(57 days)
The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
The KLS Martin Recon Talon is a two-piece clamping device, which has on either end an attached plate. Plate thickness ranges from 1.0 mm to 3.0 mm and screw diameter ranges from 2.3 mm to 3.2 mm. The two-piece clamping device utilizes a ratcheted locking system. Each piece of the device is affixed to opposing sides of the sternum and interlocks to provide stabilized fixation. The device has a three position screw, allowing the ratchet to open, close, and lock. In an emergency situation the device can be reopened by turning the screw to the open position. Secondary emergency re-entry is provided by cut points adjacent to the screw.
The KLS Martin Recon Talon is a bone fixation appliance intended for stabilization and fixation of anterior chest wall fractures, including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Here's an analysis of the provided information regarding its acceptance criteria and the study proving it:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Mode | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Fatigue Testing | No device failures after 5 million cycles using 75 N. | No device failures recorded. |
| Tensile Testing | Device withstands a significant load before failure. | Maximum load at failure: 1.06 kN. |
| System Testing (Sawbones) | No device failures; failure primarily at Sawbone interface. | Transverse: 0.92 kN (Sawbone failure/pullout) |
| Longitudinal: 1.23 kN (Sawbone failure/pullout) | ||
| Lateral Shear: 1.65 kN (Sawbone failure/pullout) | ||
| Packaging & Sterilization | Conformance to ISO 11607-1, -2 and ISO 11137-1, -2 standards. | Conformance demonstrated. |
Note: The acceptance criteria are largely implied by the reporting structure of the performance testing results. For instance, for fatigue testing, "no device failures" is the explicit outcome that validates the device meets an inherent requirement for durability. Similarly, for system testing, the phrase "method of failure in all system testing was either pullout at the screw/Sawbone interface or Sawbone failure. No device failures were noted in system testing" indicates that the device itself did not fail, meeting the intended performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The wording "individual Recon Talons" for fatigue and tensile tests, and "Sawbones" for system testing, suggests multiple units/specimens were used, but the exact number isn't quantified.
- Data Provenance: The studies were conducted by KLS Martin, L.P. The type of study is prospective, laboratory-based physical testing of the device. The data is from in-vitro testing using mechanical forces and Sawbones, not from human or animal subjects, so country of origin of patient data is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" for this device is based on engineering performance specifications and objective physical measurements rather than expert interpretation of medical images or clinical outcomes. The tests evaluate the mechanical integrity and strength of the device itself.
4. Adjudication Method for the Test Set
- Not applicable. This involves objective physical testing with measurable outcomes (e.g., force at failure, number of cycles without failure), which typically does not require expert adjudication in the same way clinical data or image interpretation would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study (MRMC) is relevant for diagnostic devices that involve human interpretation of outputs (e.g., radiologists reading images with or without AI assistance). The Recon Talon is a physical orthopedic implant, and its performance is evaluated through mechanical testing, not human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, effectively. The performance testing described (fatigue, tensile, system testing) evaluates the device's inherent mechanical properties and behavior directly, without human intervention during the test itself. While humans set up and observe the tests, the performance criteria are machine-measured and objective.
7. The Type of Ground Truth Used
- The ground truth is based on engineering specifications and established mechanical testing protocols. For example, "no device failures after 5 million cycles" is the ground truth for fatigue performance. "Maximum load was 1.06 kN" is the ground truth for tensile strength. These are objective, quantitative measures of the physical device's performance.
8. The Sample Size for the Training Set
- Not applicable. The Recon Talon is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing processes are iterative but do not involve 'training' in this sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a physical medical device, the concept of a training set and its associated ground truth establishment does not apply. Performance is validated through the tests described in point 1.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.