(334 days)
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.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Fusion Medical STI) |
|---|---|
| Material: Titanium 6AL-4V ELI | Meets: Titanium 6AL-4V ELI (Same as predicate) |
| Use: Single Use | Meets: Single Use (Same as predicate) |
| Fixation: Screw | Meets: Screw (Same as predicate) |
| Constraint: Non-Constrained | Meets: Non-Constrained (Same as predicate) |
| Indications for Use: Treat hyperpronation, stabilize subtalar joint, block displacement of talus, allow normal motion while blocking excessive pronation (including specific examples like congenital flat foot, tarsal coalition, painful flat foot, posterior tibial tendon dysfunction, paralytic flat foot, subtalar instability, foot treatment in adults and children with flat foot). | Meets: Identical indications for use as the predicate device (as per comparison table and Indications for Use statement). |
| Placement: Sinus tarsi of the foot | Meets: Placed into the sinus tarsi of the foot (Same as predicate). |
| Functionality: Allow normal subtalar joint motion while blocking excessive pronation. | Meets: Explicitly stated as performing this function, similar to the predicate. |
| Sizes: Comparable range of sizes | Meets: Available in 5 sizes (8mm-12mm diameters), comparable to predicate's 6 sizes. |
| Safety: No new materials introduced, made of industry standard materials. | Meets: No new materials, industry standard materials. |
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.
§ 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.