(59 days)
TRYPTIK® cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment.
The components added within this submission include lordotic and convex TRYPTIK® cc anterior intersomatic cervical cages. TRYPTIK® devices are made of PEEK OPTIMA LT1 conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. TRYPTIK® devices are designed for an anterior approach.
The provided document describes the TRYPTIK® Anterior Intersomatic Cervical Cage and its 510(k) summary. This document focuses on the mechanical performance testing of the device rather than directly reporting on an AI/ML-driven study or clinical performance with detailed acceptance criteria and reported device performance metrics like accuracy, sensitivity, or specificity.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device cannot be extracted from this document, as it pertains to a traditional medical device (intervertebral body fusion device) and not an AI/ML product.
The performance data summarized in the document for the TRYPTIK® Anterior Intersomatic Cervical Cage relates to mechanical testing to demonstrate substantial equivalence to predicate devices, not performance criteria for an AI/ML algorithm.
Here's a breakdown of what can be extracted, addressing the closest relevant points, alongside explanations for what cannot be:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria Basis | Reported Device Performance |
|---|---|---|---|
| Material Conformance | PEEK OPTIMA LT1 | Conforming to ASTM F2026 | Device made of PEEK OPTIMA LT1 conforming ASTM F2026. |
| Marker Material | Titanium Markers | Conforming to ASTM F136 | Markers made of titanium conforming ASTM F136. |
| Mechanical Testing | Static and dynamic compression, shear, torsion | Overall Acceptance Criteria: Demonstrate that additional components perform as safely and effectively as their predicate devices (as per Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - June 12, 2007). Implicit: Meet or exceed performance of predicate devices in these tests. | "Results demonstrate that additional components perform as safely and effectively as their predicate devices." (Detailed numerical results are not provided in this summary.) |
| Subsidence Testing | According to ASTM F2267 | Overall Acceptance Criteria: Demonstrate performance as safely and effectively as predicate devices. Implicit: Meet or exceed performance of predicate devices. | Performed according to ASTM F2267. "Results demonstrate that additional components perform as safely and effectively as their predicate devices." |
Note: This table reflects the mechanical testing requirements for this physical implant device, not the performance metrics typically associated with AI/ML systems.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document describes mechanical performance testing of a physical implant (cervical cage), not an AI/ML device that would use a test set of data. The "tests" are mechanical evaluations of the device components.
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 / Not provided. The "ground truth" for this device's performance is established by standardized material and mechanical testing methods (ASTM standards) and comparison to predicate devices, not by expert consensus on clinical data or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for human interpretation tasks, often in clinical studies or expert review of outputs, which is not what this document addresses.
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
- No. This is a physical medical device (cervical cage), not an AI/ML system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an algorithm; it is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Technical/Engineering Standards: The "ground truth" for this device's performance testing is adherence to established ASTM (American Society for Testing and Materials) standards for material properties and mechanical performance. The performance is then compared against legally marketed predicate devices to demonstrate substantial equivalence.
8. The sample size for the training set
- Not applicable / Not provided. This is a physical implant, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set for an AI/ML model, there is no ground truth for a training set to be established.
In conclusion, the document (K122366) concerns the 510(k) clearance for a physical intervertebral body fusion device (TRYPTIK® Anterior Intersomatic Cervical Cage) based on mechanical testing and substantial equivalence to predicate devices, not an AI/ML diagnostic or prognostic tool. Therefore, most of the questions relating to AI/ML device evaluation criteria are not applicable to this specific submission.
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K122366
page 1 of.1
510(k) SUMMARY
As required by section 807.92
ост 4 2012
| Submitter | SPINEARTInternational Center Cointrin 20 route de pré-bois CP18131215 GENEVA 15SWITZERLAND |
|---|---|
| Contacts | Franck PENNESI Director of Industry & QualityPhone : +41 22 799 40 25 Fax : +41 22 799 40 26Mail : fpennesi@spineart.chRegulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)idrubaix@nordnet.fr |
| Type of 510k | SPECIAL |
| Preparation date | Revised September 9th 2012 |
| Trade Name | TRYPTIK® Anterior Intersomatic Cervical Cage |
| Classification Name | Intervertebral body fusion device- Cervical |
| Class | II |
| Product Code | ODP |
| CFR section | 888.3080 |
| Device panel | Orthopedic |
| Legally marketedpredicate devices | TRYPTIK® Anterior Intersomatic Cervical Cage manufactured bySPINEART (K091873); CRYSTAL manufactured by SPINAL ELEMENTS,INC (K073351); ALEUTIAN manufactured by K2M (K101302) |
| Description | The components added within this submission include lordotic andconvex TRYPTIK® cc anterior intersomatic cervical cages. TRYPTIK®devices are made of PEEK OPTIMA LT1 conforming ASTM F2026.Markers made of titanium conforming ASTM F136 are used to visualizethe position of the implant in the disc space. TRYPTIK® devices aredesigned for an anterior approach. |
| Intended Use | TRYPTIK® cages are indicated for use in skeletally mature patients withdegenerative disc disease (DDD) of the cervical spine withaccompanying radicular symptoms at one disc level. DDD is defined asdiscogenic pain with degeneration of the disc confirmed by patienthistory and radiographic studies. TRYPTIK® cages are used to facilitateintervertebral body fusion in the cervical spine at the C3 to C7 disclevels using autograft bone. TRYPTIK® cages are to be used withsupplemental fixation. Patients should have at least six (6) weeks ofnon-operative treatment. |
| Performance data | TRYPTIK® cervical interbody fusion devices conform to Class II SpecialControls Guidance Document: Intervertebral Body Fusion Device-Document issued on: June 12, 2007.Mechanical testing including Static and dynamic compression, staticand dynamic shear, static and dynamic torsion tests have beenperformed according to ASTM F2077 and subsidence testing has beenperformed according to ASTM F2267. Results demonstrate thatadditional components perform as safely and effectively as theirpredicate devices. No clinical data has been presented. |
| Substantial equivalence | TRYPTIK® cervical interbody fusion devices are substantially equivalentto their predicate devices in terms of intended use, material, design,mechanical properties and function. Non clinical performance testingaccording to special control demonstrate that additional componentsare as safe, as effective, and performs as safely and effectively as theirpredicate devices. |
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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SPINEART % Mr. Frank Pennesi Director of Industry and Quality International Center Cointrin, 20 route de-Pré-bois CP1813 1215 Geneva, Switzerland
OCT
4 2012
Re: K122366 Trade/Device Name: TRYPTIK® Anterior Intersomatic Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 10, 2012 Received: September 11, 2012
Dear Mr. Pennesi:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Frank Pennesi
device-related adverse events) (21 CFR 803); 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.
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Mark N. Me Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K122366
Device Name: TRYPTIK® Anterior Intersomatic Cervical Cage Indications for Use:
TRYPTIK® cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment
Prescription Use >| (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)
Cal. Pf.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122366
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.