(193 days)
The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The Proximal Humerus Scaffold Fixation System (PHSFS) is intended for the repair of proximal humeral fractures. The system consists of a titanium plate, posts, cross-pegs, cortical screws, 1.5 mm K-Wires, manual surgical instruments, alignment fixture and a custom sterilization container.
The provided text describes a medical device submission (510(k)) for the Proximal Humerus Scaffold Fixation System (PHSFS). This is a device for surgical fixation, not an AI/ML powered device, therefore the typical metrics for AI/ML device evaluations (like sensitivity/specificity, AUC, agreement with ground truth, MRMC studies, sample sizes for training/test sets, expert qualifications for ground truth) are not applicable in this context.
This document describes a medical device, not an AI/ML powered device. Therefore, the standard AI/ML acceptance criteria and study components requested in the prompt (e.g., sensitivity, specificity, MRMC studies, training/test set sizes, expert qualifications) are not relevant to this content.
Instead, the acceptance criteria for this type of device are primarily based on substantial equivalence to a legally marketed predicate device and compliance with recognized consensus standards.
Here's an interpretation of the provided information in the context of a 510(k) submission for a non-AI medical device:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Compliance: Device materials meet recognized standards for surgical implants. | - Complies with ASTM F136-02a (Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications). |
- Complies with ASTM F899-07 (Stainless Steel for Surgical Instruments). |
| Substantial Equivalence (Technological Characteristics): The device has technological characteristics that are essentially identical to a legally marketed predicate device. | A 15-point comparison of technological characteristics was performed with the Synthes LCP Proximal Humerus Plate. The devices were found to be substantially equivalent. |
| Substantial Equivalence (Performance Characteristics): The device performs as well as or better than the predicate device across key performance parameters. | A multi-parameter comparison of mechanical performance was conducted with the Synthes LCP Proximal Humerus Plate. The devices were found to be substantially equivalent. |
| Safety and Effectiveness: The device is considered safe and effective for its intended use. | Based on compliance with stated standards and technological characteristics essentially identical to the predicate, the device is believed to be safe and effective and performs as well as or better than the predicate device. The implantable and tissue contact materials have a long history of safe usage in medical devices. |
| Intended Use: The device performs its intended function for specified indications. | Indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus. This aligns with or is comparable to the predicate device's indications. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Not Applicable (N/A) for an AI/ML context.
- For a mechanical medical device, "test set" typically refers to the physical units subjected to material and mechanical testing. The document does not specify the number of units tested, but rather refers to ASTM standards and "multi-parameter comparison of mechanical performance" implicitly requiring testing on a sufficient number of samples to demonstrate compliance and equivalence.
- Data Provenance: The data comes from the manufacturer's (TOBY Orthopaedics) internal testing and comparisons, implicitly conducted in the USA (where the company is located and the submission is made to the FDA). The data is retrospective in the sense that it evaluates the device after its design and manufacturing, but for a 510(k), it's a pre-market submission demonstrating intended performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable (N/A) for an AI/ML context.
- For this type of device, "ground truth" is established by adherence to engineering standards (e.g., ASTM) and demonstrated performance relative to a predicate device. This is typically evaluated by engineers and materials scientists with expertise in biomechanics, materials science, and medical device design. The document does not specify the number or qualifications of individuals who performed or reviewed these tests, but it is implied they were qualified professionals.
4. Adjudication Method for the Test Set
- Not Applicable (N/A) for an AI/ML context.
- For a mechanical device, "adjudication" usually refers to the process of reviewing test results against predefined acceptance criteria. This would typically involve internal quality control and regulatory affairs professionals from the manufacturer, and subsequently, the FDA reviewers in the Office of Device Evaluation. The document doesn't detail the internal adjudication process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC study was NOT done. This type of study is specific to AI/ML devices or diagnostic imaging interpretation where human readers' performance is being evaluated.
- For this mechanical device, comparative effectiveness is demonstrated by showing "substantial equivalence" of technological and performance characteristics to a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used
- Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance is compliance with established engineering material standards (ASTM F136-02a, ASTM F899-07) and the known, safe, and effective performance of the legally marketed predicate device (Synthes LCP Proximal Humerus Plate). The ground truth for materials is defined by the ASTM specifications, and for functional performance, it is defined by the predicate device's established mechanical properties.
8. The sample size for the training set
- Not Applicable (N/A) for an AI/ML context. There is no "training set" for a mechanical device. The design and manufacturing processes are refined through engineering development, prototyping, and testing, but not in the "training" sense of machine learning.
9. How the ground truth for the training set was established
- Not Applicable (N/A) for an AI/ML context. As there is no training set as understood in AI/ML, this question does not apply. The materials and performance characteristics of the device were chosen based on established engineering principles, regulatory requirements, and the characteristics of the predicate device.
§ 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.