(87 days)
TRYPTIK®ca 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®ca are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK®ca are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage
TRYPTIK ca of cervical interbody fusion devices made of PEEK OPTIMA conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. TRYPTIK ca devices are designed for an anterior approach. All devices are supplied sterile.
The provided text is a 510(k) summary for the TRYPTIK ca intervertebral body fusion device. It does not describe an AI/ML powered medical device, but rather a physical implant. Therefore, most of the questions relating to acceptance criteria of an AI/ML model, such as sample sizes for test and training sets, expert consensus, adjudication methods, MRMC studies, or standalone performance, are not applicable.
Here's a breakdown of the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The document states that the TRYPTIK ca cervical interbody fusion devices conform to the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007. This guidance document would contain the specific acceptance criteria for devices of this type. However, the provided text does not explicitly list these criteria or report the device's performance against them in a table format. It only states its conformance to the guidance document.
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. This is a physical medical device, not an AI/ML algorithm that uses a "test set" of data in the same way. The evaluation for this device would involve mechanical testing, biocompatibility testing, and a literature review of predicate devices, not data-driven performance metrics against a test set.
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. This concept applies to AI/ML models where human experts label data to establish ground truth. For a physical medical device, "ground truth" is established through engineering and biological testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical medical device.
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 for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a physical medical device. The device is a "human-in-the-loop" device in the sense that a surgeon implants it. Its performance is inherent to its design and material properties.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/ML model's "ground truth." For this device, "ground truth" for its safety and effectiveness would be established through:
- Conformance to ASTM F2026 (for PEEK OPTIMA material).
- Conformance to ASTM F136 (for titanium markers).
- Mechanical testing (e.g., fatigue, static compression, subsidence, expulsion) as required by the Class II Special Controls Guidance Document.
- Biocompatibility testing.
- Comparison to legally marketed predicate devices in terms of intended use, material, design, mechanical properties, and function.
8. The sample size for the training set
Not applicable for a physical medical device.
9. How the ground truth for the training set was established
Not applicable for a physical medical device.
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510(k) Summary of Safety and EFFECTIVENESS
SEP 1 8 2009
As required by section 807.92(c)
'
.
| SPINEART | |||
|---|---|---|---|
| Submitter | International Center Cointrin 20 route de pré-bois | ||
| CP1813 | |||
| 1215 GENEVA 15 | |||
| SWITZERLAND | |||
| Contacts | Franck PENNESI Director of Industry & Quality | ||
| Phone : +41 22 799 40 25 | |||
| Fax : +41 22 799 40 26 | |||
| Mail : fpennesi@spineart.ch | |||
| Regulatory contact : Dr Isabelle DRUBAIX (Idée | |||
| Consulting) idrubaix@nordnet.fr | |||
| Preparation date | June 9, 2009 | ||
| Trade Name | TRYPTIK ca | ||
| Classification Name | Intervertebral body fusion device- Cervical | ||
| Class | II | ||
| Product Code | ODP | ||
| CFR section | 888.3080 | ||
| Device panel | Orthopedic | ||
| Legally marketedpredicate devices | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM(P000028) manufactured by MEDTRONIC, BAK/C | ||
| CERVICAL INTERBODY FUSION DEVICE (P980048)manufactured by ZIMMER SPINE, CRYSTAL (K073351) | |||
| manufactured by SPINAL ELEMENTS, INC | |||
| Description | TRYPTIK ca of cervical interbody fusion devices made | ||
| of PEEK OPTIMA conforming ASTM F2026. Markers | |||
| made of titanium conforming ASTM F136 are used to | |||
| visualize the position of the implant in the disc space. | |||
| TRYPTIK ca devices are designed for an anterior | |||
| approach. All devices are supplied sterile. |
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| Intended Use | TRYPTIK®ca cages are indicated for use in skeletallymature patients with degenerative disc disease (DDD)of the cervical spine with accompanying radicularsymptoms at one disc level. DDD is defined asdiscogenic pain with degeneration of the discconfirmed by patient history and radiographic studies.TRYPTIK®ca are used to facilitate intervertebral bodyfusion in the cervical spine at the C3 to C7 disc levelsusing autograft bone. TRYPTIK®ca are to be used withsupplemental fixation. Patients should have at leastsix (6) weeks of non-operative treatment prior totreatment with an intervertebral cage | |
|---|---|---|
| Performance data | TRYPTIK ca cervical interbody fusion devices conformto Class II Special Controls Guidance Document:Intervertebral Body Fusion Device- Document issuedon: June 12, 2007 | |
| Substantialequivalence | TRYPTIK cervical interbody fusion device issubstantially equivalent to its predicate devices interms of intended use, material, design, mechanicalproperties and function. |
and the comments of the comments of the comments of
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is smaller than the caduceus symbol.
SEP 1 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Spineart % Franck Pennesi International Center Cointrin 20 Route de Pre-Bois, CP1813 Geneva Switzerland 1215
Re: K091873
Trade/Device Name: TRYPTIK CA Anterior Intersomatic Cervical Cage Regulation Number: 21 CFR 888,3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: ODP
Dated: June 22, 2009
Received: June 23, 2009
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.
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 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.
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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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Voubeu Muchm
Mark N. Melker 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): Device Name: TRYPTIK ca Indications for Use:
TRYPTIK®ca 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®ca are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK®ca are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage
Prescription Use | ★ AND/OR (Part 21 CFR 801 Subpart D)
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)
Kareem S. Burney for MxM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091873
Page 13 / 256
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§ 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.