(498 days)
The 3D Systems, Inc. VSP Cranial System is intended for use as a collection of software to provide image segmentation and transfer of imaging information from a CT based medical scanner. The is processed by the VSP Cranial System and the result is an output data file that may then be provided as digital models or used as input in the production of physical outputs including anatomical models, templates, and surgical guides for use in the marking of cranial bone in cranial surgery.
The 3D Systems VSP® Cranial System is a collection of Commercial Off-The-Shelf (COTS) software, third party medical device software, and custom software intended to provide a variety of outputs to support cranial reconstructive surgery. The system uses CT based imaging data of the patient's anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The system produces a variety of patient specific outputs including, anatomical models (physical and digital), surgical templates / guides, and patient specific case reports.
Here's a breakdown of the acceptance criteria and the study information for the VSP Cranial System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Leveraged from Predicate Device | ||
| Biocompatibility testing | (Implied: Meets established biocompatibility standards for medical devices) | Not explicitly stated for this device, but leveraged from predicate. |
| Cleaning and sterilization testing | (Implied: Demonstrates effective cleaning and sterilization methods) | Not explicitly stated for this device, but leveraged from predicate. |
| Software verification and validation | (Implied: Software functions as intended, meets specified requirements, and is safe and effective) | Not explicitly stated for this device, but leveraged from predicate. |
| Performance testing (Process validation, Simulated Use, Mechanical testing) | (Implied: All aspects of the manufacturing process, simulated use in planning, and mechanical strength/durability meet pre-established specifications) | Not explicitly stated for this device, but leveraged from predicate. |
| Specific to VSP Cranial System | ||
| Packaging Validation | Packaging and labels tested according to ASTM D4577, ASTM D642 (Method A), ASTM D4728, ASTM D3580, ASTM D5276, ASTM D6179, ASTM D880, ASTM D6179, ASTM D6653, and National Motor Freight Classification Rule 180. (Implied: Successfully withstands shipping and handling without compromise to product integrity or labeling) | All packaging and labeling met the required acceptance criteria. |
| Sterilization Compatibility | VSP® Cranial System outputs subjected to a single sterilization cycle and visually/dimensionally inspected to ensure compatibility with the validated sterilization method. (Implied: Maintains visual and dimensional integrity after sterilization.) | All acceptance criteria was met. |
| Dimensional Analysis | Sizes and shapes of VSP® Cranial System templates and guides (selected to challenge the system) were dimensionally inspected to verify conformance to the product requirements. (Implied: Dimensions are within specified tolerances.) | All acceptance criteria was met. |
| Bioburden | Bioburden testing conducted on VSP® Cranial System templates, guides, anatomical models, and metal accessories per ISO 11737-1, USP and USP . (Implied: Bioburden levels are within acceptable limits for sterilization.) | All acceptance criteria was met. |
| Pyrogenicity testing | Pyrogenicity testing conducted on VSP® Cranial System templates, guides, anatomical models, and metal accessories per AAMI ST72, USP , and USP . (Implied: Endotoxin levels are below a specified threshold.) | All samples met the acceptance criteria of ≤ 2.15 EU/device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document details performance testing that was largely leveraged from the predicate device (VSP® System, K133907) because the planning/design process, materials, manufacturing process, cleaning methods, and sterilization methods are identical.
For the tests specific to the VSP Cranial System:
- Sample Size: Not explicitly stated but "sizes and shapes of VSP® Cranial System templates and guides were selected to challenge the system" for Dimensional Analysis. For bioburden and pyrogenicity, "VSP® Cranial System templates, guides, anatomical models, and metal accessories" were tested.
- Data Provenance: This appears to be prospective testing conducted by 3D Systems for the specific VSP Cranial System device. The country of origin of the data is not specified beyond being generated by the applicant, 3D Systems, Inc., which is based in Littleton, Colorado, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The testing described focuses on engineering, material, and sterilization validation rather than clinical performance or diagnostic accuracy that would require expert-established ground truth for a test set.
4. Adjudication Method for the Test Set:
This information is not provided in the document. As mentioned above, the tests are primarily engineering and material validations, which don't typically involve an adjudication method in the way a clinical study for diagnostic accuracy would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study described is not a clinical study involving human readers or comparative effectiveness of AI assistance. It's a technical performance and validation study to demonstrate substantial equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is described as a "collection of software" that provides image segmentation and processing, resulting in an "output data file that may then be provided as digital models or used as input in the production of physical outputs." The system is operated by "trained 3D Systems employees," and the "physician does not directly input information" but provides "clinical input and review."
While there is "software verification and validation testing" (leveraged from the predicate), the document does not explicitly describe a standalone performance study for the algorithm's output in terms of accuracy against a ground truth independent of the human-in-the-loop (3D Systems employees and physician review) process. The nature of this device (planning tools for customized physical outputs) means the "human-in-the-loop" is integral to its intended use and output generation.
7. The Type of Ground Truth Used:
For the specific tests performed:
- Packaging Validation: Ground truth is defined by the technical specifications of the ASTM and National Motor Freight Classification standards.
- Sterilization Compatibility: Ground truth is visual and dimensional integrity after a validated sterilization cycle.
- Dimensional Analysis: Ground truth is the "product requirements" and specified dimensional tolerances.
- Bioburden: Ground truth is defined by the acceptable bioburden limits specified in ISO 11737-1, USP , and USP .
- Pyrogenicity: Ground truth is the acceptance criteria of ≤ 2.15 EU/device as per AAMI ST72, USP , and USP .
For the overall system, the "ground truth" for its functionality is implicitly linked to the predicate device's established performance and safety/effectiveness, as the core technologies and processes are leveraged and deemed "substantially equivalent."
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The VSP Cranial System is not described as a machine learning or AI algorithm that requires a "training set" in the conventional sense for developing predictive models. It's a software system for image segmentation and design of physical outputs based on CT data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided for the same reasons as point 8.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).