Search Results

The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.

The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.

Gruber Lapidus

The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity.

Plantar Lapidus

The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis.

Tarsalis

The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.

The RECON system – Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:

• Gruber Lapidus Plates 2.7, .
• . Plantar Lapidus Plates 2.7,
• Tarsalis Plates 2.7, ●
• Locking Screws 2.7 ●
• Standard Screws 2.7
• Minican Screws 2.7/3.5

of different sizes and designs.

The plates and screws are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.

This document describes a 510(k) premarket notification for the RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics. Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and detailed ground truth establishment) are not applicable to this type of regulatory submission.

However, based on the provided text, here's an attempt to address your request:

Acceptance Criteria and Study for the RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a standalone performance study with predefined clinical acceptance criteria, the "acceptance criteria" are implied by the performance characteristics demonstrated to be "similar" or "substantially equivalent" to legally marketed predicate devices. The "reported device performance" is characterized by meeting these similarity benchmarks.

The non-clinical performance data aimed to demonstrate that the subject device's mechanical properties and biocompatibility are comparable to those of the predicate devices, thereby ensuring similar safety and effectiveness.

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

This is a non-clinical (bench) testing study, not a clinical trial. Therefore, the concept of a "test set" for clinical performance, with associated data provenance, is not applicable. The non-clinical tests involved physical samples of the devices. The document does not specify the exact number of physical samples used for each mechanical test. Data provenance is internal to Normed Medizin-Technik GmbH in Germany, as described in the "Submission Sponsor and Correspondent" section. The data is prospective, generated specifically for this submission.

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

Not applicable. Ground truth for non-clinical engineering tests is established by standardized testing methods and measurement instruments, not by expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as it's a non-clinical bench testing study.

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

No, a MRMC comparative effectiveness study was not done. This device is not an AI/software device that would typically undergo such a study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (plates and screws), not an algorithm or AI.

7. Type of Ground Truth Used

For non-clinical performance, the "ground truth" is defined by the physical properties of the materials and designs, measured through standardized mechanical tests. For biocompatibility, it's adherence to international standards (ISO 10993-1).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device