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.

AI/ML Overview

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.

Summary

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Company Name, Address and Contacts

Praesidia, S.r.l. Via del Lapidari, 19 Bologna 40129 Italy Telephone: 39 51 321238 Contact Person: Piero Malobbia

DEC 2 7 2006

Application Correspondent

Sternal Closure Systems Medical Products, Inc. 1083 Delaware Avenue Buffalo, NY 14209 Telephone:

Establishment Registration Number: Not applicable

Device Information

Proprietary Name:	Flexigrip Sternal Closure System
Common Name:	Cerclage bone fixation
Classification Name:	Bone fixation, cerclage
Classification Panel:	Orthopedic
Classification:	21CFR888.301087JDQ
Class:	II
Substantial Equivalence:	Pioneer Surgical Technology, Cerclage cable with hex button, K974016Synthes (USA), Synthes sterile sternal fixation system, K050041Kinamed Inc., Iso-Elastic Cerclage System, K030256Metagen, Activelock Wire Cerclage System, K983976Standard sternal wires, 510(k) not applicable due to preamendment status

Device Description

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surgical instruments are also supplied to allow for proper sizing and placement of the clip around the sternum.

Intended Use

The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after sternotomy, fracture or dehiscence.

Characteristic	Flexigrip	Activelock	Iso-Elastic	Synthes	Pioneer	SurgicalWire
Material(s)	Nitinol	CoCr &Nitinol	Polymericwith metalclamp	Titanium&TiAlNbAlloy	StainlessSteel(can besilvercoated)	Stainlesssteel
Full Cerclage	No	Yes	Yes	No	Yes	Yes
Special Tools	Yes	Yes	Yes	Yes	Yes	No
Configuration	Solid wire	Solid wireand clamp	Polymericcable andmetalclamp	Plate andscrewsystem	Braidedwirecablewithmetalcrimp	Braidedwire
Clamp Method	NA	Specialclamp	Specialclamp	NA	Crimp	Twisted
SternalClosure Only	Yes	No	No	Yes	Yes	No

Summary of Technological Characteristics

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Praesidia, S.r.l. % Sternal Closure Systems Medical Products, Inc. Mr. George Haar General Manager 1083 Delaware Avenue Buffalo, New York 14209

DEC 2 7 2006

Re: K063009

Trade/Device Name: Flexigrip Sternal Closure System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ, HRS Dated: September 29, 2006 Received: October 3, 2006

Dear Mr. Haar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. George Haar

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Raubara Buehmp

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K063009

Device Name:

Flexigrip Sternal Closure System

Indications For Use:

The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after strenotomy, fracture or dehiscence.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bucknum

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Page 1 of

Regulation Number and Section

§ 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.