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The I.T.S. FR.O.H. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot.

Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tonque type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients.

This system is not intended for spinal use.

Device Description

The I.T.S. FR.O.H. Calcaneus Repair System is a combination of fracture reduction and alignment instrumentation with either calcaneus plate and/or cannulated cancellous screw fixation across calcaneal heel bone fracture site(s). The 15-hole Calcaneus Plate (universal left and right in 2 sizes) is made from CP titanium according to ASTM F 67-00 and corresponding plate locking and self-tapping 3.5 & 4.2mm Cancellous Screws from 6-4 alloyed titanium according to ASTM F 136-02. The fully threaded 7.3mm Cannulated Cancelous Screw is in various lengths from 50 to 90mm in 5mm increment sizes and is also made from 6-4 alloyed titanium according to ASTM F 136-02. All titanium plates and screws are surface conditioned with a TIODIZE, Type II preparation

AI/ML Overview

The provided document is a 510(k) summary for the "FR.O.H. Calcaneus Repair System," a bone plate and cannulated cancellous bone screw system. However, this type of regulatory submission (from 2005) does not contain the detailed study information regarding acceptance criteria and performance metrics typically found for AI/ML-based devices.

This document describes a traditional medical device (implants for bone fracture fixation) and not an AI/ML-based device that would require such performance studies.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to pre-existing devices through material composition, design, and intended use, rather than through performance metrics of a device's "performance" in diagnosing or treating conditions based on data analysis.

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K Number

K021749

Device Name

EBI DYNAFIX VS OSTEOTOMY SYSTEM

Manufacturer

EBI, L.P.

Date Cleared

2002-08-12

(76 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K010551

Intended Use

The EBI® DynaFix® VS™ Osteotomy System is intended for fixation following acute corrective opening wedge osteotomies in long bone.

Device Description

The System consists of an osteotomy plate and bone screws. This submission is for the addition of plate sizes.

AI/ML Overview

This 510(k) summary describes a device called the EBI® DynaFix® VS™ Osteotomy System. This submission is for the addition of new plate sizes to an already marketed device. As such, the 510(k) focuses on demonstrating substantial equivalence to the predicate device, rather than providing a performance study with detailed acceptance criteria and reported device performance in the same way a novel device might.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria (e.g., tensile strength, fatigue life) or corresponding reported device performance for the new plate sizes. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Intended Use	The new plate sizes must have the same intended use as the predicate device.	"The EBI DynaFix VS Osteotomy System is substantially equivalent to the predicate device in regards to intended use..."
Material	The new plate sizes must be manufactured from the same material(s) as the predicate device.	"The components of the System are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136." (Same as predicate)
Function	The new plate sizes must function in a similar manner to the predicate device for fixation following acute corrective opening wedge osteotomies in long bone. This implicitly covers mechanical properties, biocompatibility, etc. at a similar performance level.	"The EBI DynaFix VS Osteotomy System is substantially equivalent to the predicate device in regards to... function."
Design Characteristics	The design of the new plate sizes should not introduce any significant differences that would raise new questions of safety or effectiveness compared to the predicate. (The key difference here is simply added sizes).	"There are no significant differences between the modified EBI DynaFix® VS™ Osteotomy System and the currently marketed System."

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

Sample Size: Not applicable in the context of this 510(k). This submission is for additional sizes of an existing device, and the method of demonstrating safety and effectiveness relies on substantial equivalence to a predicate, not a new performance study with a test set of data.
Data Provenance: Not applicable. No new clinical or performance data is presented for a "test set" in this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. As described above, there is no performance study with a test set requiring expert ground truth establishment.

4. Adjudication Method:

Not applicable. No performance study requiring adjudication is presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device (bone plate), not an AI or imaging diagnostic device where MRMC studies are typically performed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

Not applicable. No new performance data requiring ground truth is presented. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set:

Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI or machine learning model.

9. How the Ground Truth for the Training Set was Established:

Not applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) submission process itself, demonstrating substantial equivalence to a legally marketed predicate device.

Predicate Device: EBI® DynaFix® VS™ Osteotomy System (K010551)
Methodology: The submission asserts that the modified EBI DynaFix® VS™ Osteotomy System (with added plate sizes) is "substantially equivalent" to its predicate based on the following:
- Identical Intended Use: Both the current and predicate device are intended for "fixation following acute corrective opening wedge osteotomies in long bone."
- Identical Materials: Both are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.
- Similar Function and Technological Characteristics: The document explicitly states, "There are no significant differences between the modified EBI DynaFix® VS™ Osteotomy System and the currently marketed System. The EBI DynaFix VS Osteotomy System is substantially equivalent to the predicate device in regards to intended use, material, and function."
Conclusion: The FDA reviewed the submission and concurred with the claim of substantial equivalence, allowing the device to be marketed. This regulatory determination implicitly confirms that the device, with its new plate sizes, is considered as safe and effective as the predicate device.