(85 days)
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIF ™ TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
The Surgicraft STALIFTM TT is a radiolucent vertebral body replacement device used in conjunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion. Material: PEEK-OPTIMA LT1
This is actually an FDA 510(k) summary for a medical device (STALIF TT™ SYSTEM), not a study analyzing AI performance. Therefore, most of the requested information about acceptance criteria and study design for AI models does not apply.
However, I can extract the relevant information from the provided document regarding device performance and its regulatory approval process, which serves as a form of "acceptance criteria" for medical devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
For a medical device like the STALIF TT, "acceptance criteria" are typically based on demonstrating substantial equivalence to a legally marketed predicate device, as well as meeting established performance standards through various testing. The document states "Performance data were submitted." This implies that the device underwent various tests to prove its safety and effectiveness, likely against a set of predetermined criteria based on engineering standards and expected biological response.
However, the specific quantitative acceptance criteria (e.g., minimum compression strength, fatigue life cycles) and the detailed results are not disclosed in this summary. The summary only confirms that performance data was submitted and found acceptable by the FDA for its 510(k) clearance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (DePuy AcroMed Stackable Cage™ System) | Found to be substantially equivalent by FDA (K041617) |
| Biomechanical integrity (anterior column support) | Designed to restore biomechanical integrity and provide anterior column support immediately and for prolonged periods. Performance data submitted to FDA and found acceptable for clearance. |
| Material compatibility (PEEK-OPTIMA LT1) | PEEK-OPTIMA LT1 is a known biocompatible material, implicitly meeting acceptance criteria. Performance data submitted to FDA and found acceptable for clearance. |
| Use with supplemental internal fixation | Indicated for use with supplemental internal fixation systems (list provided), implying compatibility testing was conducted. Performance data submitted to FDA and found acceptable for clearance. |
| Restoration of planar alignment and height | Designed to restore planar alignment and height of collapsed vertebral body. Performance data submitted to FDA and found acceptable for clearance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For medical devices, "test sets" typically refer to mechanical, biocompatibility, and potentially animal studies, not human clinical data in the same way an AI study would. The data provenance would refer to the testing lab and the standard(s) adhered to.
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)
This is not applicable to a medical device 510(k) submission in the context of expert consensus for ground truth. Ground truth for a device like this would be established through engineering specifications, material properties, and pre-clinical testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to a medical device 510(k) submission. Adjudication methods are typically for subjective assessments or disagreements in clinical trials or AI validation.
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
This is not applicable. The STALIF TT is a physical medical implant, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The STALIF TT is a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance would be established through a combination of:
- Engineering specifications and standards: Confirming material properties, mechanical strength (e.g., compression, fatigue, subsidence), and dimensional accuracy.
- Biocompatibility testing: In vitro and potentially in vivo (animal study) testing to ensure the material is safe for implantation.
- Pre-clinical (benchtop) testing: Simulated use conditions to verify the device's mechanical performance under expected physiological loads.
8. The sample size for the training set
This is not applicable. The STALIF TT is a physical medical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. The STALIF TT is a physical medical implant, not an AI model.
In summary: The provided document is a regulatory notice for a medical device, not a study evaluating an AI system. The "acceptance criteria" here refer to meeting FDA requirements for market clearance through demonstrating substantial equivalence and submitting adequate performance data, rather than specific performance metrics for an AI algorithm.
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14/6/7
PREMARKET NOTIFICATION 510(K) SUMMARY
STALIF TT™ SYSTEM
Company: Surgicraft 16 The Oaks, Clews Road Redditch, Worcestershire United Kingdom B98 7ST
Steve Trotman Contact:
Proposed Proprietary Trade Name:
STALIF™ TT
Classification Name: 888.3060 Orthopedics
FDA Product Code Classification:
MQP
- The Surgicraft STALIFTM TT is a radiolucent vertebral Device Description: body replacement device used in conjunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion.
Material: PEEK-OPTIMA LT1
Intended Use:
The STALIF™ TT device is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIF™ TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF™ TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
| Predicate Device: | DePuy AcroMed Stackable Cage™ SystemK990148, K001340, K013382 |
|---|---|
| ------------------- | ------------------------------------------------------------------- |
Performance Data: Performance data were submitted.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Surgicraft Ltd. c/o Ms. Janet M. Webb Medvantage Inc. 121 W. Chestnut Street, #3506 Chicago, IL 60610
Re: K041617 Trade/Device Name: STALIF TT Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral body replacement device Regulatory Class: Class II Product Code: MQP Dated: June 2, 2004 Received: June 15, 2004
Dear Ms. Webb:
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 (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 - Ms. Janet Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to oegin maine of substantial equivalence of your device to a legally premarked notification: "The PDF Intelling of bevice 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 If you ucare specific advice for your act (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain Whisbiananing by reference to presences ibilities under the Act from the Division of Small other general 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Milkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K041617 Device Name: STALIF TT Indications for Use:
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIF ™ TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
Prescription Use _ _ X Over-The-Counter Use or
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkerson
Division of General, Restorative, and Neurological Devices
510(k) Number K041617
§ 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.