(56 days)
NovaBone IRM - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone IRM (Irrigation Resistant Matrix) 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.
NovaBone IRM is an osteoconductive bioactive device used for grafting osseous defects. It is a premixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder. The bioactive particulate is composed solely of elements that exist naturally in normal bone (Ca, P, Na, Si, O). The device requires no mixing or preparation prior to application. NovaBone IRM is supplied ready-to-use, to be applied directly to the intended graft site. The binder is then absorbed from the site such that only the bioactive particulate remains.
Upon absorption of the binder, the remaining particulate material undergoes a timedependent kinetic modification of the surface that occurs when implanted in living tissue. Specifically, a series of surface reactions results in the formation of a calcium phosphate layer on the particles that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months. The timeframe for full absorption in humans has not been determined, but is expected to be at least twelve months.
The provided document is a 510(k) premarket notification from the FDA regarding the NovaBone IRM device. It details the device's indications for use, technological characteristics, and a conclusion of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML device.
The document describes a medical device (bone void filler) and its regulatory clearance process, not an AI/ML system. Therefore, most of the requested information about acceptance criteria for AI algorithms, test set sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable to this document's content.
Here's how I would answer based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance (as inferred from a non-AI context):
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (NovaBone Putty K112773). For a traditional medical device like NovaBone IRM, the "acceptance criteria" are implicitly met by demonstrating that it is as safe and effective as the predicate device.
The performance is primarily evaluated through:
- Biocompatibility: Supporting safety.
- Functional in vivo results: Demonstrating performance in a rabbit femoral defect model. This shows the device's ability to resorb and be replaced by bone during the healing process, and fill osseous defects.
- Technological Characteristics: Matching the composition and particle sizes to cleared devices.
Table of Acceptance Criteria and Reported Device Performance (as inferred for this specific device):
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (from the document) |
|---|---|
| Safety: Biocompatibility | "A biocompatibility assessment for NovaBone IRM supports safety of the device for implantation in bone voids." |
| Effectiveness: Ability to fill bony voids | "The results of a rabbit femoral defect model further support biocompatibility and show the device performance to be substantially equivalent to NovaBone Putty (K112773) for filling of osseous defects." |
| "Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months. The timeframe for full absorption in humans has not been determined, but is expected to be at least twelve months." (This speaks to the mechanism of action) | |
| Technological Equivalence | "Both devices incorporate 45S5 bioactive glass in a synthetic binder that facilitates handling and are used as bone void fillers in the extremities and pelvis. The bioglass particles sizes for the proposed device are the same as the reference predicate, NovaBone Bioactive Strip (K141207)." |
| Resorbability & Replacement by Bone | "The product provides a bone void filler that resorbs and is replaced with bone during the healing process." (Indication for Use) |
Responses to Specific Questions (Many are not applicable to this document as it's not an AI/ML device):
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A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" are implicitly those necessary to demonstrate substantial equivalence to a predicate device, primarily focusing on safety and function as a bone void filler.
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Sample sized used for the test set and the data provenance:
- The document mentions "Animal testing" and "a rabbit femoral defect model." It does not specify the precise sample size (number of rabbits) or exact data provenance beyond being an animal model. There is no "test set" in the context of an AI/ML algorithm.
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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. This is not an AI/ML device requiring expert ground truth for image interpretation. The "ground truth" for this device's performance would be the biological outcome in the rabbit model (e.g., bone formation, material resorption), likely assessed by pathologists or researchers in the field, but the document does not detail this.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/ML device relying on diagnostic interpretations.
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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 is a physical medical device, not an AI/ML system that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the animal study, the "ground truth" would be direct biological observation and analysis (e.g., histology, imaging) of the defect sites in the rabbits, which falls under "pathology" or "outcomes data" in a broad sense. The document states: "Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months." This is an outcome.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device; there is no "training set" in the AI sense.
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How the ground truth for the training set was established:
- Not applicable. As there's no AI training set, there's no ground truth establishment for it.
§ 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.