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The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of dark, unwanted body hair.

The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation.

The provided text is a 510(k) summary for the Sharplan Model 5000 Alexandrite Laser System, indicating its clearance for marketing based on substantial equivalence to predicate devices for the removal of dark, unwanted body hair. While it mentions clinical data, it does not provide detailed acceptance criteria or a comprehensive study report in the format requested.

Therefore, much of the requested information cannot be definitively extracted from the provided text. However, I will answer what is available and indicate when information is not present.

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

The document does not explicitly state quantitative acceptance criteria for device performance. It focuses on the device's substantial equivalence to predicate devices and its intended use for hair removal rather than specific metrics like success rate, adverse event rate thresholds, or hair reduction percentages.

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: 40 subjects
• 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 (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The nature of "clinical data on 40 subjects" for hair removal would typically involve physician assessment, but no details about the number or qualifications of these experts are given.

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

This information is not provided in the document.

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

An MRMC study is not relevant to this device, which is an Alexandrite Laser System for hair removal, not an AI-assisted diagnostic tool involving human readers. Therefore, no such study was done, and no effect size for human readers with/without AI assistance is applicable or reported.

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

This question is not applicable. The device is a laser system, not an algorithm. Its performance is inherent to the device's operation.

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

For a hair removal device, the "ground truth" would likely be the observed outcome of hair reduction or removal, assessed visually or through other objective measures (e.g., hair count in a defined area). The document only states "Clinical data on 40 subjects was presented," implying that patient outcomes after treatment were evaluated.

8. The sample size for the training set

This information is not provided. The term "training set" is generally used for machine learning models, which is not applicable here. The "clinical data on 40 subjects" likely refers to the pivotal clinical evidence presented for the device, not a training set in the AI sense.

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

As the concept of a "training set" in the context of AI/machine learning is not applicable here, this information is not provided. If referring to how the "clinical data on 40 subjects" established efficacy, it would be through direct observation of hair removal/reduction results post-treatment, likely by a clinician, but the methodology is not detailed.

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The Sharplan Ruby Laser System, with its fiber delivery system, is intended for use in dermatology for the removal of unwanted body hair.

The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed laser energy of a 694.3 nm wavelength in the free running mode through an optical fiber beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.

This document is a 510(k) summary for the Sharplan Modified Ruby Laser System, seeking clearance from the FDA. It states that the device is substantially equivalent to a predicate device and is intended for dermatology for the removal of unwanted dark body hair. No new indications for use were sought. Therefore, it explicitly states that no clinical data was presented.

Given this information, it is not possible to provide the details requested in your prompt as they relate to clinical studies, performance criteria, ground truth, and expert evaluation, because such studies were not conducted or submitted for this particular 510(k) clearance.

Specifically, the following information is not available from the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from a specific study are mentioned, as no clinical data was presented.
2. Sample size used for the test set and the data provenance: No test set was used for a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment occurred in the absence of clinical data.
4. Adjudication method for the test set: Not applicable as there was no test set or clinical study.
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 diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable as there was no training set for a clinical study or algorithm.
9. How the ground truth for the training set was established: Not applicable.

The basis for this 510(k) clearance was "substantial equivalence" to a predicate device (SLS Chromos 694 QD Ruby Laser System, K962109), implying that its safety and effectiveness are inferred from the predicate device's established use and technology. The document explicitly states: "No new indications were sought in this premarket notification. Therefore, no clinical data was presented."

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The Sharplan Model 5000 Alexandrite Surgical Laser System is intended for use in dermatology for the treatment of vascular lesions.

The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation

This looks like a 510(k) summary for a medical device that was cleared based on substantial equivalence to a predicate device, rather than through a study demonstrating direct device performance against acceptance criteria. Therefore, most of the requested information (like specific acceptance criteria, sample sizes, expert involvement, and ground truth methodologies) is not present in the provided document.

Here's an attempt to answer based only on the provided text:

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

The document does not provide a table of acceptance criteria or reported device performance for the Sharplan Model 5000 Alexandrite Laser System in a study against specific benchmarks. The clearance is based on substantial equivalence 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 applicable. No test set or clinical data proving direct device performance was presented. The clearance states: "No new indications were sought in this premarket notification and no clinical data was presented."

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 by experts for a test set is mentioned.

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

Not applicable. No test set or adjudication process 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 is not an AI-assisted device, and no MRMC study was conducted or referenced.

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

Not applicable. This is a laser system, not an algorithm, and no such standalone performance evaluation is mentioned.

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

Not applicable. No specific ground truth was established for the Sharplan Model 5000 Alexandrite Laser System's performance, as its clearance was based on substantial equivalence.

8. The sample size for the training set

Not applicable. This document describes a medical device cleared through substantial equivalence, not an algorithm developed with a training set.

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

Not applicable. No training set or ground truth establishment for a training set is mentioned.

Summary based on the Provided 510(k) Document:

The Sharplan Model 5000 Alexandrite Laser System was cleared based on its substantial equivalence to a predicate device, the Cynosure PhotoGenica LP Dermatological Vascular Lesion Laser (K963094).

• Basis for Clearance: The manufacturer "believes that no significant differences exist" between their device and the predicate device "From both a design and clinical perspective, the predicate and candidate laser devices, are of the same technology and have the same intended use."
• Performance Data: "No new indications were sought in this premarket notification and no clinical data was presented."
• Intended Use: The device is "intended for use in dermatology for the treatment of vascular lesions."

Therefore, the study proving the device meets acceptance criteria in the traditional sense of a performance study against specific metrics is not provided in this document. Instead, the "proof" is the argument of substantial equivalence based on technological and intended use similarities to an already legally marketed device.

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The Sharplan Model 4020 Erbium:YAG Surgical Laser System is intended for incision/excision, ablation, vaporization, and/or coagulation of soft-tissue in-Plastion-Surgery/Dermatology.

The Sharplan Model 4020 Erbium YAG Surgical Laser is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 2.94 u under the guidance of an visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) summary for the Sharplan Model 4020 Erbium YAG Laser System, focusing on establishing substantial equivalence to predicate devices for regulatory approval.

Here's what the document does state, which is relevant to your request but doesn't fulfill it:

• No new indications were sought. This implies the device is intended for the same uses as its predicate devices.
• No clinical data was presented. This is the most crucial point. Without clinical data, there's no study described that would establish device performance against acceptance criteria.
• Substantial Equivalence: The approval is based on the device being "substantially equivalent" to existing predicate devices (SEO Medical Model 2940 Erbium YAG Laser, Candela (Fotona) SkinLight Er:YAG Laser, Con Bio Erbium/2.94 Laser, ESC Derma 20 Erbium: YAG Laser, and Asculap MCL 29 Erbium: YAG Laser). This means its safety and effectiveness are inferred from the predicate devices, rather than through a new, independent performance study against specific acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies because the provided document explicitly states that "no clinical data was presented" for the Sharplan Model 4020.

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The Sharplan 15F CO2 Laser System is intended for use as a heat source to activate tooth bleaching materials.

The Sharplan Model 15F CO2 Surgical Laser is a medical device which is capable of being used as a heat source for activating tooth bleaching materials. It emits a treatment laser beam at a wavelength of 10.6 um up to 15 watts in either continuous or pulse wave modes of operation.

The provided text is a 510(k) summary for the Sharplan 15F CO2 Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria.

Therefore, the document does not contain any information regarding acceptance criteria, a study that proves the device meets acceptance criteria, or any of the specific details requested in your prompt (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

The key statement that clarifies this is:
"No new intended use for a CO2 Laser was sought in this premarket notification. Therefore, no clinical data was presented."

The submission relies on the fact that the Sharplan 15F CO2 Laser System is "substantially equivalent" to its predicate devices (the Sharplan 15F CO2 Laser and the ILT CO2 Laser System) in terms of technology, intended use, and overall performance characteristics for the expanded indication of activating tooth bleaching materials. The FDA's approval is based on this finding of substantial equivalence, not on new clinical data demonstrating specific performance metrics against acceptance criteria.

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It is intended for use in dermatology for the removal of unwanted dark body hair.

The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed (O-Switched or Free Running) laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.

The Sharplan Lasers, Inc. Ruby Laser System is intended for use in dermatology for the removal of unwanted dark body hair. The submission does not specify quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices and presenting clinical data to support safety and efficacy.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 31 patients.
• Data Provenance: The document does not specify the country of origin of the data. It is a prospective clinical study as it involved a 3-month follow-up period.

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 is a clinical trial, but details about expert assessment of hair removal outcomes (e.g., by dermatologists or other specialists) and their qualifications are absent.

4. Adjudication Method for the Test Set:

• This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study was not done. This submission describes a clinical study to demonstrate the performance of the device itself, not a comparative study of human readers with and without AI assistance.

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

• Not applicable. This device is a laser system, not an AI algorithm. Its performance is directly tied to its physical operation and effect on patients.

7. The Type of Ground Truth Used:

• The ground truth referred to implicitly by "safety and efficacy" would be clinical outcomes (e.g., observed hair removal, adverse events) as assessed during the 3-month follow-up period. However, the specific metrics and how they were measured are not detailed.

8. The Sample Size for the Training Set:

• Not applicable. This is a hardware device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

• Not applicable. See point 8.

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The Sharplan Models 20c, 30c, and 40c (for this indication) are substantially equivalent to the following devices: The Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel. They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.

The Sharplan Models 20c, 30c, and 40c CO2 Lasers are surgical lasers are medical devices which capable of incising soft tissue. They emit a treatment laser beam at a wavelength of 10.6 um up to 40 watts and a 3 mWatt HeNe aiming beam.

The provided document describes a 510(k) summary for Sharplan CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication. It does not provide detailed acceptance criteria or a comprehensive study report with the requested specifics. However, based on the available information, I can extract and infer some points:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" are provided in a quantitative table format as per a typical performance study. Instead, the document focuses on demonstrating "substantial equivalence" to predicate devices.

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

• Sample Size: 80 patients
• Data Provenance: Obtained at 2 sites. The document does not specify the country of origin but implies a clinical study was conducted. It is a prospective collection of clinical results for this submission, augmented by "historical data."

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 document refers to "clinical results" but does not detail how the outcomes of the myringotomy/tympanostomy procedures were evaluated or by whom, nor does it specify the qualifications of any experts involved in establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

An MRMC study is not applicable here as the device is a surgical laser, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.

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

This concept is not applicable for a surgical laser. The device itself performs the surgical task, and its performance is evaluated based on the clinical outcome of the procedure, not as a standalone algorithm in a diagnostic context.

7. The Type of Ground Truth Used

The document mentions "Clinical results from 80 patients." This implies that the ground truth for evaluating the safety and effectiveness of the device was based on clinical outcomes observed in patients who underwent the procedure using the Sharplan CO2 Laser. Further details on specific metrics (e.g., successful tympanostomy, complication rates, healing) are not provided.

8. The Sample Size for the Training Set

This information is not applicable as this is a medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

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

This information is not applicable as there is no training set for a medical device in this context.

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It is indicated for soft tissue incision of recipient sites for laser assisted hair transplantation.

The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is a motorized, laser beam deflection system that is attached to a CO2 laser articulating arm. The device redirects a focused laser beam through moving mirrors, within a specified pattern scan area. Similar to the common surgeon's technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the SilkTouch Flash Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels The SilkTouch Flash Scanner has controls for varying the scanned area setting the exposure time. This device is used with a CO2 handpiece. When the unit is turned off, the connected laser operates to its specifications and allows incision or manual scanning for vaporization purposes.

This document is a 510(k) summary for the Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory. It primarily focuses on establishing substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a dedicated study proving the device meets specific performance criteria as typically expected for contemporary medical device submissions, especially for AI/ML devices.

Therefore, many of the requested sections regarding acceptance criteria, study design, expert involvement, and ground truth establishment cannot be answered from the provided text. The document is from 1996 and reflects the regulatory requirements and practices of that time, which differ significantly from current standards for demonstrating device performance.

Here's a breakdown based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document mentions "histological information submitted," but does not detail the source, nature, or quantity of this data. It's unclear if this refers to animal studies, human cadaveric tissue, or limited human clinical observations.
• Retrospective/Prospective: Not specified.

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 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

• No. This is not an AI/ML device, and no MRMC study is mentioned.

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

• No. This is not an AI/ML device.

7. The type of ground truth used

• The document mentions "histological information submitted." This suggests that tissue analysis (e.g., biopsies, tissue samples) might have been used to assess the effects of the laser. However, the exact nature of this "ground truth" and how it was used to validate performance is not detailed.

8. The sample size for the training set

• Not applicable/Not specified. This is not an AI/ML device and therefore does not have a "training set" in the modern sense.

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

• Not applicable/Not specified. This is not an AI/ML device.

Summary of Limitations based on the provided text:

The provided 510(k) summary (from 1996) is focused on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria, performance metrics, and rigorous ground truth establishment that would be expected for a device submission today, especially for one involving complex algorithms or clinical decision support. The evaluation largely relies on the similar function and indication of existing devices, supplemented by unspecified "histological information."

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The Sharplan Model 713 AF Acuspot Micromanipulator is substantially equivalent to the following devices: The Sharplan Model 712 Micromanipulator, the Reliant UniMax Model 2000, and the Heraeus LaserSonics Ultraspot Micromanipulator. It is indicated for incision, excision, coagulation, ablation, and vaporization of soft tissue, to be used with compatible, legally marketed surgical lasers.

The Sharplan Model 713 AF Acuspot Micromanipulator is an accessory for a CO2 Surgical Laser. It attaches to the distal end of an articulated arm and connects to a surgical microscope. Its purpose is to allow a physician the ability to focus and steer laser beams so that when tissue is visualized, it can be selectively treated.

Here's an analysis of the provided text regarding acceptance criteria and a study to prove device performance:

Based on the provided text, the document is a 510(k) Summary of Safety and Effectiveness for the Sharplan Model 713 AF Acuspot Micromanipulator. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with statistical metrics.

Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) because the submission relies on equivalence, not a standalone performance study.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" in the sense of quantitative performance metrics for the new device. The "performance" is implicitly based on being "substantially equivalent" to the predicate devices.

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

• N/A. No formal "test set" or clinical study data is presented. The submission relies on a comparison to predicate devices.

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

• N/A. No ground truth establishment activity for a test set is described.

4. Adjudication method for the test set

• N/A. 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

• N/A. This device is a micromanipulator, not an AI or imaging device that would typically involve human readers or MRMC studies.

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

• N/A. Not an algorithm. The device is hardware (micromanipulator).

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

• N/A. Not applicable, as detailed performance validation via ground truth is not the basis of a substantial equivalence claim for this type of device. The "ground truth" for comparison is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• N/A. No training set is mentioned or relevant for this type of submission.

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

• N/A. No training set.

Summary of the Study (or lack thereof):

The document explicitly states: "No new indications were sought in the premarket notification and no clinical data was presented."

Instead of a study proving device performance against acceptance criteria, the submission leverages the concept of substantial equivalence. The "study" here is a comparison of the Sharplan Model 713 AF Acuspot Micromanipulator to its predicate devices (Sharplan Model 712 Acuspot, Reliant UniMax Model 2000 Micromanipulator, and the Heraeus LaserSonics Ultraspot Micromanipulator).

The key points of this equivalence argument are:

• Design and Intended Use: The devices, while not identical, perform the same function and are of the same technology.
• Modification: The only modification to the candidate device is the addition of an autofocus option.
• Conclusion: Based on an analysis of the overall performance characteristics, Sharplan Lasers, Inc. believes no significant differences exist, and the modification raises no concerns regarding safety or effectiveness.

Therefore, the "proof" that the device meets "acceptance criteria" (which are implicitly the criteria met by the predicate devices) is the demonstration of substantial equivalence, not a standalone performance study with quantified acceptance criteria.

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It is intended for use in dermatology for photothermolysis, for the specific indications {in adults (18 years or older)} to remove blue-black tattoos, or to remove or lighten benign epidermal pigmented lesions.

The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) Summary for a Sharplan Lasers, Inc. Ruby Laser System, focusing on its substantial equivalence to predicate devices and its intended use.

Specifically, the text states: "No new indications were sought in this premarket notification and no clinical data was presented." This indicates that no clinical studies were conducted for this submission, and therefore, no performance criteria or study results are available.

Therefore, I cannot provide the requested information.

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