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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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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, and/or lordosis), tumor and failed previous fusion.

As pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, 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® system consists of various screws, rods and associated accessories and is intended to provide temporary stabilization following surgery to fuse the spine. PathFinder NXT screws are polyaxial cannulated designs with a range of spinal rod lengths. PathFinder NXT allows the surgeon to place polyaxial pedicle screws either through an open or mini-open procedure. PathFinder NXT 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 MIS System includes instrumentation to facilitate the implantation of the PathFinder NXT implants. The prior 510(k) for the PathFinder NXT MIS System included both Class I 510(k) exempt instrumentation and those instruments considered to the implant. PathFinder NXT was cleared via 510(k) #K100845 on 21 September 2010.

The Fixed Percutaneous Rod Holder accessory that is the subject of this premarket notification instrument is intended for use with the PathFinder NXT® Pedicle Screw System. This instrument is designed specifically for use with the rod implant component of the PathFinder NXT® Pedicle Screw System and, is considered an accessory to the implant. The Fixed Percutaneous Rod Holder holds and inserts a rod percutaneously through the extender sleeves which are positioned on the implanted screw head.

This 510(k) summary describes a modification to an existing medical device, the PathFinder NXT® Minimally Invasive Pedicle Screw System, specifically an accessory called the Fixed Percutaneous Rod Holder. The submission focuses on demonstrating substantial equivalence to the predicate device, not on proving de novo clinical effectiveness of the entire system.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not describe a clinical study with a "test set" in the traditional sense of patient data. The "tests" performed were engineering design verification tests on the device itself. Therefore, the concepts of "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" are not applicable to this type of submission.

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

There were no human experts used to establish ground truth for a test set of patient data, as this was a device modification and engineering verification testing. The "ground truth" for the performance was established by the physical testing against engineering specifications and comparison to the predicate device. Therefore, this information is not applicable.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring human interpretation or labeling, an adjudication method is not applicable. The "adjudication" in this context would be the internal engineering and regulatory review process by Zimmer Spine, Inc. and ultimately the FDA.

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

This submission does not involve Artificial Intelligence (AI) or reader interpretation of images. It is for a physical medical device (pedicle screw system accessory). Therefore, an MRMC comparative effectiveness study is not applicable.

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

This is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For this device modification, the "ground truth" was established by:

• Engineering Specifications: The design verification tests measured physical properties and performance against defined engineering requirements and tolerances.
• Predicate Device Performance: The primary ground truth for substantial equivalence was the established performance and safety profile of the legally marketed predicate device (PathFinder NXT® Minimally Invasive Pedicle Screw System, #K100845). The modified accessory was deemed equivalent if it performed at least as well as the predicate under specified conditions and did not introduce new safety or effectiveness concerns.
• Industry Standards: Compliance with ASTM A-564 for material specification.

8. The Sample Size for the Training Set

There was no "training set" in the context of machine learning or AI. The design and manufacturing process for a physical device doesn't involve a training set. If interpreted in a broader sense as development and testing, the "samples" would be the prototype devices and test articles subjected to the design verification tests. The exact number of units tested is not specified in the summary but would be detailed in the full design verification report.

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

As there was no "training set" in the AI sense, this question is not applicable. If referring to the development process of the device itself, the design "ground truth" was established through engineering design processes, material selection based on established standards, and performance goals derived from clinical needs and the performance of the predicate device.

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