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BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

BioSphere Putty Bioactive Bone Graft (BioSphere Putty) is an osteoconductive, bioactive bone void filler that, like its predicate device, is composed of 45S5 bioactive glass particles. In BioSphere Putty, the bioactive glass is mixed with an inert, moldable carrier that aids in placement of the product into bony voids. Upon implantation, the carrier is absorbed by the site and the remaining bioactive glass particles provide an osteoconductive surface for bone formation. The bioactive glass particles are provided in a spherical form, and the natural packing of the spheres creates 3-dimensional, interconnected porosity that allows for bone regeneration throughout the defect site. In the posterolateral spine, BioSphere Putty can be combined with autograft as a bone graft extender.

Here's a breakdown of the acceptance criteria and the study details for the BioSphere® Putty Bioactive Bone Graft, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly list quantitative "acceptance criteria" in the format of a target value. Instead, the primary performance measure for the expanded indication (bone graft extender in posterolateral spine) was to demonstrate substantial equivalence to autograft. This was assessed through various methods, with a focus on radiographic fusion rate and biomechanical similarity.

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

• Sample Size: Five (5) animals were evaluated at each time point (6 weeks and 12 weeks) for each group (BioSphere Putty + autograft and autograft only). This implies a total of 20 animals in the test set (5 animals/group * 2 groups * 2 time points).
• Data Provenance: The study was conducted using a rabbit posterolateral fusion model, which is an animal model. The text doesn't specify the country of origin for the data or whether it was retrospective or prospective, but animal studies are typically prospective.

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

• Number of Experts: The text states that a "blinded, bilateral radiographic fusion assessment" was conducted to determine the radiographic fusion rate. However, it does not specify the number of experts who performed this assessment.
• Qualifications of Experts: The text does not specify the qualifications of the experts who performed the assessment.

4. Adjudication Method for the Test Set

• The text describes a "blinded, bilateral radiographic fusion assessment." This implies that the assessors were blinded to the treatment group (BioSphere Putty + autograft vs. autograft). However, the specific adjudication method (e.g., 2+1, 3+1, none) is not mentioned. It's unclear if multiple readers independently assessed and then reached consensus, or if a single reader performed the assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is an animal model study comparing the device to autograft. There is no mention of human readers assessing cases with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The device is a physical bone graft, not an algorithm. The study assessed the in-vivo performance of the physical product.

7. Type of Ground Truth Used

The ground truth for the animal study was established through a combination of:

• Radiographic Assessment: X-ray and microCT images.
• Histology and Histomorphometry: Microscopic examination of tissue for bone formation and integration.
• Biomechanical Testing: Direct measurement of range of motion and tensile peak load.

This represents a comprehensive approach to defining "fusion" and material performance in an animal model.

8. Sample Size for the Training Set

• The concept of a "training set" is not applicable here as the submission describes a physical medical device (bone graft), not a machine learning algorithm. Therefore, there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established

• As there is no training set for an algorithm, this question is not applicable.

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KINEX™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. KINEX™ Plus Putty and KINEX™ Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone marrow aspirate. KINEX™ Strip, KINEX™ Plus Strip, KINEX™ Putty and KINEX™ Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEX™ resorbs and is replaced with bone during the healing process.

KINEX™ Bigactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When KINEX™ is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by KINEX™.

KINEX™ implants consist of bioglass (per ASTM F1538), collagen (per ASTM F2212), and hyaluronic acid, and are available in putty, gel, and strip forms to accommodate surgical and anatomical needs.

The provided text is a 510(k) summary for a medical device (KINEX™ Bioactive), which primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and states that performance data supported its equivalence. However, it does not contain the detailed information required to answer many of your specific questions about acceptance criteria, a specific study's methodology, or a statistical comparison of performance.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted/inferred:

• Device Performance (General): The document states "Performance data demonstrates substantial equivalence to the predicate device." and "KINEX™ implants are as safe, as effective, and perform as well as or better than the predicate devices."
• Type of Testing: "In vivo performance testing (tibia defect model and posterolateral spine fusion model) and biocompatibility testing were conducted..."
• Guidance Followed: "...in accordance with the 'Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device,' June 2, 2003." This guidance would contain acceptance criteria, but they are not explicitly listed in this document.
• Ground Truth Type (Inferred for in vivo studies): For in vivo animal models, ground truth is typically assessed through histological analysis, micro-CT, or other imaging techniques to evaluate bone formation, resorption, and integration.

What cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance: This document only provides a high-level statement about meeting acceptance criteria (via substantial equivalence). It does not list specific numerical performance metrics or acceptance thresholds.
• Sample size used for the test set and data provenance: The document mentions "tibia defect model and posterolateral spine fusion model" but does not give sample sizes, animal species, or country of origin.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This is highly unlikely for a bone void filler device and is not mentioned. MRMC studies are typical for diagnostic imaging AI.
• If a standalone performance study was done: The provided text indicates in vivo testing but doesn't differentiate between standalone performance vs. comparison to a predicate in a statistically rigorous way described for AI. The "substantial equivalence" framework means the device is compared to existing devices, not necessarily tested in isolation against absolute performance metrics in the same way an AI model might be.
• The sample size for the training set: Not applicable for this type of device and study. There's no AI model being "trained."
• How the ground truth for the training set was established: Not applicable for this type of device either.

Based on the available information, here is a summary without the specific details that are not present:

The KINEX™ Bioactive device underwent in vivo performance testing in both a tibia defect model and a posterolateral spine fusion model, in addition to biocompatibility testing. These studies were conducted in accordance with the "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," issued June 2, 2003.

Acceptance Criteria and Device Performance:

Study Details (Limited Information):

1. Sample size for the test set and data provenance: Not specified in the provided text. The studies were in vivo animal models (tibia defect and posterolateral spine fusion models).
2. Number of experts and qualifications for ground truth: Not specified. For in vivo animal studies, experts would typically be veterinary pathologists, histologists, or orthopedic surgeons.
3. Adjudication method: Not specified.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device submission and no such study was performed or mentioned.
5. Standalone performance study: The in vivo performance testing evaluates the device's biological response in an animal model. The core claim is substantial equivalence to predicates, implying a comparative context, but the animal studies themselves would characterize the device's fundamental performance.
6. Type of ground truth used: Inferred to be animal in vivo outcomes, likely assessed through histological analysis, imaging (e.g., micro-CT, radiography), and macroscopic evaluation of bone repair/fusion.
7. Sample size for the training set: Not applicable; this device is not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) summary provides a regulatory overview of a traditional medical device, not a detailed technical report of an AI-powered diagnostic system, which is what most of your questions are geared towards. The "performance data" mentioned refers to standard biological, and possibly biomechanical, testing for bone void fillers, demonstrating its functional equivalence to existing products on the market.

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