(87 days)
The Trabecular Metal Osteonecrosis Intervention Implant is indicated for use in patients with Stage I or Stage II osteonecrosis of the femoral head (Steinberg/UPenn System) and who would qualify for core decompression based upon physical and radiographic examination and medical history. The Trabecular Metal Osteonecrosis Intervention Implant may be used with or without bone graft.
The Trabecular Metal Osteonecrosis Intervention Implant is fabricated from Trabecular MetalTM porous tantalum. The implant is cylindrical in shape with a 10 mm diameter and length options from 70 to 130 mm in 5 mm increments.
The Trabecular Metal Osteonecrosis Intervention Implant possesses distal threads for engagement of bone. The threaded portion is 25 mm in length and the outer diameter is 14 mm, the inner diameter is 10 mm. Slots within the lateral most aspect of the implant interface with the driving instrument.
Here's an analysis of the provided text regarding the Trabecular Metal Osteonecrosis Intervention Implant, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list distinct "acceptance criteria" in a quantitative format, which is common for mechanical devices rather than software algorithms. Instead, the device's performance is described in terms of its ability to safely support weakened bone and its clinical performance.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Mechanical Performance: Safely supports weakened bone associated with early stage osteonecrosis of the femoral head. | Mechanical Testing: Characterized per modified ASTM testing standards for THR devices, mechanical test methods that simulated bone deficiencies caused by early stage femoral head osteonecrosis, and finite element modeling of the device. Results showed the subject device safely supports weakened bone. |
| Clinical Performance: Safe and efficacious use per the indicated patient population and conditions. | Clinical Data: Data collected under IDE G990234 showed the device to perform safely and efficaciously per the indications for use in patients with Stage I or Stage II osteonecrosis of the femoral head qualifying for core decompression. |
| Substantial Equivalence: Comparable to predicate devices in technological characteristics and properties. | Comparison to Predicate Devices: Demonstrates substantial equivalence to cited predicate devices based on a comparison of device technological characteristics and properties. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "clinical data collected under IDE G990234." However, it does not specify the sample size (number of patients or cases) of this clinical study that served as the "test set" for demonstrating clinical safety and efficacy.
- Data Provenance: The document does not explicitly state the country of origin. It refers to an "IDE G990234," which is an Investigational Device Exemption from the FDA, implying the clinical study primarily occurred in the United States. The study was prospective, as it was conducted under an IDE for collecting clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth for the test set or their qualifications. The clinical data was collected to demonstrate safety and efficacy, likely evaluated by clinical investigators and an independent review board, but specific details on "ground truth" experts in the context of diagnostic performance (as would be relevant for an AI device) are absent. This is a medical implant, not a diagnostic AI device.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. This level of detail is typically not included in a 510(k) summary for a medical device like an implant unless there's a specific need to reconcile divergent interpretations of clinical outcomes, which is not highlighted here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed to assess the performance of diagnostic tools (often imaging reads) and the impact of AI assistance on human readers. This device is a medical implant, not a diagnostic tool or an AI algorithm, so an MRMC study is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical implant, not an algorithm. Therefore, "standalone" algorithm performance is not relevant, and such a study was not conducted.
7. The Type of Ground Truth Used
For this medical implant, the "ground truth" used for performance assessment was based on:
- Clinical Outcomes/Performance Data: The term "safely and efficaciously" indicates that patient outcomes, perhaps in terms of pain reduction, improved mobility, or prevention of osteonecrosis progression, served as the clinical "ground truth."
- Mechanical Properties Data: "Modified ASTM testing standards for THR devices" and "mechanical test methods that simulated bone deficiencies" represent the mechanical "ground truth" against which the implant's structural integrity and support capabilities were evaluated.
- Finite Element Modeling (FEM) Data: FEM provides a computational "ground truth" for predicting how the device interacts with bone under various stress conditions.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for AI/machine learning algorithms. This device is a physical implant, not an AI algorithm. Therefore, there is no training set in the AI sense. The mechanical testing and finite element modeling would have involved various configurations and stress scenarios, but these are not "training data" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of an AI algorithm, this question is not applicable to the Trabecular Metal Osteonecrosis Intervention Implant. For the mechanical and clinical studies, the "ground truth" (i.e., the accepted standard for safety and efficacy) was established through scientifically recognized methods:
- Mechanical Studies: Established via "modified ASTM testing standards" and "finite element modeling." ASTM standards are widely accepted industry benchmarks for material and device testing.
- Clinical Studies: Established via a prospective clinical trial conducted under an IDE (G990234), which implies adherence to ethical guidelines and scientific rigor for evaluating patient safety and efficacy outcomes.
§ 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.