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The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:

• Degenerative disc disease [DDD] defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
• Spondylolisthesis
• Spinal Stenosis
• Tumors
• . Trauma (i.e. fracture)

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

Acceptance Criteria and Device Performance Study for SpineSmith Cequence Anterior Cervical Plate System

The SpineSmith Cequence Anterior Cervical Plate System's acceptance criteria and performance are established through mechanical testing demonstrating substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document refers to "mechanical test results" in general, but does not specify the number of devices or iterations tested.
• Data Provenance: Not explicitly stated, however, the data would be generated in a laboratory setting as part of the device's design verification and validation. This is a prospective study in that tests are conducted on newly manufactured devices.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable. The ground truth for this device is established through objective mechanical testing against a predicate device, not through expert consensus on clinical cases.

4. Adjudication Method for Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., image interpretation), which is not relevant to mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a medical device for spinal fixation, and its performance is evaluated through mechanical testing, not by human readers interpreting images. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a physical implant, not an algorithm. Its performance is inherent to its design and material properties demonstrated through mechanical testing.

7. Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The ground truth is based on established mechanical testing standards relevant to spinal implants and the performance characteristics of a legally marketed predicate device. This involves objective, quantifiable measurements.

8. Sample Size for Training Set

• Not applicable. This is a physical medical device, not an algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

• Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:

• . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• . Spondylolisthesis
• Spinal Stenosis .
• Tumors .
• Trauma (i.e. fracture) .

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

The provided document is a 510(k) Summary for the SpineSmith Cequence Anterior Cervical Plate System. This document describes a medical device, specifically a spinal implant, and its mechanical testing for substantial equivalence to a predicate device.

Here's an analysis of the document regarding acceptance criteria and a study proving the device meets them, based on the provided questions:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical test results" but does not specify the sample size used for these mechanical tests. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it's a 510(k) for a spinal implant, the "data" would likely refer to physical testing of components and assemblies.

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)

This question is not applicable to this type of device and study. The "ground truth" for mechanical testing of a spinal implant is typically established by engineering standards and validated test methods, not by expert consensus in the medical field.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human assessment or a diagnostic device.

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 a spinal implant, not a diagnostic device involving human readers or AI assistance.

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

Not applicable. This is a spinal implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance is based on established mechanical engineering standards and validated test methodologies for spinal implants. The goal was to show "substantial equivalence" to a predicate device, meaning its mechanical properties and safety profile are comparable.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant.

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

Not applicable. There is no "training set" for this type of device and study.

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