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When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System 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 radies), The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤ 15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screw and 3-screw implants, respectively),

The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA ® LT1 (Invibio™) per ISO 10993-1 USP Class VI, and ASTM F2026 and CP titanium per ASTM F67. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560. The screws are fabricated from Ti6Al4V per ASTM 1472.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

The purpose of this 510(k) submission is primarily to add additional cervical and lumbar lordotic implants.

This document is a 510(k) premarket notification for the K2M Chesapeake Stabilization System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance evaluations (mechanical testing). Therefore, it does not contain the type of information typically found in a study proving a device meets acceptance criteria related to clinical performance or AI/software analysis.

Based on the provided text, the device is a medical implant, and the approval is based on demonstrating substantial equivalence to predicate devices, primarily through non-clinical mechanical testing. There is no mention of a "study" in the sense of a clinical trial or a dataset-based performance evaluation as would be done for an AI/software device.

Here's an analysis based on the information that is present in the document, and what is absent:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit from Mechanical Testing Standards): The document states that mechanical testing was performed "per ASTM F2077" (static compression, static compression shear, dynamic compression, dynamic torsion) and "per ASTM F2267" (expulsion, subsidence). For a device to be "substantially equivalent" based on these tests, it must meet the performance requirements or be comparable to the predicate devices when tested to these standards. The specific quantitative acceptance criteria (e.g., minimum load to failure, maximum deformation) are not explicitly stated in this summary document but would be defined within the referenced ASTM standards and often compared directly to the predicate's performance.
• Reported Device Performance: The document only states that "the proposed implants were determined to be substantially equivalent to predicate devices." It does not provide numerical results for the mechanical tests.

2. Sample size used for the test set and the data provenance

• Sample Size: For mechanical testing, this refers to the number of test specimens. This information is not provided in the summary.
• Data Provenance: Not applicable in the context of mechanical testing for a 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not relevant to this document. The "ground truth" for mechanical testing is derived from the physical properties and behavior of the materials and device design when subjected to specified loads, evaluated against engineering standards, not through expert human assessment of images or clinical outcomes.

4. Adjudication method for the test set

• This question is not relevant to this document. Adjudication methods like 2+1 or 3+1 are used for clinical or image interpretation studies where there's a need to resolve discrepancies among human readers/experts.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done

• No. This document describes a medical device (spinal stabilization system) and a 510(k) submission primarily based on non-clinical mechanical testing. MRMC studies are typically performed for diagnostic devices, particularly those involving human interpretation of medical images, often comparing human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This question is not relevant to this document as it relates to an algorithm/AI performance, which is not what this submission is about.

7. The type of ground truth used

• Mechanical Properties and Standards Conformance: The "ground truth" for this device's performance evaluation is implicit in the internationally recognized ASTM standards (ASTM F2077, ASTM F2267) which define methodologies for testing spinal implants. The device's physical performance (e.g., strength, stability, resistance to expulsion) under simulated physiological conditions is the "truth" being assessed for substantial equivalence.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device (implants) and mechanical testing, not an AI or software device that would require a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, there is no training set for a physical device.

In summary:

This 510(k) summary report details the premarket notification for a physical medical device, the Chesapeake Stabilization System, which is an intervertebral body fusion device. The primary method of demonstrating substantial equivalence for this submission was non-clinical mechanical testing according to established ASTM standards. The document does not describe a clinical study or an AI/software performance study with acceptance criteria, sample sizes, expert adjudication, or ground truth establishment as would be typically requested for software as a medical device (SaMD) or AI-enabled diagnostics. The acceptance criteria are implicitly meeting the performance requirements of the referenced ASTM standards and demonstrating equivalence to predicate devices in those mechanical tests, though specific numerical results are not provided in this summary.

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