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Each Pillar Chin Implant is indicated for the augmentation or reconstruction of facial chin deformities, congenital or acquired by trauma or disease.

The Pillar Chin Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.

The provided text is a 510(k) summary for a chin implant, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of device performance against specific acceptance criteria.

Therefore, the document does not contain the information requested to complete the table and answer the questions regarding acceptance criteria, device performance, study details, ground truth, or sample sizes for a scientific study.

The primary claims for the Pillar Chin Implant are:

• Substantial Equivalence: It is substantially equivalent to the Silimed Chin Implants.
• Material Equivalence: Made from identical liquid elastomer materials and manufacturing processes as the predicate device.
• Intended Use Equivalence: Intended to augment or reconstruct facial chin deformities caused by facial trauma or congenital defects, and implanted using the same accepted surgical methods of the predicate device.
• Physical/Chemical Properties Equivalence: Physical properties are the same as the predicate device, using equivalent materials (Nusil's MED 4211 unrestricted silicone fluid). Durometer (shore A) ranges from 5 to 30, appearance is clear to opaque, tensile strength averages 700 psi, and percent elongation is over 400 percent. Raw materials are certified and tested to comply with manufacturer requirements.

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Each Pillar Malar Implant is indicated for the augmentation or reconstruction of malar eminence deficiencies, whether congenital or acquired by trauma or disease.

The Pillar Malar Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.

I’m sorry, but this document does not contain the information you requested about acceptance criteria and device performance studies. The document is a 510(k) summary and FDA clearance letter for a malar implant, focusing on substantial equivalence to a predicate device, intended use, labeling, and physical/chemical properties. It does not include details on clinical studies, performance metrics, or ground truth establishment.

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Each Pillar Nasal Implant is indicated for the augmentation or reconstruction of nasal eminence deficiencies, whether congenital or acquired by trauma or disease.

The Pillar Nasal Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.

This document is a 510(k) summary for the Pillar Nasal Implant, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria. Therefore, most of the information requested in your prompt is not available in these documents.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define specific acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Silimed, Inc Elifal nasal implant).

The "performance" reported is primarily related to physical and chemical properties and intended use, aligning with the predicate device:

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

• Not applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence based on material, manufacturing, and intended use comparison to a legally marketed predicate device. It does not involve a "test set" of patient data in the way an AI/ML device would. No clinical study data is presented to prove performance.

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

• Not applicable. As above, there is no "test set" or "ground truth" establishment in the context of clinical performance evaluation for this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable.

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 implant, not an AI/ML 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.

7. The type of ground truth used:

• Not applicable. The "ground truth" for this submission would primarily be the established physical, chemical, and functional characteristics of the predicate device and the demonstration that the Pillar Nasal Implant matches these characteristics.

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.

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