(174 days)
ExoToe Staple is intended for fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation.
The ExoToe Staple is an implant that is crimped onto bone with forceps after a k-wire has been placed to achieve fixation. The ExoToe Staple is provided in a sterile package. A kit containing four sizing templates and forceps is provided non-sterile. The staple is comprised of stainless steel and is pre-formed during manufacturing. The sizing templates and pliers are comprised of stainless steel. The sizing templates are used to select staple size. The forceps are used by a surgeon to conduct the final deformation required to anchor the staple to the bone.
This document describes the premarket notification for the ExoToe Staple, a bone fixation device. The information provided does not pertain to an AI/ML medical device and therefore there is no discussion of acceptance criteria for an algorithm, test sets, training sets, ground truth establishment, or human reader studies.
The document discusses the substantial equivalence of the ExoToe Staple to previously marketed predicate devices (Memodyn Staple, Z-Staple, and Compressyn Staple) based on non-clinical performance data.
Here's the relevant information from the provided document regarding the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for non-clinical performance were based on demonstrating "substantial equivalence" to predicate devices. The reported device performance is presented as conclusions of substantial equivalence for various biomechanical tests.
| Evaluation | Acceptance Criteria (Implied) | Reported Device Performance Conclusion |
|---|---|---|
| Dorsal pull-off | Substantially Equivalent | Substantially Equivalent |
| Static 4-point bend | Substantially Equivalent | Substantially Equivalent |
| Dynamic 4-point bend | Substantially Equivalent | Substantially Equivalent |
| Protrusion | Substantially Equivalent | Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes (number of staples tested) for each biomechanical test. It also does not explicitly state the provenance of the data, but it is implied to be from laboratory testing conducted as part of the device development and submission process. This would be prospective testing, as it's performed specifically to support the regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for a physical medical device like a bone staple is established through objective biomechanical testing according to established standards or validated test methods, not through expert consensus on interpretation.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For biomechanical testing, the results are quantitative measurements, and the "truth" is the measured value against a pre-defined acceptance threshold or comparison to predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human readers' diagnostic performance is evaluated with and without AI assistance. The ExoToe Staple is a physical implant, not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The ExoToe Staple is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the ExoToe Staple was established through non-clinical performance testing (biomechanical testing). This involves objective measurements of physical properties (e.g., pull-off strength, bend strength, protrusion) against defined criteria or in comparison to predicate devices, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable because the ExoToe Staple is not an AI/ML device and thus does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for a physical device.
§ 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.