Search Results

The Bio Architects Patient Specific Cranial/Craniofacial Plate implant device is intended to replace bony voids in the cranial and/or craniofacial skeleton (e.g., frontal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, ethmoid process, vomer). It is a patient specific device.

The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is a single piece device constructed individually for each patient. It is intended to replace bony voids in the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer). It is a patient specific device. The implant is made of titanium alloy produced via Electron Beam Melting (EBM) additive manufacturing/3D printing, permitting high temperature fusion of the powdered raw material (Ti6Al4V ELI in accordance with ASTM F3001-14).

The BioArchitects plate implants come in a variety of configurations that depend upon the geometry of the application. The surgeon approves the design of the cranial/craniofacial plate by comparing his/her dimension and configuration specifications to an engineering drawing prior to construction of the implant device.

The device under review is the BioArchitects Patient Specific Cranial/Craniofacial Plate. The document is a 510(k) summary for this device, which is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative for "similarity" to the predicate's mechanical properties, rather than specific numerical thresholds. The reported performance exceeds this qualitative criterion, showing significantly higher ultimate stress, Young's modulus, and tensile strength compared to predicate devices.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the mechanical tests. It mentions "plate samples were cut into sections to prepare specimens for testing" for the Cranial Plate Static Tensile Test and "gage pins were placed through the screw hole... and the assembly placed in a gripping fixture" for the Cranial Plate Tab Static Tensile Test. The number of such specimens is not stated.
• Data Provenance: The document does not provide information about the country of origin of the data or whether the study was retrospective or prospective. Given it's a mechanical performance study, these aspects are less relevant than for clinical studies.

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

• This device is subject to a mechanical performance study, not a clinical study involving experts establishing ground truth for diagnostic accuracy. Therefore, this section is not applicable to the provided information. Mechanical tests rely on standardized methods and measurements rather than expert consensus on clinical findings.

4. Adjudication Method for the Test Set

• Not applicable, as this is a mechanical performance study and not a clinical study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms to assess human reader performance with and without AI assistance. The provided document is for a physical implant device, and its performance is evaluated through mechanical testing.

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

• Not applicable. This device is a physical implant, not an AI algorithm. Its performance is inherent to its physical properties, manufacturing, and design, and is tested mechanically, not as a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical performance tests are the measured physical properties (ultimate stress, Young's modulus, tensile strength) of the subject device and the predicate device(s) as determined through standardized mechanical testing methods. There is no pathology, outcomes data, or expert consensus used as ground truth in this context.

8. The Sample Size for the Training Set

• The provided document describes mechanical testing of a physical device. It does not mention any "training set" in the context of machine learning or AI. Therefore, this question is not applicable to the information given. The device itself is "patient specific" meaning it is designed for individual patients based on their CT/MRI data, but this design process is not described as involving a machine learning training phase in the document.

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

• Not applicable, as there is no "training set" mentioned or implied for this device in the provided document.

Ask a specific question about this device