Search Results

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.

Ask a specific question about this device

Acrylic Block is a cured base acrylic resin that is indicated for use to fabricate a denture.

The Acrylic Block is a solid block of an acrylic polymer block that includes small quantities of color pigments. This Acrylic Block is a high polymer material made from quality poly methyl methacrylate. Poly (methyl methacrylate) is commonly used for thermopolymerizable acrylic resin denture bases because of its properties, including color and durability. In vitro tests have also shown its biocompatibility and enhancement of flexural behavior properties.

To fabricate the denture base, the Acrylic Block is milling machine utilizing the CAM data. After a 3D denture image is structured using the 3D CAD software, the artificial teeth are factored out, and a 3D denture base image is obtained. The Acrylic Block is then milled to the shape of the denture base. The artificial teeth are then bonded to the milled denture base using a bonding material and polished.

The provided document is a 510(k) Pre-market Notification for the "Acrylic Block" device, a cured base acrylic resin used to fabricate dentures. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study purely on the device's performance against specific acceptance criteria in a clinical setting in the way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is largely not applicable in the context of this traditional medical device submission. The submission relies on non-clinical (bench) testing and established standards for materials.

However, I can extract and present the relevant information that is available, framed within the context of a traditional device submission.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Acrylic Block (K143265)

The "Acrylic Block" device is a cured base acrylic resin intended for fabricating dentures. Its regulatory submission (510(k)) primarily demonstrates substantial equivalence to a legally marketed predicate device (Yamahachi Denture Base Resins - K131036) by showing comparable material properties and biocompatibility, rather than assessing diagnostic performance or clinical effectiveness through human reader studies.

The acceptance criteria for this device are established through compliance with recognized international and national standards for dental materials, specifically focusing on biocompatibility and mechanical properties. The "study" proving the device meets these criteria consists of a series of non-clinical, bench-top tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical "sample size" in terms of patients or independent data points originating from specific cases, as would be common for AI/ML or clinical studies. Instead, samples refer to material specimens created and tested according to the requirements of the cited ISO and ANSI/ADA standards. These standards typically define the number of test specimens required for each specific mechanical or biological test (e.g., a certain number of flexural bars, cytotoxic extracts, etc.). The exact number for each test is not detailed in this summary.
• Data Provenance: Not applicable in the traditional sense of patient data. The data originates from laboratory testing (bench testing) performed on material specimens of the Acrylic Block. The location of these testing facilities is not explicitly stated but would typically be in certified labs in Japan (Sun Medical Co. Ltd.'s country of origin) or elsewhere. The testing is prospective in the sense that it was conducted specifically for this submission against established standards.

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

• Number of Experts & Qualifications: Not applicable. For material science and biocompatibility testing, "ground truth" is established by adherence to validated standardized test methods (e.g., ISO, ANSI/ADA) and objective measurements by trained laboratory personnel, rather than expert consensus on interpretive tasks. The results are quantitative measurements or assessments of biological reactions.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Material testing results are typically objective measurements or observations (e.g., cell viability; flexural strength in MPa, absence/presence of irritation) and do not involve human interpretation or adjudication in the way clinical image analysis might.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to assess if the device improves reader performance. The Acrylic Block is a material used for fabrication, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. The Acrylic Block is a physical material, not an algorithm or software device. Its "performance" is assessed through its inherent physical, chemical, and biological properties, not a standalone algorithmic output.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's evaluation is derived from objective, quantitative measurements and standardized biological assays as defined by the referenced international and national standards (ISO, ANSI/ADA, JIS). For example:
  • Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity as determined by specific, validated lab tests (e.g., MEM Elution, Guinea Pig Maximization, Intracutaneous Reactivity, Chromosome Aberration Test, AMES Test).
  • Mechanical Properties: Quantitative values for flexural strength, flexural modulus, sorption, solubility, etc., measured against specified thresholds in the standards like ISO 20795-1 and ANSI/ADA 12.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The Acrylic Block is not an AI/ML device that requires a "training set" to learn from data.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea. The Acrylic Splint Herbst Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

The Acrylic Splint Herbst Appliance consists of an upper and lower acrylic splint custom fabricated to the teeth. These full arch splints are connected to each other by the Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of motion while the jaws are orientated in the biting relationship dictated by the positioning of the Herbst mechanism as it connects to the respective arch splints.

The functional relationship built into the appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion of the mandible in relation to the maxilla. This forward repositioning, which is temporary while the appliance is being used, increases the pharyngeal space which assists the patient with improved air exchange.

The prescribing dentist determines the exact repositioning of the lower bite via a wax construction bite obtained from the patient in the clinic. The dentist is also able to fine tune the jaw positioning clinically as needed by altering the Herbst mechanism and/or adjusting the acrylic portions of the appliance.

The provided text is a 510(k) summary for the Acrylic Splint Herbst Appliance. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might find for a novel or entirely different technology.

Therefore, the document does not contain the information requested in the prompt regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document primarily states:

• Intended Use: "The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea."
• Substantial Equivalence: Claims substantial equivalence to the Removable Acrylic Herbst by Allesee Orthodontic Appliances (K070327) based on "the same intended use and technological characteristics."
• Risk Mitigation: Describes the design features to address potential risks like oral soreness, TMD concerns, obstruction of oral breathing, and tooth movement, as identified in the Class II Special Controls Guidance Document.

In summary, the provided text does not contain a study demonstrating device performance against specific acceptance criteria. Its purpose is to argue for substantial equivalence based on intended use, technological characteristics, and risk mitigation strategies aligned with existing guidance, rather than presenting a de novo performance study.

Ask a specific question about this device

The Acrylic is intended for the fabrication of temporary dental prostheses like temporary crowns and bridges, flippers, orthodontic retainers, and occlusal guards using the Inovativ, LLC Acrylic resin.

The Acrylic material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.

The provided text is a 510(K) summary for the "Inovativ Acrylic" device. This document is a premarket notification for a medical device which aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating similar design, materials, technological characteristics, and intended use, rather than presenting a study with specific acceptance criteria and performance metrics in the way that, for example, an AI diagnostic device would.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided text. The document asserts "substantial equivalence" based on similar fundamental characteristics and physical properties to a predicate device, rather than defining specific performance acceptance criteria and reporting against them.

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

This information is not present. No specific "test set" or clinical study data is described. The submission is based on comparison to a predicate device.

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

This information is not present. No ground truth establishment by experts is described as this is not a diagnostic device and no clinical data is presented in this summary.

4. Adjudication method for the test set:

This information is not present.

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:

This is not applicable. The device (Inovativ Acrylic) is a thermoplastic resin for dental prostheses, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.

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

This is not applicable. The device is not an algorithm.

7. The type of ground truth used:

This information is not present. No ground truth for performance is established in the document. Substantial equivalence is based on physical and chemical properties as compared to a predicate device.

8. The sample size for the training set:

This information is not present. The device is not an AI algorithm and does not have a training set.

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

This information is not present.

Summary of what is present:

• Device Name: Acrylic
• Manufacturer: Inovativ, LLC.
• Predicate Device: Health-Dent International, Inc. "Dent-Temp Acrylic"
• Basis for Equivalence: Similar in design, function, physical properties, chemical composition, handling characteristics, and intended use to the predicate device.
• Intended Use: Fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges (later expanded to include flippers, orthodontic retainers, and occlusal guards).
• Regulatory Classification: Class II, Temporary Crown and Bridge Resin (21 CFR 872.3770).

This document serves to demonstrate substantial equivalence to an existing legally marketed device, meaning it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. It does not typically involve the type of performance studies with acceptance criteria and ground truth typical of novel diagnostic devices or AI applications.

Ask a specific question about this device

Ask a specific question about this device