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For removal of caries and for cavity preparation in primary and secondary teeth.

DeL2940 Dental Erbium Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. Delivery is via fiber optic with a quartz contact tip. At 10 pulses per second an a pulse energy of 1 Joules, the average power from the laser is 10 watts.

The provided text describes a 510(k) Premarket Notification for the DeL2940 Dental Erbium Laser. It outlines the device's intended use and presents summaries of nonclinical and clinical performance data to demonstrate substantial equivalence to a predicate device. However, it does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, it states that the studies "supported the safety and effectiveness" of the Er:YAG laser.

Therefore, I cannot fill out Table 1 with specific acceptance criteria and reported device performance values. The document focuses on demonstrating substantial equivalence rather than meeting pre-defined quantitative performance targets.

Here's a breakdown of the other requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit numerical acceptance criteria are provided in the document. The studies aimed to demonstrate "safety and effectiveness" and "substantial equivalence" rather than meeting pre-defined quantitative performance thresholds for the device itself.

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

• Nonclinical Studies:
  • Bovine Studies: 22 teeth.
  • Canine Studies: 174 teeth. One study compared laser treatment to a drill.
  • Data Provenance: Not explicitly stated, but implies laboratory studies.
• Clinical Studies (Test Set):
  • Foreign Data: 245 human teeth (18 extracted, 23 scheduled for extraction, 204 in vivo).
  • Domestic Data (IDE Study): 94 pediatric subjects and 121 adult subjects.
  • Data Provenance: Foreign data from four clinical studies. Domestic data from an IDE study. Both are prospective clinical studies.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set in either the nonclinical or clinical studies.

4. Adjudication Method for the Test Set

The document does not provide information on any 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, and Effect Size

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly mentioned. One canine study compared the laser treatment to a drill, which suggests a comparative study, but it's not described as an MRMC study involving human readers and AI. The document is about a laser device, not an AI diagnostic tool.

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

This question is not applicable as the device is a medical laser system, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for the studies would be:

• For caries removal: Successful removal of carious tissue, likely confirmed visually and perhaps tactilely by dental professionals or researchers.
• For cavity preparation: Successful preparation of a cavity meeting clinical standards for restorative dentistry.
• For safety: Absence of adverse events, excessive thermal damage, or other complications.

The document does not detail how "ground truth" was formally established beyond supporting "safety and effectiveness."

8. The Sample Size for the Training Set

This question is not applicable as the device is a medical laser system, not an AI model that requires a training set.

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

This question is not applicable as the device is a medical laser system, not an AI model that requires a training set.

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For the removal or lightening of unwanted hair without adjuvant preparation
For the removal or lightening of unwanted hair in the 1064nm mode only without adjuvant preparation using one or two treatments.

Medlite™ Q-Switched Nd:YAG Laser
Medlite™ IV Q-Switched Nd:YAG Laser

The provided text states that "Clinical data was provided to support the use of the Medlite™ Q-Switched Nd:YAG Laser Systems without preparatory lotion to safely remove or lighten unwanted hair without adverse clinical findings." However, it does not detail specific acceptance criteria or an explicit study proving these criteria were met. Therefore, most of the requested information cannot be extracted from the given text.

Here is what can be inferred or explicitly stated from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified in the provided text.
• Qualifications of Experts: Not specified in the provided text.

4. Adjudication method for the test set:

• Not specified in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• There is no mention of an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device in question is a laser system, not an AI diagnostic tool.

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

• Not applicable. The device is a physical laser system, not an algorithm.

7. The type of ground truth used:

• Based on the statement "safely remove or lighten unwanted hair without adverse clinical findings," the ground truth appears to be based on clinical observation of hair removal/lightening and the absence of adverse events. Specific methods for assessing hair removal/lightening success or adverse events are not detailed.

8. The sample size for the training set:

• Not applicable, as this device is a laser system and typically does not have a "training set" in the AI sense. Clinical studies involve a cohort of patients. The sample size for the clinical study (which would be analogous to a test set in a device performance study) is not provided.

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

• Not applicable, as there is no "training set" in the context of this device.

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For the removal or lightening of unwanted hair in the 1064nm mode only.

Medlite™ Q-Switched Nd:YAG Laser
Medlite™ IV Q-Switched Nd:YAG Laser

The provided document is a 510(k) summary for a medical laser device (Medlite™ Q-Switched Nd:YAG Laser / Medlite™ IV Q-Switched Nd:YAG Laser) and does not contain information about an AI/ML powered device or software. Therefore, most of the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted.

The document indicates that the device's substantial equivalence was established by comparison to a predicate device (ThermoLase LT-100 Nd:YAG Laser Hair Removal System, K950019). The "Clinical Performance Data" section states "Authorization provided to access data in K950019." This implies that the clinical data from the predicate device was used to support the safety and effectiveness of the new device, rather than new clinical trials specifically for the Medlite laser.

Below is an attempt to answer the questions based only on the provided text, highlighting what is missing due to the nature of the document.

Acceptance Criteria and Device Performance for Continuum Biomedical's Medlite™ Q-Switched Nd:YAG Laser

This document pertains to a traditional medical device (laser system) and therefore does not include detailed acceptance criteria or a study design typical for an AI/ML-powered device. The regulatory submission relies on substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided 510(k) summary. For a traditional medical device like a laser, acceptance criteria would typically involve engineering specifications, safety standards compliance, and potentially clinical outcomes shown to be equivalent to a predicate device. The performance is assessed by comparison to the predicate.

2. Sample size used for the test set and the data provenance
Not applicable/not provided for a standalone AI/ML device study. The clinical performance data relies on the predicate device (K950019). The document states, "Clinical Performance Data: Authorization provided to access data in K950019." This implies that the data from the predicate device's studies were referenced. The specific sample size, country of origin, or retrospective/prospective nature of that predicate data is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/not provided. This concept (ground truth established by experts for a test set) is specific to AI/ML model evaluation. For this laser device, clinical efficacy against unwanted hair would likely have been assessed by clinicians or through patient outcomes in the predicate study.

4. Adjudication method for the test set
Not applicable/not provided. This refers to resolving disagreements among experts for ground truth establishment in AI/ML studies.

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, as this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm.

7. The type of ground truth used
Not applicable for an AI device. For the laser device's intended use, the "ground truth" for efficacy would likely be direct observation of hair removal/lightening by clinicians or patient self-reporting, as established in the predicate device's clinical data.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.

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For incision, excision, ablation, vaporization of soft tissue for general dermatology, as well as at the 1064nm wavelength, dark ink (blue/black) tattoo removal and Nevus of Ota and at the 532nm wavelength, light ink (red) tattoo removal, vascular and pigmented lesions.

Medlite IVTM consists of three main components: the power supply used to provide the proper voltage and current to the laser system, the water cooling system used to remove heat from the power supply and the optical bench consisting of the YAG rod, flashlamp, various mirrors, frequency doubler crystal and articulated arm.

The lasing action of the Medlite IVTM occurs when first the flashlamp is excited by a high voltage electrical pulse from the power supply. The excited flashlamp then emits an intense broad-spectrum light. The YAG rod absorbs most of this light and then releases the energy as laser light at 1064nm.

The Q-Switch acts as an extremely high speed shutter and can be set to release the light at pulse rates of 1, 2, 5, and 10 pulses per second or single shot. The frequency doubler can be enabled to change the 1064nm (infrared) light to a second wavelength at 532nm (green).

This document describes the 510(k) summary for the Medlite IV™ Q-Switched Nd:YAG Laser System. However, it does not contain the specific information required to answer your request regarding acceptance criteria and performance studies.

Here's why and what's missing:

• Type of Device: This is a medical laser system used for dermatological procedures and tattoo removal. It's a physical device, not an AI/software device that would typically have acceptance criteria based on algorithmic performance metrics like accuracy, sensitivity, specificity, etc.
• Study Data: The summary explicitly states:
  • "None presented at this time. Nonclinical Performance Data:"
  • "None presented at this time. Clinical Performance Data:"

Therefore, I cannot provide the requested information. The 510(k) summary for this device focuses on demonstrating substantial equivalence to a predicate device (Polytec PI LaseAway Nd:YAG Laser) by comparing operating parameters, physical characteristics, and intended uses, rather than presenting new performance studies against specific acceptance criteria for AI algorithms.

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Scanning Device Accessory for use with the CB Diode/532 TM Nd:YAG Laser for general dermatology (soft tissue ablation) and the treatment of vascular and pigmented lesions.

The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.

The provided text is a 510(k) summary for a medical device called "Scanning Device Accessory for the CB Diode/532TM Nd:YAG Laser." It explicitly states that no nonclinical or clinical performance data was provided. Therefore, no acceptance criteria or studies proving the device meets those criteria are mentioned.

Here's an analysis based on the information provided:

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

   • Acceptance Criteria: Not specified.
   • Reported Device Performance: Not reported.

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 as no clinical or nonclinical performance data was provided.

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 clinical or nonclinical performance data was provided.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

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

   • Not applicable. This device is a scanning accessory for a laser, not an AI-assisted diagnostic tool. No MRMC study was mentioned.

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

   • Not applicable. This device is hardware, not an algorithm. No standalone performance data was provided.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

8. The sample size for the training set

   • Not applicable as no clinical or nonclinical performance data was provided. This device is hardware and not related to machine learning algorithms requiring training sets.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

Conclusion from the provided text:

The 510(k) summary explicitly states:

• "Nonclinical Performance Data: none"
• "Clinical Performance Data: none"

The basis for clearance was a comparison to an equivalent predicate device, the SoftScanTM Scanning Device, Sahar Technologies, Inc. (K964684). The submission primarily focused on demonstrating substantial equivalence to this already cleared device. The "Conclusion" section states: "The Scanning Device Accessory for the CB Diode/532TM Nd: YAG Laser enhances the clinical application procedure while maintaining the performance characteristics," implying that its performance is presumed to be similar to its predicate.

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Scanning Device Accessory for use with the CB Erbium / 2.94TM Er:YAG Laser for general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles.

The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.

The provided document, K971879, is a 510(k) summary for a "Scanning Device Accessory for the CB Erbium / 2.94TM Er:YAG Laser." This document states that no nonclinical or clinical performance data was provided or reviewed for this submission. Therefore, there is no information available to describe acceptance criteria or a study proving the device meets those criteria.

The submission concluded that the device "enhances the clinical application procedure while maintaining the performance characteristics" but this was based on comparison to an equivalent device (SoftScanTM Scanning Device, Sahar Technologies, Inc. K964684) and not on new performance data for the K971879 device itself.

Given the absence of performance data, all sections of your request regarding acceptance criteria and performance studies cannot be answered from this document.

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For skin resurfacing in the treatment of wrinkles

CB Erbium / 2.94 TM Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second an a pulse energy of 2 Joules, the average power from the laser is 10 watts.

The provided FDA 510(k) summary and associated documents describe the CB Erbium / 2.94 TM Er:YAG Laser for skin resurfacing in the treatment of wrinkles.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission acts more as a claim of equivalency rather than defining explicit quantitative acceptance criteria or performance metrics in a table. Instead, the "Comparison" and "Clinical Performance Data" sections describe the device's performance relative to a predicate device.

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

• Sample Size: Not specified. The document only mentions "A clinical trial was conducted." No specific number of patients or lesions is provided.
• Data Provenance: Not specified. The country of origin is not mentioned. The study is described as a "clinical trial," which implies prospective data collection, but this is not explicitly stated.

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 submission. The method for assessing "reduction of wrinkles," "side effects," and "recovery time" is not detailed, nor are the qualifications of any involved assessors/experts mentioned.

4. Adjudication Method for the Test Set

• This information is not provided. Given the lack of detail on experts, an adjudication method is also not 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

• No. This is a medical device (laser), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance for human readers is not applicable and was not performed.

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

• Not applicable. The device is a direct treatment laser, not an algorithm. Its performance is directly observed in patients, not through a computational algorithm generating outputs that might be compared to a standalone algorithm.

7. The Type of Ground Truth Used

• The ground truth for effectiveness ("reduction of wrinkles") would likely have been based on clinical assessment by physicians or
  qualified medical personnel, potentially using standardized scales (though not specified).
• For safety data ("side effects" and "recovery time"), the ground truth would have been based on patient reporting and clinical observation
  by healthcare providers.
• It is not pathology, or outcomes data in the sense of long-term survival for oncology, but rather direct clinical observation of the treatment's immediate effects and complications.

8. The Sample Size for the Training Set

• This concept is not applicable as the device is a physical laser, not an AI model requiring a training set. The clinical trial serves as the performance verification.

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

• This concept is not applicable as the device is a physical laser, not an AI model.

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For use in dermatology for the removal of tattoos and the treatment of vascular and pigmented lesions.

The new Dye Accessory Handpiece for the Medlite™ Nd:YAG Laser System is consists of four primary parts: the handpiece which contains a short optical cavity and focusing optics, the plastic dye module, the commercial power meter and appropriate laser safety goggles.

This 510(k) summary, K963340, does not contain information related to software, artificial intelligence, or diagnostic device performance. The device described, the "Medlite™ Nd:YAG Laser System: New Dye Accessory Handpiece," is a dermatology laser system.

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

• No Acceptance Criteria: The document does not define any specific performance acceptance criteria for the device in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics. Its "Comparison" section focuses on delivering "slightly altered wavelengths for increased efficiency."
• No Device Performance Metrics: There are no reported device performance metrics like accuracy, AUC, sensitivity, specificity, etc., because the device is a therapeutic laser, not a diagnostic one.
• No Clinical Study Data: The sections "Nonclinical Performance Data" and "Clinical Performance Data" both explicitly state "none." This means no studies were performed to prove performance against specific criteria, clinical or otherwise.
• No Test Set/Ground Truth: Since no clinical or performance studies were conducted or reported, there's no mention of a test set, its provenance, the number of experts, adjudication methods, or the type of ground truth used.
• No MRMC or Standalone Study: These types of studies relate to diagnostic devices, particularly those involving AI or human interpretation. This laser system does not fall into that category.
• No Training Set: As there's no AI component or diagnostic algorithm, there's no mention of a training set or how ground truth for a training set would be established.

Therefore, I cannot populate the table or answer the questions as they pertain to aspects that are not relevant or present in this 510(k) summary for a therapeutic laser system.

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Treatment of pigmented lesions.

The Medlite\755 Alexandrite Laser is a flashlamp excited Q-switched solid state laser producing a broadband wavelength of 755 ±25nm. Medlite\755™ Alexandrite Laser System is currently marketed under K935631, SE date 08/23/94, for tattoo removal.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Analysis of Acceptance Criteria and Study Information for Medlite™ Alexandrite Laser System (K96006)

It's important to note that this 510(k) summary (K96006) for the Medlite™ Alexandrite Laser System states “none” for both nonclinical and clinical performance data. This indicates that the device's substantial equivalence was based on direct comparison to a predicate device (Cynosure's PhotoGenica T10 Laser, K950684) with similar characteristics, rather than new performance data or a specific clinical study for this premarket notification.

Therefore, many of the requested fields related to a detailed performance study cannot be filled based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not applicable (no new clinical performance data was provided for this 510(k)).
• Data provenance: Not applicable.

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

• Not applicable.

4. Adjudication method for the test set

• Not applicable.

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 MRMC study was done (this device is a laser system, 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 not an algorithm-only or AI device).

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

• Not applicable. The basis for clearance was substantial equivalence to a predicate device, not new ground truth establishment.

8. The sample size for the training set

• Not applicable (no new clinical or AI training data provided).

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

• Not applicable.

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For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

The Medlite\Erbium Laser is an erbium laser producing laser emissions at 2.94 $\mu$ . The laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 10 watts.

This 510(k) summary for the K961748 Medlite Erbium Laser System does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as it explicitly states:

• Nonclinical Performance Data: none
• Clinical Performance Data: none

Therefore, I cannot provide the information requested in your prompt based solely on the provided K961748 document. The device was deemed substantially equivalent to a predicate device (SEO Medical TriLase 2940 Erbium Laser System; K954013) without specific performance studies detailed in this summary.

Here's a breakdown of why each requested item cannot be answered:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported.
2. Sample sized used for the test set and the data provenance: No test set data or provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment or experts are mentioned.
4. Adjudication method for the test set: No test set or adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a laser system, not an AI-assisted diagnostic device, and no such study is mentioned.
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 performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study with ground truth is mentioned.
8. The sample size for the training set: Not applicable, as no algorithm training or training set is mentioned.
9. How the ground truth for the training set was established: Not applicable, as no algorithm training or training set is mentioned.

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