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The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.

The TriStar Bone Graft Fixation System consists of titanium alloy self-drilling screws which are tapered and have a maximum diameter of 1.75mm with lengths of 3mm, 4mm, 5mm, 6mm, 8mm, 10mm, 12mm, 15mm, 18mm, 21mm, and 24mm. The screws are manufactured using a Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes a number of accessories used to fixate the screws and/or membranes or bone blocks to the host bone including a square headed morse tapered hand screw driver, screw driver handle, and latch type driver. The system includes titanium mesh in 40mm x 60mm or 18mm x 25mm sizes each having a thickness of 0.1mm. The screws and titanium mesh are designed to be removed from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single use only.

This document describes the 510(k) premarket notification for the TriStar Bone Graft Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) is not applicable or provided in this type of regulatory submission.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not present a formal table of quantitative acceptance criteria with reported device performance values in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" for granting 510(k) clearance are related to demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through comparisons of design, materials, indications for use, standards applied, and other characteristics.

The "reported device performance" is primarily qualitative, asserting that the device is substantially equivalent and raises no new safety or effectiveness concerns.

The study that "proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which includes the results of non-clinical performance testing and a comparison to predicate devices to establish substantial equivalence.

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

• Sample Size: Not applicable. This document is for a medical device (bone graft fixation system), not a diagnostic AI/software device. The "test set" here refers to the device components themselves undergoing bench testing. The testing mentioned (ASTM F543-13 for screws and ASTM F382 for mesh) likely involved specific sample sizes as dictated by the standards, but these details are not provided in this summary.
• Data Provenance: Not applicable for a clinical study in this context, as "Clinical testing is not applicable to this device." The technical data comes from non-clinical laboratory bench testing.

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" in the context of expert consensus is typically for diagnostic/AI evaluations. For this device, performance is evaluated against engineering standards and material specifications, not expert diagnostic assessments.

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

Not applicable. This concept is for clinical or diagnostic study design, not for mechanical device testing against engineering standards.

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 medical device, not an AI or software device that would assist human readers in interpretation.

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 (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance in this context is defined by:

• Compliance with established international standards for metallic medical bone screws (ASTM F543-13) and mesh (ASTM F382).
• Compliance with biocompatibility standards (ISO 10993-5).
• Chemical composition of materials (e.g., Ti-6Al-4V (ASTM F-136)).
• Substantial equivalence to previously cleared predicate devices in terms of design, material, and indications for use.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that undergoes "training."

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

Not applicable. There is no training set for a physical medical device in this context.

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OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with Osteo Tape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue regeneration (GTR). Titanium tack-screws may be used to immobilize OsteoTape®

OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape) in various preformed shapes, is a resorbable bone grafting substitute comprised of highly purified Type I bovine collagen, used as a carrier derived from bovine Achilles tendon, combined with crystals of the product OsteoGen®, a synthetic bioactive resorbable graft of the non-ceramic hydroxylapatite category. The product is supplied in cubes and strip forms, sterile, and for single use only.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific pass/fail acceptance criteria in terms of numerical performance metrics for the OsteoTape® device (e.g., a certain percentage of bone growth, or a specific strength of bone regeneration). Instead, the acceptance criteria are framed in terms of conformance to established standards and demonstrated safety/effectiveness through testing and literature review.

• ASTM F2212-08e1 (Characterization of Type I Collagen)
• ASTM F1185-03 (Composition of Hydroxylapatite)
• ANSI/AAMI/ISO 11137 (Radiation Sterilization)
• AAMI TIR 27 (Substantiation of 25kGy as a sterilization dose - Method VDmax)
  (Sterilization and Biocompatibility standards are also referenced in Sections 14 and 15, not provided here). |
  | Compliance with Special Controls Guidance | The device adheres to "Guidance for Industry and FDA Staff: Class II Special Control Guidance Document: Dental Bone Grafting Materials, issued on April 28, 2005." |
  | Safety and Effectiveness | "OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, has been evaluated as to its safety and effectiveness by a number of standardized tests to assess its safety, viral inactivation, and biocompatibility in vivo and in vitro, and is confirmed in the medical literature as being safe and effective for a variety of dental applications." (Specific results of these tests are not detailed in the provided text, but their successful completion is asserted). |
  | Similarity of Technical Characteristics to Predicate Devices | "OsteoTape®... and its predicate devices have the same technology characteristics according to specified standards. In particular, OsteoTape® and its predicate devices are similar with respect to intended use, material application, structure, material composition, characterization and similar sizes." |

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

The provided 510(k) summary does not detail a specific "test set" in the context of an AI-driven device or a clinical trial with a defined sample size for performance evaluation. The "study" proving the device meets acceptance criteria is primarily an assertion of compliance with existing standards and a review of safety and effectiveness data (including "standardized tests" and "medical literature").

• There is no indication of a specific sample size for a clinical or in-vitro test set.
• The data provenance is broadly described as "standardized tests" and "medical literature," which could encompass both retrospective and prospective data, and potentially international data, but no specifics are given.

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

This information is not applicable or provided in the context of this 510(k) summary. The device clearance is based on material characteristics, biocompatibility, sterilization, and substantial equivalence to existing devices, not on expert-adjudicated ground truth for an AI algorithm's performance on a specific dataset.

4. Adjudication Method for the Test Set

This information is not applicable or provided. As there's no mention of a "test set" requiring human adjudication for performance evaluation (like in medical imaging AI), no 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

There is no indication of an MRMC comparative effectiveness study being done. This document describes a traditional medical device (bone graft material), not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.

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

There is no indication of a standalone algorithm performance study. This is a material device, not an algorithm.

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

The concept of "ground truth" as typically applied to AI performance evaluation is not directly mentioned or applicable in the provided document. The "truth" for this device revolves around:

• Conformity to material composition standards (e.g., ASTM F1185-03 for hydroxylapatite).
• Demonstrated biocompatibility and viral inactivation (likely through laboratory tests and animal studies, not detailed here).
• Clinical safety and effectiveness as supported by "medical literature" and "standardized tests" (which would include various forms of outcomes data, pathology in animal models, etc., but specific methods are not provided).
• Comparison to predicate devices.

8. The sample size for the training set

This information is not applicable or provided. As this is not an AI/ML device, there is no "training set."

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

This information is not applicable or provided. There is no "training set" or ground truth in the AI sense for this device.

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As an aid in sinus augmentation (sinus lift) procedures.

As an aid in the augmentation of tooth sockets and the treatment of alveolar ridge deformities, including peri-implant alveolar defects.

As an aid in the treatment of periapical and periodontal defects.

Not Found

I apologize, but the provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the OsteoGen® (SBRG) device, indicating that it has been found substantially equivalent to a legally marketed predicate device.

The content focuses on regulatory information, the device's indications for use, and contact details for the FDA. There is no mention of:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

Therefore, I cannot fulfill your request based on the input provided.

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The LAMINOSS® Osteocompressive Implant System consists of a one-piece and twopiece immediately-loaded screw implants for the maxillary and mandibular arches to support fixed or removable prostheses.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

The document is a US FDA 510(k) clearance letter for the LaminOss® Dental Implant, indicating that the device has been found substantially equivalent to existing legally marketed devices. This letter does not contain details about performance studies, sample sizes, expert qualifications, or ground truth methodologies. It primarily focuses on regulatory approval based on equivalence.

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Ask a specific question about this device