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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.

When used as a lumbar intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I 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 Chesapeake Spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.

The Chesapeake Spinal System consists of PEEK and titanium spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers 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 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 Chesapeake intervertebral body fusion devices are designed to provide support and stabilization of the cervical and lumbar segments of the spine.

The purpose of this 510(k) submission is to add offset cervical implants to the system.

The provided text is a 510(k) summary for a medical device (Chesapeake Spinal Stabilization System) seeking substantial equivalence to predicate devices. It focuses on the device's design, materials, intended use, and comparison to existing products based on mechanical testing. It does not contain information about acceptance criteria for device performance in terms of diagnostic accuracy, nor does it describe a study involving human readers or AI in a diagnostic context.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods for ground truth, MRMC studies, or standalone algorithm performance in a diagnostic context.
• Ground truth type for diagnostic purposes.
• Sample size for training sets in a diagnostic context.
• How ground truth for a training set was established in a diagnostic context.

The document focuses on the mechanical and biological safety and efficacy of an implantable device, not a diagnostic AI.

However, I can extract the following information about the device's performance based on the type of study presented (mechanical testing):

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical Testing):

2. The Study that Proves the Device Meets Acceptance Criteria:

The study referenced is a mechanical testing study performed in accordance with ASTM 2077.

Details on the study:

• Sample size used for the test set: Not explicitly stated for each test, but standard mechanical testing involves a sufficient number of samples to demonstrate statistical significance or conformity to standards.
• Data provenance: Not applicable in the context of diagnostic data. The "data" here are mechanical test results from the manufactured device.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for mechanical testing is defined by the ASTM standards and the physical properties measured.
• Adjudication method for the test set: Not applicable. Performance is measured against physical standards specified in ASTM 2077.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is a mechanical device, not a diagnostic AI.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable. This is a physical device, not an algorithm.
• The type of ground truth used: Standardized mechanical properties and performance established by ASTM 2077 specifications and comparison to the mechanical performance of established predicate devices.
• The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical device testing as described here.
• How the ground truth for the training set was established: Not applicable.

Summary of what is presented in the 510(k) summary:

The Chesapeake Spinal Stabilization System underwent mechanical testing (static compression, dynamic compression, static torsion, dynamic torsion, subsidence, and expulsion) as per ASTM 2077. The reported performance is that the device was "determined to be substantially equivalent to predicate devices." This statement implies that the device's mechanical properties and performance met or exceeded the established safety and effectiveness benchmarks set by the predicate devices and the relevant ASTM standard. The purpose was to demonstrate substantial equivalence for regulatory approval, not to assess diagnostic performance.

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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.

When used as a lumbar intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I 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 (DD) 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 Chesapeake spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.

The Chesapeake Spinal System consists of PEEK spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. The bone contacting surfaces of the implants have machined teeth which are designed to engage with the vertebral body endplates. Tantalum markers are embedded within the spacers identify the location and orientation of the implants to radiographically. Implants with footprints ranging from 24x30mm-28x36mm are available to accommodate anatomical variations. The purpose of this submission is to add 30x40mm footprints to the system.

The provided text describes a 510(k) summary for the Chesapeake Spinal System, an intervertebral body fusion device. While it details the device's description, intended use, materials, and substantial equivalence to predicate devices, it does not contain information about acceptance criteria or specific studies proving the device meets performance criteria.

The document is a regulatory submission demonstrating substantial equivalence to existing legally marketed devices, rather than a report on a clinical or performance study with defined acceptance criteria and results.

Therefore, I cannot provide the requested information based on the input text. The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and intended use, rather than requiring new clinical performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) submission might.

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The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Chesapeake implants are intended for spinal fusion procedures in skeletally mature patients who have had six months of non-operative treatment.

When used as intervertebral body fusion devices, the implants are indicated 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. This device is intended to be used with autogenous bone graft.

When used as vertebral body replacement devices the Chesapeake implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Chesapeake implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The interior of the spacer may be packed with allograft or autograft.

The Chesapeake Spinal System consists of PEEK spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers 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 spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTMA LT1 (Invibio) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads are 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 lumbar segments of the spine.

The provided document is a 510(k) summary for the Chesapeake Spinal System, an intervertebral body fusion device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets, data provenance, number of experts for ground truth, or adjudication methods for a study.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone (algorithm only) performance studies.
• The type of ground truth used in such studies.
• Sample size for training sets or how ground truth for training sets was established.

Instead, the document states:

"Documentation was provided which demonstrated that the subject Chesapeake Spinal System components are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501)."

And further, it claims:

"There are no significant differences between the Chesapeake Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."

This indicates that the "study" proving the device met its acceptance criteria was a substantial equivalence comparison to predicate devices, rather than a new performance study against pre-defined acceptance criteria. The acceptance criteria for a 510(k) submission are typically that the device is as safe and effective as a legally marketed predicate device, based on comparison of technological characteristics, materials, and intended use. Performance data, if present in a 510(k), is usually bench testing or non-clinical data demonstrating equivalence to the predicate, not clinical performance against specific acceptance metrics.

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