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For bone fixation of foot and ankle surgery and hand surgery, following a trauma or osteotomy. Screws and washers are intended for single use only

Fusion Medical Cannulated Screw System is comprised of screws in diameters 2.0mm (length 10mm-24mm), 2.5mm (length10mm-38mm),3.0mm (10mm-38mm), 5.0mm (length 30mm-70mm), 6.5mm (length 30mm-120mm) standard bone screw. 2.0mm compression (length 20mm-24mm), 2.5mm compression (length10mm-38mm), 3.0mm compression( length 10mm-38mm), 4.0mm compression (length 22mm-56mm), 6.5mm compression (length 30mm- 120mm), 8.0mm compression (length 75mm-140mm) 9.0mm compression (length 75mm-140mm) compression screws. The Screws are made from implant quality Titanium alloy Ti6a14v. (See attachments for thread length, thread pitch and head geometry of screws.) The screws will be machine finished with a 32RMS roughness. K-wires are provided. K wires are made of 316lss. Screwdrivers, drills, and countersinks shanks are made of 17-4-ph stainless steel, condition H 900 heat treated shanks. They are quick connecting shanks that are interchangeable with the handles. Washers are provided. They are made of implant quality Ti6a14v titanium alloy. (See attachment for drawing of the washers and sizes. Depth gauges, and preparation instruments are part of the system.

The provided text is a 510(k) summary for the Fusion Medical Cannulated Screw System, which is a medical device for bone fixation. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.

This document primarily outlines:

• Device Name: Fusion Medical Cannulated Screw System
• Intended Use: Bone fixation in foot, ankle, and hand surgery following trauma or osteotomy.
• Device Components: Descriptions of screws (various diameters and lengths, standard and compression types), K-wires, screwdrivers, drills, countersinks, and washers, including their materials.
• Predicate Device: Fusion Medical Cannulated Screw System (with Osteomed as the predicate's manufacturer, though the phrasing is a bit ambiguous as it says "Equivalence for this devise is based on similarities in intended use; material, design and operational principal to Fusion Medical Cannulated Screw System are the Osteomed"). This suggests the applicant's device is also named Fusion Medical Cannulated Screw System, and it's being compared to a predicate from Osteomed.
• FDA Determination: The FDA found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested table and information based on the input text. The document is a regulatory submission approving the device based on substantial equivalence to a predicate, not a detailed study report on its performance against specific acceptance criteria.

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The Fusion Medical STI is intended to treat hyperpronated foot, and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion, but blocking excessive pronation and resulting sequela.

Examples are:

Subtalar instability, painful flat foot, congenital flat foot, paralytic flat foot, tarsal coalitions, posterior tibial tendon deformity and flat foot treatment in children and adolescents.

The Fusion Medical STI (Subtalar Implant) is a one-piece device made of titanium (6AL-4V ELI) intended to be implanted into the sinus tarsi of the foot. The implant will be available in 5 sizes. 8mm-12mm diameters. The implant that is used in the treatment of excess motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.

This 510(k) submission for the Fusion Medical STI (Subtalar Implant) describes a medical device that aims to be substantially equivalent to a predicate device. This type of submission generally relies on demonstrating equivalence rather than conducting a new, exhaustive clinical study to prove novel efficacy or meet specific performance acceptance criteria with statistical rigor. Therefore, much of the requested information regarding specific acceptance criteria and detailed study data for this particular device as a standalone product may not be present in the provided text.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria for performance metrics. Instead, it aims to demonstrate substantial equivalence to a predicate device (Futura CSI 510(k) K032902). The "reported device performance" is essentially that it is substantially equivalent to the predicate device in terms of design, material, intended use, and indications.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not describe a specific clinical test set or study with a defined sample size for the Fusion Medical STI. This type of submission relies on the existing safety and effectiveness profile of the predicate device, not on new clinical data for the proposed device itself, unless significant differences warrant it. Therefore, there's no mention of sample size, country of origin, or whether it was retrospective or prospective for a new study of the Fusion Medical STI.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Since there is no new clinical study presented for the Fusion Medical STI to establish novel performance or ground truth, this information is not applicable to the provided document. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set

As no specific clinical test set is described, the adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No MRMC comparative effectiveness study is mentioned. This is typically not required for 510(k) submissions unless the device introduces new technology or significantly alters the diagnostic or treatment pathway that would necessitate human reader assessment. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable.

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

The device is a physical implant, not an algorithm or AI. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence claim is effectively the established performance, indications, and safety profile of the legally marketed predicate device (Futura CSI 510(k) K032902). The submission asserts that the Fusion Medical STI is similar enough in design, materials, and intended use that its performance can be inferred to be equivalent to the predicate, which FDA had previously determined to be safe and effective.

8. The Sample Size for the Training Set

There is no mention of a "training set" as this device is a physical implant, not an AI or machine learning model. This concept is not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned, this information is not applicable.

In summary, the provided document is a 510(k) summary for a medical device seeking clearance through substantial equivalence. It does not present data from a new clinical study with explicit acceptance criteria, sample sizes, or ground truth establishment for novel performance. Instead, it meticulously compares the Fusion Medical STI to a legally marketed predicate device, highlighting similarities in design, materials, and intended use to argue for its substantial equivalence.

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