present.

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The EpiLight™ Hair Removal System is intended for long term removal of unwanted hair.
The EpiLight TM Hair Removal System is used for the removal of unwanted hair

EpiLight™ Hair Removal System is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its long-term removal

The provided text describes the 510(k) summary for the EpiLight™ Hair Removal System. While it discusses the device's intended use and claims substantial equivalence to predicate devices, it does not provide explicit acceptance criteria in a quantitative format or details of a dedicated study to prove it meets such criteria in the way a modern regulatory submission would.

Instead, the submission relies on a comparison to predicate devices and a general statement about "clearance rates and rate of occurrence of adverse effects."

Here's an analysis of the information provided, fitting it into your requested format as much as possible, with caveats where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria are not stated in the document, I will infer what the submission implies regarding performance based on the comparison to predicate devices. The "reported device performance" refers to the general claim of being "as safe and as effective" as the predicates.

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

• Sample Size: A "multi-center clinical study" was conducted, but the specific number of participants (sample size) in this study is not provided in the document.
• Data Provenance: The document states "ESC Medical Systems has also conducted a multi-center clinical study." The origin of the data (country) is not explicitly mentioned, but ESC Medical Systems is based in Yokneam, Israel. It is a prospective clinical study, as it was "conducted" by ESC Medical.

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

This information is not provided in the document. The study establishes "clearance rates and rate of occurrence of adverse effects," which would typically involve expert assessment, but no details on the number or qualifications of these experts are given.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• Was one done? No. The study described is a clinical study on the device's effectiveness and safety, not a comparative study of human readers with vs. without AI assistance. The EpiLight™ is a standalone medical device, not an AI-powered diagnostic tool for human readers.
• Effect Size of Human Reader Improvement: Not applicable, as this was not an MRMC study related to AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Was one done? Yes, in principle. The clinical study conducted by ESC Medical Systems on the EpiLight™ Hair Removal System is a standalone performance study. The device is not an algorithm, but a physical electro-optic medical device. The study assessed the device's performance (clearance rates and adverse effects) on its own, without human intervention in the hair removal process itself (though human operators operate the device).

7. Type of Ground Truth Used

The "ground truth" for the clinical study was likely based on:

• Clinical Assessment: Observation of hair clearance (reduction in hair growth/density) over time.
• Adverse Event Reporting: Documentation of any side effects (e.g., skin irritation, burns).
  This would typically involve patient follow-ups and physician evaluations. The document states "clearance rates and rate of occurrence of adverse effects... were established," implying a direct clinical observation and measurement of outcomes.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here in the context of machine learning. The EpiLight™ Hair Removal System is an electro-optic device, not an AI/algorithm that requires a training set. The clinical study performed is a performance evaluation of the manufactured device.

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

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

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Incision, excision, ablation, vaporization and hemostasis of soft tissue

Derma™ 20 is a pulsed medical laser system incorporating an Er:YAG laser, operating at a wavelength of 2.94 microns. The device emits pulses of up to 1.7 joules on tissue. The pulse width is 350 μsec, the pulse rate is 5-12 pulses per second. The system is composed of the following units: • Laser optical rail assembly • Articulated arm • Power supply and pulse forming network (PFN) • Cooling system • Control electronics system • Power distribution box

This document is a 510(k) summary for the Derma™ 20 Laser System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than new performance claims and clinical studies for acceptance criteria.

Therefore, for aspects related to acceptance criteria, study design, and performance metrics typical of AI/software as a medical device (SaMD) clearances, the provided text contains no relevant information. This device is a laser system, not an AI or imaging diagnostic device, and thus the requested information (like sensitivity, specificity, MRMC studies, ground truth establishment, training/test set details) is not applicable to this 510(k) submission.

Here's a breakdown of why each numbered point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document is a summary for a hardware device (laser system) claiming substantial equivalence. There are no performance metrics like sensitivity, specificity, or AUC mentioned that would have acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The device's "performance" is primarily defined by its physical specifications (wavelength, pulse energy, pulse width, pulse rate) which are compared to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described as there is no diagnostic or interpretive software component.
4. Adjudication method for the test set: Not applicable. No test set requiring expert 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 is a hardware laser system, not an AI or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; there is no algorithm or standalone performance study.
7. The type of ground truth used: Not applicable. No ground truth is established for such a device. Its function is to perform surgical procedures, not to make diagnostic assessments.
8. The sample size for the training set: Not applicable. As there's no AI component, there's no training set.
9. How the ground truth for the training set was established: Not applicable. No training set or associated ground truth.

In summary, the provided 510(k) summary for the Derma™ 20 Laser System does not contain any of the requested information because it is a hardware device demonstrating substantial equivalence, not a software/AI device making performance claims that require clinical study data, ground truth, or reader studies. The "Clinical Performance Data" and "Nonclinical Performance Data" sections explicitly state "None," indicating that the submission relies on the established safety and effectiveness of the predicate devices.

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The PhotoDerm PL is a system intended for the treatment of benign pigmented lesions and tattoos.

PhotoDerm PL is an electro optic medical device designed for effective photothermal treatment of benign pigmented lesions and tattoos non-invasively.

The provided text describes a 510(k) summary for the PhotoDerm® PL device. Here's an analysis of the acceptance criteria and the study based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance goal is implicitly to achieve clearance rates and adverse effect rates comparable to those of the predicate devices.

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

• Sample Size: Not explicitly stated. The document mentions "a multi-center clinical study." The exact number of patients or lesions included in this study is not provided.
• Data Provenance: The study was "multi-center," suggesting data from multiple clinical sites. The country of origin is not specified, but the applicant (ESC Medical Systems, Ltd.) is based in Israel, so it's possible some or all centers were located there or elsewhere globally. The study was prospective as it involved treating patients with the PhotoDerm PL and then analyzing the results. The comparison to predicate devices relied on "published data," which would be retrospective in relation to the PhotoDerm PL study.

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

The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the clinical study. It states that "The clearance rates and rate of occurrence of adverse effects of the PhotoDerm PL were established," implying clinical assessment, but not specifying who performed these assessments or how inter-observer variability was handled.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. The PhotoDerm PL is a treatment device, not an AI diagnostic tool intended to assist "human readers" (e.g., radiologists, pathologists).
• The study design was a clinical trial of the device's treatment efficacy, not an assessment of reader performance with or without AI assistance.

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

• Yes, in the sense that the device's performance was evaluated independently. The clinical study assessed the PhotoDerm PL's ability to treat lesions directly. There is no "human-in-the-loop" interaction in the operational sense of an AI diagnostic tool; the device performs the treatment.
• However, the evaluation itself certainly involved human clinicians administering the treatment and assessing its outcomes.

7. The Type of Ground Truth Used

The ground truth for the effectiveness and safety of the PhotoDerm PL was based on clinical outcomes data obtained from a multi-center clinical study (e.g., observed clearance rates of lesions, observed rates of adverse effects). This was then implicitly compared to similar clinical outcome data from predicate devices, likely from published clinical trials or real-world evidence for those devices.

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable here as the PhotoDerm PL is a medical device for treatment, not an AI algorithm that learns from data.

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

As there is no "training set" in the context of an AI algorithm, this question is not relevant to the PhotoDerm PL device as described. The device's design and operating parameters would be based on engineering principles and understanding of photothermal interactions, rather than machine learning on a training dataset.

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