(160 days)
The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.
The Choice Spine Cervical Interbody Spacer System implants ("spacers") have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.
This looks like a 510(k) premarket notification for a medical device called the "Choice Spine Cervical Interbody Spacer System." This document type primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the way an AI/ML device submission would.
Therefore, the information you're asking for, such as acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training data, is not typically found in this kind of 510(k) summary for a traditional implantable device.
Here's why and what can be extracted from the provided text:
- Type of Device: The Choice Spine Cervical Interbody Spacer System is an implantable medical device (an intervertebral body fusion device made of PEEK and tantalum markers). It's a physical product, not a software algorithm or an AI/ML diagnostic tool.
- Regulatory Pathway: This device went through the 510(k) premarket notification pathway. The core requirement for this pathway is to demonstrate substantial equivalence to a legally marketed predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate.
- Focus of the Document: The 510(k) summary explicitly states: "Documentation was provided that demonstrates the Choice Spine Cervical Interbody Spacer System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, material, method of stabilization, and performance." This highlights that the "performance" demonstrated is in comparison to a predicate, not against a predefined set of acceptance criteria from a de novo clinical study in the way an AI/ML device would.
Therefore, I cannot populate the table or answer most of your detailed questions because the provided text does not contain a study that establishes acceptance criteria and then proves the device meets them in the context of an AI/ML or comparative effectiveness study.
If this were an AI/ML device, the 510(k) would include a much more extensive section on clinical performance, validation, and potentially an MRMC study.
What can be extracted from the document that might be tangentially related to some of your points:
- Intended Use/Indications for Use: These act as the fundamental "criteria" the device is designed to meet, defining its purpose and patient population.
- Materials: PEEK-OPTIMA polymer and tantalum.
- Mention of "Performance": The document mentions "performance" in the context of substantial equivalence to the predicate, implying that the device's mechanical and biological performance is considered comparable. However, no specific data or metrics are provided here.
In summary, for this specific 510(k) document, the requested information about acceptance criteria and a performance study in the context of AI/ML or a comparative effectiveness trial is not available because the device and its regulatory submission pathway are different.
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510(k) Summary
Sponsor:
NOV. 2 2009
Choice Spine, LP 306 Erin Drive Knoxville, TN 37919 ph: 865.246.3333 x4 fax: 865.588.4045
Contact:
G. Todd Hawkins Director of Regulatory Affairs/Quality Assurance
Trade Name:
Choice Spine Cervical Interbody Spacer System
Common Name:
Intervertebral body (or interbody) fusion device
Classification & Name:
888.3080 - Intervertebral Fusion Device with Bone Graft, Cervical
Device Product Code:
ODP
Device Description:
The Choice Spine Cervical Interbody Spacer System implants ("spacers") have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.
Intended Use:
The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.
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510(k) Summary (continued)
Materials:
The Choice Spine Cervical Interbody Spacers are manufactured from polyetheretherketone (PEEK-OPTIMA polymer from Invibio ) as described by ASTM F2026. Integral radiopaque markers are manufactured from tantalum as described by ASTM F560.
Substantial Equivalence:
Documentation was provided that demonstrates the Choice Spine Cervical Interbody Spacer System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, material, method of stabilization, and performance.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or other bird-like figure with outstretched wings. The bird is depicted in a simple, abstract manner, with flowing lines suggesting movement and flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Choice Spine, LP % Mr. G. Todd Hawkins Director of Regulatory Affairs/QA 306 Erin Drive Knoxville, Tennessee 37919
NOV ~ 2 2009
Re: K091531
Trade/Device Name: Choice Spine Cervical Interbody Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 27, 2009 Received: October 28, 2009
Dear Mr. Hawkins:
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 -- Mr. G. Todd Hawkins
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/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,
Mark N. Milken
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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Indications for Use
510(k) Number (if known): KO9 IS3 |
Device Name: Choice Spine Cervical Interbody Spacer System
Indications for Use:
The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.
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)
Mark H. Millhiser
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K09153
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.