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Cytoflex® Tef-Guard® Ti-Enforced membrane is a temporarily, non-resorbable, implantable material for use as a space-making barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle.

Cytoflex® Tef-Guard® Ti-Enforced membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a passive, non-load bearing material with a titanium frame enclosed within two exterior layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft migration during wound healing. The membranes are designed to reduce the migration and establishment of gingival tissue derived cells into bony defects thus providing a more favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. The membranes are intended to be submerged and implanted for more than 30 days and up to 6 months. The membrane is supplied sterile and available in a variety of shapes and sizes for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cytoflex® Tef-Guard® Ti-Enforced Membrane:

Important Note: The provided document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical efficacy testing. Therefore, many of the typical elements of a study proving a device meets acceptance criteria (like human reader studies, ground truth establishment for a test set, etc.) are not applicable in this context. The acceptance criteria here largely revolve around device performance characteristics and biocompatibility, demonstrated through non-clinical bench testing.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each test in a table format. Instead, it states that the device "was found to meet the requirements of the pre-defined acceptance criteria" for the listed ISO standards and that "The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance."

However, based on the performance testing section and the comparison table with predicate devices, we can infer the types of criteria and the reported performance:

• Density: Not to exceed a certain deviation from predicate (e.g., within 0.5 g/dm² difference).
• Material Composition: ePTFE with Titanium frame.
• Design: Multi-layer, non-resorbable, space-making barrier, trimmable, flexible. | - Thickness: 0.25mm (Predicate 1: 0.23mm; Predicate 2: 0.3mm). Considered "Substantially Equivalent."
• Density: 3.5 g/dm² (Predicate 1: 4.0 g/dm²; Predicate 2: 3.5 g/dm²). Considered "Substantially Equivalent."
• Material Composition: ePTFE membranes reinforced with a Titanium frame. Considered "Substantially Equivalent."
• Design: A variety of configurations, trimmable and shaped to fit bony defect. Considered "Substantially Equivalent." |
  | Functional Performance | - Tensile Loading: Performance similar to predicate.
• Bending: Performance similar to predicate.
• Flexibility: Performance similar to predicate.
• Delaminating Potential: Performance similar to predicate. | "The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance." (No specific quantitative values provided for the subject or predicate, just a statement of equivalence). |
  | Biocompatibility | - Cytotoxicity: No evidence of cytotoxicity (ISO 10993-5).
• Local Effects after Implantation: No adverse local effects (ISO 10993-6).
• Irritation & Skin Sensitization: No irritation or sensitization (ISO 10993-10).
• Systemic Toxicity: No systemic toxicity (ISO 10993-11). | "Found to meet the requirements of the pre-defined acceptance criteria" for ISO 10993-5, -6, -10, -11. "Biocompatible: Yes." |
  | Sterility | - Sterility Assurance Level (SAL): SAL

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Unigraft® is indicated for the repair of dental intraosseous and oral/maxillofacial defects, including: augmentation of the alveolar ridge, filling of infrabony periodontal defects, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of the maxillary sinus floor, filling of defects after cystectomy, apicoectomy and root resection, filling of periodontal and peri-implant defects in conjunction with products intended for GTR and GBR procedures, and filling of maxillofacial osseous cavities

Unigraft is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.

This document is a 510(k) summary for a medical device called Unigraft, which is a synthetic bone graft material. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Based on the provided text, a formal study demonstrating the device meets specific acceptance criteria was not included in this 510(k) summary. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria.

The 510(k) submission states: "The Unigraft device is substantially equivalent to devices currently in US commercial distribution, which are classified as endosseous implants for bone filling and augmentation. Examples of such products include Unigraft®, PerioGlas® and Osteograf®. These products are made of bioceramic materials with similar performance." This indicates that the device's acceptable performance is inferred from the established performance of its predicate devices, which are already on the market.

Therefore, many of the requested details about acceptance criteria and a specific study directly proving those criteria are not provided in this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

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

   • Not provided within this 510(k) summary. The document asserts "similar performance" to predicate devices, but does not present a table of specific quantitative acceptance criteria or reported performance metrics for Unigraft itself.

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

   • Not provided. No specific test set or study data is presented in this summary.

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 provided. No ground truth establishment for a test set is mentioned.

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

   • Not provided. No test set or adjudication is mentioned.

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

   • Not applicable and not provided. This device is a bone graft material, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable and not provided. This device is a bone graft material, not an algorithm.

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

   • Not provided. There is no mention of a specific ground truth for performance evaluation of Unigraft in this summary. Its "performance" is implicitly tied to that of its predicate devices.

8. The sample size for the training set

   • Not applicable and not provided. This is not an AI/algorithm-based device and therefore doesn't have a training set in that context.

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

   • Not applicable and not provided. Same as above.

Summary of available information:

The 510(k) summary for Unigraft primarily focuses on:

• Device Description: Synthetic bioactive glass granules for oral/maxillofacial and dental intraosseous defects.
• Predicate Devices: Unigraft®, PerioGlas® and Osteograf®, which are also bioceramic materials with similar performance.
• Intended Use: Repair of various dental and oral/maxillofacial defects (e.g., alveolar ridge augmentation, filling extraction sockets, sinus floor elevation).
• Basis for Acceptance: Substantial equivalence to already legally marketed predicate devices, implying similar performance and safety profiles. The document does not contain specific data from a performance study for K092567 showing an explicit comparison against predefined acceptance criteria.

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Benacel® Dental Dressing is intended for use as a wound dressing in extraction sites and the management of alveolar osteitis (dry socket) and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites, and traumatic injuries. Benacel® Dental Dressing may also be used as a wound dressing for the management and protection of oral lesions, including sores, ulcers, and injuries, such as cuts, lacerations and abrasions of the oral mucosa.

Benacel® Dental Dressing is an absorbable wound dressing made of oxidized regenerated cellulose material. Upon contact with moist oral mucosa, the material dissolves and transforms into a gelatinous material. By applying gentle pressure at this time, the material will adhere to the wound and form a barrier, protecting the wound from further irritation and pain. Benacel® Dental Dressing is sterile packaged and supplied in a variety of configurations and sizes.

The provided 510(k) summary for the Benacel® Dental Dressing does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative results to "prove" the device meets acceptance criteria in the manner an AI/ML device would typically be evaluated. This document is for a traditional medical device (wound dressing), and its regulatory pathway focuses on substantial equivalence to predicate devices through in vitro and in vivo testing demonstrating similar performance, rather than complex statistical performance metrics.

Therefore, I cannot populate all the requested fields as they are designed for the evaluation of AI/ML-based medical devices. However, I will extract the relevant information that is present in the document.

Here's a breakdown based on the provided text, and where the requested information is not available for this type of device:

1. Table of acceptance criteria and the reported device performance:

The 510(k) summary states that "In vitro and in vivo tests demonstrate that Benacel® Dental Dressing performs substantially equivalent to predicate devices." This is a general statement rather than specific, quantitative performance against predefined acceptance criteria. The specific results of these tests are not detailed in the provided summary.

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

Not specified in the document. For in vitro and in vivo testing of a physical wound dressing, the "test set" would refer to the number of samples tested or animals/humans included in the in vivo study, and this detail is missing.

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

Not applicable or specified. For a physical wound dressing, ground truth is typically established through direct observation of physical properties, biocompatibility, and wound healing in controlled environments (in vitro) or animal/human subjects (in vivo). Expert consensus in the way it's used for AI/ML image interpretation is not relevant here.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating human expert performance or resolving discrepancies in AI/ML outputs against ground truth. This is not a human-reader-based interpretation task.

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 wound dressing, not an AI/ML-based diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical wound dressing, not an algorithm.

7. The type of ground truth used:

Based on the mention of "in vitro and in vivo tests," the ground truth would likely be based on:

• Biocompatibility testing results: (e.g., cytotoxicity, sensitization, irritation)
• Physical performance characteristics: (e.g., absorption, adherence, dissolution time)
• Wound healing observations: In in vivo models (e.g., rate of healing, reduction in inflammation, pain management efficacy).
• Comparison to predicate device performance: The core of 510(k) substantial equivalence.

8. The sample size for the training set:

Not applicable or specified. 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.

Summary derived from the document:

The Benacel® Dental Dressing is intended for use as an absorbable wound dressing for extraction sites, alveolar osteitis, oral surgical wounds, and oral lesions. The claim for meeting acceptance criteria is through "substantial equivalence" to predicate devices (SaliCept®, "Sock It" oral pain gel, Hemcon®).

The study that proves the device meets the acceptance criteria is described as "in vitro and in vivo tests that demonstrate that Benacel® Dental Dressing performs substantially equivalent to predicate devices."

Key aspects provided by the document:

• Predicate Devices: SaliCept®, "Sock It" oral pain gel, Hemcon®
• Testing Types: In vitro and in vivo tests.
• Performance Claim: Substantially equivalent to predicate devices.

The document does not provide the granular detail requested for AI/ML device studies.

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CytoFlex® Resorb membranes are intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and regeneration of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.

CytoFlex® Resorb barriers are made from polyglycolide, polylactide and poly(glycolide-co-lactide) copolymer. CytoFlex® Resorb is a resorbable barrier membrane and is supplied in a variety of shapes and sizes in sealed pouches. CytoFlex® Resorb membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

The provided text describes a 510(k) summary for the CytoFlex® Resorb device, which is an absorbable barrier membrane. However, it does not contain information about any specific study or acceptance criteria related to device performance.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification.
• Predicate Devices: Listing of similar devices already on the market.
• Device Description: Material composition (polyglycolide, polylactide, poly(glycolide-co-lactide) copolymer), form factor (various shapes and sizes in sealed pouches).
• Intended Use/Indications for Use: Applications in periodontal defects, maxillofacial guided tissue regeneration, and as a grafting material containment matrix.
• FDA Communication: A letter from the FDA indicating that the device has been found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This type of 510(k) submission, especially for a Class II device seeking substantial equivalence, often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical performance studies with acceptance criteria in the manner you've described for AI/diagnostic devices. The "study" here is essentially the comparison to predicate devices based on material properties, manufacturing, and intended use.

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Not Found

Not Found

I am sorry, but the provided text is a letter from the FDA regarding an administrative change to a previous substantial equivalence determination for a device called "Benacel®".

This letter does not contain any information about:

• Acceptance criteria for the device's performance.
• Any study that proves the device meets acceptance criteria.
• Details about sample sizes, data provenance, expert qualifications, ground truth, or study methodologies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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For use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material.

Cytoflex Mesh is a precision titanium mesh of a specific dimension and pore size. Cytoflex Mesh is supplied in specific sizes and thickness in sealed pouches. Cytoflex Mesh is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

The provided text describes a medical device, the Cytoflex Mesh, and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device.

This document is solely focused on the regulatory clearance process for a predicate device, establishing substantial equivalence based on device description and intended use, rather than a performance study with quantitative acceptance criteria.

Therefore, I cannot fulfill your request for:

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

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Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, ridge augmentation, extraction sites, cranio-facial augmentation, sinus lifts and cystic defects

Ossiform is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.

The provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria.

The document is a 510(k) summary and FDA clearance letter for a device called "Ossiform." It describes the device, its intended use, and its substantial equivalence to predicate devices already on the market.

Specifically, it mentions:

• "The performance of Ossiform was evaluated using a variety of test methods. The results of these tests demonstrate that Ossiform is substantially equivalent to a predicate device." However, it does not detail these test methods, specify any acceptance criteria, or present performance data from a study.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth.

The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices, rather than a detailed presentation of performance study results against predefined acceptance criteria.

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A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

CytoFlex™ is a non-resorbable barrier membrane that is composed of microporous ePTFE material. The sterile membrane has a nominal thickness of 250 microns and is supplied in a variety of shapes and sizes in sealed pouches. The biocompatibility of ePTFE has been established through a long history of use in a variety of implant applications. CytoFlex™ membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

The provided document is a 510(k) summary for the Unicare Biomedical CytoFlex™ ePTFE barrier membrane, which is a medical device. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with acceptance criteria for an AI/algorithm-based device.

Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not available in the provided text, as it describes a physical barrier membrane, not an algorithmic or AI device.

Let's break down what can be extracted and what cannot:

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

• Not Applicable. The document describes a physical medical device (ePTFE barrier membrane) and its substantial equivalence to predicate devices, not an AI or algorithmic device with performance metrics like sensitivity, specificity, etc. The "acceptance criteria" here would be meeting the requirements for substantial equivalence to predicates, which is a regulatory assessment, not a device performance metric.

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

• Not Available. This information would be relevant for a study evaluating an AI/algorithmic device. The 510(k) summary for a physical device does not typically include "test datasets" in this context.

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. Ground truth for data is not relevant for a physical barrier membrane in this type of submission.

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

• Not Applicable. See point 3.

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 a physical product, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical product, not an algorithm.

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

• Not Applicable. Ground truth, in the context of AI/algorithmic devices, is not a concept applied to this type of physical medical device submission.

8. The sample size for the training set

• Not Applicable. No training set exists for this physical device.

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

• Not Applicable. No training set or ground truth for a training set exists for this physical device.

Summary of Relevant Information from the Document:

• Device Name: CytoFlex™ ePTFE barrier membrane
• Device Description: "a non-resorbable barrier membrane that is composed of microporous ePTFE material. The sterile membrane has a nominal thickness of 250 microns and is supplied in a variety of shapes and sizes in sealed pouches."
• Indication for Use: "A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects."
• Proof of Meeting Regulatory Requirements (not "acceptance criteria" in the AI sense): The device was found to be "substantially equivalent" to legally marketed predicate devices (Imtec BioBarrier membrane, Osteogenics Cytoplast GBR, Gore-tex Regenerative Material, TefGen-FD). "The biocompatibility of ePTFE has been established through a long history of use in a variety of implant applications. CytoFlex™ membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices."

The 510(k) process for a Class II device like this primarily relies on demonstrating substantial equivalence to existing devices rather than new clinical trials with predefined performance metrics and acceptance criteria as would be expected for a novel AI algorithm.

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For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge

Unigraft is a synthetic bioactive glass material for use in the repair of oral defects, including periodontal defects, extraction sites and augmentation of the alveolar ridge. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.

The bioactive glass (45S5 Bioglass) used in Unigraft is one of the most extensively studied bioactive glass compositions, which has been shown to bond to bone as well as soft tissue. The same material is used in legally marketed devices, including BioGran® and PerioGlas®. When implanted in the living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone minerals. The biological apatite layer of the granules provides an osteo-conductive scaffold for the generation of new osseous tissue.

Here's an analysis of the provided 510(k) summary for the Unigraft device, addressing your specific questions.

Important Note: The provided document is a 510(k) summary for a medical device (synthetic bone graft material), not an AI/Software as a Medical Device (SaMD). Therefore, many of your questions related to AI/SaMD performance metrics, ground truth, expert adjudication, and training/test set details are not applicable to this type of submission. I will address them by stating "Not Applicable" or explaining why they don't fit.

Unigraft (K993784) - Device Acceptance Criteria and Study Details

The Unigraft device is a synthetic bioactive glass material intended for oral defect repair. Its approval is based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The primary "acceptance criteria" in this context is the successful demonstration of this substantial equivalence through comparative testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided 510(k) summary. The summary only states that the device was "evaluated comparatively against a predicate device using a variety of test methods."
• Data Provenance: Not specified. It's likely pre-clinical (in vitro, in vivo animal studies) for material characterization and biocompatibility, but the origin (e.g., country, retrospective/prospective) is not mentioned.

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

• Not Applicable. This is a medical device (material) submission, not an AI/SaMD. "Ground truth" in the context of AI/SaMD for diagnostic accuracy is not relevant here. The evaluation would involve material science, biocompatibility, and potentially animal or limited human clinical studies (though not detailed here).

4. Adjudication Method for the Test Set

• Not Applicable. As above, this concept (common in AI/SaMD for resolving discrepancies among human readers) is not relevant for the type of testing described in this 510(k) summary.

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 a medical device (material) submission, not an AI/SaMD. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks.

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

• Not Applicable. As above, this is not an AI/SaMD submission, so there is no "algorithm" to evaluate in a standalone manner.

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

• Not Applicable (in the AI/SaMD sense). For this type of medical device, "ground truth" would relate to verifiable material properties (chemical composition, physical structure), biocompatibility test results (e.g., ISO 10993 standards), and potentially histological evidence from animal studies showing bone ingrowth or integration. The summary does not detail the specific methods or types of ground truth used in the comparative testing.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical device (material) submission, not an AI/SaMD that requires training data.

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

• Not Applicable. As above, no training set or AI model is involved.

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