Search Results

The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

The Medicon Epiplating System is an implant system consisting of various plates used as the foundation for anchoring prostheses or epitheses in the craniofacial region. The system offers various implant sizes to fit the anatomical needs of a wide variety of patients. Components are manufactured from pure titanium (ASTM F67) or Ti6Al4V alloy (ASTM F136).

The provided text describes a 510(k) premarket notification for the "Medicon Epiplating System" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of its performance against specific acceptance criteria for an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided document.

The document is a regulatory submission for a physical medical device (an implant system), not an AI/ML software device. The "Performance Data" section discusses mechanical testing, sterilization validation, cleaning validation, and biocompatibility, which are standard for such devices, but not the type of performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML solutions and their acceptance criteria.

Summary of what can be extracted based on the provided text:

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

• Not applicable/Not found. The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics that would be relevant for an AI/ML device (e.g., sensitivity, specificity). Instead, it refers to mechanical testing standards (ASTM F382) and biocompatibility standards (ISO 10993-1). The results are qualitative ("demonstrate substantial equivalence") rather than quantitative against specific clinical performance thresholds.

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

• Not applicable/Not found. This section is irrelevant for the type of device described. No "test set" of clinical data (images, patient records) is mentioned. "Performance data" refers to bench testing on the device itself.

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

• Not applicable/Not found. This information pertains to studies with human expert interpretation, typically in the context of AI/ML evaluation. This document describes a physical implant system.

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

• Not applicable/Not found. This is for clinical data interpretation, not for evaluating a physical implant.

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/Not found. This is specific to AI/ML devices that assist human readers.

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

• Not applicable/Not found. This is specific to AI/ML algorithm performance.

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

• Not applicable/Not found. For this physical device, "ground truth" would be related to material properties meeting standards, mechanical performance under specified loads, and biocompatibility, which are evaluated against established engineering and biological standards, not clinical ground truth derived from expert consensus or pathology.

8. The sample size for the training set:

• Not applicable/Not found. There is no AI/ML training set.

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

• Not applicable/Not found. There is no AI/ML training set.

Information that is mentioned in the document (but not directly addressing the AI/ML specific questions):

• Device Type: Medicon Epiplating System, an implant system.
• Purpose: Attachment of an external restoration prosthesis for physical defects in the maxillo-craniofacial region (ear, nose, eye).
• Regulatory Mechanism: 510(k) premarket notification.
• Substantial Equivalence: Demonstrated through comparison of technological characteristics (design, intended use, material composition, function) to predicate devices.
• Performance Data (for this device type):
  • Mechanical Testing: Performed in accordance with ASTM F382 (proof of load, bending strength, bending stiffness, structural bending stiffness).
  • Sterilization Validation: Pre-vacuum (steam) sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013.
  • Cleaning Validation: Manual and machine cleaning validation in accordance with AAMI TIR30:2011.
  • Biocompatibility: Based on previously cleared devices with identical material and manufacturing methods, tested according to ISO 10993-1.

The document entirely pertains to a physical medical device and does not involve AI/ML technology, which is why the specific questions about AI/ML acceptance criteria and study design cannot be answered from the provided text.

Ask a specific question about this device

Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external on prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are in the maxillo-craniofacial region (including ear, nose and eye).

The device 'Osseointegrated Fixtures' refers to a system involving endosseous implants and their accessories. The endosseous implants are solid, screw-type, self-tapping implants made from commercially pure titanium, with the same enhanced surface as the Southern Implants dental implants. The accessories include drills to prepare the site, abutments and attachments to aid the prosthetic retention, placement tools, instruments and laboratory components.

I'm sorry, but relevant information for answering your request is not provided in the document. The document describes a 510(k) premarket notification for an osseointegrated fixture, and it focuses on demonstrating substantial equivalence to predicate devices rather than outlining specific acceptance criteria, study details, or performance metrics of the new device. It lists standards for safety testing but does not present the results or how they demonstrate meeting acceptance criteria.

Ask a specific question about this device

Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour

Silicone Malar Implant – For the augmentation or reconstruction of the malar contour

Silicone Chin Implant -- For the augmentation or reconstruction of the chin contour

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the Hanson Medical Facial Implants. It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria, device performance studies, or AI/software analysis.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document primarily serves as an FDA clearance letter for a medical device, which is different from a study report detailing performance metrics.

Ask a specific question about this device

Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.

This submission extends the indication for the Nobel Biocare Endosseous Implants to use in maxillofacial reconstructive surgery. There is no change to existing product marketed for dental applications.

The provided text is a 510(k) summary and related correspondence for the Nobel Biocare Endosseous Implants for Maxillofacial Indication. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is focused on extending an existing indication.

Therefore, I cannot provide the requested information from the given text.

The document indicates that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require new performance studies to demonstrate safety and effectiveness for the extended indication. Instead, the focus is on the device description and its intended use.

Ask a specific question about this device

Ask a specific question about this device

For the Augmentation or cosmetic alteration of the nasal shape or contour by straightening the nasal dorsum or widening the narrow nose.

The Monarch Nasal Implant is a Class II Device. The Monarch Nasal Implant is available in 48mm and 44mm lengths and is 1cm wide at the ends. The thickness is 1.5mm to 2mm around the edges. The Monarch Nasal Implant may be inserted via three approaches: Transcutaneous, Intercartilaginous Approach and The Open Technique. The Monarch Nasal Implant is comprised of ePTFE and Medical Grade Titanium Alloys.

The provided text is a 510(k) summary statement for the Monarch Nasal Implant. It states the intended use of the device and information about its materials, sterilization, and sizing. However, it does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific criteria.

Therefore, I cannot provide the requested table and study information based on the input text. The document is primarily focused on establishing substantial equivalence to predicate devices for regulatory approval, rather than detailing performance studies.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Surgical Technology Laboratories, Inc. for their "Nasal Dorsal Series" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or details about the clinical studies requested in your prompt.

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

Ask a specific question about this device

Seare Biomedical Nasal Implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

"L" shaped or straight with a concave convex dorsal aspect which reaches from the alar cartilage to the radix. These silicone rubber implants are made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. Seare Biomedical Nasal Implants are intended for use in augmentation of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision. The Seare Biomedical Nasal 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 Seare Biomedical Nasal Implants will be provided sterile. Thanium Oxide and Iron Oxide pigments may be added to the silicone to prevent light translucence to these implants when ordered by the physician. These pigments are well known and widely used in cosmetic surgery implant applications, and will be lot tested for cytotoxicity.

The provided text is a 510(k) Summary for a medical device called "Seare Biomedical Nasal Implants." It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically associated with performance evaluations of AI/ML-based medical devices.

Instead, this document focuses on establishing substantial equivalence to a predicate device based on material, function, performance, and design, as well as identical indications for use.

Here's an analysis based on your requested information categories:

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

   • Acceptance Criteria: Not explicitly stated as performance metrics. The implicit "acceptance criteria" for a 510(k) submission of this type is substantial equivalence to a predicate device.
   • Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are reported because the device is a passive implant, not a diagnostic or AI-powered system that generates numerical results. The performance is deemed equivalent to the predicate device.

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

   • No test set was used for this type of evaluation. The submission states "Clinical Tests: None." This indicates that no human subject data was collected or analyzed for this 510(k) clearance.

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 test set or ground truth establishment by experts was performed for this 510(k) submission.

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

   • Not applicable. No test set required adjudication.

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

   • No MRMC study was done. This device is a silicone nasal implant, not an AI-assisted diagnostic tool.

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

   • Not applicable. The device is a physical implant, not an algorithm.

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

   • Not applicable. No ground truth measurements were described or required for this type of device clearance.

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. No training set or ground truth establishment was involved.

In summary, the provided document is a 510(k) submission for a traditional medical device (nasal implants) based on substantial equivalence, not a performance study for an AI/ML-powered device. Therefore, most of the requested information regarding acceptance criteria, test sets, experts, and AI-related studies is not present or applicable.

Ask a specific question about this device