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The Plasmapore® XP Spinal Implant System are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion surgery at the involved spinal level(s). The Plasmapore® XP Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The Plasmapore® XP Spinal Implants can be used individually or in pairs. The Plasmapore® XP Spinal Implant System is also intended for use with autogenous bone graft.

Patients must have undergone a regiment of non-operative treatment prior to being treated with the device.

The Plasmapore® XP Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK – Optima (per ASTM F2026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have titanium alloy (TiAl6V4) radiographic markers per ISO 5832-3.

The provided document, K132421, describes the 510(k) premarket notification for the Plasmapore® XP Spinal Implant System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about clinical studies with human participants, AI algorithms, or related ground truth establishment, expert consensus, or multi-reader multi-case studies.

Therefore, the following information is extracted directly from the provided text, and many of the requested sections related to AI performance, human user studies, and ground truth are not applicable or not present in this type of submission.

Acceptance Criteria and Device Performance

The device's premarket submission is based on demonstrating substantial equivalence to existing predicate devices through a series of non-clinical, laboratory performance tests. The acceptance criteria are implicitly that the Plasmapore® XP Spinal Implant System "meets or exceeds the performance of the predicate devices" for the tested parameters.

Study Details

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

   • This submission describes non-clinical (laboratory) testing of the device, not a human clinical study or AI algorithm test set. Therefore, there is no "test set" of patient data in the context of an AI algorithm or clinical trial. The "samples" would typically refer to physical device specimens tested in a laboratory. The document does not specify the number of device samples used for each test.
   • Data Provenance: Not applicable as it refers to non-clinical laboratory testing. The testing was performed by Aesculap, an American company (or its affiliates under the Aesculap brand), suggesting the data originates from their internal testing or third-party labs.

2. 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. Ground truth in this context is established by standardized laboratory testing methods (ASTM and ISO standards) and the physical properties/performance of the device specimens, rather than human expert interpretation of data.

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

   • Not applicable. This pertains to non-clinical laboratory testing.

4. 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 submission concerns a physical medical device (spinal implant), not an AI-assisted diagnostic or interpretative system.

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

   • Not applicable. This submission concerns a physical medical device, not an AI algorithm.

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

   • The "ground truth" for this device's performance is derived from standardized physical and mechanical testing protocols (ASTM and ISO standards) applied to device specimens in a laboratory setting. The acceptability is determined by meeting or exceeding the performance thresholds of the predicate devices under these controlled conditions.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm. There is no "training set" in this context.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI algorithm.

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