(85 days)
The Modular Foot System is indicated for the fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
The OrthoHelix Modular Foot System is a set of metallic, implantable, bone fixation plates and screws. The System includes 26 fixation plates and 66 screws, which include all different sizes. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti-6Al-4V ELI per ASTM F-136.
The OrthoHelix Modular Foot System is a set of metallic, implantable, bone fixation plates and screws used for fractures, fusions, and osteotomies in the hand, wrist, foot, and ankle. The provided documentation primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and performance metrics in the typical sense of a clinical trial or AI algorithm validation.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Darco Locking Bone Plate System (K061808) and OrthoHelix MaxLock Small Bone System (K050868)) | Confirmed through Finite Element Analysis, mechanical testing, and hand calculations. |
| Meets specified requirements for intended use. | Confirmed through Finite Element Analysis, mechanical testing, and hand calculations. |
| Biocompatibility (materials) | All screws and plates are made from implant grade titanium, Ti-6Al-4V ELI per ASTM F-136, a standard material for implants. |
Explanation: In the context of a 510(k) submission for this type of medical device (fixation plates and screws), the "acceptance criteria" are not typically expressed as specific performance metrics like sensitivity/specificity for a diagnostic device. Instead, the primary acceptance criterion for FDA clearance is demonstrating "substantial equivalence" to a legally marketed predicate device. This involves showing that the device is as safe and effective as the predicate device, often through engineering analyses and mechanical testing, rather than clinical trials with human subjects.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The "test set" here refers to the physical devices and materials undergoing engineering analysis and testing. This is not a study involving patient data.
- Data Provenance: The data provenance is from engineering analyses and mechanical tests performed on the device components (plates and screws). This is not retrospective or prospective clinical data from human subjects or countries of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. This submission relies on engineering and material science principles. The "ground truth" for the performance of the device is established by standardized material properties (ASTM F-136) and validated engineering methods (Finite Element Analysis, mechanical testing, hand calculations), rather than expert medical consensus on individual cases.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no "adjudication method" in the sense of reconciling disagreements among experts for a test set of clinical cases. The results of the engineering analyses and mechanical tests are objective and measurable against established engineering standards and predicate device performance.
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: No, an MRMC comparative effectiveness study was not done. This device is a surgical implant (hardware), not a diagnostic tool or an AI-assisted system for human interpretation. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study for an algorithm was not done. This device is a physical surgical implant and does not involve any algorithms or artificial intelligence.
7. The type of ground truth used
- Type of Ground Truth: The ground truth used is primarily based on engineering standards, material properties, and comparative mechanical performance against predicate devices' specifications. This includes:
- Standardized material specifications (ASTM F-136 for Ti-6Al-4V ELI titanium).
- Results from Finite Element Analysis (FEA) which provides theoretical mechanical performance data based on established physics and material science.
- Results from physical mechanical testing (e.g., fatigue, static strength) against established benchmarks or predicate device performance.
- Hand calculations, likely referring to standard engineering calculations to assess structural integrity.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no concept of a "training set" in the context of this device submission, as it does not involve machine learning or AI. The design and validation processes are based on engineering principles and material science.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by demonstrating its equivalence to predicate devices through robust engineering analysis and mechanical testing, ensuring it meets safety and effectiveness standards without the need for a training data set.
§ 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.