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The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep appea (OSA) in adults 18 years of age or older.

When a DentiTrac® micro-recorder is embeded into the Acrylic Herbst Appliance, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

The Acrylic Herbst Appliance with Micro-Recorder is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The micro-recorder is embedded within the appliance. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible. The micro-recorder permits a patient's compliance to prescribed oral therapy to be monitored. The patient contacting portions of the appliance are comprised of medical grade polymethylmethacrylate (acrylic splints) and) which are connected bilaterally via a stainless steel (Herbst) mechanism.

The provided document is a 510(k) summary for a medical device (Acrylic Herbst Appliance with Micro-Recorder) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove they are met in the way a clinical trial for a novel AI device would.

Here's an analysis based on the information provided, noting what is explicitly stated and what is not applicable or not detailed in this type of submission:

1. Table of acceptance criteria and the reported device performance

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

• Not Applicable. This submission is for a physical medical device (intraoral appliance), not an AI/software device. The "test set" for performance was material testing, not patient data in the typical sense of AI evaluation.
• The material performance data appears to be from in-vitro laboratory testing, not specific patient data.

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

• Not Applicable. This information is irrelevant for a physical device where "ground truth" relates to material properties validated by standardized tests.

4. Adjudication method for the test set

• Not Applicable. No human adjudication of patient data for 'ground truth' was performed or described in this type of submission. Material testing results are objective measurements against standards.

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

• Not Applicable. This is not an AI device. No MRMC study was performed.

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

• Not Applicable. This is not an AI device.

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

• The "ground truth" for this device's performance relies on:
  • Material Standards (ISO): For mechanical and thermal properties.
  • Predicate Device Equivalence: The primary "ground truth" for the overall device's safety and effectiveness is its substantial equivalence to previously cleared predicate devices, meaning that if the predicate was safe and effective, and this device is sufficiently similar, then it is also considered safe and effective for its stated use.
  • Risk Analysis: Per the Class II Special Controls Guidance Document to identify and mitigate risks.

8. The sample size for the training set

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria, as described in this 510(k) summary, is not a clinical trial or an AI performance study, but rather a demonstration of substantial equivalence to legally marketed predicate devices.

The key "studies" presented are:

• Material Performance Testing: The device's materials were subjected to mechanical (Tensile strength, Elongation at tear, E-modulus, Flexion strength, Impaction strength, Rockwell hardness) and thermal (Vicat softening point, Thermoform resistance) performance tests against ISO standards. The results were found "satisfactory" because the identical material is used for both the subject and predicate devices, implying that the material properties are equivalent and thus acceptable.
• Biocompatibility Justification: No additional biocompatibility testing was supplied as the materials and fabrication processes are identical to the predicate device, which had already established biocompatibility.
• Comparative Analysis of Technological Characteristics: A detailed comparison table ([pages 5-6]) highlights the similarities in intended use, target population, prescription status, basic design, adjustability, and manufacturing methods between the proposed device and two predicate devices (SomnoDent® with Micro-Recorder K150369 and Acrylic Herbst Appliance K113126). The "differences" (e.g., adjustment mechanism, materials for the micro-recorder variant, adjustable range) were deemed not to raise new questions regarding safety or effectiveness.
• Risk Analysis: A risk analysis was performed per FDA guidance for intraoral devices for snoring and OSA, and identified risks were mitigated through the use of biocompatible materials (identical to predicate) and appropriate labeling.

In essence, the "study" is a regulatory comparison and material characterization, establishing that the new device is fundamentally the same as already cleared devices, and therefore does not require new clinical data to prove its safety and effectiveness. Clinical testing of the subject device was explicitly stated as not used in support of clearance.

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The Crane Acrylic Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.

The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of movement while the jaws are oriented in the biting relationship determined by the positioning of the mechanism as it connects to the respective arch splint. The Appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion in the mandible in relation to the maxilla. The appliance aims through this repositioning (which is temporary while the appliance is being used) to increase air exchange, and to reduce snoring and apnea by increasing pharyngeal space.

The prescribing dentist determines the repositioning of the mandible through a patient-specific protrusive bite registration taken by the dentist is also able to adjust the mandible's position by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. The Acrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to support the mandible in a forward position determined by the prescribing dentist.

This document is a 510(k) premarket notification for the Crane Acrylic Herbst Appliance, an intraoral device intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea. The submission claims substantial equivalence to a predicate device, the Respire Medical LLC - Respire Pink Series (K131138), based on similar intended use and technological characteristics.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or report performance metrics (e.g., specific reductions in snoring or AHI). Instead, it focuses on demonstrating substantial equivalence to a predicate device, arguing that the new device has the same intended use and technological characteristics and does not raise new safety or effectiveness concerns.

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

The document does not describe a specific clinical study or test set with a listed sample size, data provenance, or study design (retrospective/prospective). This 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data from a dedicated study.

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 specific clinical test set is described, there's no mention of experts establishing ground truth. The submission's argument is theoretical equivalence based on design and materials, not empirical clinical performance data.

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

Not applicable. No clinical test set is described.

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

Not applicable. The device is a physical intraoral appliance, not an AI software or a device that requires "readers" for interpretation. Therefore, a MRMC study is irrelevant.

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

Not applicable. The device is a physical appliance and does not involve an algorithm.

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

Not applicable. No clinical study for the new device is presented that would require establishing ground truth from patient data. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device (Respire Medical LLC - Respire Pink Series, K131138), to which the Crane Acrylic Herbst Appliance is deemed substantially equivalent.

8. The sample size for the training set

Not applicable. No clinical study with a training set is described for this 510(k) submission.

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

Not applicable. No clinical study with a training set is described for this 510(k) submission.

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The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

The Acrylic Herbst Appliance is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.

The provided 510(k) summary for the GERGEN'S ORTHODONTIC LAB INC. Acrylic Herbst Appliance (K113126) does not include specific acceptance criteria or a dedicated study demonstrating the device meets quantitative performance metrics.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices based on technological characteristics and intended use. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance."

Therefore, based on the provided text, I cannot complete the requested tables and sections with quantitative acceptance criteria or a study proving those criteria are met for performance of the device in its intended clinical use. However, I can extract information related to the device's technical characteristics and the comparison to predicate devices, which forms the basis of its clearance.

Here's a breakdown of what can be inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study":

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there are no quantitative clinical acceptance criteria or reported clinical performance metrics for the subject device in this document. The "performance data" mentioned refers only to material properties.

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

• Sample Size for Test Set: Not applicable. No clinical test set was used for the subject device's clearance. The clearance is based on substantial equivalence to predicate devices, not on a direct clinical study of the subject device.
• Data Provenance: Not applicable for a clinical test set. The data provenance for material properties is not specified beyond "provided in support of clearance."

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

• Not applicable. No clinical test set was used for this device's clearance.

4. Adjudication method for the test set

• Not applicable. No clinical test set was used for this device's clearance.

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 an anti-snoring appliance, not an AI-powered diagnostic tool, and no MRMC study was performed.

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

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

7. The type of ground truth used

• Not applicable for clinical performance. The "ground truth" for the device's clearance is its demonstrated similarity in intended use and technological characteristics to legally marketed predicate devices, which are presumed safe and effective.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

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

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets "acceptance criteria" (in the context of this 510(k) submission) is a comparison to predicate devices (Allesee Orthodontic Appliances, Inc. (K070327), Specialty Appliances Works, Inc. (K083209), Dynaflex Inc. (K103076), and Embassy Dental (K111009)). The submission states:

"Clinical testing of the subject device was not used in support of clearance."

"The fundamental scientific technology of the Gergen's Orthodontic Acrylic Herbst Appliance is the same as previously cleared devices... i.e., each of the design features is common to one or more of the predicate devices."

"In comparison to the predicate devices, the Acrylic Herbst Appliance has

• the same intended use (as described above),
• the same technological characteristics (as described above)
  and so does not raise new questions of safety and effectiveness."

Therefore, the "proof" is the argument for substantial equivalence based on shared fundamental technology, intended use, and material properties, rather than direct clinical performance data for the subject device itself.

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The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

The Acrylic Herbst Appliance is comprised of custom-fabricated acrylic splints (methylmethacrylate) which are connected bilaterally via a telescoping Herbst mechanism (stainless steel).

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary and FDA clearance letter for the Acrylic Herbst Appliance, which establishes substantial equivalence to existing predicate devices.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device