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The intended use of the AART Malar Implant is for augmentation or reconstruction of the check areas of the face.

The AART Malar Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped concave convex implants. They are provided in four styles in pairs of right and left mirror images with dimensions varying in length, width, and height. The AART Malar Implants are intended to be used for augmentation and reconstruction of the cheek areas of the face. The surface characteristic of the implants is smooth, The AART Malar Implants will be offered sterile and non-sterile.

The provided text is a 510(k) summary and FDA clearance letter for the AART Malar Implant. This type of document establishes substantial equivalence to predicate devices, rather than conducting new studies to prove performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not present in this document.

Here's what can be extracted based on the provided text:

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

This information is not present in the provided document. The 510(k) submission focuses on demonstrating substantial equivalence to already marketed devices, not on proving performance against a specific set of new acceptance criteria through a clinical study.

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

This information is not present because no new clinical or performance test set data is described. The submission is based on the characteristics of the device itself and its similarity to predicate devices.

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)

This information is not present because no new clinical or performance test set data requiring expert-established ground truth is described.

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

This information is not present because no new clinical or performance test set data requiring adjudication 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

This information is not present. The device is an implant, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.

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

This information is not present. The device is an implant, not an algorithm.

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

This information is not present because no new clinical or performance test set data requiring ground truth is described. The "ground truth" for this type of submission would relate to the long-standing safety and effectiveness of the predicate devices.

8. The sample size for the training set

This information is not present because the document does not describe the development or training of any algorithm.

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

This information is not present because the document does not describe the development or training of any algorithm.

Summary of Device Equivalence (from the document):

The AART Malar Implant is deemed substantially equivalent to the Duralastic Anatomical Malar Implants (Allied Biomedical Corporation) and the Seare Biomedical Malar Implants (Seare Biomedical Corp.). This equivalence is based on:

• Function
• Design
• Performance
• Materials (medical grade silicone elastomer)
• Intended Use (augmentation and reconstruction of the cheek areas of the face)
• Similar shapes and sizes

The sterilization cycle will be determined and validated following ANSI/AAMI/ISO 11137-1994 for radiation sterilization, which is a standard for ensuring sterility, not specific performance criteria for the device's function within the body.

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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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Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.

Not Found

I am sorry, but the provided text does not contain the necessary information to answer your questions regarding acceptance criteria and study details for the Surgiform Anatomical Malar device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies general information about regulatory approval, but it does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery.

Seare Biomedical Malar implants are crescent shaped convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. Surface characteristics will varying degrees of texturing and porosity. Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery. The Seare Biomedical Malar Implants will be produced using standard manufacturing molding techniques. The Searc Biomedical Malar Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Searc Biomedical Malar Implants will be provided sterile and nonsterile.

The provided text is a 510(k) summary for the Seare Biomedical Malar Implants. It details the device's description, indications for use, and a comparison to a predicate device. However, it explicitly states "Clinical Tests: None" and "Adverse S&E Information: None."

Therefore, based on the information provided, there are no acceptance criteria or studies detailed that prove the device meets acceptance criteria.

The 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Allied Biomedical Malar Implants) rather than presenting new clinical performance data for this specific device.

To answer your questions based only on the provided text:

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

   • Acceptance Criteria: Not specified in the document. The submission focuses on substantial equivalence to a predicate device.
   • Reported Device Performance: Not reported as no clinical tests were performed for this device in this submission.

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

   • Not applicable. No clinical tests were performed.

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. No clinical tests were performed.

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

   • Not applicable. No clinical tests were performed.

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. No clinical tests were performed, and this device is not an AI-assisted diagnostic tool.

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

   • Not applicable. No clinical tests were performed, and this device is not an algorithm.

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

   • Not applicable. No clinical tests were performed involving ground truth establishment for this device. The "ground truth" for demonstrating regulatory acceptance was demonstrating substantial equivalence to the predicate device.

8. The sample size for the training set

   • Not applicable. This device is a physical implant, not a machine learning model requiring training data.

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

   • Not applicable. This device is a physical implant, not a machine learning model.

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The Silimed Malar Implant is designed to be used for augmentation and reconstruction of the cheek.

Not Found

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, device performance, study details, and ground truth establishment for a medical device. The text is a 510(k) clearance letter from the FDA for a Malar Implant, primarily discussing the regulatory approval process and general regulations. It does not include specific performance metrics, clinical study designs, or expert review details.

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The Spectrum Designs Profile Malar Implant is intended to augment or reconstruct the malar region of the face.

Spectrum Designs Profile Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.

The provided text is a 510(k) summary for the "Spectrum Designs Profile Malar Implant". It describes the device, its indications for use, and identifies substantially equivalent devices. However, the document does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot populate the table or answer the questions as the information is not present in the provided text. The document primarily focuses on the regulatory submission process and the characteristics of the device itself, not on performance studies or acceptance criteria.

Missing Information:

• Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are mentioned.
• Sample size and data provenance: No study details are provided, so sample size and data provenance are unknown.
• Number of experts and qualifications: No study details are provided, so expert information is unknown.
• Adjudication method: No study details are provided, so adjudication method is unknown.
• MRMC comparative effectiveness study: No such study is mentioned.
• Standalone algorithm performance: This is a physical implant, not an algorithm, so this question is not applicable.
• Type of ground truth: No study details are provided, so ground truth type is unknown.
• Training set sample size: No study details are provided, so training set information is unknown.
• How ground truth for training set was established: No study details are provided, so training set ground truth establishment is unknown.

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The Spectrum Designs Medial Malar Implant is intended to augment or reconstruct the malar region of the face.

Spectrum Designs Medial Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.

This document is a 510(k) summary for the Spectrum Designs Medial Malar Implant. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through a dedicated study. This document outlines the device description, indications for use, contraindications, and warnings related to the implant. It also identifies substantially equivalent devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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The Spectrum Designs Projection Malar Implant is intended to augment or reconstruct the malar region of the face.

Spectrum Designs Projection Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.

The provided document is a 510(k) summary for a medical device called the "Spectrum Designs Projection Malar Implant." This type of document is a pre-market notification submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not a detailed study report proving the device meets specific acceptance criteria through clinical trials or performance studies as one might expect for a new, higher-risk device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, study design, sample sizes, expert involvement, and ground truth derivation is not present in this type of regulatory submission. The 510(k) process primarily relies on demonstrating equivalence to an existing device rather than presenting novel performance data.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)

The provided document is a 510(k) summary for a malar implant. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against explicitly defined acceptance criteria. Therefore, the document does not contain the level of detail regarding acceptance criteria and performance study results typically associated with a clinical trial or a novel device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify quantitative acceptance criteria or clinical performance metrics. The "performance" described relates to the intended function and substantial equivalence, not detailed clinical outcomes or efficacy rates from a study.

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

The document does not describe a "test set" or a formal clinical study with a determined sample size. The 510(k) process is typically based on a comparison to a predicate device and may involve bench testing, but not clinical trials with human subjects for performance evaluation unless specifically required for novel aspects. Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective nature) is not available in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since a formal clinical "test set" and corresponding ground truth establishment for performance evaluation are not described in this 510(k) summary, there is no information on the number or qualifications of experts used for this purpose.

4. Adjudication Method for the Test Set

As there is no described "test set" or clinical study for performance evaluation, an adjudication method is not applicable or mentioned in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study is typically relevant for interpretative devices (e.g., imaging AI). This device is a physical implant. The document does not mention or imply any MRMC study, nor does it refer to human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

This device is a physical implant, not an algorithm or software. Therefore, a "standalone (algorithm only)" performance study is not applicable and not mentioned.

7. Type of Ground Truth Used

Given the nature of a 510(k) submission for a physical implant, and the absence of a detailed clinical study for performance evaluation, the concept of "ground truth" as typically used for diagnostic or AI-driven devices is not directly applicable or described. The "ground truth" for substantial equivalence often relates to material properties, intended use, and known safety/performance characteristics of the predicate device.

8. Sample Size for the Training Set

The document does not describe a "training set" as this is not an AI/ML device. The 510(k) process relies on demonstrating equivalence to an existing device, not training a novel algorithm.

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

As there is no training set described for this physical implant, the method for establishing "ground truth" for a training set is not applicable or mentioned.

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The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.

The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.

This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a medical device (Implantech Conform™ Binder Submalar® Implant), indicating that the device has been found substantially equivalent to a legally marketed predicate device. This letter allows the device to be marketed, subject to general controls and other regulations.

The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device ... and we have determined the device is substantially equivalent..." This is a regulatory clearance based on equivalence, not a performance study demonstrating specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts 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.

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