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The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for noncervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The New Era Orthopaedics™ (NEO) Polyscrew Pedicle Screw System is designed to provide mechanical support while biologic fusion takes place. It has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.

The New Era Orthopaedics™ (NEO) Polyscrew Pedicle Screw System is designed to provide mechanical support while biologic fusion takes place. Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

This document (K150647) is a 510(k) premarket notification for the "Polyscrew Pedicle Screw System" by New Era Orthopaedics. Based on the provided text, the device itself has not undergone new performance testing for this submission. Instead, this submission focuses on a modification to the surgical technique for an already cleared device (K141253). Therefore, much of the requested information regarding acceptance criteria and performance studies for the device itself is not present.

Here's an analysis based on the provided text:

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

The document states: "Per the risk analysis, the safety and efficacy of the device was established in the previously cleared New Era Orthopaedics™ Polyscrew Pedicle Screw System (K141253) and additional performance testing is not necessary." This means that for this specific 510(k) submission, there are no new acceptance criteria or reported device performance data because the device itself is unchanged. The substantial equivalence is based on the previously cleared device and the modified surgical technique being cleared with another predicate.

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

Not applicable, as no new performance testing for the device was conducted as part of this submission. The safety and efficacy were established in the predicate device (K141253), but the details of that study are not included in this document.

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, as no new performance testing for the device was conducted as part of this submission.

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

Not applicable, as no new performance testing for the device was conducted as part of this submission.

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 device is a pedicle screw system, a physical implant, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

Not applicable. This device is a pedicle screw system, not an algorithm.

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

Not applicable, as no new performance testing for the device was conducted as part of this submission. The substantial equivalence for the device itself was based on prior studies (K141253).

8. The sample size for the training set

Not applicable, as no new performance testing for the device was conducted as part of this submission.

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

Not applicable, as no new performance testing for the device was conducted as part of this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this document):

This 510(k) submission (K150647) is for an updated surgical technique for an already cleared device, the Polyscrew Pedicle Screw System. The core device itself (components, materials, technical characteristics) remains unchanged from the predicate device, K141253.

The study that "proves the device meets acceptance criteria" for this specific submission is essentially a demonstration of substantial equivalence to previously cleared devices, particularly regarding the added surgical technique.

• Device Performance: The document explicitly states: "Per the risk analysis, the safety and efficacy of the device was established in the previously cleared New Era Orthopaedics™ Polyscrew Pedicle Screw System (K141253) and additional performance testing is not necessary." This means the acceptance criteria and performance data for the physical device components would have been established and met in the K141253 submission.
• Surgical Technique Modification: The focus of K150647 is to "update the Surgical Technique to include in-situ assembly." The document further states that this modified surgical technique "has been previously cleared in the CREO™ Stabilization System (K124058) and raises no new types of safety or effectiveness questions."
• Conclusion: The regulatory decision is based on the "overall technological characteristics" leading to the conclusion that the Polyscrew Pedicle Screw System is substantially equivalent to the predicate devices (K141253 for the device itself, and K124058 for the specific surgical technique modification).

Therefore, this document does not contain new data on acceptance criteria or performance studies of the Polyscrew Pedicle Screw System as a standalone device. It leverages the existing clearances of its predicate devices to demonstrate substantial equivalence for a minor modification (surgical technique).

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The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The New Era Orthopaedics Polyscrew Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:

Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537

The provided document describes the New Era Orthopaedics Polyscrew Pedicle Screw System, a Class II medical device. As a Class II device approved through the 510(k) pathway, its approval hinges on demonstrating "substantial equivalence" to a predicate device, not necessarily on meeting specific numerical acceptance criteria in the same way a novel device might.

Therefore, the "acceptance criteria" for this device are implicitly tied to the performance of its predicate devices, as demonstrated through non-clinical testing. The study provided focuses on proving this substantial equivalence through mechanical testing.

Here's the breakdown of the information requested based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For 510(k) submissions, explicit numerical "acceptance criteria" and "reported device performance" in the typical sense of a novel device study are often not stated. Instead, the performance is reported as meeting or being equivalent to the predicate device, which implies satisfying the predicate's established safety and effectiveness.

• Static and dynamic compression per ASTM F1717
• Static torsion per ASTM F1717
• Dissociation testing

The results of this testing indicate that the New Era Orthopaedics Polyscrew Pedicle Screw System is equivalent to predicate devices. |
| Material Compatibility: The materials used (Ti-6Al-4V per ASTM F136; CoCr per ASTM F1537) must be biocompatible and suitable for implantation in the human body, consistent with materials used in predicate devices. | Materials: Ti-6Al-4V per ASTM F136 and CoCr per ASTM F1537 were used, which are standard, biocompatible materials for such implants and are consistent with those found in predicate devices. |
| Functional Equivalence: The device's design, intended use, and general operational principles must be substantially equivalent to the predicate devices. | Substantial Equivalence Claim: The New Era Orthopaedics Polyscrew Pedicle Screw System is claimed to be substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances. |

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the non-clinical mechanical tests (static/dynamic compression, static torsion, dissociation). For mechanical testing of medical devices, sample sizes are typically determined by statistical requirements to achieve confidence in the measurements, but are not usually reported as a single "test set sample size" in the same way as a clinical study. Instead, multiple units of each component or assembly configuration would be tested to derive statistical data (e.g., mean, standard deviation, and comparisons to predicate device performance limits).
• Data Provenance: The data provenance is from non-clinical laboratory testing. The document does not specify the country of origin for the testing, but it is typically conducted in controlled laboratory environments in accordance with international (ASTM) standards. This is not retrospective or prospective in a clinical sense, as it refers to laboratory experiments.

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

• Number of Experts: This question is not applicable to this type of submission. Ground truth, in the context of device performance, is established through standardized engineering tests (e.g., ASTM F1717) and comparison to established predicate device performance and regulatory standards, not through expert consensus on qualitative data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: This question is not applicable. Mechanical tests are quantitative and objective; their outcomes are measured directly based on physical properties and responses to applied forces, not through an adjudication process like one might find in a clinical trial or image interpretation study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, comparing their performance with and without AI assistance. The New Era Orthopaedics Polyscrew Pedicle Screw System is a physical implant, not a diagnostic tool requiring human interpretation of results in this manner.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: This question is not applicable. This device is a physical pedicle screw system, not an algorithm or AI software. Therefore, there is no "standalone performance" in the context of an algorithm. Its performance is its mechanical integrity and function as a physical implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance is established by objective mechanical performance standards (e.g., ASTM F1717) and comparison to the established performance of legally marketed predicate devices. The implicit ground truth is that the device must be safe and effective, similar to existing devices, as demonstrated by meeting standardized mechanical testing requirements and being made of recognized biocompatible materials.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This question is not applicable. This device is not an AI/algorithm that requires a "training set." The engineering and design process for such a physical device involves iteration and testing, but not in the sense of a machine learning training set.

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

• Ground Truth for Training Set: This question is not applicable as there is no "training set" for a physical implant device in the context of this submission.

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The SpineSelect Polyscrew Pedicle Screw System is intended for immobilization and stabilization of the spine. The SpineSelect Polyscrew Pedicle Screw System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The SpineSelect Polyscrew Pedicle Screw System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 5.5-7.5 mm and in lengths from 30-55 mm. Rods are available in 5.5mm diameter either straight or precurved. The straight rods range in lengths from 30-400 mm, whereas the pre-curved rods range in length from 30-150mm. The system includes a screw assembly which includes a polyscrew (solid or cannulated), a saddle and tulip head, Rods are locked in place with a set screw. Associated instrumentation to complete the procedure are provided.

The provided text is a 510(k) summary for the SpineSelect Polyscrew Pedicle Screw System, a medical device. It details the device's indications for use, description, and comparison to predicate devices, but does not describe a study involving an AI/algorithmic device or human readers interpreting data. Instead, it focuses on the mechanical performance of a physical implantable device.

Therefore, I cannot provide information on:

• Acceptance criteria and reported device performance related to an algorithm's output. The acceptance criteria discussed are for the mechanical performance of the pedicle screw system, not an algorithm's performance.
• Sample size used for the test set and data provenance. No such test set is described for an AI device.
• Number of experts used to establish ground truth and their qualifications. Not applicable to a mechanical device submission.
• Adjudication method for the test set. Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study. Not applicable.
• Standalone (algorithm only) performance. Not applicable as this is a physical device.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an algorithm. Not applicable.
• Sample size for the training set and how ground truth was established for the training set. Not applicable.

Based on the provided text, the relevant information regarding acceptance criteria and the study that proves the device meets those criteria is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Study that Proves the Device Meets Acceptance Criteria:

• Study Type: Pre-clinical mechanical testing.
• Methods: The testing performed includes "static and dynamic compression bending and static torsion bending per ASTM F1717-10." ASTM F1717-10 is a standard specification for spinal implant constructs in a corrosive environment intended for internal fixation.
• Conclusion: SpineSelect concluded that the SpineSelect Polyscrew Pedicle Screw System is "substantially equivalent to the predicates in regard to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness." This implies that the device's mechanical test results were comparable to or better than those of the predicate devices.

Missing Information (as per the prompt's request for AI-related details):

As this submission is for a physical pedicle screw system and not an AI or algorithmic device, the specific details requested regarding test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not available and not applicable to this document.

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