(230 days)
The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
The PERIMETER® Interbody Fusion Device consists of cages which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental instrumentation. This device is offered in both titanium alloy and PEEK (POLYETHERETHERKETONE) versions. This interbody device is provided in both sterile and non-sterile forms. Refer to the package label for sterility information. The subject PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height and between 19mm and 28mm in width. The device is designed with teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance.
The provided text is a 510(k) summary for the PERIMETER® Interbody Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing and literature review. It does not contain information about clinical studies with human participants, AI algorithms, or detailed performance metrics that would typically be found in an acceptance criteria and study section for a medical device with an AI component.
Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's what I can infer from the document and how it relates to the requested information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices. This is demonstrated through mechanical testing results and published literature, which would compare the PERIMETER® device's mechanical properties (e.g., strength, stiffness, resistance to expulsion) to those of the predicate devices. The document does not explicitly state numerical acceptance criteria, but rather implies they would be "comparable" or "equivalent" to the predicate devices.
- Reported Device Performance: The document states "Documentation, including mechanical test results and published literature, was provided which demonstrated that the subject PERIMETER® Interbody Fusion Device is substantially equivalent to several recently down classified interbody cages..." This indicates that performance was evaluated mechanically, but the specific numerical results or metrics are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document refers to mechanical test results, not clinical test sets with human data. Therefore, there is no information on human sample sizes, data provenance, or retrospective/prospective study design in this submission. Mechanical testing typically involves a set number of devices tested under specific conditions.
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):
- This information is not applicable as the submission is based on mechanical testing and comparison to predicate devices, not human-read interpretations or ground truth established by medical experts for a diagnostic or AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as this is related to human interpretation of data, which is not the focus of this 510(k) summary.
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, this document does not mention any MRMC study, AI, or human-in-the-loop performance. It pre-dates widespread AI integration in medical devices and focuses on the physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, there is no mention of any algorithm or standalone performance being evaluated.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" here would be the mechanical properties and performance specifications of the predicate devices, against which the PERIMETER® device was compared. The exact tests and their respective "ground truth" values (e.g., maximum load at failure, subsidence measurements) are not detailed but are implied to be part of the documentation submitted to the FDA.
8. The sample size for the training set:
- Not applicable. This is not an AI-based device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
In summary, this 510(k) summary for the PERIMETER® Interbody Fusion Device pertains to a physical medical implant and demonstrates substantial equivalence through mechanical testing and literature review, not through clinical trials or studies involving AI algorithms. Therefore, most of the requested information regarding AI device performance metrics, human reader studies, and ground truth establishment for diagnostic purposes is not present in the provided text.
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PERIMETER® Interbody Fusion Device 510(k) Summary February 2009
| Company: | Medtronic Sofamor Danek |
|---|---|
| 1800 Pyramid Place | |
| Memphis, TN 38132 | |
| (901) 396-3133 |
SEP & 8 2009
Lee Grant Contact: Principal, Regulatory Affairs
Proprietary Trade Name: PERIMETER® Interbody Fusion Device II.
Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080) III.
- IV. Product Code: MAX
Product Description V.
The PERIMETER® Interbody Fusion Device consists of cages which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental instrumentation.
This device is offered in both titanium alloy and PEEK
(POLYETHERETHERKETONE) versions. This interbody device is provided in both sterile and non-sterile forms. Refer to the package label for sterility information.
The subject PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height and between 19mm and 28mm in width. The device is designed with teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance.
V. Indications
The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative
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K040353 Page 2/2
treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Substantial Equivalence VI.
Documentation, including mechanical test results and published literature, was provided which demonstrated that the subject PERIMETER® Interbody Fusion Device is substantially equivalent to several recently down classified interbody cages including, the CLYDESDALE® Spinal System (K083026, SE 12/29/08); the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03); the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03); the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03); the Lumbar I/F Cage (DePuy, P960025); as well as to the CAPSTONE® Spinal System K073291 (SE 04/24/08) and the VERTE-STACK® Spinal System (K041452, SF. 06/24/04).
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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 depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek % Mr. Lee Grant Principal, Regulatory Affairs 1800 Pyramid Place Memphis. Tennessee 38132
SEP. 2 9 2009
Re: K090353
Trade Name: PERIMETER® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: II Product Code: MAX Dated: September 21, 2009 Received: September 22, 2009
Dear Mr. Grant:
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 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 - Mr. Lee Grant
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/ReportaProblem/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) 796-7109 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark M. Milkeran
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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510(k) Number (if known):
Device Name: PERIMETER® Interbody Fusion Device
Indications for Use:
The PERIMETER® Interbody Fusion Device is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Prescription Use X (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)
Mark M Milhum
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ KO90353
§ 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.