(74 days)
The Intended Use of the Sintea Biotech Traumafix (TFX) System is to obtain a safe, nonrigid fixation, to stimulate bone re-growth. The function of the Schanz Screw is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Sintea Biotech external fixation screw is indicated for use in the external fixation of bone.
Schanz's screws are components of the Sintea Traumafix (TFX) system and were developed for external fixation according to Ilizarov's principle to treat severe articular fractures, pseudo-arthrosis and limb lengthening. The purpose of the TFX system is to obtain a safe, non-rigid fixation, to stimulate bone re-growth. The function of the Schanz's screws is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Schanz's screws are available in three different diameters (4.0, 5.0, 6.0 mm) and three different lengths (120, 150, 180 mm). They consist of round bars having a thread at one end and a square tang at the other end to allow for easy screwing. Furthermore, the threaded length may be interrupted to allow bi-cortical fixation. The special shape of the threaded extremity makes the screws self-tapping.
Here's an analysis of the provided text regarding the Sintea Biotech Traumafix System with Schanz Screw, focusing on acceptance criteria and supporting studies:
This document is a 510(k) premarket notification for a medical device (Sintea Biotech Traumafix System with Schanz Screw). For such submissions, the acceptance criteria and study data typically revolve around demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving novel clinical effectiveness through extensive human trials. Therefore, the information provided is structured differently than what one might expect for a new drug or a high-risk novel device requiring de novo authorization or a PMA.
Based on the provided text, the device's acceptance criteria and the "study" that proves it meets them are primarily focused on mechanical testing and comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for Intended Use (Overall Goal) | "Mechanical tests of the Sintea Biotech Traumafix System with Schanz Screw demonstrate that the device is safe and effective for its intended use." (General statement) |
| Substantial Equivalence to Predicate Device (Key Criterion) | The device is found substantially equivalent to the Howmedica Osteonics Corp.'s Apex Fixation Pins (K011136, K861766). This is based on similarities in: |
- Intended use and indications
- Screw component material
- External portion material
- Mode of fixation
- Form, function, components, instruments, geometry, features, and packaging
- Labeling (non-sterile, sterilization required prior to use)
"In summary, the use of OSR-based process controls, testing standards, material standards and similarities to the predicate device establish that the Sintea Biotech Traumafix System's with Schanz Screw is equivalent to Howmedica Osteonics Corp.'s Apex Fixation Pins and that it is safe and effective for its intended use." |
| Meet applicable Testing Standards (Implied by "testing standards") | "Mechanical tests... demonstrate that the device is safe and effective." (No specific standards are listed in the provided text, but it implies compliance with relevant mechanical testing standards for bone fixation devices.) |
| Material Compatibility/Safety (Implied) | "the screw components are made of the same materials" as the predicate device. "the external portion of the devices is made of the same material" as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Mechanical tests" were performed, but it does not specify the sample size for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). This is typical for 510(k) submissions focusing on bench testing rather than clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The "ground truth" for demonstrating substantial equivalence here is primarily established through direct comparison of materials, design, and performance in mechanical tests against a predicate device, not through expert review of clinical cases or images.
4. Adjudication Method for the Test Set
This information is not applicable as there is no expert review or human-in-the-loop performance measurement described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is subject to a 510(k) clearance, which primarily relies on demonstrating substantial equivalence through bench testing and comparison to a predicate, not clinical efficacy studies involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this product is a physical medical device (bone fixation system) and does not involve any algorithms or software that would have standalone performance.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" is primarily based on:
- Engineering specifications and material standards: Ensuring the device meets predefined criteria for strength, durability, and biocompatibility.
- Direct comparison to a predicate device's established characteristics: The predicate device (Howmedica Osteonics Corp.'s Apex Fixation Pins) serves as the benchmark against which the new device is found "substantially equivalent" in design, materials, and intended function.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above.
§ 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.