(90 days)
Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.
Agilon Moldable collagen enhanced bone graft substitute is a moldable, resorbable osteoconductive bone void filler composed of 1-2mm osteoSPAN granules suspended in a biocompatible orqanic binder to facilitate implant mixing, shaping, and containment. The osteoSPAN granules in the product 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 layer of calcium phosphate throuqhout its entire porosity. The orqanic binder is a combination of a biocompatible polymer and type I collagen fibers to provide enhanced intraoperative handling. The polymer is rapidly absorbed in-situ, leaving behind osteoSPAN granules and collagen fibers as an osteoconductive scaffold.
The provided text describes a 510(k) submission for the Agilon Moldable device. This document is a premarket notification to the FDA, asserting substantial equivalence to a predicate device. It primarily focuses on the device's characteristics, indications for use, and a summary of performance data rather than a detailed study protocol for acceptance criteria.
The information necessary to fully answer all parts of your request (especially concerning specific acceptance criteria and detailed study designs for proving those criteria) is not comprehensively present in this type of FDA letter. However, I can extract the available information and indicate where details are missing.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA letter and associated documents for a 510(k) submission typically don't explicitly list "acceptance criteria" in a table format with numerical targets. Instead, the demonstration of substantial equivalence is based on comparing the subject device's characteristics and performance to a legally marketed predicate device. The performance data presented focuses on equivalence to a predicate device and positive control rather than predefined numerical thresholds for the new device.
From the text, the key performance indicator mentioned is "Fusion rates."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fusion rates (equivalence to predicate and autograft) | Fusion rates were the same between all treatment groups (Agilon Moldable, predicate, positive control (autograft)) at each time point and consistent with published literature. |
| Absence of adverse reactions | No adverse reactions were noted at the implant site or in distant organs. |
| Bone formation, remodeling, and implant resorption | New bone formation, bone remodeling, and implant resorption for the test materials were confirmed with time. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated. The study involved multiple time points and comparisons between Agilon Moldable, a predicate device (Morpheus), and a positive control (autograft) in an in vivo animal model. However, the exact number of subjects or samples per group is not provided in this summary.
- Data provenance: Prospective in vivo animal testing in a validated, clinically relevant, single-level posterolateral spinal fusion model. The country of origin of the data is not specified, but the submission is to the U.S. FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. The ground truth would likely be established by trained veterinary histopathologists and radiologists/imaging specialists for the animal study. The exact number and qualifications are not detailed in this summary.
4. Adjudication method for the test set
Not explicitly stated. For animal studies, evaluation usually involves standardized scoring by expert histopathologists for histology and morphometry, and radiologists for x-ray and micro-CT. Whether these involve independent assessment or consensus is not mentioned.
5. 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 device is a bone void filler, a physical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this is a physical implant, not an algorithm.
7. The type of ground truth used
The ground truth for the in vivo study included:
- Mechanical analysis: Objective quantitative assessments of bone strength/fusion.
- Histology and Histomorphometry: Microscopic examination and quantitative measurements of tissue samples, evaluating new bone formation, tissue integration, and implant resorption.
- X-ray and Micro-CT analyses: Imaging techniques to assess fusion status, bone volume, and structural characteristics.
- Observation of adverse reactions: Clinical and pathological assessment for any negative responses to the implant.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a distinct "training set." The in vivo study involved a test set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device. The ground truth for the in vivo performance study was established through the various analyses mentioned in 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.