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The Solea system is indicated for the following:

• Ablation of hard tissue for caries removal and cavity prevention
• Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity
• Cutting, shaving, contouring and resection of oral osseous tissue (both)
• Aiding in the reduction of mineral loss in dental enamel

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy for ablation of hard tissue for caries removal and cavity preparation; incision, excision, vaporization, coagulation, and hemostasis of soft tissue in the oral cavity; cutting, shaving, contouring and resection of oral osseous tissue (bone). The Solea system utilizes CO2 laser technology with a wavelength of 9.3 um.
The modification to the cleared Solea system is the introduction of the DR Handpiece which allows the system to deliver controlled sub-ablative energy necessary to heat the tooth surface mineral without ablation for the new treatment of aiding in the reduction of mineral loss in the tooth enamel.

The information provided describes the Solea laser system, which is intended for dental procedures, including a new indication for "aiding in the reduction of mineral loss in dental enamel."

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for the new indication ("aiding in the reduction of mineral loss in dental enamel") with corresponding reported performance values. Instead, it describes generic safety and performance testing for various aspects of the device and a specific finding from "bench testing" relating to the new indication.

Implicit Acceptance Criteria (for the new indication related to mineral loss in dental enamel):

General Safety and Performance Criteria (for the device as a whole):

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

The document states, "The in vitro studies found that the increase in pulpal temperature following the procedure was less than the maximum threshold of 5.5º C and there were no visually observed structural changes such as melting, charring or carbonization." It also mentions, "In vitro testing demonstrated a significant benefit of the Solea system in aiding in the reduction of mineral loss in dental enamel as measured by the relative mineral loss in depth and surface mineral loss, without significant damage to the enamel. Additionally, inhibition of surface softening and surface loss during pH cycling was observed."

• Sample Size for test set: Not specified.
• Data Provenance: The studies are described as "in vitro studies" and "bench testing," indicating laboratory-based studies. The country of origin of the data is not specified. The studies appear to be prospective to evaluate the device's performance under specific conditions.

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

This information is not provided in the document. The studies mentioned are in vitro/bench testing, which often relies on objective measurements rather than expert consensus on subjective interpretations (like image-based diagnoses). Thus, the concept of "ground truth established by experts" as typically seen in diagnostic AI is not directly applicable or reported here.

4. Adjudication method for the test set

This information is not provided in the document. Since the testing involves in vitro objective measurements and assessments of physical changes (pulpal temperature, structural changes, mineral loss), an adjudication method as typically used for subjective expert evaluations is unlikely to have been relevant or performed.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or implied. This device is a laser system for treatment, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance is not applicable to its stated purpose.

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

The device is a laser system operated by a healthcare professional. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the typical sense of a diagnostic AI algorithm. The performance mentioned ("significant benefit in aiding in the reduction of mineral loss," etc.) refers to the device's direct physical effect on dental enamel as tested in vitro, not an algorithmic output.

7. The type of ground truth used

For the specific new indication:

• The "ground truth" implicitly used for the effectiveness testing (reduction of mineral loss, inhibition of softening/loss) would be quantitative measurements of mineral content, depth, and surface characteristics of dental enamel, along with objective measurement of pulpal temperature and visual observation for structural damage. This falls under scientific measurement/bench testing data.

For other safety aspects (electrical, EMC, laser, sterilization):

• Compliance with established industry standards and regulatory requirements (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, AAMI TIR12, ANSI/AAMI ST79) serves as the "ground truth" for these safety parameters.

8. The sample size for the training set

The document describes this as a medical device (laser system), not an AI/machine learning algorithm that typically requires a training set. Therefore, information about a "training set sample size" is not applicable and not provided.

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

As described above, the device is a laser system, not an AI/machine learning algorithm requiring a training set, so this information is not applicable and not provided.

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The Solea system is indicated for the following:

• Ablation of hard tissue for caries removal and cavity preparation
• Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity
• Cutting, shaving, contouring and resection of oral osseous tissue (bone)

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494) and hard tissue indications (K130420). The only changes from the previously cleared device are the addition of the osseous tissue indications. There have been no software changes or graphic changes to the Solea system. The osseous tissue settings are the same as the previously cleared device (K130420). The osseous settings have substantially equivalent fluence and irradiation as the hard tissue predicate devices. There are no other hardware or software changes to the Solea system device pending herein when compared to the device cleared under K123494 and K130420.

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25μm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.

The provided text does not contain detailed acceptance criteria or a study that directly proves the device meets specific acceptance criteria in a quantitative manner as typically expected for assessing diagnostic accuracy (e.g., sensitivity, specificity).

However, it outlines a series of non-clinical tests that demonstrate the device's substantial equivalence to predicate devices in terms of safety and performance, indirectly serving as "acceptance criteria" for regulatory clearance. Since no clinical testing was performed or required due to substantial equivalence, metrics like sensitivity, specificity, or reader improvement with AI assistance are not applicable in this context.

Here's an interpretation of the non-clinical testing and how it relates to acceptance criteria fulfillment:

1. Table of Acceptance Criteria and Reported Device Performance

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The Solea system is indicated for the following:

• Ablation of hard tissue for caries removal and cavity preparation.
• Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity.

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494). The only changes from the previously cleared device are the addition of the hard tissue indications, which combines minor software and graphic changes that will be added to the Solea system. This software change does not change the operational software, but adds a material selection icon on the home screen to include enamel, dentin, and soft tissue. The enamel and dentin settings have substantially equivalent fluence and irradiation as the hard tissue predicate devices. There are no other hardware or software changes to the Solea system device pending herein when compared to the device cleared under K123494.

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25pm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.

Here's an analysis of the acceptance criteria and study information for the Convergent Dental, Inc. Solea device, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Submission for the Solea dental laser, specifically for the expansion of its indications to include hard tissue. The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute effectiveness or ideal performance against predefined, standalone acceptance criteria in the same way a new drug might. The "acceptance criteria" here are therefore inferred from the documentation's focus on demonstrating equivalence in safety and performance to predicates through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Pulpal Safety Study (Clinical Testing):

  • Sample Size: Not explicitly stated as a number of teeth or patients. The text mentions "none of the test-subjects felt pain or discomfort," implying a human subject study, but the specific number is not disclosed.
  • Data Provenance: Prospective in-vivo study conducted at the UCSF School of Dentistry (United States).

• Usability Testing:

  • Sample Size: Not explicitly stated (e.g., number of dentists participating).
  • Data Provenance: Conducted using "dentists... on simulated tissues in a laboratory environment that replicates the intended deployment environment of the dental office." This suggests a prospective simulation-based study.

• Bench Testing (Hard Tissue Performance):

  • Sample Size: Not explicitly stated (e.g., number of samples or tests).
  • Data Provenance: Bench testing, which is generally laboratory-based (likely in the US, given the sponsor location).

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

• Pulpal Safety Study: The text mentions "Histological examination of pulp immediately after extraction." While this implies expert pathological assessment, the number and specific qualifications of the experts (e.g., pathologists, oral surgeons) are not explicitly stated.

• Usability Testing: "Participant feedback and ratings of usability" were used. The participants were "dentists," implying general practitioners or specialists. The number of dentists involved is not explicitly stated.

• Bench Testing: The ground truth for performance was established by direct measurement and comparison to predicate devices, not by expert consensus on a test set in the traditional sense of diagnostic accuracy.

4. Adjudication Method for the Test Set

• No information is provided about an explicit adjudication method (e.g., 2+1, 3+1 consensus) for any of the studies 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 MRMC comparative effectiveness study was done. This device is a dental laser, not an AI diagnostic tool, so this type of study is not relevant to this submission.

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

• Not applicable. The Solea system is a medical device (laser), not an algorithm or AI. The performance studies focus on the laser's physical effects and safety when operated by a human user.

7. The Type of Ground Truth Used

• Pulpal Safety Study: Histological examination of pulpal tissues (pathology-based ground truth) and absence of pain/discomfort (patient outcome/symptom-based ground truth). Studies used "in-vivo" methods, implying actual biological response.
• Usability Testing: Direct observation and subjective feedback/ratings from dentists.
• Hard Tissue Bench Testing: Direct physical measurements of thermal effects and comparison to established predicate device performance.

8. The Sample Size for the Training Set

• Not applicable. This device is a laser system, not an AI/machine learning algorithm that requires a training set in that context. The "training" for the device is its design and engineering based on known principles of laser physics and previous device clearances.

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

• Not applicable, as there is no training set in the context of AI/machine learning. The "ground truth" for the device's development and design would be established through scientific literature, engineering principles, and the performance characteristics of previously cleared predicate devices (K091746 and K101817 for hard tissue, K123494 for soft tissue). The submission explicitly states that the new hard tissue indications "combine minor software and graphic changes" and have "substantially equivalent fluence and irradiation as the hard tissue predicate devices." This indicates the design was guided by known safe and effective parameters from existing, cleared devices.

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The Solea system is indicated for the following:

• Incision .
• . Excision
• . Vaporization
• . Coagulation
• Hemostasis .
  of soft tissue in the oral cavity.

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25μm to safely and effectively perform incision, excision, vaporization, coagulation, and hemostasis.

The provided text describes a 510(k) submission for the Solea system, a CO2 laser for dental treatment. The submission aims to establish substantial equivalence to a predicate device, the Lutronic Corporation Spectra DENTA II Laser System (K091320), rather than demonstrating a new level of performance or effectiveness through a clinical trial. Therefore, the information typically associated with acceptance criteria for device performance and a study proving those criteria (as specified in your request) is not explicitly detailed in the context of this 510(k) summary.

However, based on the provided text, we can infer some "acceptance criteria" through the non-clinical testing performed to establish substantial equivalence in safety and performance. The study described is a bench testing comparison against the predicate device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the Solea system's performance should be substantially equivalent to the predicate device in terms of safety and performance characteristics for soft tissue cutting. The reported device performance is that these criteria were met.

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

• Sample Size for Bench Testing (Soft Tissue): Not explicitly stated. The text only mentions "Performance data was collected using the Solea system and the predicate device" and "a quantitative analysis was conducted." It does not provide the number of samples, tissue types, or experimental repetitions.
• Data Provenance: The bench testing was conducted by Convergent Dental, Inc. (the submitter) as non-clinical testing to support the 510(k) submission. The exact location or origin of the tissue samples is not specified. It is an internal, retrospective study for regulatory purposes.

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

• This type of information is generally not applicable for a bench test comparing physical characteristics of a laser.
• For the histological assessment, implied in "histological assessment of changes in sample tissue," it would typically involve a pathologist. However, the number of pathologists or their qualifications are not specified in the document.

4. Adjudication Method for the Test Set

• Not applicable as this was a bench test with objective measurements and comparative histological assessment, not a diagnostic imaging study requiring expert adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

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

• This question is not applicable as the Solea system is a physical laser device, not an AI algorithm. Its "standalone performance" refers to its physical output and effect on tissue, which was assessed in the bench testing. No human-in-the-loop element beyond operating the device is relevant here in the context of device performance.

7. The Type of Ground Truth Used

• For the bench testing, the "ground truth" was established through direct physical measurement (depth, width, length of cuts) and histological assessment (microscopic analysis of tissue changes). These are objective measurements and expert pathological interpretation, respectively.

8. The Sample Size for the Training Set

• Not applicable. This device is a laser system, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable for the same reason as above.

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