Search Results

Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and monitor patient compliance to oral device/appliance therapy.

The SomnoDent intraoral devices functions as a mandibular repositioner, which acts to increase the patient's pharvngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to breather during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the sleep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.

This Rest Assure System consists of two appliances, namely the Rest Assure Elite Appliance with (formerly the SomnoDent Herbst commercially distributed under K150369) and the Rest Assure Avant. Both hold current 510(k) clearances from FDA, K150369 for the SomnoDent Herbst Advanced with embedded micro-recorder and K183443 for the SomnoDent Avant.

The provided FDA 510(k) summary for the "Rest Assure System" does not contain the acceptance criteria and the study that proves the device meets those criteria in the format requested.

The document states that "clinical testing was not required or performed." Therefore, there is no clinical study described that would establish acceptance criteria for device performance based on patient outcomes, nor details on a clinical test set, expert adjudication, or MRMC studies.

The performance testing section (8.0) lists various engineering and regulatory compliance tests:

• A. Software Testing per IEC 62304
• B. Safety Testing by UL per 60601-1 series
• C. EMC Testing per 60601-1-2
• D. Risk Analysis per ISO 14971
• E. Cybersecurity Evaluation and Assessment
• F. Co-existence Testing and Assessment
• G. Biocompatibility Assessment
• H. Usability Testing per IEC 62366
• Further, functional and systems testing was performed to demonstrate requirements were successfully completed to demonstrate compliance with the device requirements and specifications.

These tests are primarily focused on safety, electromagnetic compatibility, usability, software quality, and biocompatibility, as per regulatory standards, rather than clinical performance metrics like sensitivity, specificity, or improvement in a medical condition. The document concludes that based on these engineering tests and the device's similarity to predicates, it is "safe and effective for its intended purpose."

Therefore, I cannot populate the table and answer the subsequent questions as the information is not present in the provided text.

Ask a specific question about this device

The SomnoDent Avant is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent Avant device is an intraoral device used for treating Snoring and Sleep Apnea. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is customized for each patient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Avant is a modification to the SomnoDent Flex (K073004). The SomnoDent Avant is identical to SomnoDent Flex, except for differences in the adjustment mechanism (strap set material), and a change in adjustable range from -1.0mm to +8.0mm.

Here's an analysis of the provided text regarding the SomnoDent Avant device, focusing on acceptance criteria and the study proving it meets them.

The provided document is a 510(k) summary for the SomnoDent Avant, which primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about a clinical study with human subjects to prove the device's performance against specific acceptance criteria for effectiveness (e.g., reduction in AHI, improved snoring). Instead, the performance evaluation relies heavily on bench testing and material conformance to show that the modified device (SomnoDent Avant) is as safe and effective as its predicate (SomnoDent Flex).

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) cannot be answered from the provided text, as such studies were not the basis for this 510(k) clearance.

Key takeaway: This 510(k) relies on demonstrating the new device is fundamentally similar to an already cleared device, not on new clinical performance data.

Acceptance Criteria and Device Performance (As Inferred from the 510(k) Summary)

Since a clinical performance study with acceptance criteria for clinical outcomes (e.g., AHI reduction) is not detailed, the "acceptance criteria" here are best characterized as design and material characteristics demonstrating substantial equivalence to the predicate, and bench test results confirming the safety and functional integrity of the modifications.

Study Details Proving Device Meets Acceptance Criteria

Given that this 510(k) relies on substantial equivalence and bench testing, direct answers to many of the typical clinical study questions are not available from the provided text.

1. Sample Size Used for Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable in the context of clinical performance evaluation. The "test set" refers to materials or mechanical components undergoing bench testing. The specific number of samples for each bench test (biocompatibility, material conformance, adjustment mechanism) is not provided.
   • Data Provenance: The document does not specify a country of origin for the bench testing data. It mentions "Bench testing of the new adjustment mechanism and evaluation of the additional strap set material," implying laboratory testing. The studies were non-clinical (Summary of Non-Clinical Testing).

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

   • Not applicable. Ground truth for clinical performance was not established through expert consensus in this 510(k). The "ground truth" for material properties and functionality was established by adherence to specified ISO standards and validated test methods.

3. Adjudication Method for the Test Set:

   • Not applicable. This was not a human-reader study requiring adjudication.

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

   • No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence through design, materials, and non-clinical bench testing.

5. If a Standalone (Algorithm Only) Performance Study was done:

   • Not applicable. This device is a physical intraoral appliance, not an AI algorithm.

6. The Type of Ground Truth Used:

   • The "ground truth" for the acceptance criteria was based on established international standards (ISO) for biocompatibility, material properties, and risk management (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 20795-1, ISO 14971) and engineering principles for mechanical function. This is consistent with a 510(k) for a physical device demonstrating substantial equivalence.

7. The Sample Size for the Training Set:

   • Not applicable. No "training set" in the context of machine learning or AI models was used. The device is physically manufactured based on patient scans and a prescribed design.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as no training set was used.

Ask a specific question about this device

The SomnoDent ALPHA is temporarily intended as an aid in the reduction of simple night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older.

The SomnoDent ALPHA is a device that functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device consists of two generic splints, which fit over the upper and lower teeth. The lower splint is held in a protrusive position by an advancement mechanism. The device advances the mandible in the sagittal plane to increase the patient's pharyngeal space during sleep and reduce the apnea symptoms.

This document is a 510(k) summary for the SomnoDent ALPHA® device, which is an intraoral device for snoring and obstructive sleep apnea. The document asserts the device's substantial equivalence to predicate devices based on technological characteristics, intended use, and performance testing.

There is no detailed study described in this document that proves the device meets specific acceptance criteria with quantifiable results. Instead, the document relies on comparisons to predicate devices and general statements about performance and safety testing.

Here's a breakdown of the requested information based on the provided text, highlighting the absence of specific study details where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. It relies on the concept of "substantial equivalence" to predicate devices. However, we can infer some "performance specifications" from the comparison table (Section 7.0) and the discussion in Section 8.0.

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

This information is not provided in the document. The document refers to "performance testing" and "simulated in-use testing" but does not specify the sample size for these tests (e.g., number of devices tested, number of cycles for mechanical testing). Data provenance is also not mentioned.

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 document does not describe any human-involved assessment of the device's performance that would require establishing a ground truth by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. No adjudication method is mentioned as there's no description of a study involving multiple interpretations needing reconciliation.

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

There is no MRMC comparative effectiveness study described. This device is a physical intraoral device, not an AI-powered diagnostic or assistive tool, so this type of study is not relevant.

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

This is not applicable as the device is a physical intraoral device, not an algorithm.

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

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. The document describes performance testing based on engineering principles (e.g., ability to withstand forces, biocompatibility testing against ISO standards) rather than clinical diagnostic accuracy against a definitive truth.

8. The sample size for the training set

This information is not provided and is not applicable as this is a physical device, not a machine learning model requiring a training set.

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

This information is not provided and is not applicable as this is a physical device, not a machine learning model.

Ask a specific question about this device

The SonmoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

The SomnoDent family of intraoral devices consists of the following models: Classic, Flex, G2, Herbst Advance, and Fusion. The devices functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be seep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.

This submission adds the option for any clinician to decide to incorporate a DentiTrac® microrecorder embedded into a SomnoDent® to record a patient's compliance to the prescribed oral appliance therapy in combination with the DentiTrac® System. This option can be incorporated into the family member models listed above. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. The inclusion of the embedded DentiTrac® micro-recorder provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles or safety of the SomnoDent®

This document describes the SomnoDent® with Micro-Recorder, an oral appliance intended for the treatment of snoring and mild to moderate obstructive sleep apnea, with an optional embedded micro-recorder to measure patient compliance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or reported device performance metrics in a readily extractable table for the SomnoDent® with Micro-Recorder itself.

Instead, the submission for the SomnoDent® with Micro-Recorder relies on demonstrating substantial equivalence to a previously cleared predicate device (SomnoDent® Fusion Classic and SomnoDent® Fusion Flex, K140278). The key argument is that the addition of the DentiTrac® micro-recorder does not change the intended use or safety/effectiveness of the SomnoDent device for treating sleep apnea and snoring.

The table in Section 7.0 ("Comparison to the Predicate") lists several "Technological Characteristics" and indicates whether both the predicate and proposed device possess these characteristics. This table serves as a comparison to show that the fundamental design and intended use of the SomnoDent device itself remain unchanged. The only difference highlighted is the presence of the DentiTrac® Micro-recorder in the proposed device.

The section 8.0 Performance Testing states: "Since the characteristics of the SomnoDent® did not change, no new clinical performance data was necessary to substantiate this change." This indicates that no new clinical performance metrics or acceptance criteria for treatment effectiveness were established or evaluated for this 510(k) submission, as it is assumed to be equivalent to the predicate.

The performance testing mentioned focuses on the new component (DentiTrac® micro-recorder) and its integration:

• EMC and electrical safety
• Biocompatibility
• Software elements
• Process validation to ensure reliable embedding and retention of Quality Control functionality.

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

The document does not mention a traditional test set sample size in the context of clinical performance for the SomnoDent® with Micro-Recorder itself. The claim is substantial equivalence based on the predicate device's existing performance.

For the embedded DentiTrac® micro-recorder, the document refers to "Risk assessments and non-clinical testing." It mentions data being reported in "master file, MAF2557" which would presumably contain details on the testing of the micro-recorder's functionality, but the specifics of sample sizes or data provenance (country, retrospective/prospective) are not detailed in this 510(k) summary. Given the nature of these tests (EMC, electrical safety, biocompatibility, software, process validation), they typically involve testing of components or prototypes rather than large human subject cohorts.

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

This information is not provided as no new clinical study to establish ground truth for treatment effectiveness was necessary for this submission. For the non-clinical testing of the micro-recorder, expert involvement (e.g., in risk assessment or evaluation of test results) is implied for the master file, but not explicitly detailed regarding number or qualifications.

4. Adjudication Method for the Test Set

This information is not provided as no clinical adjudication for a human subject test set is mentioned.

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

No, a MRMC comparative effectiveness study was not done. The device is a physical intraoral appliance with an optional compliance recorder, not an imaging or diagnostic AI requiring human reader interaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

For the SomnoDent® device itself (for treatment of sleep apnea/snoring), it's a physical device that a clinician fits and adjusts. There is no algorithm-only performance in the typical sense.

For the DentiTrac® micro-recorder, its function is to objectively measure wear time, movements, and head position. This is an objective data collection function. While it uses internal algorithms to process raw sensor data into meaningful metrics (like wear time based on oral temperature), the document does not describe a standalone performance study of these algorithms in terms of accuracy against a ground truth for wear time. It refers to "software elements were assessed and tested" and "Process validation was generated from SomnoMed to ensure that the SomnoDent® devices can be repeatedly and reliably embedded and retain the Quality Control functionality of SomnoDent® and the DentiTrac®." This implies internal validation, but no external standalone study is detailed in this document.

7. Type of Ground Truth Used

For the SomnoDent® device's substantial equivalence, the "ground truth" for its effectiveness is implicitly the established effectiveness of the predicate device (K140278) which would have undergone its own clinical validation.

For the DentiTrac® micro-recorder, the "ground truth" for its compliance measurement function (wear time based on oral temperature, movement, head position) is not explicitly detailed in this document. It's likely that internal validation studies would have demonstrated the accuracy of its sensors and algorithms against known physical conditions or reference measurements, but these specifics are absent from the 510(k) summary.

8. Sample Size for the Training Set

This information is not applicable in the context of this 510(k) submission. The device is not an AI/ML algorithm that requires a separate training set. The DentiTrac® micro-recorder contains software, but it operates based on defined sensor input and algorithms, not machine learning models trained on large datasets in the way typical AI devices are.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The SomnoDent Fusion is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent Fusion is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is patient specific (it is customized for each patient) and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Fusion is a modification to the SomnoDent Classic (K050592), SomnoDent Flex (K073004), SomnoDent G2 (K121340) and SomnoDent Herbst (K130558). The SomnoDent Fusion is identical to SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst except for differences in the adjustment mechanism. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

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

Device: SomnoDent Fusion (an intraoral device for snoring and mild to moderate obstructive sleep apnea)

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

Based on the provided document, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through mechanical testing. The performance is reported as meeting this equivalence.

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

The document states: "Mechanical testing was conducted on the calibration mechanism of the subject device." However, it does not specify the sample size for this mechanical testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) of this testing data.

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 as the study described is mechanical testing, not a clinical study involving human assessment or ground truth established by experts.

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

This information is not applicable as the described study is mechanical testing, not a clinical study involving human judgment or adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. The SomnoDent Fusion is a physical intraoral device, not an AI or imaging diagnostic tool that would be evaluated with human readers.

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

A standalone performance test in the context of an algorithm or AI was not performed, nor is it applicable to this device. The device is a physical intraoral appliance. The "standalone" performance described is the mechanical testing of the device itself.

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

For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established based on the predicate devices. The document implies that the "truth" is the "applicable pressures" and successful functioning compared to the predicate.

8. The sample size for the training set

This information is not applicable as the described study is mechanical testing for substantial equivalence, not a machine learning model requiring a training set.

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

This information is not applicable as there is no training set for a machine learning model.

Ask a specific question about this device

The SomnoDent Herbst is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent Herbst is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is patient specific (it is customized for each patient) and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Herbst is a modification to the SomnoDent Classic (K050592) and SomnoDent Flex (K073004). The labeling is a modification to the SomnoDent G2 (K121340). The SomnoDent Herbst is identical to SomnoDent Classic and SomnoDent Flex, except for differences in the adjustment mechanism (which is a Herbst style titration mechanism). Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

The provided text describes a 510(k) summary for the SomnoDent Herbst device. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a predicate device, rather than providing a detailed study that proves acceptance criteria for a novel device's performance.

Therefore, many of the requested items related to a comprehensive study (like specific acceptance criteria values, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not explicitly present in this type of regulatory submission. The document focuses on demonstrating that the new device (SomnoDent Herbst) is as safe and effective as previously cleared predicate devices through a comparison of design, intended use, and mechanical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Specific quantitative acceptance criteria with numerical targets are not provided in the document. This submission relies on demonstrating substantial equivalence to predicate devices rather than establishing new performance benchmarks.

The reported device performance is described qualitatively:

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

• Sample Size for Test Set: Not specified. The "mechanical testing" mentioned refers to tests performed on the device's mechanism itself, not a clinical trial with human subjects.
• Data Provenance: The mechanical testing was conducted on the "Herbst style titration mechanism of the subject device." No country of origin for data or retrospective/prospective nature is mentioned, as it's a verification test of the device components.

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

• This information is not applicable and not provided. The "ground truth" for mechanical testing is typically based on engineering specifications and standards, not expert clinical consensus.

4. Adjudication Method for the Test Set

• Not applicable and not provided. This relates to clinical studies with ambiguous outcomes, which is not the case for mechanical testing described here.

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

• No, an MRMC comparative effectiveness study was not done. This type of study would involve human readers interpreting medical images or data, which is not relevant for this device (an intraoral device).

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

• No, a standalone performance study was not done. This device is a physical intraoral device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the mechanical testing, the ground truth is based on engineering specifications and performance requirements for medical devices of this type, ensuring the mechanism can withstand applicable pressures and function as intended. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or algorithms. It's a manufactured physical product.

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

• Not applicable/Not provided. As there is no training set for this type of device, no ground truth needed to be established in that context.

Ask a specific question about this device

The SomnoDent G2 is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent G2 device is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is customized for each patient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent G2 is a modification to the SomnoDent Flex (K073004). The SomnoDent G2 is identical to SomnoDent Flex, except for differences in the adjustment mechanism (which is an addition of a material of construction, which is biocompatible), and a change (which to an addition of a differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

The SomnoDent G2 is an intraoral device for treating snoring and mild to moderate obstructive sleep apnea. The provided text, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device (SomnoDent Flex, K073004) rather than presenting a study demonstrating its performance against specific acceptance criteria for efficacy in patients. Therefore, the device performance is primarily assessed through comparison to the predicate.

Here's an analysis of the information, acknowledging that the primary "study" is a comparative bench testing study to establish substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission focused on substantial equivalence through bench testing rather than clinical efficacy, the "acceptance criteria" discussed are largely related to mechanical performance and safety, and the "reported device performance" is framed in terms of equivalence to the predicate.

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

• Sample Size: The document does not specify a "sample size" in terms of number of devices or units tested for the bench tests. It refers generally to "the subject device" and "the predicate device," suggesting testing was performed on representative units.
• Data Provenance: Not applicable in the traditional sense of patient data. The data is from laboratory bench testing.

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

• This is not applicable to this type of submission. The ground truth for mechanical and safety tests is established by engineering standards and validated testing protocols, not expert clinical consensus on patient outcomes.

4. Adjudication Method for the Test Set

• Not applicable. Bench testing results are typically objectively measured and evaluated against predefined engineering specifications, not adjudicated by a panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This is not a study involving human readers or AI.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The ground truth for the bench testing was engineering specifications and mechanical performance standards. For comparison purposes, the performance of the legally marketed predicate device (SomnoDent Flex) served as a benchmark for equivalence. Biocompatibility standards would also serve as ground truth for material selection.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable.

Ask a specific question about this device

The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.

The SomnoBrux Splints are intraoral devices used for treating bruxism. They consist of a custom fitted tray that fits over the upper or lower teeth. There are four different designs for this application all with varying degrees of function and suitability depending on the patients needs. The Michigan and the SomnBrux "B" splints are fitted on the maxillary arch and ii) The Gelb and Tanner splints are fitted on the mandibular arch. These devices function as a protective barrier between upper and lower tooth surfaces which will prevent tooth damage caused by grinding, bruxing and will help alleviate jaw and muscle pain. The dentist prescribes the Michigan, Gelb, Tanner or SomnoBrux "B" design; whichever is best suited to the patient.

The provided text is a 510(k) summary for the SomnoBrux Splints. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about specific performance acceptance criteria or a study designed to prove the device meets those criteria in the way typically found for AI/ML devices.

The entire summary focuses on establishing substantial equivalence to previously cleared devices based on comparative analysis of features, materials, and design, rather than quantitative performance metrics for the SomnoBrux Splints themselves.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or reported performance metrics for the SomnoBrux Splints. The conclusion of substantial equivalence is based on a qualitative comparison of design and function with predicate devices.

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

• Cannot be provided. No test set or clinical study data is mentioned in relation to proving the performance of the SomnoBrux Splints. The submission relies on design and functional similarity to predicates.

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):

• Cannot be provided. No test set or ground truth establishment is described.

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

• Cannot be provided. 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:

• Cannot be provided. The device is a physical intraoral splint, not an AI/ML algorithm. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

• Cannot be provided. This is not an AI/ML device.

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

• Cannot be provided. No ground truth is established for the SomnoBrux Splints' performance in the context of a study. The "ground truth" for this 510(k) is essentially the established safety and effectiveness of the predicate devices based on their design and intended use.

8. The sample size for the training set:

• Cannot be provided. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

• Cannot be provided. Not applicable to this type of device submission.

Summary of available information regarding substantial equivalence criteria (not "acceptance criteria" in the AI/ML sense):

The document states that the SomnoBrux Splints are substantially equivalent to the predicate devices (MYOHEALTH CLENCHING INHIBITOR and DSG Relaxer Splint) based on a "comparative analysis of features, materials and design."

• Key comparison points for substantial equivalence:
  • All are custom manufactured.
  • All are all acrylic type devices.
  • All treat bruxism by relaxing the structure of the masticatory system.
  • All cover posterior occlusal surfaces (with one predicate also covering maxillary six anterior teeth).
  • Conclusion: "Any minor design differences between these various models do not affect safety and performance."

This indicates that the "acceptance criteria" for the 510(k) clearance was predominantly a qualitative assessment of functional and material similarity to legally marketed predicate devices, rather than quantitative performance benchmarks demonstrated through a specific study.

Ask a specific question about this device

The Pantino Pro Positioner is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The Pantino Pro Positioner is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable components. The device functions as a mandibular repositioner, which acts to increase the patients Pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has adjustment mechanisms enabling the amount of mandibular advancement to be set by the dentist or physician at the time of the device fitting. The Pantino Pro Positioner is offered in two model designs. The Pantino Pro "A" has a single interlocking mechanism centrically located on the anterior occlusal surface of the upper and lower arches. This design offers lateral movement of the maxillary and mandible for those patients who require this freedom of motion. The Pantino Pro "B" has dual interlocking mechanisms located parallel to one another on the left and right occlusal surfaces positioned as posterior as possible to maintain maximum protrusion and a comfortable fit for the patient. This model offers vertical adjustment control for those patients who require this dimension of vertical stability.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Pantino Pro Positioner, focusing on its substantial equivalence to predicate devices and its intended use. It does not detail specific performance metrics, clinical trials, or the methodologies that would define and test acceptance criteria for the device's efficacy or safety beyond the general regulatory requirements for substantial equivalence.

Therefore, I cannot populate the requested table and sections with the information about acceptance criteria and a study that proves the device meets them from the given text.

Ask a specific question about this device

The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time Snoring and mild to moderate Obstructive Sleep Apnea (OSA).

The Somnomed MAS Flex "S" is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

The provided document is a 510(k) Premarket Notification for the SomnoMed MAS Flex "S" device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the typical sense for algorithm performance.

Here's an analysis based on the information provided and how it relates to your request:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to existing predicate devices.

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

There is no test set sample size mentioned as this document does not describe a clinical study comparing the device's efficacy in a patient population against a gold standard for snoring or sleep apnea reduction. The submission is focused on material changes and confirming safety/equivalence through bench testing.

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. There was no human expert evaluation of a test set for clinical performance mentioned. The ground truth, in the context of a 510(k) for a modified device, is primarily the established safety and effectiveness of the predicate device for its intended use, and the demonstration that the material change does not negatively impact this.

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

Not applicable. There was no test set requiring expert adjudication.

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 physical medical device (intra-oral appliance), not an AI algorithm, and therefore an MRMC study is not relevant to its evaluation.

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

Not applicable. This is a physical device, not an 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 predicate device (SomnoMed MAS K020592) for treating snoring and mild to moderate obstructive sleep apnea, combined with bench testing data (biocompatibility, product strength) on the new material to demonstrate it does not compromise these aspects.

8. The sample size for the training set

Not applicable. This is a physical device and does not involve a training set for an algorithm.

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

Not applicable. This is a physical device and does not involve a training set for an algorithm.

In summary:

This 510(k) notification is for a modification to an existing physical medical device, primarily involving a change in catch material. The "study" referenced is bench testing to confirm the new material's biocompatibility and product strength, and a comparison table to demonstrate that the new device retains all functional attributes and indications for use of the predicate device. The primary "proof" is the demonstration of substantial equivalence to an already legally marketed device, not a new clinical efficacy trial for the device's therapeutic effect.

Ask a specific question about this device