Search Results

Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filing of defects after root resection, apicocctomy, and cystectomy Filing of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor

Filling of periodontal defects in conjunction with products intended for Guided Tissue Regencration (GTR) and Guided Bone Regencration (GBR).

Filing of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are natural non-antigenic, porous bone mineral matrixes. They arc produced by removal of all organic components from bovinc bone. Due to its natural structure, BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are physically and chemically comparable to the mineralized matrix of human bone. It is available as cortical granules and blocks.

The provided text is a 510(k) summary for BIO-OSS devices. It states that the basis for substantial equivalence is that the devices are "substantially equivalent to Geistlich's existing products..." The only difference being an alternative geographic source for the bovine bone. The document “incorporates by reference all of the information on the use of BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen in the above referenced 510(k) submissions."

Therefore, the submission does not contain any new acceptance criteria or new study data proving the device meets acceptance criteria. Instead, it relies on the safety and effectiveness demonstrated in previous submissions for the predicate devices. This type of submission, focusing on a change in a non-critical aspect (like the source of raw material, with a demonstrated equivalent safety profile of the new source), typically references prior studies rather than conducting new ones.

Given the information provided in the input, I cannot answer the questions directly as the document does not present a new study with fresh acceptance criteria and device performance evaluation.

However, I can explain why the information isn't present based on the content:

• No new acceptance criteria or reported device performance: The submission is a 510(k) for a change in the bone source (from US to Australia) for an existing product. It claims substantial equivalence to predicate devices and incorporates by reference the information from those previous 510(k)s. This means no new performance criteria or new study results are presented in this specific document.
• No new sample size or data provenance for a test set: Since no new performance study is detailed, there's no new test set, sample size, or data provenance.
• No information on experts for ground truth or adjudication method: These details would be part of a new performance study, which is not included.
• No MRMC comparative effectiveness study: This type of study would be part of a clinical trial or performance evaluation, which is not present in this submission.
• No standalone performance (algorithm only) study: This implies the device is an algorithm or software, which is not the case for BIO-OSS, a bone filling material.
• No new ground truth type: No new ground truth is established as no new performance study is conducted.
• No new training set information: Similarly, no new training set details are provided.
• No new ground truth establishment for the training set: No new ground truth for a training set is established as no new study requiring one is described.

In summary, the provided 510(k) is an administrative update based on a change in raw material source for an already cleared device, not a submission detailing a new performance study.

Ask a specific question about this device

ORTHOSS is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

ORTHOSS™ Resorbable Bone Void Filler

The provided document is a 510(k) clearance letter from the FDA for a medical device called ORTHOSS™ Resorbable Bone Void Filler. This type of letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, and it does not contain the detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way a clinical study report would.

Therefore, for the acceptance criteria and study details you requested, the document states:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter. The letter confirms substantial equivalence, which means the device is as safe and effective as a predicate device, but it doesn't detail specific performance metrics against pre-defined acceptance criteria from a 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 provided in the 510(k) clearance letter.
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 provided in the 510(k) clearance letter.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided in the 510(k) clearance letter.
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 device is a bone void filler, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is a bone void filler and not a diagnostic algorithm, this concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the 510(k) clearance letter.
8. The sample size for the training set: This information is not provided in the 510(k) clearance letter.
9. How the ground truth for the training set was established: This information is not provided in the 510(k) clearance letter.

In summary: The provided document is a regulatory clearance letter focused on substantial equivalence to a predicate device. It does not contain the detailed study design, acceptance criteria, or performance data that would be found in a clinical study report or a pre-market approval (PMA) application for a novel, high-risk device. The assessment for a 510(k) clearance primarily involves demonstrating that the new device is as safe and effective as devices already on the market, often through comparison of technological characteristics, materials, and intended use, rather than a full-scale clinical trial with pre-defined acceptance criteria and reported device performance.

Ask a specific question about this device

Augmentation of reconstructive treatment of the alveolar ridge

Filling of defects after root resection, apicoeccomy and cystectomy

Filling of extraction sockets to enhance preservation of the alveolar ridge

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for Bio-Oss® Blocks. It confirms that the device is substantially equivalent to a legally marketed predicate device. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details about a study to prove the device meets acceptance criteria.

The letter focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.

Ask a specific question about this device

Augmentation or reconstructive treatment of alveolar ridge
Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy
rilling of extraction sockets to enhance preservation of the alveolar ridge
Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR).
Filling of peri-implant defects in-conjunction with products-intended for Guided Bone Regeneration(GBR)

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Bio-Oss Collagen." It does not contain information about the acceptance criteria and study proving device performance as requested. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes or data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

Augmentation or reconstructive treatment of alveolar ridge defects also of any indeasal defects Filling of periodontal defects Filling of defects after root resection, apicoectony, and cyscecomy, and cyscecomy of the also and of and and and and enhance preservarion of- the alveola Filling of defects after root teseccion, approactory, and of the alvestar ridge Elevacion of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Filling of periodontal defects in conjunector aren production (GBR). Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR). villag of peri-implant defects in conjunction with products intended for the before Bear archier/GRP) Guided Bone Regeneration (GBR)

Anorganic Bovine Bone

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a medical device (Bio-Oss Anorganic Bovine Bone) and discusses its substantial equivalence to a predicate device for marketing purposes. It does not include acceptance criteria, study details, performance metrics, sample sizes, or information about ground truth establishment.

Ask a specific question about this device

Resor-Pin is used in oral, dental and maxillofacial surgery for the fixation of resorbable and non-resorbable membranes in augmentation and guided bone regeneration.

Resor-Pin Resorbable Membrane Pin

This is a 510(k) premarket notification for a medical device (Resor-Pin Resorbable Membrane Pin) from 1998. This type of document establishes substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding detailed study design, ground truth establishment, and sample sizes is not applicable or typically found in this kind of regulatory submission.

However, I can extract the following information that is present or can be inferred:

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

Since this is a 510(k) summary, specific numerical acceptance criteria and performance data from studies are not typically provided in this format. The "performance" being evaluated here is the substantial equivalence to a predicate device, meaning it performs similarly and has similar indications for use and safety profiles.

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

This information is not provided in the document. 510(k) submissions typically reference existing data or general scientific principles rather than detailing new large-scale clinical trials for substantial equivalence.

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 applicable as there is no mention of a "test set" and "ground truth" establishment in the context of an AI device. This document pertains to a physical medical device.

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

This information is not applicable for the same reasons above.

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 applicable as this document is for a physical medical device, not an AI-assisted diagnostic tool.

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

This information is not applicable as this document is for a physical medical device, not an algorithm.

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

This information is not applicable as there is no specific "ground truth" mentioned in the context of an AI device. The ground truth for a physical device like this would be its proven safety and effectiveness over time and through predicate device history.

8. The sample size for the training set

This information is not applicable as this document is for a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as this document is for a physical medical device, not an AI model.

Ask a specific question about this device

BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and implants: augmentation around implants placed in immediate extract sockets; - augmentation around implants placed in delayed extraction sockets; . - . localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment - filling of bone defects after root resection, cystectomy, removal of retained teeth. Becayse of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "BIO-GIDE® Resorbable Bilayer Membrane". This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Ask a specific question about this device