Search Results

Osteo-PIM Bone Graft Substitute is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis), and the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone. Subsequent to implantation, Osteo-PTM Bone Graft Substitute is resorbed and replaced with bone during the healing process.

Osteo-PTM Bone Graft Substitute is a radiolucent bone void filler composed of a porous, osteoconductive polymeric carbohydrate with a trabecular structure simulating the multidimensional interconnectivity of human cancellous bone. When placed in direct contact with host bone, Osteo-PTM supports and guides the ingrowth of new bone across the graft site and is resorbed as the healing process occurs. The consistency of Osteo-P™ allows the surgeon to easily manipulate and maximize the direct contact with viable host bone. It is intended for single patient use only and is provided sterile in single-use double sterile packaging. Osteo-P™ is available in various forms to include granules, sheets, cubes, wedges, and cylinders.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Osteo-PTM Bone Graft Substitute." This type of document is a regulatory submission for a medical device and describes its characteristics and comparisons to existing devices, usually for the purpose of demonstrating substantial equivalence.

However, it does not describe a study that establishes acceptance criteria for an AI/ML-based medical device or proves its performance against such criteria. Instead, it outlines the characteristics and pre-clinical testing (animal studies, biocompatibility) of a bone graft substitute to demonstrate its substantial equivalence to predicate devices, which is a key part of the 510(k) pathway.

Therefore, I cannot extract the information requested for AI/ML device acceptance criteria and performance according to your prompt. The document is about a biomaterial device, not an AI/ML diagnostic or assistive device.

Ask a specific question about this device

OsteoMimetic™ Synthetic Bone Matrix is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. The OsteoMimetic matrix is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone in conjunction with standard measures.

OsteoMimetic Synthetic Bone Matrix is a synthetic, multicrystalline, porous form of ß-tricalcium phosphate [Cas(PO4)2]. The matrix physically fills bone defects to prevent the collapse of soft tissue and stabilize the blood clot. It provides a biocompatible, osteoconductive, and three-dimensional scaffold to facilitate new bone formation. As the matrix is resorbed, bone and other connective tissues grow into the space previously occupied by the matrix. OsteoMimetic Synthetic Bone Matrix is provided sterile as 1-2mm particles.

Here's an analysis of the provided text regarding the OsteoMimetic™ Synthetic Bone Matrix, focusing on acceptance criteria and study details.

Based on the provided K051775 document, there is no specific performance acceptance criteria or a dedicated study described to "prove the device meets acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. This document is a 510(k) Premarket Notification, which typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting new clinical efficacy data against defined performance thresholds.

The safety and effectiveness information in this document primarily relies on:

• Compliance with an ASTM standard for composition: ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for Surgical Implantation."
• Biocompatibility testing: According to ISO 10993.
• Prior safe use of predicate devices.

Therefore, most of the requested fields related to a clinical study establishing performance criteria cannot be answered from this document.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Data)

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

   • Not applicable / Not provided. The document does not describe a clinical trial or performance study with a "test set" in the context of diagnostic accuracy or clinical efficacy. The substantial equivalence relies on existing data/knowledge of predicate devices and material standards.

2. 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 such ground truth establishment is described for a test set.

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

   • Not applicable. No test set or adjudication process is described.

4. 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 (a bone void filler) is not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to its predicate device submission.

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

   • Not applicable. This is not an algorithm-based device.

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

   • Indirectly, safety and performance are inferred from conformance to material standards (ASTM F1088, ISO 10993) and the established history of predicate devices. There is no direct "ground truth" for clinical outcomes presented for this specific device in this document, as the submission focuses on substantial equivalence for a material.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this 510(k) submission.

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

   • Not applicable. There is no "training set" or associated ground truth establishment described.

Ask a specific question about this device