(20 days)
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
- Fractures of the tarsals and metatarsals;
- Metatarsal and phalangeal osteotomies;
- Fractures of the carpals and metacarpals;
- Carpal and metacarpal arthrodesis;
- Small fragments of the hand and wrist;
- Ligament fixation, if appropriate;
- Sacroiliac joint disruptions;
- Fractures of the distal femur and proximal tibia;
- Intracapsular fractures of the hip;
- Ankle arthrodesis; and
- Pelvis and acetabulum fractures; and
- Areas where accurate screw placement is vital.
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, thread configurations, and lengths to accommodate variations in surgical technique, severity level of fracture, and differing patient anatomy. The screws are available in self-tapping or self-drilling, in partially and fully threaded configurations, in diameters ranging from 3.5mm – 7.5mm and lengths ranging from 8-200mm. The system also includes correspondingly sized washers, the use of which is optional. The purpose of this submission is to extend the available screw lengths to 200mm. The screws and washers are manufactured from Biodur 108 (ASTM F2229).
Pioneer Cannulated Screw System (K102903) - Acceptance Criteria and Study Details
This 510(k) summary describes the Pioneer Cannulated Screw System, which is a Class II device (21 CFR 888.3040 for metallic bone fixation fasteners and 21 CFR 888.3030 for metallic bone fixation appliances and accessories). The submission primarily focuses on extending the available screw lengths to 200mm.
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not outline specific, quantifiable acceptance criteria in a typical "table of acceptance criteria and reported device performance" format as one would expect for an AI/algorithm-based device. Instead, the performance demonstration for this mechanical medical device (screws) relies on demonstrating substantial equivalence to predicate devices through material similarity, comparable indications for use, and engineering analysis to address the extension of screw length.
Therefore, the "acceptance criteria" here are implied by the FDA's "substantial equivalence" determination, meaning the device's safety and effectiveness are comparable to legally marketed predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: Material composition is identical to predicate devices. | The device is composed of Biodur 108 (ASTM F2229), which is identical to the predicate Pioneer Cannulated Screw System (K003496). |
| Mechanical Performance (Worst-Case Bending): Extended screw length (up to 200mm) should not raise new issues of safety or effectiveness. | Engineering calculations were provided to demonstrate that under a worst-case bending situation, additional length of screw will not raise new issues of safety or effectiveness. |
| Indications for Use Equivalence: Identical or comparable indications for use to predicate devices. | The subject device has indications for use identical to the predicate Pioneer Cannulated Screw System (K003496). |
| Design/Mechanism of Action Equivalence: Similar design principles and mechanism of action to predicate devices. | The subject device has screw diameter (7.0/7.5mm) and mechanism of action identical to the predicate Pioneer Cannulated Screw System (K003496). |
| Length Equivalence to Other Predicate: Maximum length (200mm) is comparable to another predicate. | The subject device has the same maximum length (200mm) as the Synthes Cannulated Screw (K021932). |
2. Sample size used for the test set and the data provenance
This is a submission for a mechanical orthopedic implant (screws), not a diagnostic or AI-driven device. Therefore, the concept of a "test set" with "data provenance" (country of origin, retrospective/prospective) in the context of clinical data or image analysis is not applicable.
The "testing" mentioned in the submission refers to engineering calculations for mechanical performance (worst-case bending situations) and possibly material testing to confirm conformity with ASTM F2229 for Biodur 108. The sample sizes for such engineering tests would typically be determined by relevant ASTM or ISO standards for mechanical testing of metals, but these details are not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is not an AI/diagnostic device, there is no "ground truth" derived from expert consensus on medical images or clinical outcomes in the way this question implies. The "ground truth" for material properties and mechanical performance would be established through established engineering standards and material science principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a mechanical device submission.
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-assisted diagnostic or image analysis device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (screws), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device type is primarily based on:
- Material Specifications: Conformance to ASTM F2229 for Biodur 108.
- Engineering Principles: Validated engineering calculations to demonstrate that extended screw lengths do not compromise mechanical integrity under defined worst-case scenarios.
- Predicate Device Performance History: The long-standing safe and effective use of the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.