The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Device Description

The ACUTE Innovations® Sternal Fixation System consists of plates and accessories as well as a cerclage-based device to provide fixation for sternotomies and sternal fractures. The plate designs for the Sternal Fixation System match the general anatomy of the sternum. The components of the ACUTE Innovations® Sternal Fixation System are made of commercially pure titanium, titanium alloy or stainless steel.

AI/ML Overview

The provided text is a 510(k) summary for the ACUTE Innovations® Sternal Fixation System, a medical device for sternal fixation. It details the device's indications for use, description, and comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not describe an acceptance criteria table, device performance report, or a study (e.g., clinical, standalone, or comparative effectiveness) that would typically involve statistical analysis of a test set, expert ground truth, or MRMC studies. The "study" mentioned consists of non-clinical mechanical tests.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is the information that can be extracted or deduced, along with explanations for what cannot be found:

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

Acceptance Criteria	Reported Device Performance
Bending strength of sternum plate: Not explicitly stated as a separate acceptance criterion, but implied to be comparable to predicate devices.	Non-clinical tests included "an analysis of bending strength of the ACUTE Innovations® sternum plate." The results "demonstrate that the ACUTE® Innovations Sternal Fixation System is substantially equivalent to legally marketed predicate devices."
Tensile strength of cerclage-based device: Not explicitly stated as a separate acceptance criterion, but implied to be comparable to predicate devices.	Non-clinical tests included "tensile testing of the cerclage-based device." The results "demonstrate that the ACUTE® Innovations Sternal Fixation System is substantially equivalent to legally marketed predicate devices."
Material compatibility: Implied to be comparable to predicate devices.	"The ACUTE Innovations® Sternal Fixation System and the predicate sternal fixation systems are made of the same materials (commercially pure titanium, titanium alloy or stainless steel)."
Fixation methods: Implied to be comparable to predicate devices.	"The methods of fixation for the subject device are the same as for the predicate devices."
Screws performance: Implied to be comparable to predicate devices.	"Based on comparability to the predicate screws, no additional testing was performed on the stainless steel screws."

Explanation: The document states that the device's performance was evaluated through non-clinical tests (bending strength and tensile testing) to demonstrate substantial equivalence to predicate devices. However, it does not explicitly list specific numerical acceptance criteria for these tests nor provide quantitative performance results. The acceptance criterion is generally framed as "substantially equivalent" to the predicate devices.

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: Not applicable. The "tests" mentioned are non-clinical mechanical tests on the device components, not tests involving patient data or a "test set" in the context of AI/diagnostic device evaluation.
Data provenance: Not applicable. These were laboratory mechanical tests.

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. As this was a non-clinical device for physical fixation, no human experts were used to establish ground truth in the context of interpretation of images or patient outcomes.

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

Not applicable. There was no clinical or interpretive test set requiring adjudication.

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

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, which is not the case for a sternal fixation system.

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

Not applicable. This device is a physical implant, not a standalone algorithm or a device requiring human-in-the-loop performance evaluation in the context of AI or diagnostic imaging. The "standalone" performance here refers to the device's physical and mechanical properties tested in a lab setting.

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

Ground Truth Type: For the non-clinical tests, the "ground truth" was established by engineering standards and direct measurement of physical properties (bending strength, tensile strength) to compare against the known properties or performance of predicate devices. The concept of "expert consensus," "pathology," or "outcomes data" for ground truth is not applicable here as it refers to a physical, non-diagnostic device.

8. The sample size for the training set

Not applicable. The device is a physical implant, not an AI or machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device.

Summary

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510(k) Summary

Manufacturer:	ACUTE Innovations, LLC21421 NW Jacobson Road, Suite 700Hillsboro OR, 20005503.686.7200	SEP 17 2010
Device Trade Name:	ACUTE Innovations Sternal Fixation System
Contact:	Ms. Mariah KnightRegulatory Representative
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Classifications:	21 CFR 888.3030, Single/multiple component metallicbone fixation appliances and accessoriesand21 CFR 888.3010, Bone fixation cerclage
Class:	II
Product Codes:	KTT, IDO, and HWC

Indications For Use:

Device Description:

Predicate Devices:

Comparative information presented in the 510(k) supports the substantial equivalence of the ACUTE® Innovations Sternal Fixation System with respect to its indications for use, design, materials, and function.

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This 510(k) demonstrates the substantial equivalence of the ACUTE Innovations® Sternal Fixation System to the following predicate devices: Acumed Cerclage Crimp Sleeve (K931246); KLS-Martin Sternal Plating System (K032413); Lorenz Sternal Closure System with Modular Screw (K011076); Synthes Sternal Reconstruction System (K052683, K031508).

The geometry of the subject plates matches that of the sternum and predicate sternal plates. The cerclage-based device has the same crimping mechanism as one of the predicate devices. The ACUTE Innovations® Sternal Fixation System and the predicate sternal fixation systems are made of the same materials. The methods of fixation for the subject device are the same as for the predicate devices. The non-clinical tests performed by the company included: an analysis of bending strength of the ACUTE Innovations® sternum plate and tensile testing of the cerclage-based device. Based on comparability to the predicate screws, no additional testing was performed on the stainless steel screws. The results of the performed tests demonstrate that the ACUTE® Innovations Sternal Fixation System is substantially equivalent to legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Public Health Service

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

ACUTE Innovations, LLC % Ms. Mariah Knight Regulatory Representative 21421 NW Jacobson Road, Suite 700 Hillsboro, Oregon 20005

SEP 1 7 2010

Re: K101170

Trade/Device Name: ACUTE Innovations® Sternal Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, JDQ, HWC Dated: August 2, 2010

Received: August 4, 2010

Dear Ms. Knight:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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); medical device reporting (reporting of medical

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Page 2 - Ms. Mariah Knight

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Mikkelson

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

Enclosure

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4. Indications for Use

K101170

SEP 1 7 2010

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ACUTE Innovations® Sternal Fixation System

The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following starnony and sternal reconstructive surgical procedures.

Prescription Use V (Part 29 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (29 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jutta for mxm
(Division Sign)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101170

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.