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When intended for pedicle screw fixation from T1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

The existing, commercially available Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System ("PathFinder NXT System") consists of various screws, rods and associated accessories and is intended to provide temporary stabilization following surgery to fuse the spine. The PathFinder NXT screws are polyaxial cannulated designs with a range of spinal rod lengths. The PathFinder NXT System allows the surgeon to place polyaxial pedicle screws either through an open or mini-open procedure. The percutaneous insertion rods are for minimally invasive procedures. The PathFinder NXT System is designed to aid in the surgical correction of several types of spinal conditions and intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass.

Additionally, the PathFinder NXT System includes instrumentation to facilitate the implantation of the PathFinder NXT implants.

The provided document describes the acceptance criteria and the study conducted for the Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System to demonstrate its substantial equivalence to predicate devices, rather than an AI/ML device. Therefore, many of the requested fields, such as those pertaining to AI/ML specific studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth for training set) are not applicable to this submission.

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to legally marketed predicate devices in terms of design, materials, function, and intended use. The study focuses on performance testing to confirm this equivalence.

Here's a summary based on the provided text, with "N/A" for fields not relevant to this type of medical device submission:

1. 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)

• Sample Size for Test Set: Not explicitly stated for specific tests (e.g., number of screws, rods tested). The document mentions "components of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System" were reviewed and tested.
• Data Provenance: Not specified, but generally, bench and cadaver lab testing for FDA submissions are conducted by manufacturers or contracted labs, likely within the United States or other regulated regions. The nature of the tests (bench, cadaver) is inherently prospective within a controlled lab environment.

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. This is a physical device and not an AI/ML system requiring expert-derived ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to engineering standards and functional performance. However, cadaver lab testing would involve surgical experts for evaluation. The qualifications of these experts are not detailed.

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

• Not applicable. This is not an AI/ML system requiring adjudication of interpretations. Performance is measured against engineering standards and functional requirements.

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 not an AI/ML system.

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

• Not applicable. This is not an AI/ML system. The device itself is a "standalone" surgical implant system.

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

• The "ground truth" for this medical device's performance testing is based on:
  • Engineering Standards: Adherence to established ASTM F1717 and F1798 standards for mechanical performance.
  • Biocompatibility Standards: Ensuring materials meet medical-grade biocompatibility requirements.
  • Functional Equivalence: Demonstrating that changes to the device (e.g., instrument design, labeling) do not negatively impact the intended function or safety when compared to predicate devices, including evaluation in cadaver labs for human factors.

8. The sample size for the training set

• Not applicable. This is not an AI/ML system that uses a training set.

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

• Not applicable. This is not an AI/ML system.

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