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The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

The DIMISIL Scar Gel is manufactured from a medical grade silicone gel and is an amorphous paste that has minimal to no elasticity or strength. The scar gel is supplied in 0.34 fl. oz. (10ml) tubes. The DIMISIL Scar Gel is intended to be used for topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations.

This document is a 510(k) premarket notification for a medical device called DIMISIL Scar Gel. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device.

Here's why and what information can be extracted:

This document describes a traditional medical device (a scar gel), not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for AI/ML performance metrics (like sensitivity, specificity, F1 score, etc.) are not applicable here.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices based on design, materials, function, and intended use.

However, I can extract information relevant to the device and its regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, traditional performance metrics and acceptance criteria for an AI/ML device are not present. The "performance" for this device relates to its equivalence to predicate devices for scar management.

The following numbered points are specific to AI/ML device studies and are therefore not applicable to this document:

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) 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.
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 (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of what this document does provide:

• Device Name: DIMISIL Scar Gel
• Intended Use: Topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.
• Predicate Devices: Kelocote (marketed by Allied Biomedical Corporation) and Kelocote Scar Gel (marketed by Hanson Medical, Inc.).
• Basis for Equivalence: Substantial equivalence in function, design, performance, and materials to the predicate devices.
• K Number: K023678
• Date of Submission: Received November 1, 2003 (Dated October 28, 2002)
• Date of FDA Decision: January 23, 2003 (as per the stamp)

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The intended use of the AART Calf Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.

The AART Calf Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in two styles with dimensions varying in length, width, height and initial shape. The AART Calf Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

The provided text describes a 510(k) premarket notification for the AART Calf Implant, a silicone carving block device. The FDA's substantial equivalence determination means that the device is considered as safe and effective as a legally marketed predicate device.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies. This type of information is typically found in performance testing reports, validation studies, or clinical trial summaries, which are not included in this document.

The document primarily focuses on:

• The applicant and contact information.
• The device's proprietary and common names, classification, and regulatory information.
• A comparison to a predicate device (Silimed Calf Implant) to establish substantial equivalence based on function, design, performance, and materials.
• Device description, intended use, packaging, and sterilization information.
• The FDA's decision letter confirming substantial equivalence and outlining regulatory responsibilities.
• The "Indications For Use" statement.

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

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The AART Silicone Sheeting has a variety of intended uses. The silicone sheeting is intended for short term and long term applications.

Short term indications for use:

• Nasal splinting
• Wound dressing
• Management of keloid or hypertrophic scarring
• Temporary use in TMJ disease
• Temporary joint shims
• Laboratory-uses

Long term indications for use:

• Nasal septal repair
• Orbital floor reconstruction
• Tympanic membrane repair
• Dialysis shunt anchoring
• Durameter repair
• Staged repair of omphalocoel
• Lengthening of extraocular muscles
• As a protective sheathing to help facilitate neural regeneration and tendon anastomosis
• As a protective sheathing to help facilitate osteogenesis
• Other uses deemed appropriate by the using surgeon

Caution: The American Academy of Oral Maxillofacial Surgeons recommends against the use of silicone products for permanent treatment of Temporo Mandibular Joint Disease.

The AART Silicone Sheeting is manufactured from a medical grade silicone elastomer intended for long term implantation. The sheeting will be provided reinforced or non-reinforced in three sizes of varying thicknesses. The AART Silicone Sheeting is intended to be used for various surgical and non-surgical applications and may be trimmed by scalpel or scissors where additional shaping by the surgeon may be necessary.

The provided document is a 510(k) summary for the "AART Silicone Sheeting." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for the new device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this document as it does not contain the specifics of a performance study in the way you've outlined for AI/medical device performance evaluation.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

• None provided. This document is a 510(k) summary demonstrating substantial equivalence, not a detailed performance study with quantitative acceptance criteria and results for the AART Silicone Sheeting itself. The substantial equivalence argument is based on the material, design, function, and performance being similar to the predicate device.

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

• Not applicable / Not provided. No specific "test set" or clinical study data for the AART Silicone Sheeting is described in this document. The submission is a comparison to a predicate device.

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

• Not applicable / Not provided. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not applicable / Not provided. This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The device is a silicone sheeting for physical applications, not an AI diagnostic tool.

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

• Not applicable / Not provided. This device is a physical medical implant/sheeting, not an algorithm or AI product.

7. The Type of Ground Truth Used

• Not applicable / Not provided. No performance data requiring ground truth is presented for the AART Silicone Sheeting. The substantial equivalence argument relies on the properties and intended use being similar to a legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable / Not provided. As this is not an AI/algorithm-based device, there is no concept of a "training set."

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

• Not applicable / Not provided. No training set data or ground truth establishment is mentioned.

Summary of what the document does provide regarding the device and its regulatory pathway:

• Device Name: AART Silicone Sheeting
• Intended Use: Various surgical and non-surgical applications (short term and long term), including nasal splinting, wound dressing, management of scarring, nasal septal repair, orbital floor reconstruction, etc. (See Attachment 1 for full list).
• Predicate Device: Seare Biomedical Silicone Sheeting
• Substantial Equivalence Claim: Based on similar function, design, performance, materials, intended uses, sizes, thicknesses, and options of reinforcement/non-reinforcement as the predicate device.
• Sterilization: Gamma Radiation (minimum 25kGy) to a sterility assurance level (SAL) of 10⁻⁶.
• Regulatory Decision: The FDA found the device substantially equivalent to the predicate (K022223 letter). This means it can be marketed under general controls.

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The intended use of the AART Silicone Carving Block is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. The rectangular blocks are designed for carving flatter devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or surgery. The contoured blocks are generally used for carving curved devices such as nasals or malars or used in body contouring to minimize muscular defects.

The AART Silicone Carving Blocks are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or rectangular shapes. They are provided in seven styles with dimensions varying in length, width, height and initial shape. Pigments may be added to the silicone to make the blocks opaque if requested by the physician. The AART Silicone Carving Block is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

This submission for the AART Silicone Carving Block is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the same way one might for an AI/ML or diagnostic device. As such, the typical structure for reporting acceptance criteria and study data does not directly apply here.

The "study" in this context is the comparison made to predicate devices to establish substantial equivalence based on material, design, function, and performance, not a clinical trial with statistical endpoints.

Here's a breakdown of the information as it relates to this 510(k) submission, with an explanation of why some sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for a 510(k) are implicitly the characteristics of the predicate devices. The "reported device performance" is the manufacturer's assertion that their device meets these characteristics, thereby demonstrating substantial equivalence. There are no explicit quantitative performance metrics or acceptance thresholds in this document because it's a materials/design equivalence submission.

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

• Sample Size for Test Set: Not applicable. There was no specific "test set" in the sense of patient data or clinical samples for a performance study.
• Data Provenance: Not applicable. The "data" here refers to the characteristics of the predicate devices and the new device. The provenance is from the manufacturing specifications and regulatory history of the predicate devices.

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

• Not applicable. There was no "ground truth" to be established by experts in the context of a performance study. The ground truth, here, is the established safety and effectiveness of the predicate devices, which is generally accepted by regulatory bodies.

4. Adjudication method for the test set

• Not applicable. No adjudications by experts were performed as part of a performance study.

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/ML device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device, and no standalone algorithm performance was assessed.

7. The type of ground truth used

• Not applicable in the typical sense of a diagnostic or AI device study. The "ground truth" implicitly relies on the established safety and efficacy of the predicate devices based on their historical use and regulatory clearances. This is a "comparison to predicate" ground truth.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and no training set was used.

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

• Not applicable. No training set was used.

Summary of the "Study" (Substantial Equivalence Justification):

The "study" in this 510(k) submission is a declaration and demonstration of substantial equivalence to existing, legally marketed predicate devices. The manufacturer, Aesthetic and Reconstructive Technologies, Inc. (AART), argued that their Silicone Carving Block is substantially equivalent to:

1. Silicone Carving Block marketed by Hanson Medical, Inc.
2. Spectrum Designs Pre-Form Contour Silicone Carving Block marketed by Spectrum Designs, Inc.

The basis for this substantial equivalence claim rests on the following points:

• Identical Intended Uses: The AART device shares the same intended use for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary, and specific uses for rectangular and contoured blocks, as the predicate devices.
• Similar Materials: The device is manufactured from a medical grade silicone elastomer, which is presented as equivalent to the materials of the predicate devices.
• Similar Design and Performance: The devices are offered in similar shapes and sizes (various convex oval or rectangular shapes, seven styles) and are expected to perform comparably to the predicate devices.

The FDA reviewed this comparison and, finding the claims of equivalence sufficient, issued a determination of substantial equivalence, allowing the device to be marketed. No new clinical or performance data from a specific study with defined acceptance criteria were required or presented beyond the comparative analysis to the predicate devices.

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The intended use of the AART Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.

The AART Gluteal Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or round shapes. They are provided in four styles with dimensions varying in length, width, height and initial shape. The AART Gluteal Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

Here's an analysis of the provided text regarding the AART Gluteal Implant, focusing on acceptance criteria and study details.

Based on the provided document, there is no information about specific acceptance criteria or an associated study that proves the device meets such criteria.

The document is a 510(k) Summary and an FDA clearance letter for a medical device called the "AART Gluteal Implant (Silicone Carving Block)." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, most of the requested information cannot be extracted from this document. However, I can still fill in what's available and explain why other sections are blank.

Analysis of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not applicable. The document describes a 510(k) submission based on substantial equivalence, not a clinical study involving a test set of data.
• Data provenance: Not applicable. No clinical data is presented for this device.

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

• Number of experts: Not applicable. No test set requiring ground truth establishment is described.
• Qualifications of experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. No test set requiring adjudication is described.

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

• MRMC study performed: No. The document does not describe any MRMC comparative effectiveness study. The submission is for substantial equivalence.
• Effect size of human readers with vs. without AI assistance: Not applicable. This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone study performed: No. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used for the Test Set

• Type of ground truth: Not applicable. No test set is described.

8. Sample Size for the Training Set

• Sample size for training set: Not applicable. As this is a physical implant and not an AI-based system, there is no concept of a "training set."

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

• Method of ground truth establishment: Not applicable.

Summary Explanation:

The provided document is a 510(k) clearance for a Class II medical device (ear, nose, and throat synthetic polymer material, although the device is a gluteal implant, it was classified under this regulation number for some reason, as noted in the FDA letter). The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing material properties, design, intended use, and performance characteristics to show they are sufficiently similar, meaning the new device is as safe and effective as the predicate.

For devices cleared through the 510(k) pathway, especially those like physical implants, extensive clinical trials with strict acceptance criteria and performance data (as would be seen in a PMA submission or for AI/diagnostic devices) are often not required if substantial equivalence can be adequately demonstrated. The document clearly states: "The AART Gluteal Implant is substantially equivalent in function, design, performance and materials to the Silimed Gluteal Implant marketed by Silimed LLC." This statement, along with the device description and comparison to the predicate, forms the basis of the FDA's clearance, not performance against specific, pre-defined acceptance criteria.

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The intended use for the AART Pectoralis Implant is augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).

The AART Pectoralis Implants are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in three styles, each with a right and left mirror image. Dimensions of the implants will range from 14.4 cm to 17.6 cm in length with widths from 10.0 cm to 13.5 cm and projection (height) from 1.6 cm to 3.2 cm. The AART Pectoralis Implants are intended to be used for augmentation of the chest by placing the implant submuscular of the pectoralis muscle. They can also be used to reconstruct the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle). The surface characteristic of the implants is smooth. The AART Rectoralis. Implants will be offered non-sterile.

The provided document is a 510(k) summary for the AART Pectoralis Implant. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or any of the detailed study parameters requested in your prompt (such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

The document is a regulatory approval notice based on substantial equivalence, meaning the device is considered safe and effective because it is similar to devices already legally marketed. It does not typically involve detailed performance studies with acceptance criteria in the way you've described for AI models or diagnostic devices.

Therefore, I cannot provide the requested table and study information based on the given text.

However, I can extract the following relevant information:

• Device Name: AART Pectoralis Implant
• Intended Use: Augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).
• Predicate Devices: Pectoralis Implant marketed by Allied Biomedical Corporation and the Seare Biomedical Pectoralis Implant marketed by Seare Biomedical Corp.
• Regulatory Basis: Substantial equivalence based on similarity in function, design, performance, and materials to the predicate devices.

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The intended use of the AART Nasal Implant is for cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

The AART Nasal Implants are manufactured from a medical grade silicone elastomer that has been molded into various "L" or straight shapes with concave convex dorsal aspects which reach from the alar cartilage to the radix. They are provided in seven styles with dimensions varying in length, width, and height. Titanium Oxide and Iron Oxide pigments may be added to the silicone to make the implant opaque if requested by the physician. These pigments are widely used in cosmetic surgery implant applications and will be lot tested for cvtotoxicity. The AART Nasal Implants are intended to be used for augmentation and reconstruction of the nasal contour during rhinoplasty. The surface characteristic of the implants is smooth. The AART Nasal Implants will be offered sterile and non-sterile.

This 510(k) submission (K021418) for the AART Nasal Implant details its substantial equivalence to previously marketed predicate devices rather than providing a study demonstrating specific performance acceptance criteria for the device itself. Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) are not applicable as they relate to performance studies, which are not present in this document.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is based on substantial equivalence to predicate devices, not a new performance study requiring a test set of data.

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

• Not Applicable. See point 2.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 nasal implant, not an AI or imaging device that would involve human readers or comparative effectiveness studies with AI assistance.

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

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

7. The type of ground truth used

• Substantial Equivalence: The "ground truth" for this submission is the established safety and effectiveness record of existing, legally marketed predicate nasal implants (Duralastic Anatomical Nasal Implant and Seare Biomedical Nasal Implant). The AART Nasal Implant demonstrates that it is substantially equivalent in material, design, function, and performance to these predicates.

8. The sample size for the training set

• Not Applicable. As this is not an AI or machine learning device, there is no training set in the conventional sense.

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

• Not Applicable. See point 8.

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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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The intended use for the AART Chin Implant is augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.

The intended use for the AART Chin Implant is for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.

The AART Chin Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped convex implants. They are provided in seven styles with dimensions varying in length, width, and height. The AART Chin Implants are intended to be used for augmentation and reconstruction of the chin or anterior mandibular contour. The surface characteristic of the implant is smooth. The AART Chin Implants will be offered sterile and non-sterile.

This is a 510(k) premarket notification for a medical device, the AART Chin Implant. It is not a study proving the device meets specific acceptance criteria in the way a diagnostic AI/ML device would be evaluated. Instead, this document demonstrates substantial equivalence to predicate devices already on the market. Therefore, most of the requested information regarding acceptance criteria, study details, and AI/ML specific evaluations are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided document:

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

This document does not specify quantitative acceptance criteria or device performance in the way a clinical study would for a diagnostic or AI/ML device. The "acceptance criteria" here implicitly refer to the demonstration of substantial equivalence to existing predicate devices in terms of material, design, function, and performance, which allows the device to be marketed.

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

Not applicable. This is a 510(k) submission based on substantial equivalence to existing devices, not a study involving a test set of data for performance evaluation in the context of AI/ML or diagnostics.

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

Not applicable. Ground truth for a test set is not established in this type of submission.

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

Not applicable. No test set or adjudication method 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. This is not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. There is no ground truth, expert consensus, pathology, or outcomes data used in the typical sense of a performance study for this type of device. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. No training set is involved as this is not an AI/ML device.

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

Not applicable. No training set is involved.

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