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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 and intervertebral disc space. When used in intervertebral disc space, BioSphere MIS Putty is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. 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 MIS Putty device is composed primarily of medical-grade 45S5 bioactive glass particles. The composition and formula of this material are unchanged and identical to that used in the BioSphere Reference Device (K173301). This submission expands the device's indication to include use in the intervertebral spine and incorporates minor changes to the applicator, delivery gun, and packaging.

The provided text is an FDA 510(k) clearance letter and associated summary for a medical device called "BioSphere MIS Putty." It outlines the device's indications for use, its classification, and its substantial equivalence to predicate devices.

However, the provided document does not contain information regarding specific acceptance criteria for a study demonstrating device performance, nor details of a study setup (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), as would be expected for an AI/software device submission.

The document states:

• "The subject device has been previously cleared under K173301, which serves as a Reference Device. This submission is leveraged to support the device's sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterizations/bench performance as recommended in FDA's Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices."
• "The device's performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies."

This indicates that the submission relies on bench performance, biocompatibility, and prior clinical (potentially animal or human) studies that supported the initial clearance (K173301) and general knowledge of bone grafting materials.

Therefore, I cannot provide the requested information about acceptance criteria and study details (sample size, data origins, expert involvement, ground truth, MRMC, standalone performance) because this document describes a physical medical device (bone void filler) and not an AI or software device that would typically undergo such performance evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the biological and physical properties of the bone putty, not an AI model's diagnostic or predictive performance.

If this were an AI/software device, the 510(k) summary would include sections detailing the clinical validation study with metrics like sensitivity, specificity, AUC, and comparative performance against human readers. This document does not.

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BioSphere Flex is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Flex 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 created from traumatic injury to the bone. BioSphere Flex must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

BioSphere Flex is a sterile, single-use resorbable bone void filler that is composed of porous bioactive glass granules suspended in a carrier. BioSphere Flex utilizes 45S5 bioactive glass, which has been shown to be osteoconductive and bioactive. The carrier is composed of a porous scaffold of collagen and sodium hyaluronate. BioSphere Flex has the ability to absorb fluid such as bone marrow aspirate and becomes flexible following hydration. Following implantation into the target site, BioSphere Flex supports bone formation through the porosity of the implant and on the surface of the bioactive glass granules. As the materials resorb, the device is eventually replaced by host bone. BioSphere Flex is provided in a variety of forms.

This document describes the BioSphere Flex, a resorbable bone void filler. The information provided is based on a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study design with specific acceptance criteria and performance against those criteria in a tabular format as you requested.

Therefore, many of the specific questions you asked about acceptance criteria and study details cannot be directly answered from the provided text. The document primarily discusses the types of tests performed and the conclusions drawn regarding substantial equivalence.

Here's an attempt to extract and infer information relevant to your questions, along with explicit statements where information is not available:

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

No explicit table of acceptance criteria or specific quantitative performance metrics are provided in the regulatory summary. The summary focuses on demonstrating equivalence to predicate devices rather than meeting predefined numerical acceptance criteria against a specific benchmark.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: For the in vivo critical-sized sheep femoral defect study, the exact sample size (number of sheep) is not specified.
• Data Provenance: The in vivo animal study was conducted in a critical-sized sheep femoral defect, which can be inferred as a preclinical study. The origin country is not specified but is typically within the country of manufacture or a collaborating research institution. It is a prospective study in the sense that the animal model was specifically used to test the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Ground truth in this context would likely be established through histological analysis and radiographic interpretation by veterinary pathologists/radiologists, but the number and qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied. This type of study is more common for diagnostic imaging devices involving interpretation by multiple human readers. The BioSphere Flex is a therapeutic bone void filler.

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

This question is not applicable as the BioSphere Flex is a physical medical device, not an algorithm or AI software, and does not have a "standalone" or "human-in-the-loop" performance in the context of AI. Its performance is inherent in its material properties and biological interaction.

7. The type of ground truth used

For the in vivo animal study, the ground truth was established through:

• Histology: Microscopic examination of tissue.
• Histomorphometry: Quantitative analysis of tissue structure, likely measuring new bone formation, remaining biomaterial, etc.
• Radiographic Analysis: X-ray and micro-CT imaging.

8. The sample size for the training set

This question is not applicable as this is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

This question is not applicable for the same reason as above.

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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 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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