(74 days)
This reprocessed external fixation device is indicated for use in the construction of an external fixation frame. When used with sterile bone pins and Kirschner wires, this device is used to provide stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation
SterilMed's reprocessed external fixation devices consists of the standard bridge elements (rods, articulating and telescoping components), and connection elements (clamps) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Note: Only the non-patient contact, external frame elements are the subject of this submission, the anchorage pins and wire elements are not included in the scope of this submission
The provided text describes a 510(k) submission for a Reprocessed External Fixation Device by SterilMed, Inc. It claims substantial equivalence to the Stryker Hoffman II® External Fixation System.
However, the document does not contain the kind of detailed information requested about acceptance criteria and a study proving device performance in the context of diagnostic accuracy, which is typical for AI/ML devices or those with measurable performance metrics (e.g., sensitivity, specificity, AUC).
Instead, this submission focuses on the performance claims related to a reprocessed medical device, where the "performance" is more about functional integrity, sterility, and safety after reprocessing, rather than a diagnostic accuracy metric.
Here's a breakdown of what can be extracted based on the nature of this submission, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a reprocessed device, the "acceptance criteria" and "performance" are framed around maintaining the original device's functionality and safety after reprocessing. There are no specific numerical metrics like accuracy, sensitivity, or specificity.
| Aspect of Performance/Criteria | Reported Device Performance |
|---|---|
| Functional Characteristics | Representative samples of reprocessed external fixation constructs were tested to demonstrate appropriate functional characteristics. |
| Cleaning Procedure | Process validation testing was performed to validate the cleaning procedure. |
| Manufacturing Process Quality | The manufacturing process includes visual and validated functional testing of all products produced. |
| Substantial Equivalence | The Reprocessed External Fixation Devices are substantially equivalent to the Stryker Hoffman® II external fixation devices in functional design (principle of operation), materials, indications for use and methods of construction. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Representative samples" were used for functional testing and cleaning procedure validation. Specific numbers are not provided in this summary.
- Data Provenance: Not applicable in the context of data origin (e.g., country) as this pertains to the testing of the reprocessed physical device itself, not data collected from patients or diverse populations. The testing would have been conducted by SterilMed, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not present in the document. For device reprocessing, the "ground truth" would be established by validated engineering and quality control standards, rather than expert interpretation of medical images or patient data.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation or consensus is required to establish ground truth for a diagnostic device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance (e.g., of an AI system vs. human readers) and is not applicable to the reprocessing of a surgical fixation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not an algorithm or AI device. Hence, a standalone performance study in that context is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for this device would be established by engineering specifications, regulatory standards, and validated testing protocols to ensure the reprocessed device meets the functional and safety requirements of the original device and regulatory guidelines for reprocessing. This is based on physical and mechanical testing, not expert consensus on medical cases, pathology, or outcomes data in the usual sense for diagnostic devices.
8. The Sample Size for the Training Set
- Not applicable. There is no AI/ML algorithm requiring a training set mentioned in this document.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
Conclusion on Document Suitability:
The provided document is a 510(k) summary for a reprocessed medical device. The information requested in points 2 through 9 (and parts of point 1) is typically relevant for evaluating diagnostic devices, especially those incorporating Artificial Intelligence or Machine Learning, which rely on large datasets, expert ground truth, and statistical performance metrics (e.g., sensitivity, specificity, ROC analysis). This document does not pertain to such a device, and therefore, most of the requested details are not present or applicable.
§ 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.