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BioSphere MIS Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere MIS 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 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 MIS Putty ("BioSphere MIS") is an osteoconductive, bioactive bone void filler that, like its predicate device, is composed primarily of medical-grade 4555 bioactive glass particles. The composition and formula of this material is unchanged and is identical to that used in the BioSphere Putty predicate. The bioactive glass is mixed with an inert, moldable carrier using the exact same composition and formula as used in the predicate device.

The only difference between the two devices is that BioSphere MIS Putty is supplied in a prefilled cannula with a delivery gun to aid with placement into certain types of bony voids that are otherwise difficult to reach. The manner in which the device is delivered to the target site does not play any role in the putty achieving its intended clinical purpose (i.e., supporting bone regeneration).

Upon implantation of BioSphere MIS Putty into the target site, 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 supplied 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. This is the same mechanism of action as with the predicate. In the posterolateral spine, BioSphere MIS Putty can be combined with autograff as a bone graft extender in the same manner as the predicate BioSphere Putty.

The provided text describes a 510(k) premarket notification for a medical device called "BioSphere MIS Putty". The purpose of this 510(k) is to modify the existing BioSphere Putty (predicate device) by changing its delivery mechanism from an open bore syringe to a pre-filled cannula with a delivery gun.

Based on the information provided, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative format as would typically be found in a clinical study report. Instead, it describes performance characteristics that were tested to demonstrate the device's functionality with the new delivery system. The goal of these tests was to show that the new delivery mechanism does not negatively impact the device's safety or effectiveness, and that the device remains "substantially equivalent" to its predicate.

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

The document does not specify exact numerical sample sizes for each test. For example, it says "measuring the dispensed putty amount following each pull of the delivery gun trigger" and "evaluating with room temperature and refrigerated samples". It also refers to "A 3-point bending test" and "Confirmatory testing" but without detailing the number of units tested.

The data provenance is not explicitly stated. However, given that these are performance tests conducted by the manufacturer for regulatory submission, it is assumed to be prospective testing performed in a laboratory setting. There is no information regarding country of origin for the data that would be relevant to clinical studies (e.g., patient data).

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

This submission does not involve clinical data or "ground truth" established by experts in the context of diagnostic accuracy. The tests described are engineering and material characterization tests of the device's physical and biological properties. Therefore, there were no experts used to establish ground truth in this context. The "ground truth" for these tests would be the measured physical and chemical properties themselves against predefined specifications.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this submission involves engineering and material characterization tests, not human-based assessments requiring adjudication.

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 bone void filler and does not involve "human readers" or "AI assistance". It's a medical implant/material.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests described is based on engineering specifications, material science standards, and established biocompatibility testing protocols. For example, the non-cytotoxicity test would have a defined standard (e.g., ISO 10993) that dictates what constitutes a "non-cytotoxic" result. Similarly, "reproducible amount," "effective extrusion," and "preferentially failed through plastic deformation" would be evaluated against internal design specifications and industry best practices for device performance.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set.

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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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