(261 days)
The Dyna-EXTOR(L) II and Dyna-EXTOR(M) II external fixation systems are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
The Dyna-EXTOR(SM) II external fixation system is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.
The Dyna-EXTOR II is unilateral external fixation device. The system has 4 detailed systems according to the intended use. The Dyna-EXTOR 11 external fixation system is composed of pins or wires inserted into the bone, above and below the fracture or surgery site. These pins are then attached to a strong external frame. This allows the bone to be held relatively firmly, while some mobility and weight bearing can take place.
The provided 510(k) summary for the Dyna-EXTOR® II External Fixation System does not contain specific acceptance criteria or a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy, which are typical for AI/ML-based devices.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on materials, configuration, indications for use, and through comparative testing to established standards.
Therefore, many of the requested details (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study, standalone performance, type of ground truth) are not applicable to this type of submission, which is for a physical medical device (an external fixation system) and not an AI/ML diagnostic or prognostic tool.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Compliance with ASTM F1541-02 requirements for external fixation devices. | Testing was conducted according to ASTM F1541-02. (Implies compliance, as the device received 510(k) clearance). |
| Material Equivalence: | |
| Materials used are substantially equivalent to predicate devices. | Stated as "substantially equivalent to Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin according to materials used." |
| Configuration Equivalence: | |
| Configuration is substantially equivalent to predicate devices. | Stated as "substantially equivalent to Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin according to...configuration." |
| Indications for Use Equivalence: | |
| Indications for Use are substantially equivalent to predicate devices. | Stated as "substantially equivalent to Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin according to...indications for use." |
Note: For physical devices like this external fixation system, "acceptance criteria" and "device performance" primarily revolve around meeting recognized industry standards (like ASTM F1541-02) and demonstrating equivalence in design and function to devices already on the market. There are no performance metrics like sensitivity or specificity because it's not a diagnostic or AI/ML device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The submission references "testing conducted according to ASTM F1541-02." This typically involves laboratory mechanical testing of device prototypes or production samples, not clinical data sets with "test sets" in the context of AI/ML. The provenance of such mechanical testing data is usually the manufacturer's R&D or an accredited testing lab.
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" in the context of this device would refer to the physical and mechanical properties of the materials and component designs, which are verified through engineering tests against established standards, not expert clinical consensus on a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As there is no clinical "test set" requiring human interpretation or consensus, no adjudication method is relevant here.
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 device is an external fixation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is compliance with mechanical and material specifications as defined by engineering standards (e.g., ASTM F1541-02) and demonstrated equivalence to physically manufactured predicate devices. This is established through laboratory testing and engineering analysis.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an external fixation system.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this 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.