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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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For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

Connexus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

The provided text describes the 510(k) summary for the Connexus Putty, a bone void filler. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a dedicated study demonstrating how the device meets such criteria through quantitative performance metrics.

Instead, the document focuses on demonstrating substantial equivalence primarily through:

• Technological Characteristics: Stating similarities in design, materials, and function with predicate devices, and that both are osteoconductive and osteoinductive.
• Viral Inactivation Validation: Describing a study that evaluated the viral inactivation potential of the DBM processing methods.
• Osteoinductivity Potential: Explaining an in vitro assay for osteoinductive potential of the DBM, validated against an in vivo athymic rat model.
• Product Performance Testing: Mentioning evaluations in rabbit and sheep models for safety and effectiveness, but without presenting specific performance data or acceptance criteria.

Therefore, many of the requested details cannot be extracted directly from this document because it is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.

Here's an attempt to answer based on the available information:

1. A table of acceptance criteria and the 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)

• Viral Inactivation Validation: No specific sample size mentioned for viruses, just "a select panel of viruses." No data provenance specified.
• Osteoinductivity Potential (Test Set):
  • In vivo athymic rat model: 67 test lots were evaluated.
  • Data Provenance: Not specified, but likely laboratory-based. The study appears to be prospective in nature for validation, and then individual lots are tested prospectively.
• Product Performance Testing (Animal Models): Samples for "rabbit and sheep models" were used, but specific numbers are not provided. The data is likely prospective experimental data from these animal studies.

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)

Not applicable. The ground truth for viral inactivation is laboratory-based (viral assays). For osteoinductivity, it's based on biochemical markers (alkaline phosphatase) and histological confirmation of bone formation in rats, not expert review of images or clinical outcomes. For the animal performance studies, evaluation by "radiographic and histological methods" likely implies expert interpretation (e.g., veterinary pathologists, radiologists) but the number or qualifications are not stated.

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

Not applicable. This type of adjudication is typically for image-based diagnostic studies or clinical outcomes, which are not the primary focus of the performance data presented here.

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, not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical medical device.

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

• Viral Inactivation: Direct viral load measurements and inactivation assays.
• Osteoinductivity:
  • In vitro: Alkaline phosphatase activity (biochemical marker).
  • In vivo (rat model): Histological confirmation of intramuscular bone formation (pathology/histology).
• Product Performance: Radiographic and histological findings in animal models (pathology/histology, imaging interpretation).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a "training set" in the conventional sense. The "validation" of the in vitro osteoinductivity assay against the in vivo model could be considered a form of training/validation, where the 67 test lots served to establish the correlation.

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

Not applicable in the typical AI sense. For the osteoinductivity assay validation, the ground truth for the in-vitro assay was established by correlating its results with the in-vivo osteoinductivity confirmed via histological analysis of intramuscular bone formation in athymic rats.

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