(23 days)
The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.
The IP-XS Compression Nail system is for bones with small comes in diameters of 3.5mm and 4.5mm. They have a circular cross section with multiple transverse holes for interlocking components. The two proximal transverse holes are elongated to allow the interlocking component to move axially and apply compression to the bone fragments. The proximal end has an internal axial threaded hole to receive a compression screw. Threaded Kirschner wires 02.0mm and 01.6mm are used as the interlocking components.
The provided text describes a medical device, the IP-XS Compression Nail System, and its clearance through the FDA 510(k) process. This process focuses on establishing substantial equivalence to existing legally marketed devices, rather than conducting new clinical trials or detailed performance studies with acceptance criteria in the way a novel device might.
Therefore, the requested information elements such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment are not applicable in the context of this 510(k) submission.
Here's why and what information can be extracted:
- Acceptance Criteria and Reported Device Performance: No explicit acceptance criteria or numerical performance data (like sensitivity, specificity, accuracy) are reported for the IP-XS Compression Nail System. The 510(k) process for this type of device relies on demonstrating equivalence to predicate devices and generally involves non-clinical testing to ensure safety and function.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): These concepts are typically relevant for studies evaluating the diagnostic or predictive performance of a device (e.g., AI-powered diagnostic tools, imaging systems). The IP-XS Compression Nail System is an intramedullary fixation rod, a mechanical orthopedic implant. Its evaluation is based on mechanical testing and comparison to similar devices, not on data analysis or expert adjudication.
Information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Cantilever testing and validated FEA analysis indicate the device will support in-vivo loads expected for its application. |
Explanation: The document does not specify formal acceptance criteria in a quantitative manner as one might see for a diagnostic device (e.g., "sensitivity must be >90%"). Instead, the "performance" is described in terms of non-clinical testing demonstrating structural integrity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The "testing" mentioned is mechanical (cantilever testing, FEA analysis), not clinical or using a "test set" of patient data.
- Data Provenance: Not applicable. The data is from non-clinical laboratory testing.
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)
- Number of Experts & Qualifications: Not applicable. Ground truth as typically understood for diagnostic performance is not relevant for this mechanical device's evaluation in the 510(k) submission. Mechanical testing results are based on engineering principles and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is a mechanical device, not one requiring diagnostic interpretation or adjudication.
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
- MRMC Study & Effect Size: Not applicable. This is not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the conventional sense. The "ground truth" for evaluating this device's performance would be the physical properties and mechanical behavior under simulated loads, as measured by engineering tests.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not AI/ML-based; there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. There is no training set for this type of device.
Summary of Device Evaluation in 510(k):
The evaluation of the IP-XS Compression Nail System for its 510(k) clearance focused on demonstrating substantial equivalence to predicate devices (Small Bone Nail - Accumed K031438 and SST Small Bone Locking Nail - Biomet) in terms of materials, design, and indications for use. The "study" mentioned, non-clinical testing (cantilever testing and validated FEA analysis), served to confirm that the device would support in-vivo loads, thereby supporting its safety and effectiveness relative to its predicates. This is a common approach for mechanical devices in the 510(k) pathway, which does not typically involve the extensive clinical performance studies, ground truth establishment, or expert evaluations associated with novel diagnostic technologies.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.