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CMFlex™ is a synthetic bone grafting material provided in block form of varying sizes (See Table 1.1) that can be easily trimmed or cut by the surgeon to fit the patient's bone defect(s). CMFlex™ is composed of majority synthetic hydroxyapatite powder bound by minority biodegradable polylactide-co-glycolide. CMFlex™ is fabricated via extrusion-based 3D-printing of liquid inks into regular porous structures. The combined macroscopic 3D-printed porosity, microporosity within the printed struts, and micron-sized hydroxyapatite particles gives CMFlex unique microstructural and physical properties. CMFlex™ is an osteoconductive, highly absorbent, and flexible bone graft that can be used in defects where new bone is needed. Although it is not intended for immediate load bearing applications, the implant remodels over time and is replaced by new bone tissue, functioning in the same manner as the predicate device. The blocks are provided sterile and are intended for single use. There are no accessories associated with CMFlex™.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called CMFlex™, a synthetic bone grafting material. The document focuses on demonstrating the substantial equivalence of CMFlex™ to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" in the sense of predefined thresholds for performance metrics that the device must meet. Instead, it compares the characteristics and performance of the CMFlex™ (subject device) to those of predicate devices to establish substantial equivalence. The "Conclusions" column in Table 1.3 effectively serves as the reported performance relative to the predicate devices for each performed test.

Purpose	Acceptance Criteria (Implied by Comparison)	Reported Device Performance (CMFlex™)
Chemical composition	Similar composition to predicate devices (majority calcium phosphate, minority biodegradable polyester).	The subject and predicate devices are composed of a majority calcium phosphate component and minority biodegradable polyester component. (CMFlex™: 90% HA, 10% PLG; Primary Predicate: 78% CP, 22% PLG; Secondary Predicate: 99% β-TCP, 1% PLG).
Crystallinity (of calcium phosphate component)	Similar crystallinity (e.g., >90%) to predicate devices.	The subject and predicate devices have calcium phosphate crystallinities >90%. (CMFlex™: 96%; Secondary Predicate: 92%).
Calcium phosphate particle morphology	Similar spherical particle morphology to predicate devices.	The subject and predicate devices possess spherical calcium phosphate particles. (CMFlex™: 23 µm on average; OsteoScaf™: 27.5 µm on average).
Pore structure	Similar interconnected pores around 0.2mm and primary pores around 1mm.	The subject and predicate devices have interconnected pores around 0.2mm and primary pores around 1mm. (CMFlex™ and OsteoScaf™ are described as having >80% porosity with 0.25-1.20 mm pore size; Easy-Graft® also has interconnected pores).
Porosity	Porosities greater than 50%.	The subject and predicate devices have porosities greater than 50%. (CMFlex™: 85%; Primary Predicate: 80%; Secondary Predicate: 53% *reported, but noted that actual total porosity may be significantly greater and similar to CMFlex™ and OsteoScaf™. Both CMFlex™ and OsteoScaf™ exceed 80% porosity).
Mechanical strength (compressive)	Adequate handling properties and strength to ensure dimensional integrity; similar compressive properties to predicate devices.	The devices provide adequate handling properties and strength to ensure dimensional integrity when handled by the surgeon and delivered to bony application sites; devices have similar compressive properties.
pH in phosphate buffered saline	Similar pH to predicate devices.	The subject and predicate device have similar pH.
Biocompatibility	Passed all relevant ISO 10993 series of standards (cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, genotoxicity, and systemic toxicity).	Devices passed cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, genotoxicity, and systemic toxicity testing according to ISO 10993.
Performance in animal model (bone formation, remodeling)	Similar performance and biocompatibility to the predicate device in terms of new bone growth, residual implant material, preservation of ridge, changes to surrounding bone, and absence of significant adverse findings.	CMFlex™ was able to maintain ridge height, width, and depth and showed similar bone forming capacity and steady state inflammatory response accompanying the absorption process when compared to the predicate device. No significant adverse findings (exuberant necrosis, proliferative granulation tissue/fibrosis, extensive inflammation, or evidence of infection) were observed.
Sterilization Validation	Passed all acceptance criteria for validating the end sterilization method.	CMFlex™ passed all acceptance criteria for validating the end sterilization method.
Shelf Life	No significant mechanical property changes or clinically meaningful compositional and microstructural changes after accelerated and real-time aging.	CMFlex™ had no significant mechanical property changes or clinically meaningful compositional (ceramic and polymer component) and microstructural changes after accelerated (12-month simulation) and real-time aging (6 months and 12 months).
Package Integrity Testing (Initial and aged samples)	Passed all package integrity testing as is and after accelerated and real-time aging.	CMFlex™ packaging passed all package integrity testing as is and after accelerated (12-month simulation) and real-time aging (6 months and 12 months).

2. Sample Sizes Used for the Test Set and Data Provenance:

Test Set for Animal Model:
- The document states "Canine critical sized defect model" but does not specify the exact number of canines or defects used.
- Data Provenance: Prospective (animal model). The country of origin is not specified, but typically such studies supporting U.S. FDA submissions are conducted under GLP (Good Laboratory Practice) regulations, often in the U.S. or facilities elsewhere compliant with those standards.
Test Set for Benchtop/Material Characterization:
- For tests like mechanical strength, pH, crystallinity, porosity, etc., standard ASTM or ISO methods were used, which imply specific sample sizes for replicate testing. However, the exact sample sizes (e.g., "n=5" for each test) are not explicitly stated in this summary.
- Data Provenance: Not specified, but generally refers to laboratory testing of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The animal study involves assessments (radiography, microCT, histomorphometric analysis), which would typically be performed and interpreted by qualified experts (e.g., veterinary radiologists, pathologists specialized in bone and biomaterials), but their number or specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document. For assessments in the animal study, it is common practice to have blinded assessments and potentially multiple reviewers, but the specific adjudication method 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 document describes a traditional 510(k) submission for a physical bone grafting material, not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. As stated above, this is not an AI/software device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For the animal study:

Pathology/Histomorphometry: "histomorphometric analysis" was explicitly conducted, which relies on expert pathological evaluation of tissue sections.
Imaging: "radiography, microCT" implies radiological interpretation.
Outcomes Data: "new bone growth, residual implant material, preservation of ridge (height, width, depth), changes to surrounding bone, and any significant adverse findings" refer to biological outcomes assessed in the animal model.

For benchtop tests, the "ground truth" is derived from the results of the specified standard test methods.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context. The manufacturing specifications and quality control procedures ensure consistent device characteristics, which are then verified through the performance data described.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As stated above, there is no training set for this type of device.

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