The Device for Sternal Synthesis is a surgical implant that is available in two sizes manufactured of unalloyed titanium sheet. It is applied to the anterior surface of the sternum and inferior surfaces of the adjacent ribs on both the left and right sides of the sternum. It is circumferentially secured with monofilament surgical steel sutures.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the "Device for Sternal Synthesis (DSS)," and includes information on its performance testing. However, it does not contain detailed acceptance criteria or a comprehensive study report with all the requested information for a device that relies on complex metrics like accuracy, sensitivity, or specificity, which are typical for diagnostic or AI-driven devices.

The DSS is a surgical implant designed for sternal closure, and its performance is evaluated based on mechanical stability and clinical outcomes related to sternal dehiscence. Therefore, many of the requested categories (like number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device and its evaluation process as described.

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Stability:
* Sufficient load to breakage for sternal repair.	"Demonstrated a significant difference in load to breakage... of reinforced and unreinforced sternal repairs." (Implied: DSS significantly improves load to breakage compared to unreinforced repairs).
* Minimal lateral displacement of sternal repair.	"Demonstrated a significant difference in... lateral displacement of reinforced and unreinforced sternal repairs." (Implied: DSS significantly reduces lateral displacement compared to unreinforced repairs).
Clinical Efficacy/Safety:
* Low incidence of intraoperative complications.	"Revealed no intraoperative complications related to the DSS."
* Low incidence of postoperative sternal dehiscence (compared	"A low incidence of postoperative sternal dehiscence typical of the post-operative course for patients with identified risk factors." (Implied: The incidence is not worse than expected for this high-risk patient population and comparable to standard care for similar risk factors, suggesting acceptable device performance in preventing dehiscence in a challenging patient group).
to typical rates for high-risk patients).

Note: The acceptance criteria are largely implied based on the performance testing descriptions, as explicit numerical thresholds are not provided in this summary. The goal for this type of device is typically to demonstrate improvement over traditional methods or at least non-inferiority/acceptable performance in a relevant clinical context.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set (Clinical Study): 45 patients undergoing cardiothoracic surgery with sternotomy who were at high risk for sternal wound complications.
Data Provenance:
- Country of Origin: Not explicitly stated, but the submitter is Sic Brevetti s.r.l. based in Rome, Italy. It's reasonable to infer the clinical study might have been conducted in Italy or Europe unless stated otherwise.
- Retrospective or Prospective: "Published data on testing of the Device for Sternal Synthesis in 45 patients... revealed..." The phrasing "published data on testing" suggests a retrospective analysis of previously collected clinical data, but it doesn't explicitly state whether the original data collection was prospective or retrospective. For regulatory purposes, the study design would have been rigorously defined.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: For this type of orthopedic surgical device, "ground truth" as typically defined for diagnostic AI (e.g., expert consensus on image interpretation) is not relevant. Clinical outcomes (complications, dehiscence) are observed and recorded by medical staff (surgeons, nurses, etc.) based on objective clinical signs and diagnostic findings, not by a panel of experts establishing ground truth in an interpretive sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: As above, adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., for image-based diagnoses). Clinical outcomes for a surgical device are typically recorded as observed events and diagnoses, not requiring such adjudication among expert interpreters.

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 is an implantable surgical device, not an AI-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study and effects on human readers with/without AI assistance are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: The device is a physical implant, not an algorithm. Standalone performance as an algorithm is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Mechanical Testing: The ground truth for the mechanical testing (load to breakage, lateral displacement) would be objective measurements obtained via standardized engineering tests on the artificial sternal model.
Clinical Study: The "ground truth" for the clinical part refers to observed clinical outcomes, specifically:
- Absence/presence of intraoperative complications.
- Absence/presence of postoperative sternal dehiscence.
  These are observed and documented clinical events, which could be confirmed through various clinical assessments, imaging, or re-interventions.

8. The sample size for the training set

Not Applicable: This device is not an AI algorithm, so there is no "training set" in the computational learning sense.

9. How the ground truth for the training set was established

Not Applicable: As above, there is no training set for this type of device.

Summary

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K090686 '/

510(k) Summary Sic Brevetti s.r.l., Device for Sternal Synthesis (per 21CFR 807.92)

SUBMITTER/510(K) HOLDER 1.

DEC - 8 2009

Sic Brevetti s.r.l. Via Concesio, 325 00188 Rome Italy

Contact Person: Gianfranco Panattoni, CEO Telephone: 39.06.336.7948

Date Prepared: March 13, 2009

2. DEVICE NAME

Proprietary Name: Device for Sternal Synthesis Common/Usual Name: Sternal fixation device Classification Name: Bone fixation cerclage, Accessory to suture, nonabsorbable, steel, monofilament and multifilament, sterile

3. PREDICATE DEVICES

SternumFix Sternal Closure System (K063017)
. Flexigrip Sternal Closure System (K063009)
. Ethicon Stainless Steel Suture (K931271 and K946173)
. SuturTek Stainless Steel Suture (K063603)

DEVICE DESCRIPTION 4.

INTENDED USE న్.

The Device for Sternal Synthesis is indicated for closure and repair of the sternum after sternotomy to stabilize the sternum and promote fusion.

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K090686$\frac{2}{2}$

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

A claim of substantial equivalence is based on intended use, indications for use, design, materials, technological, and operational characteristics.

PERFORMANCE TESTING 7.

Performance testing of the Device for Sternal Synthesis was performed in an artificial sternal model and demonstrated a significant difference in load to breakage and lateral displacement of reinforced and unreinforced sternal repairs.

Published data on testing of the Device for Sternal Synthesis in 45 patients undergoing cardiothoracic surgery with sternotomy who were at high risk for sternal wound complications revealed no intraoperative complications related to the DSS and a low incidence of postoperative sternal dehiscence typical of the post-operative course for patients with identified risk factors.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Sic Brevetti S.r.l. % Medical Device Consultants, Inc. % Ms. Rosina Robinson 49 Plain Street North Attleboro, MA 02760

DEC - 8 2009

Re: K090686

Trade/Device Name: Device for Sternal Synthesis (DSS) Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: November 11, 2009 Received: November 12, 2009

Dear Ms. Robinson:

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. Isting 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 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 mav 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Ms. Rosina Robinson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jonetu Jo

Mark N. Melkerson 100 Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 长090686

Sic Brevetti s.r.l., Device for Sternal Synthesis (DSS) Device Name:

Indications for Use:

The Device for Sternal Synthesis is indicated for closure and repair of the sternum after sternotomy to stabilize the sternum and promote fusion.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Smita for mxm

Division Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090686

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Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.