(88 days)
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:
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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 . -
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. -
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. -
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. -
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. -
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. -
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.
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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. -
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.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.