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OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, filling of defects after root resection, apicoectomy and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of maxillary sinus floor and treatment of periodontal defects.

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g. hydroxyapatite/tri-calcium phosphate) scaffold. The open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 200μm -2000um.

This document, a 510(k) Summary for IsoTis NV OsSatura™ Dental, relies on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving those criteria are met for the device itself.

Therefore, many of the requested categories (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, training set details) are not applicable (N/A) in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• N/A. This submission is a 510(k) for substantial equivalence. It refers to "pre-clinical animal data" and "extensive bench and animal testing" but does not specify sample sizes for these tests in a way that aligns with a traditional "test set" for performance evaluation in the context of AI/software. The primary "data provenance" is the long history of safe clinical use of the material class and the predicate devices.

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

• N/A. Ground truth in the context of expert consensus is not relevant to this submission. The "ground truth" for the safety and effectiveness claims is derived from the established safety profile of the material class (calcium phosphates) and the safe use of predicate devices, as well as general biological principles verified in animal models.

4. Adjudication method for the test set:

• N/A. No formal adjudication method is mentioned as this is not a study requiring expert consensus on specific cases.

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:

• N/A. This device is a bone graft material, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers" are irrelevant.

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

• N/A. This is a physical medical device (bone graft material), not an algorithm or software. "Standalone performance" in this context refers to the device's inherent material properties and biological performance, which were assessed through bench and animal testing.

7. The type of ground truth used:

• The "ground truth" for this submission is based on:
  • Established Material Standards: Compliance with ASTM F1185-88 and F1088-87 for hydroxyapatite and tricalcium phosphate.
  • Biological/Physiological Response: Demonstrated bone ingrowth, degradation, and resorption through pre-clinical animal data and extensive bench and animal testing.
  • Historical Clinical Data: Over 25 years of safe clinical use for calcium-based ceramic materials (hydroxyapatite and tri-calcium phosphate) and safe use of predicate devices.
  • Regulatory Guidance: Compliance with applicable FDA guidance documents on bone void fillers.

8. The sample size for the training set:

• N/A. This is not an AI/machine learning device. The concept of a "training set" is not applicable.

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

• N/A. As above, this is not an AI/machine learning device.

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OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, filling of defects after root resection, apicoectomy and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge and elevation of maxillary sinus floor.

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 1 - 2 mm.

The provided text is a 510(k) summary for a medical device, OsSatura™ Dental. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full efficacy study with specified acceptance criteria in the way a clinical trial for a new drug or novel device might.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study.

Here's an explanation of what an ideal response would look like if the information were available, and why it's not present in this document:

Why the requested information isn't here:

• 510(k) Process: The 510(k) pathway (Premarket Notification) is for devices that are "substantially equivalent" to an existing legally marketed device (a predicate). The focus is on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness profiles as the predicate. It generally does not require new clinical efficacy studies with predefined acceptance criteria and statistical power calculations like a PMA (Premarket Approval) application would for a novel, high-risk device.
• "Testing" Section: The "Testing" section {1} states:
  • "Pre-clinical animal data demonstrate that OsSatura™ Dental chips support bone ingrowth into a variety of bony defects."
  • "Biocompatibility, extensive bench and animal testing using OsSatura Dental have successfully been performed to confirm that the device is degraded and resorbed over time and allow bone ingrowth."
  • It also mentions compliance with ASTM standards (F1185-88 and F1088-87) and FDA guidance documents on bone void fillers.
  • It references the long history of safe clinical use of the materials (calcium-based ceramics) and the predicate devices.
• Lack of Specifics: While "testing" was done, the document does not provide:
  • A table of specific quantitative acceptance criteria (e.g., "bone ingrowth percentage must be > X%")
  • The raw performance data from these tests
  • Details on sample sizes for these preclinical/animal studies
  • Information about expert adjudication of results, ground truth methodology, or how a "test set" was defined for performance evaluation in the clinical sense.

If this were a different type of submission (e.g., a PMA or a more involved clinical study), the requested information would be structured as follows:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The actual document does not provide such a table because it's a 510(k) summary, not a clinical trial report with specific quantifiable acceptance criteria for a primary endpoint.)

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

• Test Set Sample Size: Not specified for a clinical performance evaluation in this document. The testing mentioned is preclinical (animal) and bench testing.
• Data Provenance:
  • Preclinical Animal Data: The document mentions "Pre-clinical animal data" {1}. Specific species, number of animals, and origin are not provided.
  • Bench Testing: The document mentions "extensive bench... testing" {1}. Specifics are not provided.
  • Clinical Data: The submission relies on the "long history of safe clinical use for hydroxyapatite and tri-calcium phosphate products" and the safety record of the predicate devices. No new clinical study data with a defined "test set" is presented for OsSatura™ Dental in this summary.

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

• Not applicable as no specific clinical "test set" with expert-adjudicated ground truth is described in this document for the OsSatura™ Dental product itself. The preclinical and bench testing would involve researchers and scientists evaluating the results, but not in the context of expert consensus for ground truth on patient outcomes in a clinical trial.

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

• Not applicable. No clinical "test set" requiring expert adjudication is described in this document.

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 synthetic bone graft material, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

• Not applicable. This device is a physical biomaterial, not a standalone algorithm.

7. The type of ground truth used:

• For the preclinical/animal studies and bench testing, the "ground truth" would be established through direct observation, histology, material science analysis, and quantitative measurements of bone growth, degradation, and mechanical properties. This is distinct from, say, pathology or outcomes data in a human clinical trial.
• The overall "ground truth" for regulatory clearance under a 510(k) is primarily the substantial equivalence to legally marketed predicate devices, which already have an established safety and effectiveness profile based on their own testing and clinical use.

8. The sample size for the training set:

• Not applicable. This document describes a medical device (bone graft material), not a machine learning model that requires a training set.

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

• Not applicable for the same reason as #8.

In summary, the provided 510(k) document is a regulatory submission for a device demonstrating substantial equivalence, not a detailed clinical study report. Therefore, it lacks the specific, quantifiable performance acceptance criteria and detailed study methodologies that would be found in such a report. The "proof" for this device's safety and effectiveness relies on its similarity to existing, legally marketed devices and successful preclinical and bench testing.

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