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PROGENIX™ DBM Putty is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX™ DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. When used in the extremeties or pelvis, the device is used by itself. When used in the spine, the device must be mixed with autograft bone and used as a bone graft extender.

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX™ DBM Putty is a single use product intended for use as a bone graft substitute, bone graft extender, and bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

Acceptance Criteria and Device Performance for Medtronic Sofamor Danek PROGENIX™ DBM Putty

This document describes the acceptance criteria and the study used to demonstrate the performance of the PROGENIX™ DBM Putty, as outlined in the provided 510(k) summary (K072265).

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the expanded indication of PROGENIX™ DBM Putty (use as a bone graft extender in spinal fusion procedures) were based on demonstrating its effectiveness in producing spinal fusion.

2. Study Design and Data Provenance

The study that demonstrated the expanded indication for PROGENIX™ DBM Putty was a rabbit study.

• Sample Size: Not explicitly stated in the provided text, but the study was conducted on a sufficient number of rabbits to "suggest that PROGENIX™ DBM Putty is effective."
• Data Provenance: The study was conducted in a pre-clinical animal model (rabbit). No country of origin is specified for the study location. The study is prospective as it evaluates the device's performance in a controlled environment.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not specify the number of experts used or their qualifications for establishing the ground truth of the rabbit study. However, the assessment of spinal fusion (radiographic and manual palpation) would typically involve trained veterinary radiologists and/or surgeons.

4. Adjudication Method

The adjudication method used for the rabbit study is not explicitly stated. However, given the nature of radiographic assessment and manual palpation, it is likely that the evaluation was performed by one or more trained individuals.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed as this is a pre-clinical animal study for a bone graft substitute, not a diagnostic imaging device.

6. Standalone Performance (Algorithm Only)

Not applicable. This device is a bone graft substitute, not an algorithm or software. Its performance is assessed through biological outcomes in vivo.

7. Type of Ground Truth Used

The ground truth used in the rabbit study was based on direct observation and objective assessments of fusion in an animal model:

• Radiographic criteria: Imaging evidence of spinal fusion.
• Manual palpation criteria: Physical assessment of spinal fusion.

8. Sample Size for the Training Set

Not applicable. This is a biological device, not an AI/ML algorithm that requires a training set. The "study" refers to the pre-clinical validation for the expanded indication.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8.

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The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Accell DBM family of products are used for orthopaedic bone grafting procedures. They are osteoconductive human allogenic demineralized bone filling materials for use as fillers for gaps or voids that are not intrinsic to the stability of the bony structure.

Accell DBM family of products are products that are manufactured using human donor demineralized bone and may contain up to 70% poloxamer reverse phase medium carrier (RPM). The demineralized bone is derived from human ground, cortical allograft bone. Poloxamer RPM is an inactive product ingredient that is utilized as a containing agent for the demineralized bone and provides appropriate product handling characteristics for the products.

The products of the Accell DBM family are comprised of the same DBM and RPM components as found in DynaGraft II Gel, FDA cleared under 510(k) number K040419 and Connexus cleared under 510(k)'s K050690 and K052098. In addition, the Accell DBM family of products may contain up to a maximum of 70% of RPM carrier. This is the concentration of RPM already cleared in DynaGraft II gel.

Acceptance Criteria and Device Performance Study for IsoTis Accell DBM Family of Products (K061880)

This submission for the IsoTis Accell DBM Family of Products focuses on demonstrating substantial equivalence to predicate devices, primarily through material characterization and animal studies, rather than clinical efficacy against a specific set of performance criteria for human use.

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not outline specific numerical acceptance criteria for device performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices primarily through:

• Material Characterization: Ensuring the chemical composition, pH, and physical characteristics of the carrier (poloxamer RPM granules) are consistent with previously cleared products.
• Resorption Studies: Demonstrating suitable resorption rates of both the carrier and the DBM in animal models, comparable to the predicate.
• Osteoinductivity Potential: Verifying that each lot of DBM exhibits osteoinductive potential using an in vitro assay correlated to an athymic rat assay.
• Viral Inactivation: Confirming the processing methods effectively inactivate a panel of viruses.
• Safety and Performance in Animal Models: Demonstrating no safety or performance issues in animal studies (critical size defects, spinal fusion) compared to the predicate.

Given this, a table of acceptance criteria and reported device performance would look like this:

2. Sample Size for Test Set and Data Provenance

The provided document does not specify exact sample sizes for each animal study conducted for the Accell DBM family of products. It mentions:

• Carrier Resorption: "A resorption study has been performed to examine the rate and extent of carrier elimination in male adult rats." (No sample size provided)
• DBM Resorption: "Resorption of the DBM was demonstrated during rabbit animal studies." (No sample size provided)
• Specific Performance Studies: "These studies included rabbit tibial critical size defects and rabbit spinal fusion studies." (No sample size provided)

The data provenance is prospective animal studies conducted in rabbits and rats. There is no indication of country of origin for the data; typically, such studies would be conducted in the country of device manufacture or where the research facilities are located.

The document also references "Several animal studies were performed on both Connexus and DynaGraft II Gel and were submitted as part of their original 510(k) submissions (K050690 and K040419)." This suggests reliance on previously submitted data for predicate devices.

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

This submission relies on animal models and laboratory testing (in vitro), not human clinical data with expert-established ground truth. Therefore, there were no human experts used to establish ground truth for a test set in the traditional sense involving clinical outcomes. The "ground truth" for the animal studies would be the physiological and histological observations made by veterinarians, pharmacologists, and histopathologists during the animal experiments, but their specific number and qualifications are not detailed.

For the in vitro osteoinductive potential assay, the validation to the athymic rat model serves as the ground truth correlation, established through laboratory methods rather than expert clinical consensus.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here as the studies are animal and in vitro based, not human clinical trials requiring consensus on clinical endpoints. The interpretation of animal study results would typically be done by the research team involved (e.g., veterinary pathologists, histologists) following standard scientific protocols.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance is being evaluated for its impact on reader performance. This device is a bone void filler/graft extender, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This is not a software algorithm or AI device that operates independently. The "device" is a physical material (Demineralized Bone Matrix with a carrier).

7. Type of Ground Truth Used

The ground truth used was:

• Animal Outcomes/Histopathology: For resorption studies (in rats and rabbits) and safety/performance in animal models (tibial critical size defects, spinal fusion in rabbits). This involves observation of tissue remodeling, graft integration, and absence of adverse reactions.
• In Vitro Assay Correlation: For osteoinductive potential, where an in vitro cell culture assay was validated to correlate with an athymic rat osteoinductive potential assay.
• Laboratory Characterization: For chemical composition, pH, and physical characteristics of the carrier, confirmed through analytical testing.
• Viral Inactivation Assays: For demonstrating the efficacy of processing methods against a panel of viruses.

8. Sample Size for the Training Set

The concept of a "training set" in the context of machine learning or AI is not applicable to this submission. The device is a medical material, and its development and testing involve traditional biological and material science studies, not AI model training. Therefore, there is no training set as typically defined for AI/ML products.

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

As there is no training set in the AI/ML sense, this question is not applicable. The "ground truth" for the various performance aspects of the material (as described in point 7) was established through established scientific methodologies in animal research, in vitro assays, and chemical characterization.

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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.

IsoTis OrthoBiologics is expanding the range of sizes previously cleared in 510(k) K050690 to include Connexus, 0.5cc. The intended use of this additional size does not change from that previously cleared.

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).

Here's a breakdown of the acceptance criteria and the study information for the Connexus, 0.5cc device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document, a 510(k) Summary for Connexus, 0.5cc, does not explicitly state quantitative acceptance criteria for its performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Connexus, K050690) and adherence to various standards and validated processes.

The "reported device performance" is described in terms of the results of these tests and validations, rather than specific numerical targets met.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This document describes a pre-market notification (510(k)) for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting large-scale clinical trials. The "studies" mentioned are primarily pre-clinical or in-vitro validations.

Here's a breakdown of the specific points requested:

1. Sample size used for the test set and the data provenance:

   • Viral Inactivation Validation: "A select panel of viruses representing various virus types, sizes, shapes, and genomes were evaluated." (Specific number not provided). Data provenance is from in vitro laboratory validation.
   • Osteoinductivity Potential (DBM component):
     • In vitro assay: Not specified, but each lot of DBM is tested.
     • In vivo athymic rat model validation: "67 out of 67 test lots" that passed the in vitro assay were confirmed in the in vivo model. This indicates a sample size of 67 athymic rat tests. Data provenance is from in vivo animal testing.
   • Overall Product Performance: Evaluated in "rabbit and sheep models." (Specific sample sizes not provided). Data provenance is from in vivo animal testing.

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

   • The document does not mention human experts establishing ground truth for the presented studies.
   • For the osteoinductivity study, the "ground truth" (or validation reference) for the in vitro assay was the in vivo athymic rat model (confirmation of intramuscular bone formation).
   • For animal performance studies, ground truth was established by "radiographic and histological methods" which would typically involve qualified veterinary pathologists or radiologists, but no specific number or qualifications are mentioned.

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

   • Not applicable/Not mentioned. The studies described are lab validations and animal studies, not human reader assessments requiring adjudication.

4. 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 MRMC or AI-assisted studies are mentioned. This device is a bone void filler, not an AI-powered diagnostic tool.

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

   • Not applicable. This device is a physical bone void filler, not an algorithm.

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

   • Viral Inactivation: Laboratory validation of viral reduction efficacy (presumably based on standard laboratory assays and controls).
   • Osteoinductivity Potential:
     • In vitro: Alkaline phosphatase activity assay (biochemical marker).
     • In vivo (for validation of in vitro assay): Histological confirmation of intramuscular bone formation in athymic rats (pathology).
   • Overall Product Performance (animal models): Radiographic and histological methods (imaging and pathology).

7. The sample size for the training set:

   • Not applicable as this is not an AI/machine learning product requiring a training set in the conventional sense. The "training" for the DBM osteoinductivity assay involved validating it against 67 athymic rat cases.

8. How the ground truth for the training set was established:

   • If we consider the validation of the in vitro osteoinductivity assay as a "training" of the assay to predict in vivo performance, then the ground truth for its validation was established by histological confirmation of intramuscular bone formation in athymic rats.

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