(73 days)
The BioPro - Infinity™ Plate Anchor System is indicated for ligament reattachment or fixation. The BioPro Infinity™ Plate and Screw(s) is supplied 'sterile' and intended for 'singleuse' only. The system is not intended for spinal use.
The BioPro- Infinity™ Plate Anchor System is a multiple plate system composed of a: 1). 2-hole Curved Plate, 2). 1-hole 10mm Plate, 3). 1-hole 12mm Plate, 4). 1-hole 14mm Plate, 5). 3-hole Flat Straight Plate, and 6). 3-hole T-Plate. Two(2) 3.0mm Cancellous Screws in a 15mm and 20mm length accompany the system for fixing the plate through soft-tissue to bone. Both the plates and screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 with an anodize Type II surface treatment. Ancillary screwdriver and K-wire instrumentation is offered as 'sterile' and disposable and is made available for implantation and removal of the device. The plate and screw implant combination with instrumentation is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.
The BioPro – Infinity™ Plate Anchor System is a medical device in the field of orthopedics, specifically designed for ligament reattachment or fixation.
Here's an analysis of its acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in the typical format of metrics like accuracy, sensitivity, or specificity. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Equivalence: The device materials are comparable to the predicate device. | The BioPro - Infinity™ Plate Anchor System and its screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 with an anodize Type II surface treatment. This is implicitly considered similar and acceptable to the predicate device, Synthes - Metallic Spiked Washers (K013806), which is also a metallic bone fixation appliance. (Note: Specific material details of the predicate are not provided in this summary, but the claim of similarity implies this was verified). |
| Geometry Design/Markings Equivalence: The device's design and markings are comparable to the predicate device. | The system includes various plates (2-hole Curved, 1-hole 10mm, 12mm, 14mm, 3-hole Flat Straight, 3-hole T-Plate) and 3.0mm Cancellous Screws in 15mm and 20mm lengths. The document states the system is "Similar in Material, Geometry Design/Markings, and Indications" to the predicate. This implies the design is functionally equivalent for its intended use. |
| Indications for Use Equivalence: The intended use is comparable to the predicate device. | The BioPro - Infinity™ Plate Anchor System is indicated for ligament reattachment or fixation. It explicitly states "The BioPro - Infinity™ Plate Anchor System is Similar in Material, Geometry Design/Markings, and Indications to the Synthes Metallic Spike Washers currently sold in the U.S. market." The predicate device likely has a similar indication related to soft-tissue fixation to bone. |
| Safety and Effectiveness: The device is safe and effective for its intended use. | The summary concludes: "The BioPro - InfinityTM Plate Anchor System is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting." This statement is based on the comparison to the predicate device and the assumption that if it's substantially equivalent in materials, design, and indications, it will also be safe and effective. Specific studies to demonstrate safety and effectiveness for this device are not detailed beyond the substantial equivalence claim. |
| Sterilization Method: The sterilization method is appropriate for a single-use, sterile device. | The sterilization method used is Ethylene Oxide. This is a common and accepted method for sterilizing medical devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not contain information about a test set in the context of a clinical trial or performance study with human subjects or a defined dataset. The "study" for this device's acceptance is primarily a comparative analysis against a legally marketed predicate device (Synthes - Metallic Spiked Washers, K013806) to demonstrate substantial equivalence. Therefore, there is no explicit test set with a sample size or data provenance in the traditional sense of a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable as there was no test set in the context of diagnostic interpretation or a clinical performance study requiring expert ground truth establishment. The "ground truth" for demonstrating equivalence is based on engineering principles, material science, and regulatory evaluation by the FDA, correlating the new device's characteristics to those of the predicate.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. There was no test set requiring multi-reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess the impact of AI on human reader performance. The BioPro - Infinity™ Plate Anchor System is a surgical implant, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance study was not done. This device is a passive surgical implant; it does not involve algorithms or AI, nor does it have a "standalone" operational mode in the way a diagnostic algorithm would. Its performance is tied to its mechanical properties and biocompatibility as an implant.
7. The Type of Ground Truth Used:
The "ground truth" used for the acceptance of this device is primarily regulatory precedent and engineering standards. The ground truth is that the predicate device (Synthes - Metallic Spiked Washers) is safe and effective and legally marketed. By demonstrating that the BioPro - Infinity™ Plate Anchor System is "substantially equivalent" in materials, design, and indications, the new device is then considered to share the safety and effectiveness profile of the predicate. This involves:
- Engineering specifications and material property verification: Ensuring the titanium alloy meets ASTM F136 and the anodization is Type II.
- Design comparison: Assessing the geometry and form factor against the predicate.
- Intended use comparison: Verifying the indications are the same or highly similar.
- Sterilization validation: Ensuring the Ethylene Oxide method is effective.
8. The Sample Size for the Training Set:
Not applicable. This device is a mechanical implant and does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/ML algorithm.
§ 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.