(126 days)
EP Granules™ BVF is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. EP Granules™ BVF resorbs and is replaced with bone during the healing process.
EP Granules™ BVF is an osteoconductive device comprising hydroxyapatite (HA) and calcium carbonate (CaCO3) and calcium chloride (CaCl2) particles bound together with a degradable polymer-based binding matrix of poly(caprolactone) (PCL), poly(ethylene glycol) (PEG), and poly(lactide-co-glycolide) (PLGA). The hydroxyapatite and calcium carbonate particles are dispersed throughout the entire structure of the device. Upon implantation, the ceramic hydroxyapatite and calcium carbonate particles resorb over time. The polymer-based binding matrix also resorb over time. It is supplied sterile in a granulated form of various sizes. When EP Granules™ BVF is placed in direct contact with viable non-infected bone, porous regions form in the device and are infiltrated with bone tissue. Bone formation occurs in apposition to the hydroxyapatite and calcium carbonate surface and within the pores of the device. As the device resorbs, bone and soft tissue grow into the space previously occupied by the device.
This document describes the regulatory submission for Elute, Inc.'s EP Granules™ BVF, a resorbable calcium salt bone void filler. The submission aims to demonstrate substantial equivalence to predicate devices. Here's an analysis of the acceptance criteria and study data:
Unfortunately, the provided document does not contain a table of acceptance criteria and reported device performance for quantitative metrics. Instead, it states that "All necessary verification steps met pre-determined acceptance criteria to confirm safety and effectiveness" and "All data met pre-determined acceptance criteria" for functional/safety testing. This indicates that while acceptance criteria were established and met, the specific values or thresholds are not detailed in this excerpt.
However, based on the provided text, we can infer the types of criteria and studies involved:
Acceptance Criteria and Device Performance (Inferred from Document)
Since specific numerical acceptance criteria and reported performance values are not present, this table will reflect the types of criteria and the general statement of compliance.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance (as stated in document) |
|---|---|---|
| Functional Performance | In-vitro degradation and surface characterizations | Met pre-determined acceptance criteria |
| X-ray diffraction (XRD) | Met pre-determined acceptance criteria | |
| Compressive mechanical testing | Met pre-determined acceptance criteria | |
| In-vitro pH exposure study | Met pre-determined acceptance criteria | |
| Biocompatibility | Cytotoxicity (ISO 10993-1) | Met pre-determined acceptance criteria |
| Sensitization (ISO 10993-1) | Met pre-determined acceptance criteria | |
| Irritation/ Intracutaneous Toxicity (ISO 10993-1) | Met pre-determined acceptance criteria | |
| Systemic Toxicity (Material-Mediated pyrogenicity) | Met pre-determined acceptance criteria | |
| Sub-Acute Toxicity | Met pre-determined acceptance criteria | |
| Genotoxicity | Met pre-determined acceptance criteria | |
| Implant Study | Met pre-determined acceptance criteria | |
| Bacterial Endotoxin (LAL - Pyrogenicity) | Met pre-determined acceptance criteria | |
| Pre-Clinical Safety | Critical size defect model (Large animal models) | Met pre-determined acceptance criteria |
| Risk Management | Assessment within Elute's Risk Management and Design Controls systems | All necessary verification steps met pre-determined acceptance criteria |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the individual tests. The document broadly refers to "bench-top testing" and "pre-clinical testing."
- Data Provenance:
- Bench-top testing: In-vitro (laboratory).
- Pre-Clinical Testing: "Large animal models." The country of origin for the animal study is not specified. Given the company's location in Salt Lake City, Utah, it is likely the study was conducted in the USA, but this is not confirmed.
- Biocompatibility testing: In-vitro and in-vivo (animal; e.g., for sensitization, irritation, systemic toxicity, sub-acute toxicity, implant study).
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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. This device is a bone void filler, and its performance is evaluated through material science, biological compatibility, and animal model studies, not through expert interpretation of images or other data where "ground truth" is established by human experts. The data are objective measurements or observations from laboratory and animal experiments.
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Adjudication method for the test set: Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of medical images or data.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images). This device is a bone void filler, and its effectiveness is determined by its properties, resorption, and bone regeneration in animal models and clinical use (though clinical data is not detailed in this excerpt).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (bone void filler), not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench-top Testing: Objective measurements from laboratory equipment (e.g., XRD patterns, compressive strength, pH measurements, degradation rates against known standards).
- Biocompatibility Testing: Standardized biological assays and observations from animal studies (e.g., cell viability, immune response, tissue reaction, pyrogenicity) compared to established toxicity profiles or controls.
- Pre-Clinical Testing (Large animal models): Histological analysis, imaging (if performed), and gross pathology to assess bone regeneration, integration, and resorption in the "critical size defect model" compared to control groups or expected healing patterns. This often involves pathology and outcomes data from the animal models.
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The sample size for the training set: Not applicable. This document pertains to a physical medical device, not a machine learning model that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of 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.