(490 days)
The KLS-Martin Sternal 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 Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw. The KLS Martin Sternal Talon is manufactured from TI-6AL-4V Titanium Alloy
Here's an analysis of the provided text regarding the KLS Martin Sternal Talon, focusing on the acceptance criteria and supporting study information.
It's important to note that the provided documents (a 510(k) summary and FDA clearance letter) are for a medical device (implant), not a software algorithm or AI model. Therefore, many of the typical questions for AI performance studies (like sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance) are not applicable here. The "acceptance criteria" for a medical device involve demonstrating substantial equivalence to a predicate device through engineering tests and material properties, rather than diagnostic accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (Summary) |
|---|---|---|
| Material Properties | Made from TI-6AL-4V Titanium Alloy (biocompatibility and strength) | Confirmed Ti-6Al-4V Titanium Alloy. (Implied acceptability based on predicate device materials) |
| Intended Use | Stabilization and fixation of anterior chest wall fractures, including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures. | Device mechanism (two-piece clamping, ratcheted locking, curved foot plates) designed to achieve this intended use. Deemed substantially equivalent to predicate devices for this use. |
| Functionality | - Two-piece clamping device with various foot depths and lengths. |
- Utilizes a ratcheted locking system.
- Three-position screw (open, close, lock).
- Emergency re-entry (turning screw to open, cut points).
- Interlocking design for stabilized fixation. | Device description confirms these features. (Implied successful functioning based on substantial equivalence) |
| Biocompatibility | (Not explicitly stated as a test in the summary, but implied by material choice and predicate comparison) | Usage of Ti-6Al-4V Titanium Alloy, a commonly accepted biocompatible material for implants. |
| Mechanical Strength/Fixation | (Not explicitly detailed as a specific test in the summary, but implied necessity for sternal fixation) | Designed to "interlock providing a stabilized fixation" and "apply pressure medially to ensure fixation." Substantial equivalence to predicate suggests comparable mechanical performance. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the submission is for a medical device (implant), not a diagnostic algorithm. There is no "test set" in the context of an AI performance study. The evaluation is based on material properties, design, and comparison to legally marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for a medical device like this is established through engineering principles, material science, and regulatory standards, not by expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" requiring adjudication in this type of submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI or diagnostic algorithm, so no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this medical device submission is centered around:
- Substantial Equivalence: The primary ground truth is the demonstration that the KLS Martin Sternal Talon is "substantially equivalent" in intended use, indications for use, technological characteristics, and safety/effectiveness to existing, legally marketed predicate devices (e.g., Ethi-Pack Surgical Stainless Steel Suture, Pioneer Silicoat Sternal Cable, PectoFix DSF System, Synthes Sternal Fixation System, Sternal Band, Lorenz Sternal Closure System, KLS Martin Sternal Plating System).
- Material Science and Engineering Principles: The use of Ti-6Al-4V Titanium Alloy is a fundamental "ground truth" for biocompatibility and mechanical strength in implantable devices.
- Regulatory Standards: Compliance with relevant FDA regulations for Class II devices (21 CFR 888.3030) implies adherence to established safety and performance benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of medical device submission.
§ 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.