(130 days)
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, noncervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:
- Trauma (i.e. fracture or dislocation).
- Spinal stenosis.
- Vertebral tumors.
- Pseudoarthrosis and failed previous fusion in skeletally mature patients.
- Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
The system is intended to be used with autograft or allograft to facilitate fusion.
The CB PROT II Posterior Spinal System consists of non-sterile rods, monoaxial and polyaxial pedicle screws. The thoraco-lumbar rods are available in a variety of lengths (one diameter). Screws are available in various lengths and diameters according to practical requirements.
This document is a 510(k) premarket notification for a medical device called the "CB PROT II Posterior Spinal System." It is a regulatory submission to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
The document does not describe an acceptance criteria or study for an AI/CADe/CADx device that relies on diagnostic performance metrics like sensitivity, specificity, or AUC, nor does it involve human readers, expert ground truth, or training sets in the typical sense of AI device evaluation.
Instead, this document describes the acceptance criteria and a study for a spinal implant system, which is a physical device subject to mechanical and material performance standards. Therefore, the questions in the prompt, which are tailored for AI/diagnostic devices, do not directly apply to this submission.
However, I can extract the information relevant to the device's "performance" and "acceptance criteria" in the context of this specific regulatory submission for a spinal system:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material: Components manufactured from medical grade titanium alloy (Ti6Al4V) meeting ASTM F136 & ISO 5832-3 standards. | Components are manufactured from medical grade titanium alloy (Ti6Al4V) that meets ASTM F136 & ISO 5832-3. |
| Mechanical Performance: Performance as well as or better than the predicate device (SmartLocTM spinal fixation system) in:Static axial compression bending testDynamic axial compression bending testStatic torsion test (All referring to ASTM F1717 standards). | The results represented that the CB PROT II Posterior Spinal System performs as well as or better than the predicate device in static/dynamic axial compression bending tests and static torsion tests, conducted referring to ASTM F1717. |
| Substantial Equivalence: Demonstrated substantial equivalence to predicate system with respect to technical characteristics, performance, and intended use. | The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a test set of images or patient data. For mechanical testing, the "test set" would refer to the number of physical device units tested. This specific number is not provided in the summary, but such tests typically involve multiple units to ensure statistical significance for mechanical properties. The provenance is implied to be from the manufacturer's internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/diagnostic device that requires expert review for ground truth in clinical data. The "ground truth" for this device relates to engineering specifications and mechanical performance standards.
4. Adjudication method for the test set
Not applicable. There is no adjudication method described as this is not a diagnostic performance study involving human reviewers.
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 not an AI-assisted diagnostic device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to meet mechanical standards independently, which was indeed what the mechanical tests evaluated.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation is based on established engineering and material science standards (ASTM F136, ISO 5832-3, ASTM F1717) and comparative performance against a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
Chin Bone Technique Corporation Mr. Cheng-Kung Cheng Number 165, Section 2, Xi'an Street, Beitou District Taipei, Taiwan 11274 CHINA
Re: K142655
Trade/Device Name: CB PROT II Posterior Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: December 26, 2014 Received: December 31, 2014
Dear Mr. Cheng:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Cheng-Kung Cheng
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142655
Device Name CB PROT II Posterior Spinal System
Indications for Use (Describe)
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, noncervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:
- Trauma (i.e. fracture or dislocation).
- Spinal stenosis.
- Vertebral tumors.
- Pseudoarthrosis and failed previous fusion in skeletally mature patients.
- Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
The system is intended to be used with autograft or allograft to facilitate fusion.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92(c).
| Submitter Information: | Chin Bone Technique Corp.No. 165, Sec. 2, Xi'an St., Beitou Dist.Taipei 11274, Taiwan, R.O.C. |
|---|---|
| Contact Person: | Prof. Cheng-Kung Cheng |
| TEL: +886-2-2827-4262 | |
| Fax: +886-2-2822-8557 | |
| E-mail: ckcheng@chin-bone.com | |
| Date prepared: | December 26, 2014 |
| Trade Name: | CB PROT II Posterior Spinal System |
| Device Class: | Class II |
| Produce Code: | MNI, MNH |
| Common Name: | Pedicle screw system |
| Classification Name: | Pedicle screw spinal system |
| Regulation Number: | 21 CFR 888.3070 |
| Predicate Devices: | SmartLocTM spinal fixation system (K111883) |
| Material: | The CB PROT II Posterior Spinal System componentsare manufactured from medical grade titanium alloy(Ti6Al4V) that meets ASTM F136 & ISO 5832-3 |
Device Description:
The CB PROT II Posterior Spinal System consists of non-sterile rods, monoaxial and polyaxial pedicle screws. The thoraco-lumbar rods are available in a variety of lengths (one diameter). Screws are available in various lengths and diameters according to practical requirements.
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Indications for Use:
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, non-cervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:
- Trauma (i.e. fracture or dislocation). -
- Spinal stenosis. -
- Vertebral tumors. -
- Pseudoarthrosis and failed previous fusion in skeletally mature patients. -
- Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
The system is intended to be used with autograft or allograft to facilitate fusion.
Performance Data:
Mechanical testing including static/dynamic axial compression bending test and static torsion test were conducted referring to ASTM F1717 to demonstrate substantial equivalence to the predicate system. The results represented that the CB PROT II Posterior Spinal System performs as well as or better than the predicate device.
Conclusion of Substantial Equivalence:
The CB PROT II Posterior Spinal System has been demonstrated to be substantially equivalent to predicate system with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device.
N/A