(217 days)
The Qualgenix Ayers Rock Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation.
The Ayers Rock Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical Cage is manufactured from PEEK OPTIMA LT1 polymer. The Ayers Rock Cervical Cage is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
The provided text describes a medical device, the Qualgenix Ayers Rock Cervical Cage, and its clearance through the 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a predicate device rather than conducting clinical trials to establish new safety and effectiveness. Therefore, the information typically requested regarding acceptance criteria based on a study, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (like MRMC) is not applicable or not provided in this type of submission for this particular device.
Here's a breakdown of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity) for device performance in a clinical study. Instead, the device's acceptance is based on demonstrating substantial equivalence to predicate devices through preclinical testing and comparison of indications, design, and function.
| Acceptance Criteria (from 510(k) framework) | Reported Device Performance |
|---|---|
| Substantially equivalent in indications for use, design, and function to predicate devices. | The Ayers Rock Cervical Cage was shown to be substantially equivalent to previously cleared devices. |
| Compliance with ASTM F2077 (static compression, compression-shear, static torsion, dynamic compression) | Preclinical testing performed per ASTM F2077 (static compression, compression-shear, static torsion, dynamic compression) indicates substantial equivalence. |
| Compliance with expulsion testing | Preclinical expulsion testing indicates substantial equivalence. |
| Compliance with ASTM F2267 (subsidence testing) | Preclinical subsidence testing (ASTM F2267) indicates substantial equivalence. |
2. Sample size used for the test set and the data provenance
Not applicable. The clearance is based on preclinical testing and comparison to predicate devices, not a clinical study with a "test set" of patients or data provenance in the context of clinical outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For medical devices cleared via 510(k), especially for implants, the "truth" is established through engineering and biomechanical testing demonstrating equivalence to established devices, not expert consensus on patient data.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication in the way it's done for diagnostic algorithms.
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. This device is an implantable cervical cage, not a diagnostic AI device that would involve human readers or AI assistance in reading medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for the Ayers Rock Cervical Cage is established through preclinical testing results (biomechanical and mechanical testing) demonstrating that its performance characteristics (e.g., static compression, dynamic compression, subsidence, expulsion) are equivalent to those of the predicate devices. The equivalence in design, materials (PEEK OPTIMA LT1 polymer), and intended use also serves as a critical part of the "truth" in the 510(k) context.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device 510(k) submission, as it's not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
{0}------------------------------------------------
MAY - 1 2012
510(k) Summary
:
| Manufacturer: | Qualgenix LLC1 Jack's Hill Road (Unit 3E)Oxford, CT 06478(203) 982 – 4239 |
|---|---|
| Device Trade Name: | Ayers Rock Cervical Cage |
| Contact: | Richard Deslauriers, M.D.CEO |
| Date Prepared: | September 21, 2011 |
| Classification: | §888.3080; Intervertebral body fusion device |
| Class: | II |
| Product Code: | ODP |
| Indications For Use: | The Qualgenix Ayers Rock Cervical Cage is indicated foruse in skeletally mature patients with degenerative discdisease (DDD) with accompanying radicular symptoms atone level from C2-T1. DDD is defined as neck pain ofdiscogenic origin with degeneration of the disc confirmed byhistory of radiographic studies. These patients should havehad 6 weeks of non-operative treatment. The QualgenixAyers Rock Cervical Cage implants are to be used withautogenous bone graft and implanted via an open, anteriorapproach. The Qualgenix Ayers Rock Cervical Cage is to beused with supplemental fixation. |
| Device Description: | The Ayers Rock Cervical Cage consists of cervical spinalinterbody fusion devices as well as instrumentation designedspecifically for the implantation of these devices. The AyersRock Cervical Cage is manufactured from PEEK OPTIMALT1 polymer. The Ayers Rock Cervical Cage is for singlelevel anterior spinal use from the C2-C3 to C7-T1 disc levels. |
| Predicate Device(s): | The Ayers Rock Cervical Cage was shown to besubstantially equivalent to previously cleared devices andhas the same indications for use, design, and function.Predicate devices include the LDR Spine MC+ (K080588)and SpineArt Tryptik (K091873). |
{1}------------------------------------------------
Performance Standards: Preclinical testing has been performed per ASTM F2077 (static compression, compression-shear, static torsion, dynamic compression), expulsion testing, and ASTM F2267 (subsidence testing) indicating that the Ayers Rock Cervical Cage is substantially equivalent to predicate devices.
Conclusion: Comparisons of device indications, intended use, design, and performance were made to predicate devices in order to determine substantial equivalence.
{2}------------------------------------------------
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 eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Qualgenix LLC % Richard Deslauriers, M.D. CEO 1 Jack's Hill Road (Unit 3E) Oxford, Connecticut 06478
MAY - 1 2012
Re: K112801
Trade/Device Name: Ayers Rock Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 3, 2012 Received: April 4, 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 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.
{3}------------------------------------------------
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.goy/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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
K-11280 510(k) Number (if known):
Device Name: Qualgenix Ayers Rock Cervical Cage
The Qualgenix Ayers Rock Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation.
Prescription Use (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 of Surgical, Orthopedic, and Restorative Devices
KIL2801 510(k) Number_
§ 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.