(779 days)
Exactech Resorbable Bone Paste is intended for use as a bone graft extender (extremities, spine, pelvis) and as a bone void filler for bony voids or gaps of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Exactech Resorbable Bone Paste may be used with rigid fixation systems.
Exactech Resorbable Bone Paste is a mixture of demineralized bone matrix (DBM) in a biginert polvethylene divcol (PEG) based polymer and is provided as an aseptic manufacture single use. ready to use implantable device derived from a single donor. DBM resorbs and is replaced with new bone during the healing process.
Acceptance Criteria and Device Performance Study for Exactech Resorbable Bone Paste
This document summarizes the acceptance criteria and the study that demonstrates the Exactech Resorbable Bone Paste meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices and establishing safety and biocompatibility. It does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., specific percentages of bone formation or healing time) for the Exactech Resorbable Bone Paste itself in human subjects. Instead, the "acceptance criteria" are implied through established safety principles, biocompatibility, and qualitative osteoinductivity in an animal model, proving that the device is fit for its intended use as a bone void filler and graft extender.
However, a key "performance" aspect evaluated is the osteoinductivity of the Demineralized Bone Matrix (DBM) component.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Biocompatibility: | |
| No adverse reactions from the polymer carrier. | Polymer carrier (polyethylene glycol-based) is "bioinert and biocompatible with host tissue and presents no new safety issues." |
| Human DBM is biocompatible, safe, and effective. | "Human demineralized bone used in Exactech Resorbable Bone Paste is single-donor processed, biocompatible, safe and effective for the repair of bone defects. ...The biocompatibility and efficacy of manufactured demineralized bone matrix has been established through its long history of safe and effective use as a human tissue for transplant without reported incidents of infection or complication." |
| Effective viral reduction of donor bone. | "This study demonstrates the demineralization process used on donor bone contained in Exactech Resorbable Bone Paste effectively eliminates or reduces the virus responsible for potential infectious disease, which include HIV and Hepatitis... and can reasonably be anticipated to diminish the titers of other viruses." |
| Device is sterile. | "Exactech Resorbable Bone Paste is aseptic manufactured for single patient use." |
| Osteoinductivity (DBM Component): | |
| DBM demonstrates osteoinductivity potential. | "Each lot of DBM is screened for osteoinductivity potential, with only acceptable DBM being manufactured into Exactech Resorbable Bone Paste. Osteoinductivity of each lot of Exactech Resorbable Bone Paste is verified using a single test protocol and demonstrates the DBM and the product to be osteoinductive in the athymic mouse." A score of 2 or higher implies some level of endochondral ossification or new bone formation, aligning with osteoinductivity. |
2. Sample Size Used for the Test Set and Data Provenance
The primary non-clinical testing described is for osteoinductivity and viral reduction.
- Osteoinductivity Test Set:
- Sample Size: 4 samples (implanted bilaterally into the gastrocnemius muscle of 2 animals). This is for each lot of DBM and the final product.
- Data Provenance: Prospective animal study in athymic mice. No country of origin is explicitly stated, but the submission is to the FDA (United States).
- Viral Reduction Study Test Set:
- Sample Size: The number of biological samples (e.g., infected bone tissue used in the study) is not specified. However, the study involved testing against four distinct virus models (HAV, HIV-1, PPV, PrV).
- Data Provenance: Prospective in vitro study conducted by a CLIA certified testing laboratory. No country of origin is explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Osteoinductivity: The scoring for osteoinductivity (ranging from 1 to 4) is performed "in accordance with the test protocols defined by Schwartz S. Melloniq, Jl. Carnes, Jr. DL. de la Fontaine J. Cochran DL. Dean DD, Boyan BD (1996) Ability of Commercial Demineralized Freeze-dried Bone Allograft to Induce New Bone Formation J. Perio 67:918-926 and the ASTM Draft Standard Guide for the Assessment of Bone Inductive Material." While it's implied that an expert or trained personnel would perform this scoring, the number and qualifications of specific human experts (e.g., pathologists, histologists) involved in the scoring process for this specific device's study are not detailed in the summary. The ground truth is therefore based on established, standardized histological assessment criteria.
- Viral Reduction: The study was conducted by a "CLIA certified testing laboratory." This implies that the ground truth (e.g., viral titers, reduction efficiency) was established by qualified laboratory professionals following validated protocols. The number of experts is not specified.
4. Adjudication Method for the Test Set
- Osteoinductivity: The summary does not describe a formal "adjudication" method (like 2+1 or 3+1 expert consensus) for the osteoinductivity scoring. The scoring is done "in accordance with the test protocols." This suggests a standardized, objective assessment criterion rather than a subjective human opinion requiring adjudication.
- Viral Reduction: As a laboratory test, adjudication would typically involve internal quality control and validation procedures based on quantitative scientific data, rather than expert consensus on subjective interpretations. No specific adjudication method similar to those used for image interpretative tasks is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this device. The submission is for a bone void filler/graft extender and focuses on demonstrating substantial equivalence, safety, and basic biological function (osteoinductivity) rather than comparing human reader performance with and without AI assistance. The device itself is biological/biomaterial, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. Exactech Resorbable Bone Paste is a physical medical device (bone void filler), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Osteoinductivity: Histological analysis of explanted muscle tissue from athymic mice, scored against defined criteria for endochondral ossification and new bone formation. This is a pathology-based ground truth (histological assessment).
- Viral Reduction: Quantitative viral assays (e.g., plaque assays, PCR) measuring viral titers before and after the demineralization process. This is a laboratory-based, quantitative ground truth.
- Biocompatibility & Safety: Based on established literature ("long history of safe and effective use as a human tissue for transplant") and in vitro testing for the carrier. This is a combination of historical evidence and laboratory testing.
8. The Sample Size for the Training Set
The concept of "training set" is not applicable as this is not an AI/machine learning device. The studies described are for verification and validation of the product's properties for regulatory submission, not for training a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. For the development of the DBM processing and the PEG carrier, extensive biological research and material science principles would have guided their design and selection, but these are not referred to as "training sets" in this context.
§ 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.