(87 days)
Intended Use: Intramedullary knee arthrodesis
Indications include:
- Irretrievably failed total knee arthroplasty
- Limb salvage
- Oncology surgery
- Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice
The intramedullary rods can be fixed with interlocking screws without or with bone cement.
OsteoBridge® Intramedullary Knee Arthrodesis Rod Fixation System (IKA) 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 a semicircular hollow angled attachment shell that is clamped together with multiple screws to create a firm fixation of the bone. We strongly recommend covering the attachment shell with bone graft to enhance callus formation.
all components are manufactured from Ti-6Al-4V conforming to ISO 5832-3. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
The device consists of:
Nails with collar: Dia.: 10, 12, 14 and 16 mm in Lengths: 110, 130 and 150 mm Nails without collar: Dia.: 14, 16 and 18 mm in Lengths: 130, 150 and 200 mm Attachment Shells: 10° Angled: 50 mm length
Interlocking Screws: Dia. 5 mm in lengths: from 20 mm to 56 mm in two millimeter intervals
The provided text describes a medical device called the OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System and its 510(k) submission for FDA clearance. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing rather than clinical performance based on diagnostic accuracy or reader studies.
Therefore, many of the requested criteria related to diagnostic performance (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type for test set and training set, training set size) are not applicable or not provided in the given summary. This type of submission relies on engineering and material performance data.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Mechanical Strength (Static Torsion Test) | All tests were passed. The device performed as well as or better than the predicate device. | Mechanical Testing (Worst Case Scenario) |
| Mechanical Strength (Four-Point Bending Fatigue Test) | All tests were passed. The device performed as well as or better than the predicate device. | Mechanical Testing (Worst Case Scenario) |
| Mechanical Strength (Three-Point Bending Fatigue Test of IDSF Locking Screws) | All tests were passed. The device performed as well as or better than the predicate device. | Mechanical Testing (Worst Case Scenario) |
| Material Compatibility | All components manufactured from Ti-6Al-4V conforming to ISO 5832-3. | Material Specification |
| Comparable Functionality to Predicate Devices | Same functional characteristics as predicate device (modular internal rod fixation system), same intended use as predicate (K050938). | Comparison to Predicate Devices |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of diagnostic accuracy/reader studies. The "test set" here refers to the physical devices and materials used for mechanical testing. The specific number of physical units subjected to each mechanical test is not provided in this summary, but it implies a sufficient number for robust engineering evaluation.
- Data Provenance: Not applicable in the context of diagnostic accuracy/reader studies. The mechanical testing was conducted by Merete to assess the physical properties of their device. The location of the testing is not explicitly stated beyond Merete Medical GmbH being in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a mechanical implant, and the assessment is based on its physical and mechanical properties, not expert interpretation of medical images or symptoms.
4. Adjudication method for the test set
- Not applicable. This relates to expert consensus in diagnostic studies, which is not relevant here. Mechanical tests follow predefined engineering standards and objective measurements.
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
- No. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not a diagnostic algorithm; it is a physical implant.
7. The type of ground truth used
- For the mechanical tests, the "ground truth" is defined by engineering standards and specifications for strength, fatigue resistance, and material properties. The device's performance against these pre-defined mechanical thresholds serves as the ground truth for its acceptability.
8. The sample size for the training set
- Not applicable. This refers to training data for machine learning algorithms, which is not relevant for this device.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not relevant for this device.
§ 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.