Search Results

Ask a specific question about this device

The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery.

The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System consists of anatomically contoured, lowprofile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking Extremity Plating System (EPS) screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. Screws lengths are offered in 10-40mm for the 2.7mm diameter plate screws and in 10 – 60mm in 3.5mm and 4.0mm diameter plate screws. All components (implants and the associated instruments) are provided sterile and for single use only.

The provided document does not describe an AI/ML device or software. It pertains to the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System, which is a metallic bone fixation appliance used for surgical fusion in the foot.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable and cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and engineering analysis for a physical medical implant.

Ask a specific question about this device

The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.

The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.

The provided text does NOT contain information regarding the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria for an AI/ML medical device.

The document is a 510(k) premarket notification for a physical medical device called the "GEO Bone Screw System." It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K161904).

Therefore, I cannot provide the requested information. The document explicitly states:

"No additional performance testing was required. The GEO Bone Screw System components have been subjected to design controls and previously tested to appropriate device-specific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device system."

This indicates that no new studies were conducted to prove this specific submission of the device met acceptance criteria, but rather it relies on prior testing of its predicate device and general design controls.

Ask a specific question about this device

The GEO 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion or revision surgery.

The GEO 188 MTP Joint Arthrodesis Plating System consists of anatomically contoured, low- profile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. All screws are offered in lengths of 10-40mm. The system also includes associated instrumentation consisting of plate tacks, quide-wire, drill bit, drill bit, drill guides (locking and non-locking), AO driver tip, reamers, depth gauge, non-locking drill guide handle, AO driver handle, and templates for plate and reamer sizing. All GEO 1ª MTP Joint Arthrodesis Plating System components (implants and instruments) are provided sterile and for single use only.

This document is a 510(k) premarket notification for a medical device called the "GEO 1st MTP Joint Arthrodesis Plating System." As such, it describes a mechanical device for internal fixation of bones, not a software algorithm or AI-powered diagnostic tool. Therefore, the questions related to AI/algorithm performance, such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training sets, are not applicable to the content provided.

The performance data section for this type of device focuses on physical and mechanical testing to ensure its safety and effectiveness when used for bone fixation.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document highlights compliance with these standards and concludes substantial equivalence, implying the device met the performance requirements outlined in these standards. Specific numerical results or pass/fail thresholds against explicit acceptance criteria are not detailed in this summary document.

2. Sample size used for the test set and the data provenance

Not applicable for this type of mechanical device testing. The testing would involve physical samples of the plates and screws, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a mechanical device is established through physical and mechanical testing against recognized standards.

4. Adjudication method for the test set

Not applicable. Mechanical testing is typically objectively measured against established engineering standards.

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

Not applicable, as this is a mechanical bone fixation device, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a mechanical bone fixation device, not an algorithm.

7. The type of ground truth used

For a mechanical device, the "ground truth" is typically defined by the established performance requirements and specifications outlined in the referenced ASTM standards (ASTM F382-17-17 and ASTM F543-17). These standards detail specific tests (e.g., bending strength, fatigue, pull-out strength for screws) and criteria that the device must meet.

8. The sample size for the training set

Not applicable, as this is a mechanical bone fixation device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device

The GEO Staple System is intended for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis.

The GEO Stable System consists of symmetric, barbed and smooth, superelastic Nitinol allov compression bone staples in varying lengths and widths. The System also includes associated instrumentation consisting of a stable inserter, drill bit and locator pins. The nitinol implant material conforms to ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. GEO Staples are offered in widths ranging from 8mm – 25mm. To facilitate implantation, GEO Staples are provided preloaded in the Staple Inserter. All GEO Staple System components (implants and instruments) are provided sterile and for single use only.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "GEO Staple System" does not contain any information about a study involving software or AI performance, acceptance criteria for such a study, or details about ground truth establishment or expert involvement.

The document is purely related to the clearance of a physical medical device (bone staples) and its equivalence to predicate devices based on material properties, mechanical testing, and biocompatibility.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the context of an AI/software-driven medical device. The information you are asking for (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) is not present in this document, as it pertains to the validation of a different type of medical device (AI/Software as a Medical Device).

Ask a specific question about this device