(26 days)
The KALIX® II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
- flat foot treatment in children and adolescents
- congenital flat foot
- non successful long term orthopaedic treatment (shoes, insoles ... )
- tarsal coalitions
- painfully flat foot
- supple deformity in posterior tibial tendon dysfunction
- paralytic flat foot
- subtalar instability.
The KALIX® II Flat Foot implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This is the same indication for use as the Kalix® II Implant, K053093.
The KALIX® II Flat Foot implant is a combination of three components. Two of them are made from Titanium alloy (Ti-6Al-4V) that conforms to both ISO 5832-3 and ASTM F136 standards. The outer sleeve is made from Ultra High Molecular Weight Polyethylene (UHMWPE) is an conforms to ASTM F648-00 standard. These are the same materials as the unmodified device, KALIX® II Flat Foot implant, K053093.
This document (K061765) is a 510(k) premarket notification for a medical device called the KALIX® II Flat Foot implant. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and does not pose new questions of safety or effectiveness.
Therefore, this document does not describe acceptance criteria for device performance in the way you might find in a clinical trial or performance study, nor does it present a study that proves the device meets such criteria. Instead, the "acceptance criteria" here are regulatory criteria for substantial equivalence to a predicate device. The "study" is the submission itself, which primarily focuses on demonstrating similarities to a previously cleared device.
Specifically, the device is being cleared based on its substantial equivalence to the KALIX® II Flat Foot implant, K053093. The modifications to the new device are minor (anodization of the device) and are stated not to change the intended use or fundamental scientific technology.
Given this context, I cannot populate all the fields in your request directly as they pertain to a performance study with defined acceptance criteria and detailed study methodology. However, I can interpret the document's information in relation to a "regulatory acceptance" framework for substantial equivalence.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Regulatory) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Intended Use: Device has the same intended use as the predicate device. | Same Intended Use: "The KALIX® II Flat Foot implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This is the same indication for use as the Kalix® II Implant, K053093." (Page 1) |
| Materials: Device uses same or equivalent materials as the predicate device. | Same Materials: "The KALIX® II Flat Foot implant is a combination of three components. Two of them are made from Titanium alloy (Ti-6Al-4V)... The outer sleeve is made from Ultra High Molecular Weight Polyethylene (UHMWPE)... These are the same materials as the unmodified device, KALIX® II Flat Foot implant, K053093." (Page 2) |
| Basic Design: Device has the same basic design as the predicate device. | Same Basic Design: Explicitly stated under "Comparison of Technological Characteristics" (Page 2). |
| Instructions for Use: Device has the same Instructions for Use as the predicate device. | Same Instructions for Use: Explicitly stated under "Comparison of Technological Characteristics" (Page 2). |
| Manufacturing Process: Device uses same or equivalent manufacturing process as the predicate device, with any changes not affecting safety/effectiveness. | Same Manufacturing Process: "Same manufacturing process (but anodization of the new device)" (Page 2). The submission implies this change does not raise new issues of safety or effectiveness. |
| Sterilization & Packaging: Device is delivered sterile using the same materials and processes as the predicate device. | Same Sterilization & Packaging: "Are delivered sterile packaged using the same materials and processes" (Page 2). |
| Does not raise new safety or effectiveness concerns. | No New Concerns: "The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness." (Page 2) This is the overarching conclusion drawn from the comparison of characteristics. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a 510(k) submission based on substantial equivalence to a predicate device, not a performance study on live subjects or retrospective data with a "test set" in the typical sense. The "test" is the comparison of characteristics against the predicate device.
- Data Provenance: Not applicable. The data provenience is the comparison of the characteristics of the proposed device against the predicate device (K053093) as reported by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" with a ground truth requiring expert consensus for this submission. The "ground truth" for the predicate device's safety and effectiveness was established during its own 510(k) clearance (K053093). For this submission, the "ground truth" is primarily based on the documented specifications and characteristics of both the new and predicate devices.
4. Adjudication method for the test set
- Not applicable. No "test set" requiring adjudication.
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. This is a surgical implant, not a diagnostic imaging device with human readers or AI components.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence is the predicate device (K053093) and its previously established safety and effectiveness. The comparison relies on documented device specifications, materials standards (ISO, ASTM), and the manufacturer's assessment that changes are minor.
8. The sample size for the training set
- Not applicable. There is no "training set" for this type of submission.
9. How the ground truth for the training set was established
- Not applicable. No "training set." The "ground truth" for the predicate device and its characteristics as a basis for comparison was established through its prior 510(k) clearance process.
§ 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.