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Synthes Hemostatic Bone Putty is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Synthes Hemostatic Bone Putty (HBP) stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, HBP forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure and dissolves postoperatively, permitting normal tissue healing and bone regeneration. HBP is a blend of synthetic water soluble polymers that form a ready-to-use hemostatic agent that is substantially eliminated from the defect site in less than 48 hours.

The constituents of Synthes Hemostatic Bone Putty and Ostene, the predicate, are similar. Ostene is comprised of a proprietary mixture of water soluble alkylene oxide copolymers. HBP is also comprised of water soluble alkylene oxide polymers. The remainder of HBP is a polysaccharide, carboxymethylcellulose (CMC), to improve handling. Ostene does not contain CMC.

The provided document is a 510(k) summary for the Synthes Hemostatic Bone Putty. It details the device's description, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device. However, it does not describe specific acceptance criteria and detailed device performance results in a format that would allow for the construction of the requested table.

Specifically, the document lists several non-clinical tests but does not provide:

• Specific acceptance criteria for each test (e.g., "cytotoxicity level must be below X").
• Reported device performance in quantitative terms against such criteria.
• Any information related to clinical studies (MRMC, standalone, human readers, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods).

Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text. The document focuses on demonstrating substantial equivalence through non-clinical biocompatibility and resorption studies, not on providing performance metrics against predetermined acceptance criteria typically seen in clinical performance studies of diagnostic or AI-powered devices.

Based on the provided text, the following information is available (and what is not):

1. Table of acceptance criteria and reported device performance:
* Not available. The document lists types of non-clinical tests but does not define specific acceptance criteria or report quantitative device performance against them. It states that "Documentation is provided that demonstrates that Synthes Hemostatic Putty is substantially equivalent to other legally marketed devices," implying that the results of these tests met the necessary standards for equivalence, but without providing the specifics.

2. Sample size used for the test set and the data provenance:
* Not applicable/Not available. The studies described are non-clinical (in vitro/animal studies), not human clinical trials with test sets derived from human data. The "test set" concept as usually applied to AI/diagnostic devices doesn't fit here.
* Data provenance: The animal studies mentioned include those in rats and rabbits for resorption rates, and sheep for vertebral body defect evaluation. The specific countries of origin for these animal studies are not stated. All studies appear to be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not available. As these are non-clinical animal studies, the "ground truth" would likely be established by trained laboratory personnel or veterinary pathologists, not human medical experts in the context of diagnostic interpretation. No specific numbers or qualifications are provided.

4. Adjudication method for the test set:
* Not applicable/Not available. Not relevant for the types of non-clinical studies described.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
* No. This document is for a hemostatic bone putty, not an AI-powered diagnostic device. An MRMC study is not relevant to this type of medical device's submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* No. This is not an algorithm or AI device.

7. The type of ground truth used:
* For the animal studies, the "ground truth" would be determined by direct observation, histological analysis, or quantitative measurements (e.g., resorption rates, evaluation of bone healing) in the animal models.

8. The sample size for the training set:
* Not applicable/Not available. This is not an AI/machine learning device; therefore, no training set is mentioned or relevant.

9. How the ground truth for the training set was established:
* Not applicable/Not available. See point 8.

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Norian PDC is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall.

Norian PDC Cement is intended to be used in the treatment of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.

Norian PDC is a paste-like bone cement which is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall. Norian PDC is an injectable and moldable, biocompatible, bone cement. The Norian PDC Reactants Pack contains the two sterile components used in Norian PDC: Calcium Phosphate Powder and Sodium Phosphate Solution. The Reactants Pack is mixed in a pneumatic mixer to form a smooth, viscous paste which is applied to the operative site. Norian PDC cures into a carbonated apatite that is substantially similar to the mineral component of bone, and over time, the Norian PDC is gradually resorbed over time.

The provided text is a 510(k) summary for the Norian® PDC™ bone cement. It describes the device, its intended use, and device testing. However, it does not contain the detailed information needed to answer the specific questions about acceptance criteria for a device's performance, a specific study proving it, or AI/human reader performance.

The document states: "Biocompatibility testing showed that Norian PDC Cement is acceptable for its intended use as a bone implant material. Norian Cement passed all tests, and showed no toxic, mutagenic or irritating effect." This is a general statement about meeting biocompatibility requirements, not specific performance metrics (like accuracy, sensitivity, specificity) for a diagnostic or AI-based device, nor details of a study with human readers.

Therefore, I cannot provide the requested information based on the provided text. The questions are geared towards the evaluation of AI/diagnostic devices, which is not the subject of this 510(k) summary for a bone cement.

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Norian CRS is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.

Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for the restoration or augmentation of bony contours in the craniofacial skeleton, such as burr hole voids and other cranial defects. Norian CRS is an injectable and moldable, biocompatible, bone coment. The Norian CRS Reactants Pack contains the two sterile components used in Norian CRS: Calcium Phosphate Powder and Sodium Phosphate Solution.

When the Reactants Pack is mixed, a smooth, viscous paste is applied directly to the opcrative site, where it hardens in about 10 minutes to provide initial structural support. Within 24 hours, Norian CRS cures into a carbonated apatie that is similar to the mincral component of bone. The compresssive strength of Norian CRS is approximately 50MPa. Over time, Norian CRS is gradually resorbed.

The Norian Mixer. Delivery Device, and Delivery Needles are used to mix and deliver the Norjan CRS to the operative site.

This document describes the Norian CRS (Craniofacial Repair System), a bone cement intended for filling craniofacial defects. The information provided outlines its technological characteristics, performance data, and regulatory approval.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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