(56 days)
The Milagro® BR interference screws are designed to attach soft tissues to bone in orthopedic surgical procedures. The screws may be used for interference fixation of soft tissues (such as ligaments or tendons) to bone, when the implant sizes offered are patient appropriate. The implant operates, in conjunction with the appropriate postoperative immobilization, throughout the healing period.
The DePuy Mitek Milagro® Interference Screws are absorbable, tapered, cannulated, threaded fasteners for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).
The provided document is a 510(k) Summary for a medical device (Milagro® Interference Screws) seeking substantial equivalence to predicate devices. It focuses on demonstrating that the new device shares similar technological characteristics and performance to already legally marketed devices. As such, it does not involve the typical assessment of a new diagnostic algorithm or AI system, which would require the specific details outlined in your request.
Therefore, many of the requested items (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance of an algorithm, ground truth methods for AI training) are not applicable to this type of submission.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its performance relative to its predicates.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state "acceptance criteria" in the same way a diagnostic algorithm's F1 score or AUC would be presented. Instead, its acceptance is based on demonstrating "substantial equivalence" through nonclinical testing. The "acceptance criteria" can be inferred as meeting the performance levels demonstrated by the predicate devices or demonstrating acceptable mechanical performance for the intended use.
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Comparable Insertion Torque to predicate devices. | Performed. Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." (Specific torque values are not disclosed in this summary but would have been part of the full 510(k) submission). |
| Comparable Anchor Pullout (at T=0, 3, 6, and 12 weeks in-vitro physiological aging) to predicate devices. | Performed. Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." (Specific pullout resistance values over time are not disclosed but would have been part of the full 510(k) submission). |
| Comparable Torque to Failure to predicate devices. | Performed. Results "demonstrated that the proposed device is substantially equivalent to the predicate devices." (Specific torque to failure values are not disclosed but would have been part of the full 510(k) submission). |
| Similar Technological Characteristics (design construct, packaging, indications, material). | "Technological characteristics including design construct, packaging and indications are similar to the predicate devices and use similar or identical material and packaging as the predicates." The new devices are absorbable, tapered, cannulated, threaded fasteners made from Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP). |
| Safe and Effective for Indications for Use. | "Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices." The device is designed to attach soft tissues (ligaments or tendons) to bone in orthopedic surgical procedures through interference fixation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary. Nonclinical testing typically involves a set number of physical samples (e.g., screws) tested under laboratory conditions.
- Data Provenance: Not applicable in terms of human patient data. The tests are "in-vitro physiological aging" and mechanical tests on the physical devices. This is not retrospective or prospective human clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This document describes the mechanical testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. No human-based adjudication is mentioned for these nonclinical, mechanical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is relevant for diagnostic imaging or interpretation systems with human readers, not for the mechanical performance of a physical interference screw.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable. For mechanical tests, the "ground truth" is typically the measured physical properties based on standardized testing methods, comparing against established benchmarks or predicate device performance. It doesn't involve expert consensus, pathology, or outcomes data in the way a diagnostic study would.
8. The Sample Size for the Training Set
- Not Applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Same as above.
In summary:
This 510(k) summary is designed to demonstrate "substantial equivalence" of a new version of an interference screw to existing, legally marketed devices. The "study" involves nonclinical, mechanical, and material characteristic tests to show that the new device performs similarly and is as safe and effective as its predicates. It does not involve human subjects, imaging interpretation, or AI algorithms, which are the contexts where most of your specific questions would apply.
§ 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.