(240 days)
The Converge™ is indicated for fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.
The BME Converge™ consists of a sterile bone plate offered in various configurations and sterile titanium screws. The Converge™ is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Converge™ is activated at room temperature upon release from retention brackets. In its final configuration, the plate actively provides continuous compression across the fusion site.
The Converge™ system contains plates and screws in similar shapes and sizes and manufactured from the same materials according to the same steps as the reference device, Nitinol Compression Plating System™ (NCP). However, the Converge™ includes the addition of K-wire and retention brackets (as opposed to NCP's restraining instrument). The configurations of the BME Converge™ system include Straight shaped implants. Additionally, the BME Converge has been MR tested and results indicate it is MR Conditional, whereas the BME Nitinol Compression Plating System has not undergone MR testing.
The main differences between the BME Converge™ and the primary predicate, GPC Medical Bone Plates and Bone Screws include the configurations and the material. The GPC Medical Bone Plates are made out of titanium whereas the BME Converge plates are made out of nitinol. The GPC Medical Bone Plate system is either a rectangular or "T" shaped implant with four to seven holes for screws, while the Converge plate system includes a straight shape. Additionally, results of MR testing conclude that BME's Converge™ may be listed as MR Conditional. It is unclear whether GPC Medical bone Fixation Plates and Screw System have undergone MR testing.
This document describes a 510(k) premarket notification for the "Converge™" device, a bone plate and screw system. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "The results demonstrate substantial equivalence to predicate device" for a series of non-clinical tests. This implies that the acceptance criteria were met by demonstrating performance comparable or superior to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static bend performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Dynamic bend performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Post fatigue corrosion performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Post fatigue nickel leaching performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Corrosion performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Galvanic corrosion performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| MRI compatibility (MR Conditional determination). | Results indicate it is MR Conditional. |
| MRI RF heating simulation performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Bone screw insertion and removal performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Plate compression performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Bone screw torsion performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Bone screw pull-out performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
| Bone screw corrosion resistance performance comparable to predicate. | Results demonstrate substantial equivalence to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each of the non-clinical tests. It only lists the types of tests performed. The data provenance (country of origin, retrospective/prospective) is not mentioned, but as this is a non-clinical study, it would typically be conducted at an engineering or testing lab and not involve human subjects or geographical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable as the submission is for a medical device (bone plate and screws) and relies on non-clinical engineering and material testing, not human-read clinical data. Therefore, there's no "ground truth" to be established by medical experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes.
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
This section is Not Applicable. The document explicitly states "Clinical Evidence: Not Applicable." The submission is for a device, not an AI or imaging diagnostic tool, and therefore does not involve human readers interpreting data or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is Not Applicable. The device is a physical bone plate and screw system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is established by engineering standards and direct measurement according to scientifically validated test methods. For example, a "static bend" test would establish its ground truth based on measurable mechanical properties and material failure points as defined by engineering principles, rather than expert consensus or pathology reports.
8. The sample size for the training set
This section is Not Applicable. There is no "training set" as this is a non-clinical device submission, not a machine learning or AI algorithm.
9. How the ground truth for the training set was established
This section is Not Applicable for the same reason as point 8.
§ 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.