(76 days)
The ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The ExsoMed INnate Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The INnate system screws are cannulated and feature a headless design that allows for the screw to be countersunk below the surface of the bone. The system is provided sterile. The subject of this submission is the addition of a Ø3.6mm version of the INnate screw to the system to be offered in lengths of 25 to 55mm.
This document is a 510(k) summary for the ExsoMed INnate Cannulated Screw System, which is a line expansion to a previously cleared device. Therefore, it is exempt from needing to provide comprehensive study information typically found in submissions for novel devices or software. The information provided focuses on demonstrating substantial equivalence to a predicate device through performance testing.
Here's the breakdown of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Driving Torque (to ensure proper insertion) | Met predetermined acceptance criteria through functionality testing. |
| Torque to Failure (to assess strength/integrity) | Met predetermined acceptance criteria through functionality testing. |
| Torsional Strength (Engineering Calculations) | Met predetermined acceptance criteria through engineering calculations. |
| Bending Strength (Engineering Calculations) | Met predetermined acceptance criteria through engineering calculations. |
| Pullout Resistance (Engineering Calculations) | Met predetermined acceptance criteria through engineering calculations. |
| Simulated Use (to validate user needs) | Met predetermined acceptance criteria through simulated use testing, demonstrating the device performs as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test (e.g., number of screws tested for driving torque, torque to failure). It broadly states that "functionality testing" and "simulated use testing" were performed.
Data Provenance: The tests were conducted by ExsoMed Corporation, the device manufacturer. No information on country of origin of data is provided beyond the manufacturer's location in Phoenix, Arizona, USA. The testing would be considered prospective, as it was performed specifically for this submission to demonstrate equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the submission is for a medical device (screws for bone fixation), not an AI/Software as a Medical Device (SaMD) that relies on expert interpretation for ground truth. The "ground truth" for these tests comes from objective mechanical measurements and engineering calculations.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons outlined in point 3. Mechanical tests and engineering calculations do not involve expert adjudication in the same way clinical or image-based studies do.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging or diagnostic devices where human readers interpret results, and the study aims to assess the impact of AI assistance on their performance. The INnate Cannulated Screw System is a physical implant, not a diagnostic tool requiring human interpretation.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
This section is not applicable as the device is a physical implant and does not involve an algorithm or AI.
7. Type of Ground Truth Used
The ground truth used for performance testing was based on objective mechanical measurements (e.g., force, torque values) and engineering principles/calculations (e.g., for torsional strength, bending strength, pullout resistance). The criteria for each test would have been established based on industry standards, predicate device performance, and biomechanical requirements for bone fixation.
8. Sample Size for the Training Set
This section is not applicable as there is no "training set" in the context of a physical medical device like cannulated screws. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.