(104 days)
The Agent Medical - ArthroBridge System is intended to facilitate bone healing following reduction and fracture fixation of the small bones.
The Agent Medical - ArthroBridge System is indicated for use for small bone fractures and osteotomy fixation and for distal phalangeal inter-digital fusion of the fingers and toes.
The Agent Medical - ArthroBridge System is not for spinal use.
The Agent Medical - ArthroBridge System is an intramedullary small joint arthrodesis/fusion system for fixation of osteotomies, fractures and reconstruction of the phalanges of the lesser digits in the foot and hand. The Agent Medical - ArthroBridge System is a 2-piece cannulated compression screw system composed of 1). A threaded Proximal Module (in a 4.0, 4.5 & 5.0mm size) that is placed within the proximal phalangeal medullary canal, and 2). A Screw with low profile head (in lengths of 25, 30, 35, 40, 45 and 50mm) that is introduced/threaded into the previously inserted Proximal Module. The Proximal Module is cannulated to fit over an insertion instrument and the Screw is cannulated to fit over a .035" K-wire for guided insertion of both components within the phalangeal digit medullary canal. The threaded advancement of the Screw body within the stationary threaded Proximal Module allows internal compression across the debrided digit joint space for stabilization and eventual fusion/ arthrodesis – and for bone fixation and joint deformity correction. The threaded Proximal Module and Screw with low profile head are manufactured from high strength Ti6Al4V ELI Titanium Alloy with an Anodized Type II surface. Disposable, single use, Cannulated Drills, Guide Wires, and Driver/Depth Gauge instruments are available for insertion of the system. Removal (when necessary) of the device is carried out percutaneously. All Implants and Instruments are packaged 'Sterile' for single use. The method of sterilization is Ethylene Oxide.
This document, K142528, is a 510(k) premarket notification for a medical device called the "Agent Medical - ArthroBridge System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria. Therefore, the information typically found in a study proving a device meets acceptance criteria for diagnostic performance (like sensitivity, specificity, or AUC) is not present in this document.
Here's a breakdown of what is available in the document, and what is not applicable or not provided for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable / Not provided. For a 510(k) for a bone fixation device, the "acceptance criteria" are not reported as statistical performance metrics (like sensitivity/specificity) but rather as demonstrations of substantial equivalence in design, materials, and intended use as compared to predicate devices. There are no performance metrics reported in the way they would be for a diagnostic AI device.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. This document describes a medical device for bone fixation, not an AI or diagnostic system that would have a "test set" in the context of performance evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable / Not provided. This concept of "experts establishing ground truth" is relevant for diagnostic performance studies, not for this type of device submission.
4. Adjudication Method:
- Not applicable / Not provided. Adjudication methods are typically used in clinical trials or diagnostic studies where there's a need to resolve discrepancies in expert interpretations of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:
- No, a MRMC study was not done. This is a bone fixation system, not a diagnostic AI device that would participate in such a study for comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This describes a mechanical bone fixation device, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable / Not provided. The concept of "ground truth" as pathology, outcomes data, or expert consensus is used in diagnostic algorithm evaluations, not for a substantial equivalence demonstration of a bone fixation device.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. This is a physical medical device, not an AI/ML algorithm that would have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. See explanation for #8.
What the document does describe related to deeming the device acceptable:
The document states that the FDA reviewed the 510(k) premarket notification and "determined the device is substantially equivalent... to legally marketed predicate devices." This is the core "acceptance criteria" for a 510(k) pathway.
The study that proves the device meets this acceptance criteria (i.e., substantial equivalence) is summarized as follows:
- Equivalence Statement: "The Agent Medical - ArthroBridge System is Substantially Equivalent(SE) to the predicate systems (as listed). No nonclinical testing was used in the determination of substantial equivalence." (Page 4)
- Summary of Technological Characteristics: "The Agent Medical - ArthroBridge System is Similar in Material, Design, and Indications to the listed predicate devices." (Page 4)
- Conclusion: "The Agent Medical - ArthroBridge System has similar indications for use, materials, dimensions, and designs when compared to the predicate devices. An engineering/dimensional comparison to the predicate devices was performed to demonstrate Substantial Equivalence (SE). Based on these similarities, the Agent Medical – ArthroBridge System is substantially equivalent to the predicates identified in the 510(k)." (Page 4)
In essence, for this specific bone fixation device, the "acceptance criteria" are met by demonstrating that its indications for use, materials, dimensions, and design are sufficiently similar to already legally marketed predicate devices. The "study" was an engineering/dimensional comparison to these predicate devices, which led to the conclusion of substantial equivalence.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.