(104 days)
Agilon Strip is indicated for use in voids or gaps of the skeletal system. i.e., the extremities, pelvis, and posteroateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. Agilon Strip may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Strip resorbs and is replaced with bone during the healing process.
Agilon Strip is a flexible, resorbable, wicking, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules bound by type I collagen fibers to facilitate shaping and containment of the implant. The osteoSPAN granules in Agilon Strip are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate, with a thin laver of calcium phosphate throughout its entire porosity.
The provided text describes a 510(k) premarket notification for a medical device called "Agilon Strip," a resorbable calcium salt bone void filler. The submission aims to demonstrate substantial equivalence to a predicate device, Morpheus (K142828).
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity. Instead, the document focuses on demonstrating substantial equivalence through:
- Comparison of technological characteristics: Comparing the composition and properties of Agilon Strip to the predicate.
- Bench testing: Verifying that the addition of collagen does not affect granule chemistry, crystallinity, porosity, pore diameter, and pore interconnectivity, along with sterilization and shelf-life studies.
- Biocompatibility testing: Following ISO 10993-1 for biological effects such as cytotoxicity, sensitization, systemic toxicity, genotoxicity, and implantation.
- In vivo testing: Using critically sized defect models and a clinically relevant spinal fusion model to assess bone formation, resorption, remodeling, and fusion rates compared to the predicate and controls.
The "Performance Data" section discusses various tests and their outcomes but does not specify quantitative acceptance criteria for these tests (e.g., "fusion rate must be X% or higher"). The conclusion is based on the device being "substantially equivalent" to the predicate, implying that its performance in these tests was comparable and acceptable, but no explicit thresholds are provided.
Therefore, I cannot populate the requested table and details as the necessary information (explicit acceptance criteria, detailed quantitative performance metrics against those criteria, data provenance, expert qualifications for ground truth, sample sizes for test/training sets with detailed ground truth establishment methods, MRMC studies, or standalone algorithm performance) is not present in the provided text.
The document is a regulatory submission for a bone void filler, not an AI/ML device that would typically have performance metrics like sensitivity, specificity, or accuracy, which necessitate the kind of detailed study design outlined in the prompt (e.g., multi-reader multi-case studies, expert adjudication for ground truth).
§ 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.