(241 days)
The Scient'X Anterior Buttress Plate is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The Anterior Buttress Plate is a graft containment device that features a Ti plate fixed by a vertebral body screw. The Ti plate is connected to a PEEK buttress that extends over the adjacent intervertebral space maintaining the position of the bone graft.
The provided text is for a 510(k) summary for a medical device (Scient'X Anterior Buttress Plate), which falls under the category of spinal implants. These summaries are typically for demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than clinical studies with human subjects or AI performance metrics.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI standalone performance, training set size) are not applicable to this type of regulatory submission and information will not be found in the provided document.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices | "Testing performed indicates the Scient'X Anterior Buttress Plate is substantially equivalent to predicate devices." |
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. The submission focuses on substantial equivalence based on mechanical testing and comparison to predicate devices, not on a clinical test set with human data as would be relevant for AI/diagnostic devices. The document does not specify sample sizes for mechanical tests, nor details about data provenance in the context of clinical studies.
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, in the sense of expert consensus for diagnostic accuracy, is not relevant to this type of device submission. The primary "ground truth" for substantial equivalence would be the performance characteristics of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation of results (e.g., imaging). This is a mechanical device submission.
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 is a medical device (spinal implant), not an AI or diagnostic tool where MRMC studies would be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical spinal implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is the performance characteristics and safety profiles of the legally marketed predicate devices. Substantial equivalence means the new device is as safe and effective as existing devices. This would be established through mechanical testing results compared to the predicate, and possibly design comparisons.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI or machine learning device.
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Koris48
2. 510(k) Summary
JAN 2 9 2009
| Contact: | Glenn StiegmanMusculoskeletal Clinical & Regulatory Advisers, LL1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800 |
|---|---|
| Device Trade Name: | Scient'X Anterior Buttress Plate |
| Manufacturer: | Scient'X USA Inc.900 Airport RoadSuite 3BWest Chester, PA 19380 - USA |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Classification: | 21 CFR §888.3060 |
| Class: | II |
| Product Code: | KWO |
Indications For Use:
The Scient'X Anterior Buttress Plate is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Device Description:
The Anterior Buttress Plate is a graft containment device that features a Ti plate fixed by a vertebral body screw. The Ti plate is connected to a PEEK buttress that extends over the adjacent intervertebral space maintaining the position of the bone graft.
Predicate Device(s): .
The Scient'X Anterior Buttress Plate was shown to be substantially equivalent to the predicate devices.
Performance Standards:
Testing performed indicates the Scient'X Anterior Buttress Plate is substantially equivalent to predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 stripes representing the department's mission of providing essential human services. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
11:14
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SCIENT'X USA % Mr. James McCracken Manager Regulatory and Quality 900 Airport Road, Suite 3B West Chester, Pennsylvania 19380
Re: K081548
Trade/Device Name: SCIENT'X Anterior Buttress Plate Regulation Number: 21 CRF 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: May 30, 2008 Received: June 03, 2008
Dear Mr. McCracken:
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.
JAN 2 9 2009
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.
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Page 2 - Mr. James McCracken
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1. Indications for Use
510(k) Number (if known):
K0815418
Device Name: Scient'X Anterior Buttress Plate
The Scient'X Anterior Buttress Plate is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 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)
Mark A. Milkman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
§ 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.