(89 days)
The Futura Biomedical Arthrorisis Implant 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 the resulting sequela. Examples include: Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ...) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability
The Futura Biomedical 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 is designed in 6 sizes. The implant which is used in the treatment of excessive 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.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This document is a 510(k) premarket notification for a medical device (Subtalar Arthrorisis Implant). The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device's design, materials, indications for use, and performance characteristics to a predicate device, rather than performing de novo clinical trials to establish new safety and effectiveness criteria.
As such, the information provided does not contain details about specific acceptance criteria or an independent study to prove the device meets new acceptance criteria beyond equivalence to the predicate device. Instead, it focuses on demonstrating substantial equivalence to an existing, legally marketed device.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from a de novo efficacy study) | Reported Device Performance (from a de novo efficacy study) |
|---|---|
| Not applicable - This submission aims for substantial equivalence, not to establish new performance criteria. | Not applicable - Performance is implicitly "equivalent" to the predicate device. |
The document explicitly states: "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device."
However, we can infer the comparison points that serve as the basis for demonstrating equivalence to the predicate device, which are presented in the "Comparison to Predicate Device" table (Table 1). These are not 'acceptance criteria' in the traditional sense of a specific performance metric to be met by the new device in an independent study, but rather aspects that must be sufficiently similar to the predicate to establish equivalence.
Inferred Comparison Points (from Table 1, used to establish equivalence):
| Item | Futura Product (Reported Characteristics) | New Deal Product (Predicate Characteristics) | Equivalence Assessment |
|---|---|---|---|
| Product Name | Subtalar Arthrorisis Implant | Subtalar Arthrorisiss Implant | Similar |
| Use | Single use | Single use | Equivalent |
| Fixation | Screw | Screw | Equivalent |
| Constraint | Non constrained | non constrained | Equivalent |
| Material | Titanium 6AL-4V ELI | Titanium alloy and UHMWPE | Difference noted (Titanium vs. Titanium alloy and UHMWPE) However, the summary states "both devices are made of industry standard materials, no new materials are introduced in either device." This implies the material difference is not considered a barrier to equivalence for this submission. |
| Sizes | 6 sizes | 5 sizes | Similar (range of sizes provided) |
| Indications for use | Intended to treat hyperpronated foot and stabilize the subtalar joint. Block forward, downward and medial displacement of the talus, allowing normal subtalar joint motion but blocking excessive pronation. Examples include: Flat foot treatment in children and adolescents, Congenital flat foot, Unsuccessful long term orthopaedic treatment, Tarsal coalitions, Painful flat foot, Supple deformity in posterior tibial tendon dysfunction, Paralytic flat foot, Subtalar instability. | Identical indications for use as Futura product. | Identical |
2. Sample size used for the test set and the data provenance
- Not applicable. No independent "test set" (i.e., patient data from a clinical trial or study for the Futura device) is mentioned or used to establish new acceptance criteria. The submission relies on a comparison to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for an independent test set for the Futura device is established or described. The "ground truth" for the predicate device would be its prior regulatory clearance and market history, implicitly approved by regulatory bodies and deemed safe and effective for its indicated uses.
4. Adjudication method for the test set
- Not applicable. There is no test set for clinical performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used
- Substantial Equivalence to a Predicate Device. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed New Deal Kalix Implant, which serves as the predicate device. The Futura device demonstrates equivalence to this predicate through comparison of design, materials, and intended use as described in the summary.
8. The sample size for the training set
- Not applicable. This submission is for a physical implant and does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned or relevant for this type of device submission.
§ 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.