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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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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 (i.e. the extremities and pelvis). 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 is an osteoconductive, bioactive bone void filler that, like its predicate device (NovaBone), is composed of 4555 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.

The provided document is a 510(k) summary for the BioSphere™ Bioactive Bone Graft (BioSphere Putty) and its FDA clearance letter. It describes the device, its intended use, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria and the results of a study that directly proves the device meets those specific quantitative acceptance criteria.

The performance data section describes several tests performed, but it lacks specific quantitative acceptance criteria and detailed results to compare against them. Instead, it concludes with a statement that "Performance data demonstrate that BioSphere Putty is as safe and effective as the predicates."

Therefore, I cannot populate the table or answer all the questions as requested because the specific, quantitative acceptance criteria and the detailed study results directly comparing the device's performance against these criteria are not present in the provided text.

Here is what I CAN extract and infer from the document:

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

• Acceptance Criteria: Not explicitly stated in quantitative terms. The primary acceptance criterion appears to be "substantial equivalence" to predicate devices, meaning it is "as safe and effective" and "raises no new issues of safety or effectiveness."
• Reported Device Performance:

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

• Sample Size (Animal Model): Not specified.
• Data Provenance: Not specified for the animal model or in vitro testing. The submission is from Synergy Biomedical, LLC, located in Phoenixville, PA, USA, implying the company is US-based.

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 device is a bone void filler, not an AI/imaging device that requires expert review for ground truth. Therefore, this information is not applicable and not present in the document.

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

• Not applicable as this is not an expert-adjudicated test set in the context of AI/imaging.

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

• No. This is a medical device (bone void filler), not an AI-assisted diagnostic tool.

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

• Not applicable as this is a medical device, not an algorithm.

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

• For in vitro tests: Chemical analysis (XRF, particle size, ion dissolution), observation of calcium phosphate layer formation in SBF.
• For in vivo tests (animal model): Observation and assessment of "bone formation similar to the predicate device." The method of assessing bone formation (e.g., histology, imaging) and the ground truth standard for "similar" are not detailed.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device.

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

• Not applicable as this is not an AI/machine learning device.

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