(84 days)
Osteophil B-TCP is a resorbable bone void filler intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Osteophil B-TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product consists of beta-Tricalcium Phosphate and is about 80% porous. The product is provided sterile and is available in granules 1-4 mm². Osteophil B-TCP has a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Osteophil B-TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Osteophil B-TCP resorbable bone filler is intended to prevent premature resorption.
The provided document describes the Osteophil B-TCP device, a resorbable bone void filler. The submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are focused on proving this substantial equivalence rather than on a clinical trial to establish device performance against specific clinical acceptance criteria.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
The document states that Osteophil B-TCP has "substantially equivalent critical specifications" and "substantially equivalent technical characteristics" as its predicate device, CAMCERAM TCP (K050357). The acceptance criteria are implicitly that all listed characteristics are substantially equivalent to the predicate. The "reported device performance" is that the device met these equivalence criteria through testing.
| Characteristic | Acceptance Criteria (Substantially Equivalent to Predicate) | Reported Device Performance |
|---|---|---|
| Device Design | YES | YES |
| Material Characterization | YES | YES |
| Biocompatibility | YES | YES |
| Sterilization | YES | YES |
| Identification of Device Material | YES | YES |
| Additives | NA* | NA |
| Ca/Phosphorus Ratio | YES | YES |
| Elemental Analysis | YES | YES |
| X-Ray Diffraction Patterns | YES | YES |
| Dimensional Specifications | YES | YES |
| Physical Form of the Device | YES | YES |
| Device Density | YES | YES |
| Device Mass | YES | YES |
| Device Volume | YES | YES |
| Device Porosity (Total Porous Volume, Pore Diameter, Interconnectedness) | YES | YES |
| pH Testing | YES | YES |
| Dissolution Testing (mg/L/hr) | YES | YES |
| Energy Source | NA* | NA |
| Chemical Composition by XRD spectra (Phases present, Ca:P ratio) | YES | YES |
| Physical Properties (Physical Form, Dimensional Specifications, Porosity, Bulk density) | YES | YES |
| Performance Testing (pH, In vitro dissolution rate, Animal testing for bone in-growth and resorption) | YES | YES |
*NA indicates 'Not Applicable', as described in the document.
Study Details
The study conducted is a bench and animal testing comparison study to demonstrate substantial equivalence to the predicate device, K050357 (CAMCERAM TCP). This is not a clinical study on human subjects but a comparison of technical and performance attributes.
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Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a single "sample size" number in terms of human subjects or distinct clinical cases, as this is primarily a bench and animal study. For the specific technical characteristics, standard laboratory test methods were used, implying internal samples sizes as required for those tests (e.g., multiple samples for chemical analysis, dissolution testing). The document mentions "Animal testing to determine bone in-growth and resorption of the implant over time," which would involve an animal cohort, but its size is not specified.
- Data provenance: Not explicitly stated. Given it's a 510(k) submission for a medical device manufacturer (Cytophil, Inc. in East Troy, WI, USA), the testing would likely have been conducted in a laboratory setting, potentially internal or outsourced, presumably in the USA. The data is retrospective in the sense that it evaluates pre-existing device characteristics against a predicate rather than prospective clinical outcomes.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. "Ground truth" in this context refers to the established standards and properties of the predicate device and the new device as determined by laboratory analyses and animal studies, not by expert human interpretation of images or clinical data.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or diagnostic studies involving human interpretations, where conflicts in expert opinions need resolution. Here, the "truth" is determined by scientific measurement and comparison.
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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 not a diagnostic imaging device or an AI-assisted device. Therefore, no MRMC study was conducted, and there's no concept of human readers improving with or without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical resorbable bone void filler, not an algorithm or AI system.
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The type of ground truth used:
- The "ground truth" for demonstrating substantial equivalence was established through standardized laboratory test methods for chemical composition, physical properties, pH, in vitro dissolution rate, and animal testing for bone in-growth and resorption. The predicate device's established characteristics serve as the benchmark for comparison.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such a device would be the R&D and manufacturing process to ensure it consistently meets its specifications.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this device and submission type.
§ 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.