(111 days)
The Sterispine™M CC is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. Sterispine™ CC is intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
Sterispine™ CC system includes one cervical cage and four cervical fixations (two cervical fixations screws and two rescue screws) but only two screws are used within the cervical cage. Implantable components of Sterispine™ CC are made of Titanium Ta6V Eli grade conforming to ASTM F136 for screws and the cervical cage is made of VESTAKEEP i4R (PEEK) conforming to the ASTM F2026 with one Tantalum marker conforming to ASTM F560 to visualize the position of the cervical cage in the disc space. The Sterispine™ CC range of products is supplied sterile with a sterile single-use set of surgical instruments.
This document describes the 510(k) premarket notification for the Sterispine™ CC intervertebral body fusion device. It does not contain information about an AI/ML medical device, human readers, or AI assistance. Therefore, it is impossible to describe the acceptance criteria and study proving device performance as requested in the format of the prompt.
The document primarily focuses on demonstrating substantial equivalence of the Sterispine™ CC to predicate devices through technical characteristics, indications for use, and a series of mechanical tests.
The information provided in the document pertains to a medical device (intervertebral body fusion device) and not an AI or imaging-based diagnostic device. Therefore, the questions related to AI/ML device performance, human readers, ground truth, and training/test sets are not applicable.
However, I can extract the information relevant to this specific device from the provided text:
Acceptance Criteria & Device Performance (Based on Mechanical Testing for Substantial Equivalence):
The document implicitly states that acceptance criteria were met by demonstrating "substantially equivalent performance to the identified predicate devices" through various mechanical tests. The specific numerical acceptance criteria (e.g., minimum load, maximum displacement) for each test are not explicitly provided in the text, only that the device met the requirements.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance (per FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and ASTM Standards) | The Sterispine™ CC demonstrated substantially equivalent performance to the identified predicate devices in the following tests: |
| Static Compression | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Static Compression Shear | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Static Torsion | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Dynamic Compression | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Dynamic Compression Shear | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Dynamic Torsion | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Subsidence | Performance compliant with ASTM F2267. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Expulsion | Performance compliant with an "in-house protocol". Specific values for the Sterispine™ CC are not provided, only that it met the protocol. |
| Wear testing | Performance compliant with ASTM F1877. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Material Conformance | Implantable components are made of Titanium Ta6V Eli grade conforming to ASTM F136 (screws) and VESTAKEEP i4R (PEEK) conforming to ASTM F2026 (cervical cage). Tantalum marker conforms to ASTM F560. |
| Sterility | Supplied sterile for single-use. |
Information Not Applicable to This Device (as it's not an AI/ML medical device):
- Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices for mechanical testing, not a dataset of patient images or clinical data. The provenance of the physical test units is not specified.
- 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. Ground truth for mechanical testing is based on engineered specifications and standardized test methods, not clinical expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 imaging or AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the requirements of the ASTM standards and the FDA guidance document for intervertebral body fusion devices. This is a physical "truth" established by engineering metrology and material science, not clinical or image-based ground truth.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.