(86 days)
The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after sternotomy, fracture or dehiscence.
The device consists of a specially shaped clip made of shape memory metal alloy, Nitinol, which is malleable at 10°C and returns to its original shape and stiffness at 27°C. The clip is open on one side and is expanded when cold, placed around the sternum, and returns to shape when warm clamping the sternum together. It is made in a series of 9 sizes from 20 to 40 mm across and 11 to 14 mm deep. The material conforms to the ASTM F2063-05 standard for shape memory alloys and is supplied sterile. Appropriate surgical instruments are also supplied to allow for proper sizing and placement of the clip around the sternum.
The Flexigrip Sternal Closure System operates in generally the same manner as stainless steel sutures or any of the listed predicate devices in that it holds the surfaces of the surgically split sternum together after open chest surgery allowing the sternum to heal. Nitinol has a long history of successful implantation in orthopedic and cardiovascular applications dating back to the mid-1970's. The major difference between this device and the predicate devices is that this device does not completely encircle the sternum.
The provided text is a 510(k) premarket notification for a medical device called the Flexigrip Sternal Closure System. It is focused on demonstrating substantial equivalence to predicate devices, rather than providing detailed acceptance criteria and a study report with specific performance metrics as requested. Therefore, much of the requested information is not available in the given document.
Here's an attempt to extract and infer what's available and an explanation of what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or provide specific performance metrics in a quantitative manner as typically found in a clinical study report. The substantial equivalence argument relies on comparing the device's characteristics and intended use to existing predicate devices.
| Acceptance Criterion | Device Performance (Flexigrip Sternal Closure System) |
|---|---|
| Material conformance to standard | Nitinol material conforms to ASTM F2063-05 standard for shape memory alloys. |
| Sterility | Supplied sterile. |
| Functionality in sternal closure | Operates in generally the same manner as stainless steel sutures or predicate devices by holding surgically split sternum surfaces together. |
| Biocompatibility | Nitinol has a long history of successful implantation in orthopedic and cardiovascular applications dating back to the mid-1970's. |
| Intended Use | Intended for use in closure or repair of the sternum after sternotomy, fracture, or dehiscence (matches predicate devices by implication). |
| Configuration | Specially shaped clip, open on one side, expands when cold, returns to shape when warm, clamping sternum. |
| Sizes available | Series of 9 sizes from 20 to 40 mm across and 11 to 14 mm deep. |
2. Sample size used for the test set and the data provenance
No specific test set or clinical study with a defined sample size is described for the Flexigrip Sternal Closure System. The document focuses on demonstrating substantial equivalence based on material properties, design, and intended use compared 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. No ground truth establishment for a specific test set is described or required for this type of 510(k) submission based on substantial equivalence to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is mentioned as there is no specific clinical test set described.
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 a surgical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The ground truth concept as typically applied to diagnostic AI models is not relevant here. The "proof" for this device's acceptance is its substantial equivalence to predicate devices, which are already deemed safe and effective based on prior market authorization and clinical experience. The "truth" in this context is the established safety and efficacy of similar devices made from comparable materials for the same intended use.
8. The sample size for the training set
Not applicable. The device is not an AI model, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
Summary of the Study (Implied by the 510(k) Process):
The "study" in this context is a bench and literature review demonstrating substantial equivalence. The manufacturer, Praesidia, S.r.l., submitted a 510(k) premarket notification to the FDA to demonstrate that their Flexigrip Sternal Closure System is as safe and effective as existing legally marketed predicate devices.
Key elements of this "study" as presented:
- Comparison to Predicate Devices: The document explicitly lists five predicate devices: Pioneer Surgical Technology, Synthes (USA), Kinamed Inc., Metagen, and Standard sternal wires. A table compares key characteristics like material, cerclage type, special tools, configuration, clamp method, and primary use.
- Material Equivalence and History: The device utilizes Nitinol, a shape memory metal alloy. The submission highlights that Nitinol conforms to ASTM F2063-05 and has a "long history of successful implantation in orthopedic and cardiovascular applications dating back to the mid-1970's." This substitutes for novel clinical data by leveraging existing knowledge and performance of the material.
- Mechanism of Action Equivalence: The document states the Flexigrip "operates in generally the same manner as stainless steel sutures or any of the listed predicate devices in that it holds the surfaces of the surgically split sternum together after open chest surgery allowing the sternum to heal."
- Intended Use Equivalence: The stated "Indications for Use" for the Flexigrip Sternal Closure System are "closure or repair of the sternum after sternotomy, fracture or dehiscence," which aligns with the established uses of the predicate devices.
- Device Description: A detailed description of the device's design, material properties (malleable at 10°C, returns to shape at 27°C), sizes, and sterility are provided to demonstrate its characteristics.
Conclusion based on the document:
The FDA's decision to clear the device (K063009) on December 27, 2006, indicates that they agreed with the manufacturer's assessment that the Flexigrip Sternal Closure System is substantially equivalent to the identified predicate devices, based on the information provided regarding its materials, design, intended use, and functional principles. This substantial equivalence determination means a full clinical trial for novel device performance was not deemed necessary by the FDA.
§ 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.