(160 days)
The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
The OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedullary rod segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semicircular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod. The complete unit is designed to accept interlocking bone screws for additional rotational stability. The implants from this submission are an extension of the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K051965/K113303). The components from this submission can be used in combination with the rod segments from the OsteoBridge™ IDSF diameter 10 to 16 mm (K051965) as well as with the dia. 5 mm interlocking screws. In addition sterile intramedullary rod segments are available in diameters of 18 mm and 20 mm in lengths of 90 mm and 110 mm. The hollow central attachment shell for use in the femur has a diameter of 34 mm and is available in four lengths 40 mm, 50 mm, 60 mm and 70 mm with reducing bushings to allow the use of different diameter rods proximally and distally to better fit the medullary canal. If the defect size is larger than 70 mm, two attachment shells can be connected by a spacer connector. All components of the OsteoBridge™ IDSF system are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F 136-13.
This section describes the acceptance criteria and study proving the device meets said criteria for the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System.
The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with explicit acceptance criteria for performance against a specific clinical outcome. Therefore, the "acceptance criteria" here refer to the mechanical performance standards necessary to be "as safe and effective as" the predicate device, as determined by recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Test Performed | Predicate Device Performance / Standard Requirement | OsteoBridge™ IDSF System Performance |
|---|---|---|---|
| Mechanical Properties for Intramedullary Rods (ASTM F-1264-03) | Mechanical and Functional Testing (specific tests not detailed in this summary, but implied by standard) | Assumed to meet or establish the benchmark for the standard. The predicate devices (K051965, K113303) also met these standards. | "All products have successfully passed all tests." |
| "The OsteoBridge™ IDSF system has hereby been proven to be mechanically safe." Performance is stated to be "as well as or better than the predicate device." | |||
| Worst-Case Scenario Loading | Worst case scenario for the strength of the system was tested. (Specific loading conditions not detailed) | Implied to be adequately withstood by the predicate devices. | Successfully passed. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials. The testing refers to mechanical and functional testing of device components. This typically involves a certain number of manufactured units or material samples to ensure consistency and meet statistical requirements for mechanical testing. However, the exact number is not provided in this summary.
- Data Provenance: The "Non-Clinical Performance Data" was generated by Merete Medical, the manufacturer. The location of the testing facilities is not specified, but the applicant (Merete Medical GmbH) is based in Berlin, Germany. The data is retrospective in the sense that the testing was performed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the "test set" in this context refers to physical device components undergoing mechanical testing, not human-interpreted data requiring expert consensus or ground truth from medical professionals. The "ground truth" here is metallurgical and mechanical performance meeting a defined ASTM standard.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as above. Mechanical tests are typically evaluated against predefined pass/fail criteria from a standard, not through adjudication.
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 submission is for a medical device (intramedullary rod system) and concerns mechanical performance, not an AI or imaging diagnostic algorithm that would typically involve MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data is adherence to the ASTM F-1264-03 standard for intramedullary fixation rods. This standard specifies test methods and performance requirements for the mechanical properties of such devices. The ground truth refers to whether the device's mechanical properties (e.g., strength, fatigue resistance) meet the requirements set forth in this recognized standard.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of mechanical device testing or a 510(k) submission for a physical implant. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as above.
§ 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.