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Porous Biologic Scaffold is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Porous Biologic Scaffold is indicated to be packed gently into bony voids or gaps of the pelvis, intervertebral disc space, and posterolateral spine and is used combined with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Porous Biologic Scaffold must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Porous Biologic Scaffold is a resorbable bone void filler that is available in two versions:

Version 1 is comprised of a porous collagen mesh that is either prefilled or separately packaged with human demineralized allograft bone matrix. In the prefilled format, the demineralized bone matrix is completely enclosed inside the collagen mesh. In the separately packaged format, an open-ended collagen mesh bag is supplied with separately packaged demineralized bone matrix and is filled and sewn closed with absorbable suture by the clinician. Version 1 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation.

Version 2 is comprised of a porous resorbable collagen mesh bag either prefilled or separately packaged with activated biphasic ceramic granules. In the prefilled format, the biphasic granules are completely enclosed inside the collagen mesh. In the separately packaged format, an openended collagen mesh bag is supplied with separately packaged biphasic granules and is filled and sewn closed with absorbable suture by the clinician. Version 2 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation.

Both formats of the Porous Biologic Scaffold are supplied terminally sterile and are available in sizes of 18 x 50 mm, 18 x 100 mm, 24 x 50 mm, and 24 x 100 mm.

This document is an FDA 510(k) clearance letter for a medical device called "Porous Biologic Scaffold." It's important to note that this document primarily focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating acceptance criteria for an AI/software-based medical device.

Therefore, I cannot extract the information required for an AI/software-based medical device's performance study acceptance criteria, as this document describes a physical medical device (bone void filler) and its regulatory clearance process, which relies on demonstrating equivalence to previously cleared devices rather than extensive new clinical performance studies with acceptance criteria like those for AI.

The document states:

• "The subject device has been previously cleared under K240775, 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."
• "Based on the clinical analysis, the device is substantially equivalent to the predicates."

These statements indicate that the "performance" demonstrated is primarily based on established characteristics (sterility, biocompatibility, material properties) and leveraging prior studies on similar devices or the same device from a previous submission, rather than a new, detailed clinical trial with specific acceptance criteria that would be typical for an AI software.

Therefore, I cannot fill out the requested table and answer the detailed questions about acceptance criteria specific to an AI/software study because the provided text describes a physical medical device and its substantial equivalence clearance, not an AI/software performance study.

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Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Synthetic Bone Putty is composed of biphasic ceramic granules in an alkylene oxide polymer carrier, and it is identical to the device cleared in K221644. This submission expands the device's indication to include use in the intervertebral spine.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Synthetic Bone Putty." It outlines the FDA's determination of substantial equivalence to predicate devices and discusses regulatory requirements.

However, the document does not contain any information regarding:

• Acceptance criteria for device performance.
• A study proving the device meets specific acceptance criteria.
• Sample sizes used for test sets or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The "Performance" section mentions that the subject device's performance has been previously cleared and leverages prior studies for sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterization/bench performance. It also states that "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 implies that performance data exists, but the details of the studies themselves (methodology, acceptance criteria, results) are not included in this FDA communication.

Therefore, I cannot provide a table of acceptance criteria and reported performance or details about the studies as requested, because that information is not present in the provided text.

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Synthetic Bone Putty is a bone void filler intended for use in bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or a result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis and posterolateral spine and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process.

Synthetic Bone Putty is a resorbable bone void filler comprised of biphasic ceramic granules suspended in an alkylene oxide polymer carrier. The device can be used either standalone or in combination with autograft bone as a bone graft extender. Synthetic Bone Putty is supplied terminally sterile in an open-barrel syringe applicator that is packaged in a sterile barrier blister pack. The device is offered in sizes of Small, Medium, and Large.

The provided text describes a medical device called "Synthetic Bone Putty" and its 510(k) premarket notification. The document focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed acceptance criteria and a study dedicated to proving those criteria for an AI/ML powered device.

Therefore, many of the requested elements for an AI/ML device study are not present in this document. However, I can extract the relevant information from the provided text regarding the non-clinical testing performed.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a specific table of quantitative acceptance criteria for device performance with numerical targets (e.g., minimum tensile strength, specific resorption rate percentages) followed by reported performance results. Instead, it indicates that the device "meets relevant requirements" of certain standards and that it "demonstrated substantially equivalent new bone formation and spine fusion rates as compared to the predicate device."

   Acceptance Criterion (Implicit)	Reported Device Performance
   Compliance with FDA Class II Bone Void Filler Guidance Document	Characterization of implant materials conducted as recommended.
   Compliance with ASTM F1185-03 and F1088-04a requirements	The device meets relevant requirements of ASTM F1185-03 and F1088-04a.
   Compliance with ISO 10993 Biocompatibility Requirements	The device has met all ISO 10993 biocompatibility requirements relevant to bone void filler devices.
   Sterilization Efficacy	Sterilization evaluations performed with passing results.
   Packaging Integrity	Packaging evaluations performed with passing results.
   Shelf-life Stability	Shelf-life stability evaluations performed with passing results.
   Substantially equivalent new bone formation in comparison to predicate in a posterolateral spine fusion rabbit model (radiographic, biomechanical, histological)	Synthetic Bone Putty demonstrated substantially equivalent new bone formation as compared to the predicate device via radiographic, biomechanical and histological evaluations across multiple time points.
   Substantially equivalent spine fusion rates in comparison to predicate in a posterolateral spine fusion rabbit model (radiographic, biomechanical, histological)	Synthetic Bone Putty demonstrated substantially equivalent ... spine fusion rates as compared to the predicate device via radiographic, biomechanical and histological evaluations across multiple time points.
   Meeting pyrogenicity limit specifications	The device met pyrogenicity limit specifications according to FDA-recognized standards ANSI/AAMI ST72:2019, USP , and USP .

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document mentions a "posterolateral spine fusion rabbit model" for performance testing. It does not specify the number of rabbits or individual test samples (sample size) used in this model. The data provenance (country of origin, retrospective/prospective) and type of data are related to animal studies, not human data.

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 information is not provided as the study involves an animal model and laboratory evaluations (radiographic, biomechanical, histological), not human expert interpretation of clinical data in the context of an AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as this is an animal model study with laboratory analysis, not an expert panel review of clinical cases.

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, an MRMC comparative effectiveness study was not done. The context is a bone void filler device, not an AI/ML diagnostic tool, so "human readers" and "AI assistance" are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is a medical device (bone putty), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For the animal study, the "ground truth" was established through objective and scientific evaluations:

   • Radiographic evaluations: Imaging results.
   • Biomechanical evaluations: Mechanical properties testing.
   • Histological evaluations: Microscopic examination of tissue samples (likely pathology) to assess new bone formation and fusion.
   • Bacterial Endotoxins Test (BET): Laboratory testing against recognized standards.

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The "training" for this device would refer to its development and refinement based on scientific principles and previous research, not algorithm training.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set in the context of an AI/ML device.

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