(276 days)
Biogennix RPC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Biogennix RPC is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Biogennix RPC bone void filler may be used as a bone graft extender for posterolateral spine fusion when mixed in a one to one ratio with autogenous bone graft. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
Biogennix RPC is an osteoconductive, open cell, resorbable ceramic. The ceramic is a composite of calcium salts. The open pores and porosity provide space and structure for bone and vascular ingrowth. The calcium salts resorb over time. The product is available in block and granular forms.
The provided text describes a 510(k) summary for the Biogennix RPC bone void filler, which is a medical device. This type of regulatory document focuses on establishing substantial equivalence to a predicate device, rather than defining novel acceptance criteria and conducting a new study to prove it.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted directly from this specific document, as they pertain to the evaluation of a new device's performance against predefined criteria, a Multi-Reader Multi-Case (MRMC) study, or a standalone algorithm performance study.
Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:
Acceptance Criteria and Device Performance
The "acceptance criteria" for a 510(k) submission like this are primarily demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The device performance relates to its ability to meet the characteristics of the predicate device.
| Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance (Biogennix RPC) |
|---|---|
| Same Intended Use as the predicate device. | Biogennix RPC has the same intended use: filling bony voids or gaps not intrinsic to bony structure stability, and as a bone graft extender for posterolateral spine fusion when mixed with autogenous bone graft. |
| Same Technological Characteristics or differences do not raise new questions of safety or effectiveness. | Biogennix RPC has the same technological characteristics (osteoconductive, open cell, resorbable ceramic, composite of calcium salts, provides space for bone/vascular ingrowth, resorbs and replaced by bone). Bench testing (x-ray diffraction, FTIR, IPS-MS, biomechanical, morphometry, in vitro dissolution, biocompatibility) and animal implantation studies demonstrated substantial equivalence to the predicate device (Pro Osteon 500R). |
| Conformity to Applicable Standards (e.g., biocompatibility, sterilization). | Conforms to ISO 10993 series (Biological evaluation of medical devices) and ANSI/AAMI/ISO 11137 (Sterilization of Health Care Products for Radiation Sterilization). |
| Biocompatibility consistent with legally marketed devices. | Biocompatibility testing was included in the studies demonstrating substantial equivalence. |
| Mechanical Properties (e.g., structural integrity, handling) comparable to predicate. | Biomechanical and morphometry studies were conducted to demonstrate substantial equivalence. |
| Resorption and Bone Replacement characteristics (for resorbable materials). | In vitro dissolution and animal implantation in long bone defects and posterolateral spine demonstrated the device's resorption and replacement with bone during the healing process, consistent with the predicate. |
Study Information
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable in this context. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a predicate device through various tests (bench, animal) rather than a clinical "test set" in the context of diagnostic performance. The studies mentioned are:
- x-ray diffraction, FTIR, IPS-MS, biomechanical, morphometry, in vitro dissolution (likely laboratory-based, not involving human subjects for a "test set").
- Biocompatibility (likely in vitro and animal studies).
- Animal implantation (in long bone defects and posterolateral spine).
- Details on the sample sizes for these specific tests (e.g., number of animals, number of specimens for bench tests) are not provided in this summary.
- Data provenance (country of origin, retrospective/prospective) is not specified.
- Not Applicable in this context. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a predicate device through various tests (bench, animal) rather than a clinical "test set" in the context of diagnostic performance. The studies mentioned are:
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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. As this is not a diagnostic device submission focusing on human interpretation of data, there is no "ground truth" established by experts in the sense of image interpretation or clinical diagnosis. The "truth" in this context is the performance of the device in various physical, chemical, and animal models.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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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. The device is a bone void filler (a physical implant), not a diagnostic tool or AI software 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. The device is a physical bone void filler, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the established scientific and engineering principles for material performance, biocompatibility, and biological response in animal models. For example, for biomechanical tests, the ground truth would be the measured physical properties; for animal studies, it would be histological analysis of bone ingrowth and resorption. This is not "expert consensus" on diagnostic findings or patient outcomes in a clinical trial, but rather expert assessment of experimental results.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that would require a "training set."
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.