ABBOTT SPINE UNIVERSAL CLAMP SYSTEM by ABBOTT SPINE, INC.

The Universal Clamp System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications:

Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions;
The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

Device Description

The Universal Clamp System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

AI/ML Overview

This looks like a 510K submission document used to obtain FDA clearance for a medical device. These documents generally focus on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical study with acceptance criteria and detailed performance metrics as would be found in a PMA (Pre-Market Approval) application.

Therefore, the provided text does not contain the acceptance criteria or a detailed studyproving the device meets acceptance criteria in the way a clinical trial report would. The document focuses on demonstrating that the Abbott Spine Universal Clamp System is substantially equivalent to the CFix Cable System (K974020) through engineering evaluations and bench testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

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

Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical or performance study. The "acceptance criteria" here is implicitly "demonstrate substantial equivalence to the predicate device."
Reported Device Performance: The document states: "Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Universal Clamp System is substantially equivalent to the CFix Cable system."
- Comment: The specific results of these "engineering evaluations and bench testing" (e.g., tensile strength, fatigue life, material compatibility) are not provided in this summary. Therefore, a table of acceptance criteria and specific performance values cannot be constructed from this text.

Remaining Information Categories (2-9):

The following information points are typically found in detailed clinical study reports or significant clinical trials. This 510(k) summary focuses on substantial equivalence based on bench testing, not on human clinical outcomes or the kind of performance metrics implied by these questions. Consequently, most of these details are not available in the provided text.

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

Not available. The document refers to "engineering evaluations and bench testing," which implies tests on device units, not human subjects. The sample size for these bench tests (e.g., how many clamps were tested for their physical properties) is not specified. Data provenance is not applicable in the context of bench testing described here.

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/Not available. This type of information is relevant for studies involving human interpretation (e.g., image analysis by radiologists). For engineering evaluations and bench testing of physical properties, ground truth is established by standardized testing methods and measurements, not expert consensus in this context.

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

Not applicable/Not available. Adjudication methods are used in clinical studies where expert opinions (e.g., diagnosis, outcome assessment) need to be resolved. This is not relevant for physical property bench testing.

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/Not available. This is a medical device, specifically a surgical implant, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this device.

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

Not applicable/Not available. As mentioned, this is a physical medical implant, not an algorithm or AI system.

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

For bench testing: The "ground truth" would be established by the physical and mechanical properties measured according to recognized standards (e.g., ASTM, ISO). For example, the breaking strength of a clamp measured on a testing machine. Specific details are not provided.
Not available for clinical outcomes: There is no mention of clinical outcomes data in this summary.

8. The sample size for the training set

Not applicable/Not available. This concept relates to machine learning models. For a physical device, there isn't a "training set" in this sense. If referring to product development, it would be R&D testing, but "training set" is not the correct terminology.

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

Not applicable/Not available. See point 8.

In summary:

This document is a 510(k) summary, which aims to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device. The primary evidence presented for this equivalence comes from "engineering evaluations and bench testing" of the physical and mechanical properties of the device. It explicitly states that these results "demonstrate that the performance... is substantially equivalent to the CFix Cable system." However, the specific details, raw data, acceptance criteria, and methodologies of these tests are not included in this summary document. It does not describe a clinical study with human subjects, nor does it provide the detailed performance metrics or "acceptance criteria" that would be associated with such a study.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings outstretched. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abbott Spine, Inc % Ms. Maritza Elias Senior Regulatory Affairs Specialist 5301 Riata Park Court, Building F Austin, Texas 78727

Re: K060009

Trade/Device Name: Abbott Spine Universal Clamp System Regulation Number: 21 CFR 888.3010 Regulation Names: Bone fixation cerclage. Regulatory Class: II Product Code: JDQ Dated: February 17, 2006 Received: February 18, 2006

Dear Ms. Elias:

This letter corrects our substantially equivalent letter of March 06, 2006.

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. Drue. 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 - Ms. Maritza Elias

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

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): K060009

Device Name:

Abbott Spine Universal Clamp System

Indications for Use:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques:
1. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis:
1. Spinal degenerative surgery, as an adjunct to spinal fusions;

The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

Mark M. Milless

abuir aurologic

510(k) Number

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)

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ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:

Abbott Spine Inc.

October 03, 2008

JDQ

Universal Clamp® System

Bone Fixation Cerclage

21 CFR § 888.3010

Establishment Registration Number:

Contact Person:

1649384

Maritza Elias Senior Regulatory Affairs Specialist Telephone: 512.533.1908 Fax: 512.918.2784

Trade Name:

Date:

Product Code:

CLASSIFICATION NAME:

CLASSIFICATION REFERENCE:

Predicate Device:

Device Description:

INDICATIONS:

CFix Cable System (K974020)

The Universal Clamp System is a temporary implant for use in orthopedic surgerv. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

Spinal reconstructive surgery, incorporated into constructs for the purpose of correction

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of spinal deformities such as scoliosis, kyphosis, spondylolisthesis;

Spinal degenerative surgery, as an adjunct to spinal fusions;

The Universal Clamp System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Universal Clamp System is substantially equivalent to the CFix Cable system.

SUBSTANTIAL EQUIVALENCE:

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.