(56 days)
The Spartan S3 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
- Trauma, including spinal fractures and/or dislocations;
- Spondylolisthesis;
- Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity:
- Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
The Spartan S Facet System will provide temporary stabilization as an adjunct to spinal fusion.
The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. This submission ads a swivel washer and screw skirt to the 5mm diameter screw. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
The provided text describes a 510(k) premarket notification for a medical device (Spartan S3 Facet System), not a study proving a device meets acceptance criteria related to an AI or diagnostic algorithm's performance. The information pertains to a physical implantable device used for spinal fusion.
Therefore, many of the requested categories in the prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, how ground truth was established for training set) are not applicable to this type of device submission.
The "acceptance criteria" for a physical medical device like this are typically related to mechanical performance (e.g., strength, durability), biocompatibility, and manufacturing quality, demonstrated through pre-clinical testing, rather than diagnostic accuracy or algorithmic performance.
Here's the information that is extractable and relevant, framed within the context of a physical device's "acceptance criteria" and the study that proves it:
Acceptance Criteria and Device Performance for Spartan S3 Facet System
For a physical implantable device like the Spartan S3 Facet System, "acceptance criteria" are generally related to its physical performance characteristics, primarily mechanical integrity and equivalence to predicate devices, rather than diagnostic accuracy metrics. The "study" proving it meets these criteria is the pre-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Mechanical Performance | 1. Static Cantilever Bend Strength comparable to predicate devices. | "The test results indicate that the Spartan S Facet System is substantially equivalent to the predicate devices and is adequate for the intended use." (Specific numerical values for strength are not provided in this summary.) |
| 2. Dynamic Cantilever Bend Durability (fatigue testing) comparable to predicate devices. | "The test results indicate that the Spartan S Facet System is substantially equivalent to the predicate devices and is adequate for the intended use." (Specific numerical values for durability are not provided in this summary.) | |
| Biocompatibility | Material (Ti 6AL4V-ELI) must be biocompatible for permanent implantation. | This is an inherent property of the material and is accepted due to common use in similar predicate devices. No specific testing on biocompatibility is mentioned, but it's a fundamental requirement. |
| Design Equivalence | Addition of swivel washer and screw skirt does not negatively impact performance and maintains features beneficial for surgical placement. | "The swivel washer for both systems allows the screw to be directed 360° to accommodate optimal screw placement." (Implied acceptance based on similarity and performance.) |
| Asepsis/Sterility | Device must be supplied sterile or sterilizable for surgical use. | Not explicitly stated in the provided summary, but a fundamental requirement for implantable devices. |
| Material Composition | Adherence to specified material (Titanium alloy TI 6AL4V-ELI). | "The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI." (Meets this criterion by declaration). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test in the provided summary. Performance testing was "following ASTM F2193-02," which specifies test methods but not the exact number of samples. Typically, these tests involve a statistically significant number of samples to ensure robust results.
- Data Provenance: The testing was "pre-clinical testing," implying laboratory-based mechanical and physical property testing. No geographic origin is specified, but it would have been conducted by the manufacturer or a contract testing lab. The testing is prospective in the sense that it's performed specifically to support the 510(k) submission prior to market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical device, and "ground truth" for its performance is established through objective, standardized mechanical and material testing (e.g., tensile strength, fatigue life) against established ASTM standards and equivalence to predicate devices, not through expert consensus or clinical interpretation of data.
4. Adjudication Method for the Test Set
- Not Applicable. As above, "adjudication" (typically for subjective expert review) is not relevant for physical and mechanical performance testing. Test results are objective measurements.
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 physical implantable device, not an AI or diagnostic algorithm, so MRMC studies are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implantable device, not an AI or diagnostic algorithm.
7. The Type of Ground Truth Used
- For mechanical performance: The ground truth is established by objective, quantitative measurements of physical properties (e.g., force, displacement, cycles to failure) as defined by the ASTM F2193-02 standard and compared against the performance characteristics of legally marketed predicate devices. The "ground truth" is the device's ability to withstand specified loads for a required number of cycles without failure, demonstrating substantial equivalence.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, there is no "training set" for a physical medical device.
Summary of the "Study" Proving Acceptance:
The "study" described is pre-clinical mechanical performance testing conducted according to the ASTM F2193-02 standard. This testing included:
- Static cantilever bend tests: Measures the device's strength under a constant, increasing load until failure.
- Dynamic cantilever bend tests: Measures the device's durability and resistance to fatigue under cyclic loading, simulating physiological stresses over time.
These tests were performed both with and without the added swivel washer and screw skirt to ensure the new components did not compromise the device's performance. The conclusion drawn from these tests was that the Spartan S3 Facet System is substantially equivalent to the predicate devices in terms of its mechanical performance, thereby demonstrating it meets the necessary safety and effectiveness criteria for its intended use and market clearance.
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510(k) Summary according to 807.92(c)
| Date: | November 18, 2011 |
|---|---|
| Contact: | Tim Lusby |
| Amendia™, INC | |
| 1755 W. Oak Parkway | |
| Marietta, GA 30062 | |
| 770-874-0935 | |
| Trade Name: | Spartan S³ Facet System |
| Classification: | Unclassified |
| Product Codes: | MRW |
| Panel Code: | 87 |
Indications for Use: The Spartan S3 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
-
- Trauma, including spinal fractures and/or dislocations:
-
- Spondylolisthesis;
-
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity:
-
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
The Spartan S Facet System will provide temporary stabilization as an adjunct to spinal fusion.
The Spartan S Facet System is a permanent implant device made from a titanium Device Description: alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. This submission ads a swivel washer and screw skirt to the 5mm diameter screw. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
Technological Characteristics: The Spartan S Facet System has technological characteristics similar to the predicate devices. Screw sizes, materials, and use of a swivel washer and screw skirt. The swivel washer for both systems allows the screw to be directed 360° to accommodate optimal screw placement. The indications for use are the same for both systems.
The predicate devices previously cleared by FDA are the previously cleared Predicate Device(s): Spartan S2 Facet Screw System (K092568), the Lanx Concero Facet Screw System (K101364), DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K020411), Oasys Bone Screw (K031657) and the Trans1 Facet Screw (K073515).
Performance Testing: The pre-clinical testing was performed following ASTM F2193-02. Testing consisted of static and dynamic cantilever bend tests with and without the swivel washer and skirt. The test results indicate that the Spartan S Facet System is substantially equivalent to the predicate devices and is adequate for the intended use.
Conclusion: Amendia concludes that the data provided demonstrates substantial equivalence to the predicate devices.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 6 2011
Amendia, Inc. % Silver Pine Consulting. LLC Rich Jansen, Pharm. D. 13540 Guild Avenue Apple Valley, Minnesota 55124
Re: K113011
Trade/Device Name: Spartan S Facet System Regulation Number: Unclassified Product Code: MR W Dated: November 18. 2011 Received: November 18, 2011
Dear Dr. Jansen:
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
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Page 2 - Rich Jansen. Pharm. D.
CFR Part 807); labeling (21 CFR Part 801); medical device 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
ly yours,
Fife
L. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Amendia 510(k)
Statement of Indications for Use
510(k) Number (if known): KII 301
The Spartan S Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
l ) Trauma, including spinal fractures and/or dislocations;
-
Spondylolisthesis:
-
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity:
-
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.
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)
(Division Sign-Off) Diyslon of Surgical, Orthopedic, dic, and Restorative Devices
Pg l of
KI:3011
N/A