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The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK Spacers are to be implanted via posterior approach.

The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The AVS PL Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The AVS PL PEEK Spacers are rectangular shaped, hollow frame implants with lateral fenestrations. The spacers incorporate two (2) Tantalum marker pins to aid in radiographic visualization.
The AVS PL PEEK Spacers are available in a variety of sizes, from 6 mm to 13 mm in height, two lengths: 30 mm and 33 mm and one width: 11 mm. There are also 0° and 4° wedge shaped options that allow the surgeon to best choose the size suited to the patient's anatomy and pathology.

The device described is the Stryker Spine AVS PL PEEK Spacers, an intervertebral body fusion device. The submission is a Traditional 510(k) Premarket Notification (K073470).

The provided text describes a medical device submission (510(k)) and its clearance. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing specific performance acceptance criteria for a new, innovative diagnostic device that requires rigorous clinical study with statistical endpoints.

Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or could not be extracted from the provided document. The document describes a device for spinal fusion, not a diagnostic AI device. The "study" mentioned is a set of bench tests to confirm mechanical and material properties, rather than a clinical trial to assess diagnostic accuracy or algorithm performance.

Here's an attempt to answer the questions based on the available information, noting the limitations:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in the format typically seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for a medical implant like this are related to its material properties, mechanical strength, and biocompatibility, ensuring it functions as intended and is safe. The performance is reported in terms of meeting the requirements of recognized standards.

Note: The document references compliance with a Class II Special Controls Guidance Document for Intervertebral Body Fusion Devices. This guidance document would outline the specific benchmarks and testing methodologies (e.g., static and dynamic compression, subsidence, expulsion, torsional testing) that the device must meet to demonstrate substantial equivalence to legally marketed predicates. The provided text confirms that such testing was performed and demonstrated substantial equivalent performance, but does not list the specific quantitative criteria or results.

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

• Sample Size for Test Set: Not applicable in the context of a diagnostic dataset. The "test set" for this device would refer to the physical prototypes subjected to bench testing. The document does not specify the number of individual spacers tested, but rather states that "Testing... was performed."
• Data Provenance: Not applicable in the context of diagnostic data. The "data" pertains to engineering and material testing results.

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

Not applicable. Ground truth for mechanical and material properties is established through standardized engineering tests and measurements, often conducted by engineers or technicians, rather than clinical experts or radiologists.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. For device performance based on engineering tests, the results are objectively measured against predefined standards.

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. This device is an intervertebral body fusion spacer, not an AI-powered diagnostic tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant.

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

No. This device is a physical medical implant, not an algorithm.

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

The "ground truth" for this device would be established engineering standards, material specifications, and biomechanical performance requirements as outlined in relevant ASTM/ISO standards and the FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." It's based on objective measurements from bench testing to ensure mechanical integrity, biocompatibility, and functional equivalence to predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable.

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