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Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)

GC ACRYLIC PRIMER is a primer which raises the adhesiveness to acrylic resin and composite resin. GC ACRYLIC PRIMER is intended to use for bonding acrylics to acrylic resin, composite to composite resin, and acrylics to composite resin respectively.

The device in question is GC ACRYLIC PRIMER, a resin tooth bonding agent.

Here's a breakdown of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical or performance testing with human subjects or a defined dataset for AI. The performance bench tests appear to be conducted on the device itself.

• Sample Size for Test Set: Not explicitly stated for performance bench tests, but implied to be sufficient to demonstrate conformity to specifications.
• Data Provenance: Not applicable in the context of a "test set" as typically understood for AI/clinical studies. The performance data is generated from laboratory bench testing of the device.

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

Not applicable. The performance testing involves laboratory measurements and assessments against predefined physical and chemical specifications, not expert-derived ground truth on clinical data.

4. Adjudication method for the test set

Not applicable. The performance testing involves objective measurements rather than 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

No MRMC comparative effectiveness study was conducted. This device is a dental material (primer) and not an AI-powered diagnostic tool.

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

Not applicable. This device is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance criteria is based on:

• Predefined physical and chemical specifications: For appearance, application characteristics, refractive index, and bond strength. These are objective laboratory measurements.
• Biocompatibility standards: ISO 10993-5 guidelines for cytotoxicity.

8. The sample size for the training set

Not applicable. This device is a dental material, not an AI model, and therefore does not have a training set.

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

Not applicable. This device is a dental material, not an AI model, and therefore does not have a training set or associated ground truth establishment.

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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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Orthodontic Acrylic 2 is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.)

Orthodontic Acrylic 2 is a fast curing self-cure 2 part system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.

The provided text describes the regulatory clearance for "Orthodontic Acrylic 2" and details its performance against specific acceptance criteria.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Clinical Study: "a limited clinical study involving 32 patients"
• In-vitro Testing (QAMS inhibition): Not explicitly stated, but performed "In-vitro."
• In-vitro Studies (3-month biofilm reduction): Not explicitly stated, but performed "in-vitro."
• Physical/Mechanical Properties: Not explicitly stated, but performed according to ISO 20795-2:2010.
• Biocompatibility Testing: Not explicitly stated, but tested per ISO 10993-1:2009 for various tests.

The provenance of clinical data is not specified (e.g., country of origin, retrospective or prospective), but the mention of a "limited clinical study" suggests it was likely a prospective study. The in-vitro tests are laboratory-based.

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 conducted (physical/mechanical, in-vitro antimicrobial, biocompatibility, and a limited clinical study) likely relied on standard laboratory measurements and clinical observations rather than expert consensus for ground truth determination in the way it's typically applied to AI model evaluations (e.g., radiologists reviewing images).

4. Adjudication method for the test set:

This information is not provided. Given the nature of the tests (laboratory measurements, in-vitro studies, and a limited clinical trial comparing biofilm formation), a formal adjudication method like "2+1" or "3+1" for establishing ground truth from multiple readers/experts is not applicable here.

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

No, an MRMC comparative effectiveness study was not conducted. This device is a material (Orthodontic Acrylic), not an AI-assisted diagnostic or therapeutic tool for human readers.

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

No, this is not an AI algorithm. The performance evaluation is for a physical medical device (orthodontic acrylic material), not a software or AI product.

7. The type of ground truth used:

• Physical/Mechanical Properties: Manufacturer's specifications and compliance with international standards (ISO 20795-2:2010) for material properties (e.g., flexural strength).
• Anti-bacterial/Anti-fungal Testing: Laboratory assays measuring microbial inhibition and biofilm reduction.
• Biocompatibility: Results from validated in-vitro and in-vivo tests as per ISO 10993-1:2009 (e.g., cytotoxicity, irritation, sensitization).
• Clinical Study: Direct measurement of biofilm formation on orthodontic appliances in patients.

8. The sample size for the training set:

This information is not applicable/provided. This is a physical material being evaluated, not a machine learning model that requires a training set. The development of the material involved chemical formulation and testing, not AI training.

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

This information is not applicable/provided as there is no training set for this type of device.

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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

• No Sensitization: Considered to cause no sensitization per ISO 10993-10, IIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20.
• Not Irritant: Caused no signs of irritation and met requirements per ISO 10993-10, JIS T 6001, and Yakushokukihatsu No. 0301-20.
• No Significant Systemic Toxicity: Considered to not cause significant systemic toxicity per ISO 10993-11, JIS T 6001, Yakushokukihatsu No. 0301-1. And Yakushokukihatsu No. 0301-20.
• Non-clastogenic: Considered non-clastogenic per ISO 10993-3, JIST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20.
• Non-mutagenic: Considered non-mutagenic per ISO 10993-3, JJST T 6001:2012 Yakushokukihatsu No. 0301-1, and Yakushokukihatsu No. 0301-20. |
  | Mechanical Properties | EN ISO 1567:1995: Denture Base Polymers.
  ISO 20795-1: Dentistry -- Base polymers -- Part 1: Denture base polymers.
  ANSI/ADA Specification No. 12:2002 (Reaffirmed 2008): Denture Base Polymers (including surface characteristics, color, translucency, freedom from porosity, flexural strength, flexural modulus, residual methyl methacrylate monomer, sorption and solubility). | - Met all acceptance criteria for denture base polymers as outlined in ISO 20795-1 and ANSI/ADA Specification No. 12:2002.
• Demonstrated substantially similar performance to predicate denture base resins during non-clinical bench testing. |
  | Risk Management | ISO 14971: Medical devices - Application of risk management to medical devices. | - Risk analysis conducted. Outcomes considered acceptable, and all potential risks mitigated to the lowest form. |
  | Quality Systems | ISO 9001:2007
  ISO 13485:2002 | - Confirmed compliance (as listed for both subject and predicate device). |

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.

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Orthodontic Acrylic intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).

Orthodontic Acrylic is a fast curing self-cure 2-part system. The system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.

The provided document is a 510(k) premarket notification for an orthodontic acrylic device. It does not contain any information about an AI/ML powered device, a comparative effectiveness study, or details about ground truth establishment with experts. The document focuses on the substantial equivalence of the Orthodontic Acrylic to a predicate device based on chemical composition and physical/mechanical properties.

Therefore, many of the requested sections regarding AI/ML powered devices, expert adjudication, and ground truth establishment cannot be answered from the provided text.

Here's a breakdown of the information that can be extracted, acknowledging the limitations for AI/ML related questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance data in terms of physical/mechanical properties and biocompatibility. It does not explicitly state "acceptance criteria" with numerical targets, but rather mentions "meeting the requirements" or providing "similar" results to the predicate.

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

• Test Set Sample Size: Not specified. The document refers to "in-vitro testing" and "biocompatibility testing" but does not give sample sizes for these tests.
• Data Provenance: Not explicitly stated but implied to be laboratory testing ("tested in the lab") for physical/mechanical properties and in-vitro/in-vivo animal testing for biocompatibility. There is no information regarding country of origin for the data (beyond the applicant being in Illinois, USA) or if it's retrospective or prospective.

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

• Not Applicable. This document describes the evaluation of a dental material, not an AI/ML device that would require expert-established ground truth from medical images or clinical data. The "ground truth" for this device comes from standardized chemical, physical, and biological tests.

4. Adjudication method for the test set

• Not Applicable. As above, no expert adjudication is mentioned or relevant for this type of device evaluation.

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

• No. This document is for a dental material, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.

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

• No. This document is for a dental material. There is no algorithm discussed.

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

• The "ground truth" for this device's performance is established through objective, standardized laboratory measurements of physical/mechanical properties (e.g., flexural strength, water sorption) and biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) against established international standards (ISO). For the in-vitro testing, the ground truth would be the observed bacterial/fungal growth or inhibition under controlled lab conditions.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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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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MANUKA FOAM HC wound dressings are sterile, single-use wound care dressings for use in moist wound management of:

• Leg Ulcers
• Pressure Ulcers
• 1st and 2nd Degree Burns
• Diabetic Foot Ulcers
• Surgical Wounds
• Trauma Wounds
  A moist wound environment allows autolytic debridement of necrotic tissue.

MANUKA FOAM HC wound dressings are sterile, single use wound care dressings that help maintain a moist wound environment. The primary device consists of 100% Leptospermum scoparium honey from New Zealand impregnated into an absorbent foam-fiber hybrid material. One version of the product includes a polyurethane border with a silicone adhesive. Another version of the product includes a polyurethane border with an acrylic adhesive.

The provided 510(k) summary for the MANUKA FOAM HC Wound Dressing describes nonclinical testing performed but does not outline specific numerical acceptance criteria or a comparative study against a predefined benchmark for device performance that would involve an AI or algorithmic component.

The summary focuses on demonstrating substantial equivalence to predicate devices (MANUKA IG Wound Dressing and BioAquaCare) based on:

1. Biocompatibility tests: These are standard tests (cytotoxicity, primary skin irritation, skin sensitization) performed according to ISO 10993-1.
2. Wound healing study: Conducted on swine to assess the impact of repeated application on full-thickness dermal wounds.
3. Other standard testing: Sterilization validation, shelf-life (accelerated and real-time), and packaging validation.

The statement, "The MANUKA FOAM HC wound dressings met the acceptance criteria for all tests conducted," signifies that the product passed these specific nonclinical tests. However, the document does not present a table of acceptance criteria for performance metrics that can be numerically correlated with a "reported device performance" in the way one might expect for an AI or diagnostic device (e.g., sensitivity, specificity, accuracy thresholds).

Therefore, based on the provided text, the specific information requested about acceptance criteria and studies (especially those relating to AI/algorithmic performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance) is not present. This device is a wound dressing, a physical medical product, not an AI-driven diagnostic or treatment algorithm.

If this were a device where such criteria would be applicable (e.g., an imaging diagnosis AI), the expected table and study details would be as follows, but currently, they cannot be populated from the provided text.

Unavailable Information Based on Provided Text:

The document describes a physical wound dressing and its nonclinical testing to demonstrate safety and effectiveness for a 510(k) submission, primarily focusing on biocompatibility and general performance (sterilization, shelf-life, packaging, wound healing in an animal model). It does not involve any AI, algorithmic, or diagnostic performance evaluation that would require the specific details requested above (e.g., sensitivity/specificity acceptance criteria, expert ground truth, MRMC studies, or training/test set data).

Therefore, none of the requested points regarding acceptance criteria, reported device performance in the context of an algorithm, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types and establishment for training sets can be extracted from this document as they are not relevant to the type of device and testing described.

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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 Dr Greenburgs Hybrid Acrylic Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea

The Dr Greenburgs Hybrid Acrylic Anti-Snoring Device is a removable intraoral device for repositioning the upper and lower jaw into a prescribed relationship for a single an resure in Creatiourgs Hybrid Anti-Snoring Device is a removable intraoral device for muliple times at home or sleep laboratories. and theming the upper and lower jaw into and one multiple times at home or sleep laboratories.

The Dr Greenburgs Hybrid Azalea

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Dr Greenburgs Hybrid Acrylic has a front area opening that is large enough for emergency

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The provided text describes a 510(k) summary for the "Dr Greenburgs Hybrid Acrylic" anti-snoring and apnea device. This document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with specific acceptance criteria and detailed device performance metrics. Therefore, some information requested might not be directly available or explicitly stated in the provided text.

Here's an attempt to answer your questions based on the available information:

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

The document does not explicitly state acceptance criteria or provide a table of performance metrics in the way a clinical study report would. The primary "performance" discussed is the intended use of reducing snoring and mild to moderate obstructive sleep apnea. The submission relies on citing existing literature and presenting anecdotal "clinical data" to support its claims of efficacy.

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 mentions "clinical data provided (Jonathan Greenburg's Sleep Study Table)" and refers to literature. However, it does not provide details about a specific test set, its sample size, or its provenance (e.g., country of origin, retrospective/prospective nature). The "Sleep Study Table" is mentioned as "provided" but its contents are not detailed.

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)

There is no information provided in the document about the number or qualifications of experts used to establish ground truth for any test set. The efficacy claims largely refer to general medical literature and an internal "Sleep Study Table," without describing the methodology for how "ground truth" was established within those contexts.

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

There is no information provided regarding an adjudication method for a test set.

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 device is an intraoral anti-snoring and apnea device, not an imaging or diagnostic AI device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance would not be applicable to this type of medical device.

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

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

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

The type of "ground truth" used for efficacy claims appears to be:

• Clinical Outcomes Data: The mention of "Jonathan Greenburg's Sleep Study Table" suggests some form of patient outcomes data (e.g., reduction in AHI, reported snoring). However, the specific metrics and how they were verified as "ground truth" are not detailed.
• Literature Review/Expert Opinion: The document heavily relies on existing scientific literature (e.g., "The Abstract Oral Appliances for Snoring and Observe Steep Apnea: A Reviews and Check Charact Crail States" from Sleep Vol. 2, 2006) which synthesizes existing clinical evidence and expert understanding of oral appliances.

8. The sample size for the training set

As this is a physical medical device and not a machine learning algorithm, the concept of a "training set" in this context is not applicable. The device's design is based on established biomechanical principles and comparisons to existing predicate devices.

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

Not applicable, as there is no "training set" for this physical device.

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