(135 days)
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).
This 510(k) summary describes a medical device, the "Quantum Vertebral Body Replacement," which is an implantable surgical device, not a diagnostic AI/ML device. Therefore, the traditional acceptance criteria and study designs relevant to AI/ML devices (e.g., sensitivity, specificity, ROC curves, expert ground truth, multi-reader multi-case studies) are not applicable here.
The "Performance Data" section of the document states: "Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use." This indicates that the acceptance criteria for this device are based on mechanical performance standards relevant to spinal implants, rather than diagnostic accuracy.
Here's an attempt to answer the questions based on the provided text, adapted for a non-AI/ML medical device where possible:
Acceptance Criteria and Device Performance for Quantum Vertebral Body Replacement
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability (Implied) | "Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use." |
| Biocompatibility (Implied, as it's an implantable device made of titanium or PEEK) | Not explicitly stated in the provided text but would be a standard requirement for such a device. |
| Proper Fit & Range of Sizes (Implied by device description) | "Available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient." |
| Resistance to Migration (Implied by design feature) | "The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. For mechanical testing of a medical implant, the "sample size" would refer to the number of physical devices tested. The document does not provide this detail.
- Data Provenance: The mechanical testing would have been conducted in a laboratory setting, likely by the manufacturer (Quantum Orthopedics, Inc.) or a contracted testing facility. The document does not specify the country of origin of the testing. The testing would be considered prospective in the sense that physical new devices are tested to predetermined standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the "ground truth" for a mechanical implant device is defined by engineering standards and biomechanical properties, not human interpretation or expert consensus in a diagnostic sense. The "experts" involved would be biomechanical engineers or materials scientists who design and conduct the mechanical tests and interpret the results against established performance standards. Their qualifications would involve expertise in materials science, biomechanics, and medical device regulations.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert opinions or interpretations, typically in diagnostic studies. For mechanical testing, results are typically quantitative and compared against engineering specifications, not subject to subjective adjudication in this manner.
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. MRMC studies are designed for diagnostic performance evaluation, especially for AI-assisted interpretation, where human "readers" (e.g., radiologists) interpret "cases" (e.g., medical images). This device is a physical implant, not a diagnostic tool or an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- Not applicable. This device is a physical implant and does not involve an AI algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on established biomechanical engineering standards and specifications for spinal implants. This includes properties like compressive strength, fatigue life, torsional stability, and biocompatibility, as outlined in relevant ASTM/ISO standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/ML evaluation.
8. The sample size for the training set
- Not applicable. The concept of a "training set" is specific to machine learning algorithms. For a physical medical device like this, product development involves design, prototyping, and iterative testing, but not a "training set" in the AI/ML context.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the AI/ML sense for this device. The design specifications and performance goals for the device would have been established based on anatomical considerations, clinical needs, existing predicate device performance, and current engineering standards for spinal implants.
{0}------------------------------------------------
JUL 7 - 2005
21/2
Premarket Notification - Quantum Vertebral Body Replacement
510(k) Summary Quantum Vertebral Body Replacement
510(k) Number K050449
| Manufacturer IdentificationSubmitted by: | Quantum Orthopedics, Inc.2744 Loker Ave. W., Suite 100Carlsbad, CA 92008760-607-0121 |
|---|---|
| Contact Information: | Jason BlainChief Technology OfficerQuantum Orthopedics, Inc.2744 Loker Ave. W., Suite 100Carlsbad, CA 92008760-607-0121jblain@quantumorthopedics.com |
| Date Prepared: | May 13, 2005 |
| Device IndentificationProprietary Name: | Quantum Vertebral Body Replacement |
| Common Name: | Vertebral Body Replacement |
| Classification Name: | Spinal Vertebral Body Replacement |
Device Description
The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).
Intended Use of the Device
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and
{1}------------------------------------------------
rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Substantial Equivalence
The Quantum Vertebral Body Replacement was shown to be substantially equivalent to Sustain Radiolucent Spacer (Globus Medical, Inc., K040284), Cadence™ and Traxis™ (Spinal Concepts, K033517), PEEK Tetris™ (Signus Medical LLC, K031757 and K041888), STALIFTM TT (Surgicraft, K041617), and SynMesh (Synthes, K003275).
Performance Data
Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use.
{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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Mr. Jason Blain Chief Technology Officer Quantum Orthopedics 2744 Loker Avenue West. Suite 100 Carlsbad, California 92008
Re: K050449
Trade/Device Name: Quantum Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: May 13, 2005 Received: May 16, 2005
Dear Mr. Blain:
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. Iisting 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.
{3}------------------------------------------------
Page 2 - Mr. Jason Blain
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
S. Hugh Rudder, Ph.D.
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Quantum Vertebral Body Replacement Device Name:
Indications For Use:
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
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)
Hupt Plurdu
(Division Division of General, Restorative and Neurological Devices
Page 1 of _1 _
510(k) Number K050449
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.