(216 days)
The Qualgenix Twin Peaks Lumbar Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Qualgenix Twin Peaks Lumbar Cage is to be used with supplemental fixation.
The Qualgenix Twin Peaks Lumbar Cage consists of lumbar spinal interbody fusion devices in 20mm and 25mm footprints as well as instrumentation designed specifically for the implantation of these devices. The cage is manufactured from PEEK OPTIMA LT1 polymer. Bone graft is intended to be placed in the middle of the device.
The provided text describes a medical device, the Qualgenix Twin Peaks Lumbar Cage, and its 510(k) summary for FDA clearance. However, the document does not contain information related to software performance, AI algorithms, or clinical studies involving human readers or ground truth establishment for diagnostic purposes, which are typically found in submissions for AI/ML-enabled devices.
Instead, this document focuses on the mechanical and material performance of a medical implant and its substantial equivalence to predicate devices. Therefore, I cannot provide a response that includes acceptance criteria and study details relevant to an AI-powered diagnostic device based on the given text.
The information provided pertains to:
- Device Trade Name: Twin Peaks Lumbar Cage
- Manufacturer: Qualgenix
- Indications For Use: Intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.
- Device Description: Lumbar spinal interbody fusion devices made of PEEK OPTIMA LT1 polymer, with 20mm and 25mm footprints.
- Predicate Devices: DePuy Spine Lumbar Cages (K081917), SpineArt Juliet Cage (K101710), and Scient'X Tribeca Cage (K080588).
- Performance Standards/Testing: Preclinical testing per ASTM F2077 (static compression, static torsion, dynamic compression), expulsion testing, and ASTM F2267 (subsidence testing). These standards evaluate the physical and mechanical properties of the implant.
Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance (in the context of AI/ML), sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types related to an AI device.
The document states that performance standards were met through preclinical testing to demonstrate substantial equivalence, not through clinical or diagnostic performance studies typical for AI/ML products.
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K 112696
510(k) Summary
. .
APR 18 2012
| Manufacturer: | Qualgenix-87 Carmel Hill RoadWoodbury, CT 06798(203) 982 – 4239 |
|---|---|
| Device Trade Name: | Twin Peaks Lumbar Cage |
| Contact: | Richard Deslauriers, M.D.CEO |
| Date Prepared: | August 29, 2011 |
| Classification: | §888.3080; Intervertebral body fusion device |
| Class: | II |
| Product Code: | MAX |
| Indications For Use: | The Qualgenix Twin Peaks Lumbar Cage is indicated forintervertebral body fusion with autogenous bone graftmaterial in patients with degenerative disc disease (DDD) atone level or two contiguous levels from L2 to S1. DDD isdefined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies.These DDD patients may also have up to Grade Ispondylolisthesis or retrolisthesis at the involved level(s).These patients should be skeletally mature and havecompleted six months of non-operative treatment. TheQualgenix Twin Peaks Lumbar Cage is to be used withsupplemental fixation. |
| Device Description: | The Qualgenix Twin Peaks Lumbar Cage consists of lumbarspinal interbody fusion devices in 20mm and 25mmfootprints as well as instrumentation designed specifically forthe implantation of these devices. The cage is manufacturedfrom PEEK OPTIMA LT1 polymer. Bone graft is intended tobe placed in the middle of the device. |
| Predicate Device(s): | The Qualgenix Twin Peaks Lumbar Cage was shown to besubstantially equivalent to previously cleared devices,including the DePuy Spine Lumbar Cages (K081917)SpineArt Juliet Cage (K101710), and Scient'X Tribeca Cage(K080588), and has the same indications for use, design, |
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and function. For example, the Qualgenix Twin Peaks Lumbar Cage has the same footprint and mechanical equivalence as the cited predicate devices.
Performance Standards: Preclinical testing has been performed per ASTM F2077 (static compression, static torsion, dynamic compression), expulsion testing, and ASTM F2267 (subsidence testing) indicating that the Qualgenix Twin Peaks Lumbar Cage is substantially equivalent to predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is depicted with two snakes entwined around a staff, and a pair of wings at the top.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Oualgenix % Richard Deslauriers, M.D. CEO 87 Carmel Hill Road Woodbury, Connecticut 06798
APR 1 8 2012
Re: K112696
Trade/Device Name: Qualgenix Twin Peaks Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 8, 2012 Received: March 9, 2012
Dear Dr. Deslauriers:
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 Of ice rated adverse events) (21 CFR 803); good manufacturing practice requirements as set de rece related and verse overal (2) 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 - Richard Deslauriers, M.D.
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) 796-7100 or at its Internet address
Sincerely yours,
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
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): __ K112696
Device Name: Qualgenix Twin Peaks Lumbar Cage
The Qualgenix Twin Peaks Lumbar Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Qualgenix Twin Peaks Lumbar Cage is to be used with supplemental fixation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Part 29 CFR 801 Subpart D)
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)
Division Sign Off
(Division Sign-Ofi) Division of Surgical, Orthopedic, and Restorative Devices
KN2696 510(k) Number.
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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.