(198 days)
The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.
The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, templates, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).
Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.
The VSP® Orthopedics System also contains Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP® Orthopedics System guides and templates.
The provided text describes a 510(k) summary for the VSP® Orthopedics System, which is a device for surgical planning and guiding. However, the document does not contain specific information regarding acceptance criteria for device performance studies, nor does it detail a study that proves the device meets specific performance acceptance criteria.
Instead, the document focuses on:
- Regulatory classification and intended use.
- Comparison to a predicate device, highlighting that the new device is "substantially equivalent" with only differences in a new material (SLA printing resin Accura ClearVue for anatomical models).
- Verification and validation testing related to manufacturing processes, cleaning, sterilization, biocompatibility, and shelf life of the components of the system, rather than a clinical performance study measuring an output metric against an acceptance criterion.
The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This means a clinical performance study, often involving human readers or direct measurement of an output against a functional criterion, was not performed or deemed necessary for this 510(k) submission.
Therefore, I cannot provide the requested table or answer the specific questions about performance studies, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided text.
The closest information found pertains to general testing conducted:
Summary of Testing Mentioned (not device performance acceptance criteria):
| Testing Type | Acceptance Criteria (General Statement) | Reported Performance (General Statement) |
|---|---|---|
| Operational Qualification | All test method acceptance criteria met | Manufacturing process assessed over the range of allowable process parameters; all criteria met. |
| Performance Qualification | All test method acceptance criteria met | Manufacturing process repeatability assessed at nominal parameters; all criteria met. |
| Cleaning Validation | All test method acceptance criteria met | Following soiling and cleaning of the subject device, bioburden, protein levels, and hemoglobin levels were examined; all criteria met. |
| Sterilization Validation | All test method acceptance criteria met | Steam sterilization validations performed in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 10-6; all criteria met. |
| Biocompatibility Validation | Pre-defined acceptance criteria met | Sensitization, irritation, and acute systemic toxicity testing conducted on Accura ClearVue were within pre-defined acceptance criteria. |
| Shelf Life Validation | Maintain functionality | Accura ClearVue anatomical model outputs maintain functionality following a shelf life of 3 months. |
| Clinical Performance Data | N/A | Clinical testing was not necessary for the determination of substantial equivalence. |
Regarding the specific questions:
- A table of acceptance criteria and the reported device performance: See table above, but note these are for manufacturing/material V&V, not device performance in terms of accuracy or clinical utility.
- Sample sizes used for the test set and the data provenance: Not specified for device performance. Sample sizes for validation tests (e.g., biocompatibility batch sizes, number of sterilization cycles) are not detailed. Data provenance is implied to be internal testing by 3D Systems.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such performance study is described. The device involves "physician input" and review, but this is part of its design and workflow, not a ground truth establishment for a performance study.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical testing was not necessary."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a system involving physical and digital outputs, and intended for use "to assist in preoperative planning and/or in guiding..." indicating a human-in-the-loop product. No standalone algorithmic performance is described.
- The type of ground truth used: Not applicable, as no performance study requiring ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense. It's a surgical planning and guiding system.
- How the ground truth for the training set was established: Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.