The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.

The Acumed Rib Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the rib.

Device Description

The Acumed Rib Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All nlates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Acumed Rib Congruent Bone Plate System) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance criteria. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving performance cannot be extracted directly from this document.

However, I can extract what is implied and stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Biocompatibility (via material conformance)	Made from titanium in conformance with ASTM F67 and ASTM F136.
Mechanical integrity (via material conformance)	Made from titanium in conformance with ASTM F67 and ASTM F136.
Equivalent intended use to predicate devices	Intended use for fixation during fractures, fusions, and osteotomies for the rib is similar to predicate devices and "do not raise new issues of safety and effectiveness."
Similar technological characteristics to predicate devices	Plates made of Titanium per ASTM F136, similar to predicate devices which use Titanium per ASTM F67 and ASTM F136.
Substantial equivalence to predicate devices	Stated as substantially equivalent based on similarities.

Explanation: The acceptance criteria are "implied" because the 510(k) process for this type of device often relies on demonstrating substantial equivalence to legally marketed predicate devices. This means that if the materials, intended use, and technological characteristics are similar enough and meet recognized standards (like ASTM), the device is presumed to meet the safety and effectiveness criteria already established for the predicate devices. No specific quantitative performance metrics or thresholds are explicitly stated as "acceptance criteria" in this document.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. The document explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This indicates that no specific test set of data was used to demonstrate performance against explicit criteria in this submission.
Data Provenance: Not applicable for the reasons above.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as no specific test set with ground truth was used for evaluation of this device in this submission.

4. Adjudication Method for the Test Set:

Not applicable, as no specific test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This type of study would fall under clinical or performance data.

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

No. This device is a bone plate system, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI is not applicable.

7. The Type of Ground Truth Used:

Not applicable, as no specific test set with ground truth was used for evaluation of this device in this submission. The "ground truth" for this submission is essentially the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a bone plate system, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

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

In summary: This 510(k) submission is based on demonstrating substantial equivalence to previously cleared devices by comparing device characteristics (materials, intended use, technological features). It explicitly states that performance data, clinical trials, and non-clinical tests are "not applicable" for this specific submission to clear the device. Therefore, the detailed study information you've requested beyond the comparison to predicate devices is not present in this document.

Summary

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Ko51410

JUL 2 1 2005

구로 디

5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432

Tel (503) 627-9957

510(k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter Information:	Acumed LLC5885 N.W. Cornelius Pass RoadHillsboro, OR 97124-9432USAPhone: (503) 627-9957FAX: (503) 686-7102Contact: Ed Boehmer, Regulatory & Documentation Supervisor
Classification Name:	Single/multiple Component Metallic Bone Fixation Appliances andAccessories
Common Name:	Plate, Fixation, Bone
Proprietary Name:	Acumed Rib Congruent Bone Plate System
Proposed Regulatory Class:	Class II, 21 CFR 888.3030
Device Product Code:	HRS
Legally Marketed Equivalent Device(s):	Acumed LLC Congruent Bone Plate System K012655KLS-Martin Sternal Plating System K032413MacroPore OS Trauma K024169

Device Description: The Acumed Rib Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All nlates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.

Intended Use: The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.

These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.

Technological Characteristics: The Acumed Rib Congruent Bone Plate System plates are made out of Titanium as per ASTM F136. The predicates devices listed use Titanium as per ASTM F67 and ASTM F136.

An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.

Based upon the similarities of the Acumed Rib Congruent Bone Plate System and the predicate devices studied, the safety and effectiveness of the Acumed Rib Congruent Bone Plate System is substantially equivalent to the predicate devices referenced.

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" encircling the eagle. The text is arranged in a circular fashion around the eagle, with the words "DEPARTMENT OF HEALTH" at the bottom and "SERVICES. USA" at the top.

JUL 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ed Boehmer Regulatory & Documentation Supervisor Acumed, LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432

Re: K051410

Trade/Device Name: Acumed Rib Congruent Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 20, 2005 Received: May 31, 2005

Dear Mr. Boehmer:

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

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Page 2 - Mr. Ed Boehmer

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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Brown

Miriam C. Provost, Ph.D. Acting 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):

Device Name: Acumed Rib Congruent Bone Plate System

Indications For Use:

;

The Acumed Rib Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the rib.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

. Fion Sign-Off) Asion of General. Restorative J Neurological Devices

K051410

Page 1 of 1

Acumed LLC Page 61

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.