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CalMatrix Calcium Sulfate Bone Graft Binder, when mixed with allograft or other bone Gallwathx Calcium Oulfato Drives of maxillary and mandibular osseous and periodontal defects such as:

• Intrabony/infrabony defects .
• Furcation defects .
• Recession defects .
• Dehiscence/fenestration defects (natural teeth and prosthetic root form implants) ●
• Extraction socket (ridge preservation) defects .
• Ridge augmentation defects .
• Sinus lift defects .
• Endodontic bony defects .

Lifecore Biomedical Calcium Sulfate Bone Graft Binder (CalMatrix) is a calcium sulfate material that contains resorbable surgical grade plaster of paris with approximately 10% of a pharmaceutical grade sodium carboxymethylcellulose (CMC).

The Binder is a white, free-flowing powder. Calcium sulfate (CS) hemihydrate and PHARMACEUTICAL grade sodium carboxymethylcellulose are commercially available as raw materials for use in several orthopedic and dental devices. Calcium sulfate/CMC, when used in conjunction with demineralized bone matrix (DBM), controls the particles in the bony defect where bony walls may be insufficient to stabilize the graft. It increases the graft volume, and reduces particle migration during the early healing phase. CalMatrix remains pliable after mixing which allows the clinician an extended time period to complete the bone regeneration procedure.

The CalMatrix™ Calcium Sulfate Bone Graft Binder 510(k) submission (K041324) does not present acceptance criteria or a study directly proving the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices. Instead, the submission focuses on establishing substantial equivalence to legally marketed predicate devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not define specific quantitative acceptance criteria or present a table of device performance against such criteria. The "performance data" section describes animal studies confirming biocompatibility and new bone growth, but these are not framed as meeting pre-defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. There isn't a "test set" in the context of evaluating a diagnostic or AI device's performance metrics. The "animal studies" involved "animal models," but the specific number of animals or defects is not provided.
• Data Provenance: The animal studies were conducted using calcium sulfate/CMC with and without DBM. The country of origin is not specified, but the submission is to the US FDA. The studies appear to be prospective to evaluate the biocompatibility and bone growth response of the material. "Clinical use of this product was evaluated in animal and human studies," but details on the human studies are not provided in this summary.

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

Not applicable. There is no "ground truth" establishment in the context of diagnostic assessment for this type of device submission. The animal studies would likely have involved veterinary pathologists or orthopedic surgeons assessing findings.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for evaluating human reader performance with and without AI, which is not the focus of this device submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI/algorithm-driven device.

7. Type of Ground Truth Used

For the animal studies, the "ground truth" would implicitly be histopathology and radiographic assessment to confirm "new bone growth" and "no inflammatory or foreign body response."

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-driven device that requires a training set.

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

Not applicable.

Summary of the Device's "Proof" of Meeting "Acceptance Criteria" (Substantial Equivalence Approach):

The "acceptance criteria" for the CalMatrix™ Calcium Sulfate Bone Graft Binder are implicit in the substantial equivalence pathway for FDA 510(k) clearance. The manufacturer's proof that the device meets these (unwritten) criteria is based on:

• Technological Characteristics Comparison: CalMatrix is composed of calcium sulfate hemihydrate with carboxymethylcellulose (CMC). It is compared to:
  • CAPSET Calcium Sulfate Bone Graft Barrier (K955096): Also composed of calcium sulfate hemihydrate.
  • ALLOMATRIX® Putty (K020895): Utilizes the same calcium sulfate (CS)/CMC blend.
    The primary difference is that ALLOMATRIX comes pre-mixed with DBM, while CalMatrix is mixed by the clinician. The submission argues they are substantially equivalent in "mechanical characteristics, product configuration, anatomical site, safety characteristics, and sterilization."
• Intended Use Comparison: The indications for use for CalMatrix are explicitly stated as "the same as CAPSET" and are for treating multiple types of maxillary and mandibular osseous and periodontal defects.
• Performance Data (Biocompatibility and Bone Growth):
  • Animal Studies: These studies demonstrated that the materials (calcium sulfate/CMC, with and without DBM) were well tolerated, showing "no inflammatory or foreign body response," and "substantial new bone growth" in filled defects. While not providing specific quantitative acceptance thresholds, these findings support the material's safety and efficacy for its intended use, aligning with the expected performance of predicate devices.
  • Historical Use: The submission heavily relies on the "well-documented" historical use and established biocompatibility of calcium sulfate (Plaster of Paris) and the widespread use and known biocompatibility of sodium carboxymethylcellulose (CMC) in medical devices. This serves as a significant part of the "proof" for safety and general expected performance.
• Conclusion of Equivalence: The manufacturer concludes that the data supports substantial equivalence based on indications for use, product design and configuration, and materials used, directly comparing it to the specified predicate devices.

In essence, the "study" demonstrating that CalMatrix meets its "acceptance criteria" is the presentation of comparative analysis, biocompatibility data from animal studies, and reliance on the long-standing safety and efficacy profile of its constituent materials (calcium sulfate and CMC) in comparison to predicate devices, rather than a prospective study against novel, quantitatively defined performance metrics.

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