(30 days)
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The subject EXPEDIUM Spine System components are designed to accept a 6.35mm rod and are available in various geometries and sizes. The EXPEDIUM Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification.
The provided text describes a 510(k) summary for the EXPEDIUM™ Spine System. This submission is for a medical device (spinal implant system), not an AI/ML powered device. As such, the typical acceptance criteria and study designs relevant to AI/ML software (e.g., diagnostic accuracy, reader studies, ground truth establishment) do not apply here.
The performance data for this device refers to mechanical testing of the implant, not clinical or diagnostic performance.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualification, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found or is not applicable in the context of this 510(k) summary.
However, I can extract the relevant performance data mentioned:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Characterization per ASTM F 1798 | Performance data submitted per ASTM F 1798 to characterize the EXPEDIUM™ Spine System components. |
Note: ASTM F 1798 is a standard specification for the mechanical testing of spinal implant constructs. The 510(k) summary states that data was submitted according to this standard, implying the device met the mechanical performance requirements outlined therein, although specific numerical acceptance values and results 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)
- Not applicable / Not specified as this relates to mechanical testing, not a clinical study involving a test set of data.
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)
- Not applicable. Ground truth for mechanical testing is based on engineering specifications and measurements, not expert clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 a physical implant, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For mechanical testing, the "ground truth" would be the physical properties and mechanical behavior of the materials and constructs as measured by standardized engineering tests, compared against the specifications of ASTM F 1798.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
{0}------------------------------------------------
510(K) SUMMARY
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 | JAN 17 2007 |
|---|---|---|
| Contact Person: | Christopher Klaczyk, Regulatory Project ManagerVoice: (508) 828-2852Fax: (508) 828-3797 | |
| Date Prepared: | December 15, 2006 | |
| Device Class: | Class III | |
| Classification Name: | Spinal interlaminar fixation orthosisper 21 CFR §888.3050 | |
| Spinal intervertebral body fixation orthosisper 21 CFR §888.3060 | ||
| Pedicle screw spinal fixationper 21 CFR §888.3070 | ||
| Classification Panel: | Orthopedics | |
| FDA Panel Number: | 87 | |
| Product Code(s): | KWP, MNH, MNI, NKB, KWQ | |
| Proprietary Name: | EXPEDIUM™ Spine System | |
| Predicate Devices: | EXPEDIUM™ 6.35mm Spine System (K062174,K063156) | |
| Device Description: | The subject EXPEDIUM™ Spine System components aredesigned to accept a 6.35mm rod and are available invarious geometries and sizes. | |
| The EXPEDIUM™ Spine System also contains Class Imanual surgical instruments, trays and cases and areexempt from premarket notification. | ||
| Intended Use: | The EXPEDIUM Spine System is intended for noncervicalpedicle fixation and nonpedicle fixation for the followingindications: degenerative disc disease (defined as back painof discogenic origin with degeneration of the discconfirmed by history and radiographic studies);spondylolisthesis; trauma (i.e., fracture or dislocation);spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/orlordosis); tumor; pseudoarthrosis; and failed previousfusion in skeletally mature patients. | |
| Materials: | Manufactured from ASTM F 138 implant grade stainlesssteel and ASTM F 136 implant grade titanium alloy. | |
| Performance Data: | Performance data per ASTM F 1798 were submitted tocharacterize the subject EXPEDIUM™ Spine Systemcomponents addressed in this notification. |
:
K063741 Page 1 of 2 .
{1}------------------------------------------------
K063741
Page 2 of 2
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Depuy Spine Incorporated c/o Mr. Christopher Klaczyk 325 Paramount Drive Raynham, Massachusetts 02780
JAN 1 7 2007
Re: K063741
Trade Name: EXPEDIUM Spine System (Addition of 11 mm Sacral Screws) Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNH,MNI, KWQ, KWP Dated: December 15, 2006 Received: December 18, 2006
Dear Mr. Klaczyk:
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 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 (OS) 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. Christopher Klaczyk
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,
Barbara Brichum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K063741
Device Name: EXPEDIUM™ Spine System (addition of sacral screws)
Indications For Use:
The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
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)
Barbara Bruckner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K063741
Page 1 of 1
N/A