(87 days)
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
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- Fractures of the tarsals and metatarsals;
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- Metatarsal and phalangeal osteotomies;
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- Fractures of the carpals and metacarpals;
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- Carpal and metacarpal arthrodesis;
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- Small fragments of the hand and wrist;
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- Ligament fixation as appropriate;
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- Sacroiliac joint disruptions;
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- Fractures of the distal femur and proximal tibia;
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- Intracapsular fractures of the hip;
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- Ankle arthrodesis; and
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- Pelvis and acetabulum fractures;
This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.
The Cannulated Screw System by Pioneer consists of cannulated screws of varying diameters, lengths and thread configurations to accommodate variations in surgical technique and severity level of fracture. The system includes correspondingly sized washers, the use of which is optional. The cannulated screws are self-cutting and self-tapping in appropriate bone stock, which maximizes OR efficiency. The threads are reverse batting, facilitating of engle use and will be offered both sterile and nonsterile.
The provided document is a 510(k) summary for the Pioneer Surgical Technology Cannulated Screw System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing clinical studies to establish novel performance criteria or the effectiveness of an AI algorithm.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this document.
The document describes the device, its intended use, and states that substantial equivalence is claimed based on existing predicate devices (Zimmer MAGNA-Fx, Zimmer Mini MAGNA-Fx, and Synthes Cannulated Screw System). The performance evaluation relies on demonstrating equivalence in material and adherence to established ASTM standards relevant to bone screws, rather than a clinical study or AI performance evaluation.
Summary of relevant information from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (ASTM Standards for comparison to predicate) | Reported Device Performance (Claimed) |
|---|---|
| F 1691: Standard Test Method for Determining the Axial Pull-Out Strength of Medical Bone Screws | Logically derived as at least equivalent based on screw material equivalence to predicate devices. |
| F 117: Standard Test Method for Driving Torque of Medical Bone Screws | Logically derived as at least equivalent based on screw material equivalence to predicate devices. |
| F 1622: Standard Test Method for Measuring the Torsional Properties in Metallic Bone Screws | Logically derived as at least equivalent based on screw material equivalence to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The performance evaluation is based on in-vitro testing against ASTM standards for medical devices, not a test set derived from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth for a clinical or AI study is not relevant here. The "ground truth" in this context would be the adherence to validated ASTM standards and material equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for clinical or AI studies involving human interpretation, not for mechanical device testing.
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 is not an AI device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the device's safety and effectiveness determination in this 510(k): The ground truth utilized is the established performance characteristics of legally marketed predicate devices (Zimmer MAGNA-Fx, Zimmer Mini MAGNA-Fx, and Synthes Cannulated Screw System) as demonstrated through compliance with recognized ASTM standards (F 1691, F 117, F 1622) for metallic bone screws.
8. The sample size for the training set:
Not applicable. This is not an AI device, and thus no training set was used.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI 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.