(41 days)
The I.T.S. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder. Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The I.T.S. Humeral Head Plate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length cancellous self-tapping stabilization screws. The humeral head plate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
The provided text describes a 510(k) premarket notification for a medical device called the "Humeral Head Plate with Angular Stability." This document focuses on demonstrating the device's substantial equivalence to previously approved devices, rather than conducting a de novo study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, study details, and AI-related performance metrics is not directly present in the provided text.
Specifically:
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Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) review, which means it aims to demonstrate substantial equivalence to predicate devices already on the market. The provided text doesn't define specific quantitative acceptance criteria for performance; instead, it focuses on the device's design, materials, and intended use being similar to existing, legally marketed devices. Therefore, a table of acceptance criteria and reported device performance as would be found in a performance study is not available here.
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Sample Size for Test Set and Data Provenance: Not applicable, as this is not a clinical performance study with a test set of data. The document focuses on regulatory approval based on equivalence.
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Number of Experts and Qualifications: Not applicable. There is no information on expert review for ground truth establishment for a test set.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done or is described. The device is a bone plate, so AI assistance for human readers is not relevant in this context.
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Standalone (Algorithm Only) Performance: Not applicable. This is a physical implant, not an AI algorithm.
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Type of Ground Truth Used: Not applicable, as there's no performance data being evaluated against a ground truth.
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Sample Size for Training Set: Not applicable. There is no AI model or training set involved.
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How Ground Truth for Training Set Was Established: Not applicable.
However, based on the information provided, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission:
1. Acceptance Criteria (for 510(k) Substantial Equivalence):
| Acceptance Criterion | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Material Composition | Plate: CP titanium (ASTM F 67-00). Screws: 6-4 alloyed titanium (ASTM F 136-02). Surface conditioned with TIODIZE, Type II preparation. |
| Device Design | Low-profile universal left and right titanium 4, 6, and 8 hole plate with various length cancellous self-tapping stabilization screws. |
| Intended Use / Indications for Use | Stabilize fracture(s) of the proximal humerus bone in the shoulder, including fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. This is congruent with predicate devices. |
| Substantial Equivalence (Safety & Effectiveness) | The device is deemed substantially equivalent to the Synthes LCP Proximal Humerus Plates (K041860 & K011815), Hand Innovations Shoulder Fixation System (K042059), Arthrex Humeral Fracture Plates and Screws (K041965), DePuy ACE TIMAX® Meta Plate (K983853), and ACE Humerus & Radius Plates (K955472). This implies that its safety and effectiveness are comparable to these legally marketed devices based on non-clinical data and existing knowledge of these device types. |
2. The "Study" (in the context of 510(k)):
The "study" that proves the device meets the acceptance criteria is the 510(k) Premarket Notification process itself, specifically the provided Summary of Safety and Effectiveness. In this context, the "study" is a comparative assessment against legally marketed predicate devices, and it relies on non-clinical data (e.g., material testing, mechanical testing, design comparisons, and adherence to recognized standards for bone plates).
- Data Provenance: The nature of a 510(k) implies that the "data" is primarily based on engineering analysis, material specifications, and comparative design reviews against established predicate devices. There is no mention of clinical data or patient outcomes in this summary. The materials comply with ASTM standards (F 67-00, F 136-02), indicating adherence to recognized engineering and material specifications.
- Ground Truth: For a 510(k) submission, the "ground truth" is typically the established safety and effectiveness profile of the predicate devices. The new device aims to demonstrate that it is as safe and effective as these already approved devices.
- Sample Size for Test/Training set & Ground Truth Establishment: These concepts are not directly applicable since this is a regulatory submission for a physical implant based on substantial equivalence, not a clinical trial or an AI performance study. The "evidence" is the comprehensive documentation submitted to the FDA demonstrating that the device is comparable to predicates in terms of intended use, technological characteristics (materials, design), and performance (implied by material and design similarity, and adherence to standards).
§ 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.