(77 days)
The Synthes 2.7 mm Reconstruction Plates are intended for distal humerus fractures.
Synthes 2.7 mm Reconstruction Plates are used with 2.7 mm Syllules 2.7 min Reconbilable in lengths from 48 mm Cortex Serews: "The places oured with bending irons. The plates to 192 film and can be connects steel and are available as sterile.
The provided text is a 510(k) summary for the Synthes 2.7 mm Reconstruction Plates, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a modern clinical trial would for AI/ML devices. Therefore, much of the requested information cannot be found in this type of regulatory submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or report device performance in the manner of a clinical trial or a study assessing performance metrics for a medical device. The 510(k) process in 1998 for devices like bone plates relied heavily on demonstrating a high degree of similarity to already-marketed devices (predicate devices) concerning materials, design, and intended use. The "acceptance criteria" here implicitly refer to the FDA's regulatory requirements for a 510(k) submission, primarily demonstrating substantial equivalence.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance (from summary) |
|---|---|
| Substantial Equivalence to Predicate Device (Synthes 2.7 mm Reconstruction Plates) regarding: | "Synthes 2.7 mm Reconstruction Plates are used with 2.7 mm Cortex Screws. The plates are available in lengths from 48 mm to 192 mm and can be contoured with bending irons. The plates are made of stainless steel and are available as sterile." (This describes the device's characteristics and its similarity to predicate devices). |
| - Intended Use | "Intended for distal humerus fractures." (Matches the general use of predicate bone fixation plates). |
| - Materials | "made of stainless steel" (Common material for bone plates, expected to be similar to predicate). |
| - Design/Technology | "used with 2.7 mm Cortex Screws" and "can be contoured with bending irons" (Standard design features for reconstruction plates, expected to be similar to predicate). |
| - Performance (e.g., mechanical testing, if included) | Not explicitly detailed in this summary. For metallic implants, mechanical testing (fatigue, bending strength) would typically be performed to ensure material and design integrity, and the results would be compared to predicate devices or established standards. However, specific results are not provided here. |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets acceptance criteria in this context is the 510(k) submission itself, which argues for substantial equivalence. It is not a clinical study in the sense of comparing outcomes in patients, nor an AI performance study.
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This is a submission for a medical device (bone plate), not a data-driven AI/ML device. There is no "test set" of data in the context of an AI algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no AI algorithm being evaluated, and thus no "ground truth" establishment for a test set by experts in this context.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" or adjudication method for an AI algorithm.
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
Not applicable. This device is a passive bone plate and does not involve human readers interacting with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
Not applicable in the AI/ML sense. For medical devices like bone plates, "ground truth" would relate to accepted engineering standards for material properties, biomechanical performance, and surgical outcomes (from literature or predicate device history). The 510(k) relies on the established safety and effectiveness of the predicate device as fundamental "ground truth" against which the new device is compared.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and thus there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, there's no ground truth to establish for it in this context.
Summary of what can be gleaned from a 1998 510(k) for a bone plate:
- Acceptance Criteria: Implicitly, the device must be "substantially equivalent" to a legally marketed predicate device (Synthes 2.7 mm Reconstruction Plates) in terms of intended use, technological characteristics (materials, design), and principles of operation to ensure similar safety and effectiveness.
- Study Proving Acceptance: The 510(k) submission itself serves as the "study." It would typically include:
- Comparison tables detailing similarities and differences between the new device and the predicate.
- Biocompatibility data (if materials are novel or not well-established).
- Mechanical testing results (e.g., fatigue, static strength) to demonstrate equivalent performance to the predicate or established standards, though specifics are not in this summary.
- Manufacturing process controls.
- Key Missing Information (from the AI/ML context): All points related to data sets, expert review, AI performance metrics, and clinical outcomes specific to the new device are not typically found in this type of 510(k) summary from this era. The focus is on demonstrating equivalence, not necessarily on a de novo demonstration of safety and effectiveness through a dedicated clinical study for every new iteration.
§ 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.