(214 days)
OsteoFlo® NanoPutty®- Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bonedus ing the healing process.
The OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft is an osteoconductive, non-hardening bone void filler. The device is comprised of macroporous calcium phosphate particulates in a bioresorbable polymer binder. The quadphasic particles are composed of HA, a-TCP, B-TCP and bioactive glass. The device also contains micro-sized HA particles. On implantation, the binder is resorbed and bone forms on and between the porous particles as they are gradually resorbed. OsteoFlo® NanoPutty can be easily packed into osseous defects and adheres to bone surfaces. The device is ready to use, requiring no mixing before application. The single-use device is supplied sterile in multiple package formats.
This document is a 510(k) premarket notification for a medical device called OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft. As such, it does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance study with defined statistically significant acceptance criteria for efficacy.
Instead, this document provides evidence for substantial equivalence to a legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, rather than proving a novel therapeutic effect against strict, predefined performance metrics.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, there aren't formal "acceptance criteria" for a specific performance metric like sensitivity or specificity. Instead, the acceptance is based on demonstrating that the new device is as safe and effective as the predicate.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Characteristics (Composition, particle size, porosity) | OsteoFlo NanoPutty: Quadphasic macroporous calcium phosphate particulates (HA, α-TCP, β-TCP, bioactive glass) in a bioresorbable polymer binder; micro-sized HA particles |
| Intended Use (Bone void filling, resorption, replacement with bone) | OsteoFlo NanoPutty: Indicated to fill bony voids or gaps of the skeletal system (extremities and pelvis) not intrinsic to stability; resorbs and is replaced with bone during healing process. |
| Mechanism of Operation (Pre-mixed putty, binder resorption, osteoconductive scaffold) | OsteoFlo NanoPutty: Applied as pre-mixed putty, synthetic binder resorbs to expose quadphasic particles, which act as osteoconductive scaffolds for new bone formation as they are slowly resorbed. |
| Biocompatibility | Demonstrated in compliance with ISO 10993-1:2018. |
| Sterilization Validation | Validated in compliance with ISO 11137-1:2006 and ISO 11137-2:2013 (E-beam radiation; SAL 10-6). |
| Packaging Validation | Validated in compliance with ISO 11607-1:2009 and ISO 11607-2:2006. |
| Shelf-life Testing | Tested in compliance with ASTM 1980-16. |
| In Vivo Performance (Local biological effects, bone formation, absence of adverse events/failures) | OsteoFlo NanoPutty: In vivo evaluation in a critical-size rabbit femoral defect model demonstrated performance substantially equivalent to the predicate, with no evidence of adverse events or device-related failures. |
Study Details for Substantial Equivalence
-
Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a numerical sample size for the in vivo rabbit study. The document mentions "a critical-size rabbit femoral defect model." This typically implies a small number of animals (e.g., 5-10 per group) used for preclinical evaluation in medical device submissions, but an exact 'n' is not provided.
- Data provenance: Preclinical in vivo study. Country of origin not specified, but typically conducted in a controlled lab environment. This is a prospective study (the rabbit study was designed and executed to compare the device to the predicate).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The in vivo study's evaluation of "local biological effects and bone formation" would be assessed by trained histopathologists or researchers specializing in bone biology, but their number and specific qualifications are not detailed in this regulatory summary. The "ground truth" here is objective biological/histological analysis, not expert interpretation of an image or signal.
-
Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of human-interpreted results. The assessment of in vivo bone formation and biological effects is typically performed by a single or limited number of expert pathologists/researchers on tissue samples.
-
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 document describes a material and its in vivo biological performance, not an AI or imaging-based diagnostic device that would involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes a material device, not an algorithm.
-
The type of ground truth used:
- For the in vivo study, the ground truth was histological analysis and biological assessment of tissue regeneration and local effects in the rabbit femoral defect model.
-
The sample size for the training set:
- Not applicable. This device is not an AI algorithm requiring a training set. The "training" for such a device would be the R&D and manufacturing processes to ensure the material consistently meets its specifications.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned 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.