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The laser system MeDioStar H (with and without skin cooling system) is intended to remove unwanted body hair and vascular lesions.

The laser system MeDioStar H is restricted to sale to or use by licensed professionals in the United States.

The laser system MeDioStar H operates as a pulsed diode laser which emits a beam of coherent light at 808 nanometers.

The provided text does not contain specific acceptance criteria or a study proving the device meets those criteria. Instead, it is a 510(k) summary for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H, asserting substantial equivalence to predicate devices rather than presenting performance data.

Here's a breakdown of why the requested information cannot be fully provided based on the input:

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

• Acceptance Criteria: Not explicitly stated in the document. For 510(k) submissions, acceptance criteria often relate to demonstrating substantial equivalence in terms of technological characteristics and intended use compared to legally marketed predicate devices, rather than specific performance metrics against pre-defined thresholds.
• Reported Device Performance: The document explicitly states: "Performance data: None. The specifications and intended uses of the laser system MeDioStar H are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required."

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

• No test set or performance data is mentioned, therefore no sample size or data provenance is available.

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 as no test set or ground truth establishment process is described.

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

• Not applicable as no test set 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 such study was mentioned. The device is a laser system, not an AI-powered diagnostic tool, so an MRMC study involving human readers and 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, as this is a physical medical device (laser system), not a standalone algorithm.

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

• Not applicable as no performance data or ground truth establishment process is described. The basis for clearance is substantial equivalence to predicate devices.

8. The sample size for the training set:

• Not applicable as no training set or algorithm development is mentioned.

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

• Not applicable as no training set is described.

Summary based on the provided text:

The 510(k) submission for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H relies on substantial equivalence to predicate devices rather than presenting novel performance data against specific acceptance criteria. The document explicitly states that "performance data were not required" because the device specifications and intended uses are "the same or very similar" to those of legally marketed lasers (Conerent / Palomar - LightSheer (K982940), LASERSCOPE - Lyra (K990903), and Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER (K984601)).

Therefore, the "acceptance criteria" in this context are primarily met by demonstrating that the device is as safe and effective as its predicate devices, based on their established performance and the fundamental principles of laser technology for hair removal and vascular lesions. No specific clinical study results or detailed performance metrics are provided in this summary.

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The laser system DERMABLATE ER:YAG LASER SYSTEM is intended for laser assisted site preparation for hair transplantation. This indication is in addition to previously cleared indications.

The laser system DERMABLATE ER:YAG LASER SYSTEM is restricted to sale to or use by licensed professionals in the United States.

The laser system DERMABLATE ER:YAG LASER SYSTEM is an Erbium:YAG laser with a wavelength of 2.94µm.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the AESCULAP-MEDITEC GMBH DERMABLATE ER:YAG LASER SYSTEM, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a study.

Specifically, the document states:

• "Performance data: None. The specifications and intended uses of the laser system DERMABLATE ER:YAG LASER SYSTEM are the same or very similar to those of claimed predicate devices. Because that, performance data were not required."

Therefore, I cannot fill out the requested table and information.

If there were performance data, the table would look like this:

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The laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair.

The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.

Some examples of pigment lesions are:

Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker's naevi, Blue naevus, Naevus spilus, and Mongolian spot.

The laser system Ruby Star is restricted to sale or use by licensed professionals in the United States

The laser system RubyStar operates as a normal pulse or as a Q-Switched ruby laser which emits a beam of coherent light at 694 nanometers. In Q-Switched mode the beam has much shorter pulse duration than in the normal pulse mode.

The provided text states: "Performance data: None. The specifications and intended uses of the laser system RubyStar operating in Q-Switch or normal mode are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required."

Therefore, the following information cannot be extracted from the document:

• Table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

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The Meditec Link is intended to be attached to slit lamps to allow green laser energy light to be delivered to the slit lamp via fiber optic.

Once the Meditec Link is attached to a slit lamp the user should refer to the User's Manual or Operator's Manual provided with the laser for clinical use information regarding the laser and for additional use instructions or information.

The Meditec Link is presently designed for attachment to Zeiss Slit Lamps or to Haag Streit 900 BQ and 900 BM Slit Lamps.

The Meditec Link is an adapter which attaches to slit lamps, e.g., Zeiss Slit Lamps and Haag Streit 900 BQ and 900 BM Slit Lamps, to allow green laser light, to be delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.

Here's an analysis of the provided text regarding the Meditec Link device, addressing your specific questions.

Based on the provided documentation, the Meditec Link is an adapter for ophthalmic slit lamps, designed to deliver green laser light (532 nm) via fiber optic for use by an ophthalmologist.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence:

The documentation states that the Meditec Link is considered substantially equivalent to its predicate device, the Infinitech Multi-Spot Slit Lamp laser Adapter. This means the acceptance criteria are primarily based on demonstrating:

• Same Intended Use: The device must have the same fundamental purpose as the predicate.
• Same Technological Characteristics: The device's design and operating principles must be similar to the predicate.
• No new questions of safety and effectiveness: The device should not introduce new risks or effectiveness concerns compared to the predicate.

Given these overarching criteria, the specific performance aspects are implicitly tied to the predicate device's established performance. The submission explicitly states: "The specifications and intended uses of the Meditec Link are the same or very similar to those of the claimed predicate devices. There are no significant differences between the Meditec Link in design or intended use and the claimed predicates under conditions of intended use of these accessories to ophthalmic lasers."

Reported Device Performance:

Study that Proves the Device Meets Acceptance Criteria:

The documentation does not describe a detailed study with specific acceptance criteria beyond the substantial equivalence comparison. The conclusion is based on a comparative analysis of the device's design, specifications, and intended use against a legally marketed predicate device (Infinitech Multi-Spot Slit Lamp laser Adapter).

The key statement is from the "Performance Data" section: "The specifications and intended uses of the Meditec Link are the same or very similar to those of the claimed predicate devices. There are no significant differences between the Meditec Link in design or intended use and the claimed predicates under conditions of intended use of these accessories to ophthalmic lasers. Because of this, performance data were not required."

This indicates that a formal efficacy or safety study with acceptance criteria, as one might expect for a novel device, was not conducted or submitted because the device was deemed sufficiently similar to an already approved device. The "study" here is essentially the 510(k) substantial equivalence determination process itself, where the manufacturer provides evidence (in the form of descriptions and comparisons) to establish similarity to a predicate.

Additional Requested Information:

Given that the submission asserts "performance data were not required" due to substantial equivalence, most of the following questions cannot be answered as no specific performance study was conducted.

1. Sample size used for the test set and the data provenance: Not applicable. No test set or performance study was conducted.
2. 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 for a test set was performed.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 device is a physical adapter for a laser system, not an AI or imaging diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical accessory, not an algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the submission is the regulatory acceptance and established performance of the legally marketed predicate device.
7. The sample size for the training set: Not applicable. The device is not a machine learning model, so there is no "training set."
8. How the ground truth for the training set was established: Not applicable.

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The Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The Dermablate laser is an erbium: YAG laser operating at 2.94 microns and with a maximum pulse energy of 2 J.

The provided text describes a 510(k) summary for the DERMABLATE ERBIUM LASER SYSTEM. It explicitly states that no performance data, acceptance criteria, or studies were required for this device.

Here's why, based on the provided text:

• The summary in section {1} states: "None. The specifications and intended uses of the Dermablate laser are the Performance Data: same or very similar to those of the claimed predicate devices, including the MCL 29 Dermablate. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

Therefore, I cannot populate the requested information regarding acceptance criteria and studies. The device's clearance was based on its substantial equivalence to legally marketed predicate devices without the need for new performance testing.

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The SL07 and SL08 laser slit lamps are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. Both include an adapter to deliver green laser light (532 nm) to the slit lamp by fiber optic. The user should refer to the User Manual provided with the laser for clinical use information for the laser or for additional information.

The SL07 and SL08 slit lamps are commercially available slit lamps which have been modified by Aesculap-Meditec to accommodate an adapter through which green laser light, e.g., from the EyeLite™ Laser, is delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.

This document describes the SL07 and SL08 Laser Slit Lamps, which are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. They also include an adapter for delivering green laser light (532 nm) via fiber optic.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for substantial equivalence. Therefore, there are no specific performance acceptance criteria or reported device performance metrics in the typical sense (e.g., sensitivity, specificity). Instead, the device's performance is accepted based on its similarity to legally marketed predicate devices.

The "Performance Data" section explicitly states:

"The specifications and intended uses of the SL07 and SL08 laser slit lamps are the same or very similar to those of the claimed predicate devices and other legally marketed slit lamps (as devices or as accessories to ophthalmic lasers). There are no significant differences between the SL07 and SL08 devices and claimed predicates under conditions of intended use. Because of this, performance data were not required."

The comparison table highlights key characteristics of the SL07 and SL08 in comparison to predicate devices, demonstrating their equivalence in design and function rather than quantitative performance.

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

• Not applicable. This submission relies on substantial equivalence to predicate devices, not on a new clinical performance study requiring a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable. No new ground truth for a test set was established. The basis for safety and effectiveness is the established usage and regulatory approval of predicate devices.

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

• Not applicable. No test set was used.

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. No MRMC study was conducted. This device is a modified slit lamp, not an AI-powered diagnostic tool.

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

• Not applicable. This device is a physical instrument (slit lamp) with an adapter for laser delivery, which is inherently used with a human ophthalmologist. It does not involve a standalone algorithm.

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

• The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices (Zeiss and Haag Streit Slit Lamps, Infinitech Multi-Spot Slit Lamp laser Adapter, Oculight SLx), as well as the general understanding of ophthalmic slit lamps as described in 21 CFR 886.1850 and ophthalmic lasers in 21 CFR 886.4390. The modifications made to the slit lamps (to accommodate the laser adapter) were deemed not to raise new questions of safety or effectiveness.

8. The sample size for the training set:

• Not applicable. No training set was used, as this is not an AI/machine learning device.

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

• Not applicable. No training set was used.

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