(92 days)
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation.
When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
The Chesapeake Spinal System consists of interbody implants and titanium bone screws intended for fusion, without the need for supplementary fixation. The implants are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The cervical interbody implants are made of CP titanium and the screws are fabricated from Ti6Al4V titanium, in accordance with ASTM F67 and F1472
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical segments of the spine.
This document, K111439, describes the 510(k) summary for the Chesapeake Spinal System from K2M, Inc. It's a medical device submission, and as such, the "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to existing legally marketed devices, rather than a clinical study establishing AI performance metrics.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone AI performance) are not applicable in the context of this device and its 510(k) submission. This is a traditional medical device, not an AI/ML-driven device.
Here's the breakdown based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Mechanical Testing | Device performance should be "equally to or better than" predicate devices in static and dynamic compression, expulsion, subsidence, and torsion, in accordance with ASTM F2077 and F2267. | "The Chesapeake Spinal System performed equally to or better than these systems in static and dynamic compression, expulsion, subsidence, and torsion, in accordance with ASTM F2077 and F2267." |
| Component Comparison | Device components should be "substantially the same as" predicate devices. | "[Other] components were also compared and the Chesapeake Spinal System was found to be substantially the same as these systems." |
| Design, Function, Material, Intended Use Equivalence | No significant differences compared to other marketed wires (implants) that would affect the use of the product, and it should be substantially equivalent to other devices in design, function, material, and intended use. | "There are no significant differences between the K2M implants and other wires currently being marketed. This will not affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." |
| Materials | Cervical interbody implants made of CP titanium and screws from Ti6Al4V titanium, in accordance with ASTM F67 and F1472. | "The cervical interbody implants are made of CP titanium and the screws are fabricated from Ti6Al4V titanium, in accordance with ASTM F67 and F1472." (This is a description, but implicitly an acceptance criterion for material compliance.) |
| Intended Use | To be used with bone screws provided, requiring no additional supplementary fixation. Indicated as a cervical intervertebral body fusion device with autogenous bone graft in skeletally mature patients, at one level (C2-T1) for cervical disc disease (discogenic neck pain with degeneration confirmed by history/radiography), for patients with six weeks of non-operative treatment. | "The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment." (This is a statement of intended use, which the device is claimed to meet.) |
The subsequent points (2-9) are largely not applicable to this 510(k) submission, as it pertains to a mechanical intervertebral body fusion device, not an AI/ML diagnostic or prognostic tool. The "study" mentioned is primarily a series of mechanical bench tests demonstrating physical equivalence to predicate devices.
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 specified for a clinical AI test set. The "test set" here refers to the physical devices and materials used in the mechanical and material testing. The document does not specify the number of devices or components tested. The provenance would be the manufacturing site of K2M, Inc. (Leesburg, VA, USA).
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. No expert ground truth establishment for an AI test set is mentioned. The ground truth for mechanical testing is established by engineering standards (ASTM F2077, F2267).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies in image interpretations or other subjective assessments in AI studies. It is not relevant for mechanical device testing.
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, not applicable. This is a mechanical device, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Standards / Material Specifications: For mechanical testing, the "ground truth" is defined by the performance requirements outlined in the ASTM standards (F2077, F2267) and the material specifications (ASTM F67, F1472). For the comparison to predicates, the "ground truth" is the established performance and characteristics of those predicate devices.
8. The sample size for the training set
- Not applicable. There is no AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML model or training set, this question is irrelevant.
§ 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.