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a-BSM™ Bone Substitute Material is a synthetic calcium phosphate hydroxyapatitic material intended to be implanted for use in the filling, repair, reconstruction and augmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas with a surface area no larger than 25cm².

ETEX x-BSM™ Bone Substitute Material for Cranioplasty is a self-setting, synthetic calcium phosphate hydroxyapatitic powder that hardens in an aqueous environment at body temperature. The a-BSMM powder is mixed with saline at the time of use and the resulting paste is applied directly to the defect site. Prior to implantation, it remains moldable for several hours. After implantation, the material hardens in approximately one hour. The material is dimensionally stable during setting, and has been demonstrated to be highly biocompatible with mammalian tissues. After implantation, the material resorbs and is replaced by natural bone.

As supplied, each transparent plastic pouch of a-BSMTM Bone Substitute Material contains a unit dose of sterile a-BSM™ Bone Substitute Material (dry white powder) contained within an elastomeric mixing bulb (available in 0.5, 1.0, 2.5, 5.0, 10 and 25 gram dose sizes); a sterile syringe, a 16 gauge needle, and a vial containing sterile saline; and Instructions for Use. The saline is injected aseptically into the mixing bulb and the material is mixed by kneading the bulb with the fingers. The material can be shaped into the desired form prior to application or shaped in situ in the defect. &-BSM™ Bone Substitute Material is synthesized from reagent grade inorganic raw materials composed of salts of calcium and phosphates. There are no substances of biological origin used in the synthesis or processing of the product. No additional preservatives or medicinal substances are present.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the a-BSM™ Bone Substitute Material for Cranioplasty:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K983009) for a-BSM™ Bone Substitute Material for Cranioplasty does not explicitly list numerical "acceptance criteria" in the format typically seen with performance metrics for AI/software devices (e.g., sensitivity > X%, specificity > Y%). Instead, it establishes "substantial equivalence" to a predicate device (BoneSource™) by demonstrating similar physico-chemical properties and superior or equivalent biocompatibility and functional outcomes through a series of tests.

The "acceptance criteria" can be inferred as demonstrating that a-BSM™ is either equivalent or superior to BoneSource™ in relevant aspects, and that it meets general safety and biocompatibility standards. The reported device performance is presented as a comparison table and a summary of test results.

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

This document describes pre-clinical (in vitro and animal) testing, not human clinical trials with "test sets" in the context of diagnostic device assessment. Therefore, the concept of sample size for a "test set" and provenance (country of origin, retrospective/prospective) as typically applied to clinical data for AI/software evaluations is not directly applicable.

Instead, we can identify the following from the document:

• Animal Studies:
  • Dog Femur Model: Used for "Chronic Safety/Efficacy Study," "Histology and Histomorphometry Evaluation," and "Biomechanical Strength Testing." The precise number of dogs/femurs is not specified but the studies ran for "one year."
  • Rabbit Model: Used for "Muscle Implantation" (implantation in rabbit muscle sites) and "Pyrogen Test." The number of rabbits is not specified.
• In Vitro/In Vitro Equivalent Studies:
  • Mutation Assay (Ames Test), Micronucleus Test, Hemolysis Assay, MEM Elution Test, USP Systemic Toxicity Test, Delayed Contact Sensitization Test, Intracutaneous Toxicity Test, Bacterial Endotoxin (LAL) Evaluation, Physico-Chemical Testing (FTIR, X-ray Diffraction, Ca:P ratio, Solubility, Mechanical properties). These typically involve lab samples, cell cultures, or specialized testing apparatus, not "test sets" of patient data.

Data Provenance: The document does not specify the country of origin for the animal studies or laboratory tests. Given it's an FDA 510(k) submission from "ETEX Corporation" in "Cambridge, Massachusetts, U.S.A.", it's highly probable the studies were conducted in the U.S. or by labs compliant with U.S. regulatory standards. All tests described are preclinical.

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

This information is not applicable to the type of device and study described. Since this is a bone substitute material, the "ground truth" is established through direct observation (e.g., absence of mutation, signs of inflammation), histological examination (e.g., new bone formation), and biomechanical measurements, rather than expert consensus on diagnostic images. The evaluations were performed by laboratory and pathology experts, but their specific number or detailed qualifications (e.g., "radiologist with 10 years experience") are not provided in this summary.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a diagnostic device involving a "test set" requiring adjudication of interpretations. The studies are pre-clinical evaluations of material properties and biological response.

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 substitute material, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This device is a bone substitute material, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the various tests can be categorized as follows:

• Physiological/Biological Response:
  • Absence/Presence of Toxic Effects: (e.g., no mutations, no cytotoxicity, no systemic toxicity, no pyrogenic effects, no irritation, no hemolysis).
  • Histopathology: Microscopic evidence of tissue response to the implant (e.g., slight cellular effects in muscle implantation, new bone growth and remodeling in femurs).
  • Macroscopic Observation: Gross observation of tissue irritation (e.g., no macroscopic evidence of tissue irritation in muscle implantation study).
• Engineered Properties:
  • Chemical/Crystalline Composition: Determined via spectroscopy (FTIR) and diffraction (X-ray Diffraction).
  • Quantitative Measurements: Calcium:Phosphorus ratio, Solubility Product, Hardening Time, Biomechanical Strength (torsion loading to fracture).

8. The Sample Size for the Training Set

Not applicable. This device is a bone substitute material, not a machine learning model, so there is no "training set" in this context.

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 preclinical studies was established through standard scientific methodologies, laboratory protocols, and animal model evaluations as described in point 7.

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