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When Optio-C Anterior Cervical Plate is used with structural allograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1). The implant has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of the Optio-C Anterior Plate with structural allograff/ autograft include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The Optio-C Anterior Cervical Plate is intended to be used with a structural allograft and with three Optio-C bone screws.

When Optio-C Anterior Cervical Plate is used with an Optio-C PEEK IBF Spacer it becomes an Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD), indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.

The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.

The Optio-C Anterior Cervical System consists of two different configurations, an Optio-C Anterior Cervical PEEK Intervertebral Body Fusion Device (IBFD) (K132894, SE on January 16, 2014) and the subject of this submission, the Optio-C Anterior Cervical Plate System. Both configurations share the same cervical plate, bone screws and instrumentation and are used only in anterior surgical procedures and at the same spinal level of C2 to T1.

The subject cervical plate and bone screws of this submission are designed for use with structural allograft or autograft and is supplied sterile to the end user. The bone screws and instrumentation are supplied non-sterile and are intended to be sterilized by the end user.

The cervical plate with an Optio-C PEEK IBF Spacer or an allograft/autograft is placed in the cervical disc space, flush with the adjacent vertebral bodies. Bone screws pass through the screw holes of the plate and affix to bone to help prevent implant migration. The implant construct can be implanted in two orientations: Standard orientation, two screws cephalic and one screw caudal or Inverted orientation, one screw cephalic and two screws caudal.

The Optio-C Anterior Cervical Plate System is a stand-alone system designed to provide structural stability in skeletally mature individuals following discectomy. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The Optio-C Anterior Cervical Plate System is used with structural bone graft material and is manufactured from Titanium with Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

The Optio-C Anterior Cervical System is provided for single use only.

The provided document is a 510(k) premarket notification for the Optio-C Anterior Cervical System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of document.

However, I can extract information related to the device description, indications for use, and a summary of performance testing that aims to establish substantial equivalence.

Here's a breakdown of the information that can be extracted, and where the requested details are not applicable:

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

The document does not provide a table of acceptance criteria in terms of specific performance targets (e.g., accuracy, sensitivity, specificity, or clinical outcomes) for the Optio-C Anterior Cervical System as would be found for a diagnostic or AI-based device. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices. The reported device performance is qualitative, indicating acceptability for intended use and substantial equivalence to predicates.

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

This information is not provided. The document describes bench testing (mechanical tests) and cadaveric testing (biomechanical tests), but not a patient-based "test set" in the context of clinical data for an AI/diagnostic device.

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. The ground truth for this type of device (spinal implant) is related to mechanical and biocompatibility standards, and biomechanical performance, not expert assessment of clinical images or data.

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

Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints, not for the engineering and biological tests described for this spinal implant.

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 an AI-assisted diagnostic device or a system for human readers to interpret.

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

Not applicable. This is a physical medical device (spinal implant), not an algorithm.

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

The "ground truth" for the performance testing of this device is based on:

• Engineering standards: ASTM 1717 for mechanical properties.
• Biomechanical principles: Used in cadaveric testing.
• Biological safety standards: ISO 11137, ISO 11737, ISO 11607, ISO 17665, AAMI TIR12 for sterilization and packaging; ISO 10993-1 for biocompatibility.
• Comparison to predicate devices: The ultimate "standard" for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

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

Not applicable, as there is no "training set."

Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for this device type):

The "study" described in the document is a series of non-clinical performance tests designed to demonstrate that the Optio-C Anterior Cervical System is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.

Components of the Study:

• Bench Testing: Performed according to ASTM 1717 for Static Torsion, Static and Dynamic Compression Bending. This tested the mechanical properties of the cervical plate. The results concluded that its performance is "acceptable for its intended use" and comparable to the predicate devices (Synthes CSLP and Trinica devices).
• Design Validation / Cadaver Testing: This type of testing assesses the biomechanical performance and confirms the device's acceptability for its intended use, ensuring substantial equivalence to the predicate(s).
• Biomechanical Cadaveric Testing: Conducted to evaluate the device's performance in a more realistic anatomical setting.
• Sterilization Validation:
  • Gamma Sterilization: Performed for sterile implant components under international standards ISO 11137 and ISO 11737.
  • Packaging Sterility Testing: Conducted per ISO 11607 to ensure the packaging maintains a sterile barrier.
  • End-user Sterilization: Validated for non-sterile components (instrumentation and bone screws) under ISO 17665 and AAMI TIR12 to ensure equivalence to predicate devices, including dry time and cleaning instructions.
• Biocompatibility Assessment: Conducted per ISO 10993-1 to ensure the materials used in the Optio-C System are biocompatible and similar to those of the predicate devices.

Conclusion of the Study:

The document explicitly states: "The test results conclude the Optio-C™ Anterior Cervical Plate System to be substantially equivalent to the predicate devices listed above." It further notes that "The Optio-C Anterior Cervical Plate System performance, intended use and fundamental scientific technology remain unchanged from the predicate devices. The implant construct design does not change the stabilization fixation of the cervical vertebra found in the predicate devices. The Optio-C Anterior Cervical Plate is substantially equivalent to the predicate devices, a traditional anterior cervical plate."

In essence, the "acceptance criteria" for this 510(k) submission are met by demonstrating that the device performs mechanically, biologically, and functionally in a manner that is substantially equivalent to already approved predicate devices for the same indications for use.

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The Optio-C™ Anterior Cervical Intervertebral Body Fusion Device (IBFD) is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C™ IBFD is comprised of one Optio-C™ PEEK IBF Spacer, one Optio-C™ Anterior Cervical Plate and three Optio-C™ bone screws.

The Optio-C™ IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.

The Optio-C™ Anterior Cervical System is comprised of an anterior cervical plate, PEEK IBF spacer and three bone screws and is intended for stand-alone cervical interbody fusion procedures at one level from C2 to T1. The subject device is used to provide structural stability in skeletally mature individuals following discectomy and is offered in multiple contours, lordotic angles, footprints and heights in order to accommodate variations in cervical anatomy.

The plate and PEEK spacer are assembled prior to implantation and placed in the disc space, flush with the adjacent vertebral bodies via an anterior surgical approach. The PEEK spacer is filled with autograft to facilitate fusion. The bone screws pass through the screw holes of the plate and affix to bone to help prevent implant migration.

The plate, with integrated anti-backout locking cap mechanism, is offered in a standard width (16mm)as a one-level configuration in multiple heights (6-12mm). The Diamond Tip bone screws are offered in self-drilling and self-tapping tip design, with a variableangle and have a cortical/cancellous thread design.

The subject device can be implanted in two orientations: Standard orientation- two screws cephalic and one screw caudal or Inverted orientation- one screw cephalic and two screws caudal.

The plate and screws are also made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The PEEK spacer is manufactured from radiolucent Polyetheretherketone (PEEK) per ASTM F2026 and contains radiographic markers comprised of Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136.

The plate and PEEK spacer are supplied sterile; the bone screws and instrumentation are supplied non-sterile and are to be sterilized by the end user.

The Optio-C™ Anterior Cervical System is supplied with the instrumentation necessary for use of the system, e.a. trials, rasps, and inserters that facilitate assembly, insertion and removal of the implants.

The provided text describes a medical device, the Optio-C™ Anterior Cervical System, and its clearance by the FDA. However, it does not include information about acceptance criteria for device performance, nor does it detail a study proving the device meets specific acceptance criteria in the way clinical studies for diagnostic or AI-powered devices usually do.

The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing efficacy or accuracy through new clinical trials with defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment is not present in the provided document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the context of specific performance metrics with acceptance limits. The document describes bench testing conducted to ensure the device's mechanical properties, material biocompatibility, and sterility, with the general statement that "performance is acceptable for its intended use" and that the device is "substantially equivalent" to predicate devices. There are no quantitative acceptance criteria or reported specific performance results in terms of sensitivity, specificity, or similar metrics for diagnostic devices.

The bench tests performed are:

• For the Intervertebral Body Fusion Device (IBFD):
  • ASTM F2077 Static and Dynamic Axial Compression
  • ASTM F2077 Static and Dynamic Compression Shear
  • ASTM F2077 Static and Dynamic Torsion
  • ASTM F2267 Subsidence testing
• For the cervical plate:
  • ASTM 1717 Static Torsion
  • ASTM 1717 Static and Dynamic Compression Bending
• Other tests:
  • Wear Testing for particulate evaluation (ASTM 1877)
  • Gamma Sterilization (ISO 11137 and ISO 11737)
  • Packaging Sterility Testing (ISO 11607)
  • Sterilization for end user facility (ISO 17665 and AAMI TIR12)
  • Biocompatibility Assessment (ISO 10993-1)

The document states that "The test results conclude the Optio-C™ Anterior Cervical System to be substantially equivalent to the predicate devices listed above." This implies that the device performed comparably to, or within acceptable limits defined by, the predicate devices for these engineering and material tests.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and therefore not provided in the document as it describes a medical implant (hardware), not an AI/diagnostic device that would typically have test sets of data (e.g., images, patient records). The "testing" referred to is bench testing on the physical device components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and therefore not provided. The ground truth for mechanical and material properties of an implant is established through validated engineering standards (ASTM, ISO) and laboratory measurements, not through expert consensus on a test set of data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for human expert ground truth establishment in studies involving interpretation of data, which is not the nature of this device's testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable and therefore not provided. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI-assisted interpretation, especially concerning human reader performance. The Optio-C™ Anterior Cervical System is a physical implant, not a diagnostic tool requiring interpretation.

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

This information is not applicable and therefore not provided. This concept is for AI algorithms, not for physical medical implants.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" is defined by established engineering standards and material specifications (e.g., ASTM F2077, ASTM F2267, ASTM 1717, ASTM 1877, ISO 11137, ISO 11737, ISO 11607, ISO 17665, AAMI TIR12, ISO 10993-1). The device's performance is compared against these standards or against the performance of predicate devices as measured against these standards.

The document also mentions "Design Validation / Cadaver Testing will be conducted to ensure the Optio-C™ Anterior Cervical System performance is acceptable for its intended use and to ensure substantial equivalence to the predicate(s)." This type of testing would assess the device's mechanical stability and surgical handling in a more realistic setting, with the "ground truth" being the device's ability to maintain structural integrity and facilitate fusion as intended, likely compared to established clinical benchmarks or predicate performance. However, no results from this cadaver testing are included in this summary.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. "Training set" refers to data used to train AI models, not relevant for this physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a cervical spine implant to previously cleared predicate devices through engineering bench testing and material compatibility assessments, rather than presenting clinical study data with specific performance acceptance criteria found in submissions for diagnostic or AI-powered devices. Much of the requested information is not relevant to this type of device and submission.

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