Search Results

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).

Ask a specific question about this device

The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, undergoing surgery for total knee replacement due to:

• . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
• . Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
• Post-traumatic loss of joint configuration, particularly when there is . patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities. .

The cruciate retaining (CR) femur with CR tibial insert is for use when the posterior cruciate ligament (PCL) is intact. The CR femur with UC tibial inserts is for use when the PCL is sacrificed. The posteriorly stabilized (PS) femur with PS tibial insert is for use when the PCL is sacrificed.

The NEO Total Knee System components are indicated for use only with cement and are single use devices.

The NEO Total Knee System includes:

• Cruciate retaining (CR) Femoral Components and Posteriorly stabilized (PS) Femoral . Components in right and left configurations in sizes 1 to 10, manufactured from Cast CoCr.
• Tibial Trays manufactured from titanium alloy in sizes 1 – 10.
• . Tibial Inserts in cruciate retaining (CR), ultracongruent (UC), and posteriorly stabilized (PS) designs, manufactured from standard ultrahigh molecular weight polyethylene, in sizes A to E and in thicknesses 6 to 21 mm (total thickness with tibial tray is 9 to 24 mm).
• Patellar Components in diameters of 26 to 41 mm and in thicknesses of 8, 9 or 10 mm, manufactured from standard ultrahigh molecular weight polyethylene.

The NEO Total Knee System is designed with the potential to have an active clinical flexion of 150°.

This document is a 510(k) summary for the NEO Total Knee System, a medical device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving the device meets specific acceptance criteria in the way an AI/software device would. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this type of device submission.

Here's an attempt to extract the relevant information where applicable, and indicate when the requested information is not provided or not relevant for this submission type:

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

This document does not present explicit "acceptance criteria" in the format of pass/fail thresholds for performance metrics. Instead, it relies on demonstrating that the device has the "same design features" and "same indications for use" as its predicate devices, and that performance testing confirmed its structural integrity and functional characteristics are comparable or acceptable within the context of a knee replacement system.

The "Performance Testing" section lists the types of tests conducted:

• Tibial tray fatigue strength
• Insert locking mechanism strength
• Tibial post strength (for PS design)
• Femorotibial range of motion
• Femorotibial range of constraint
• Patellofemoral range of constraint
• Femorotibial contact areas/contact stress
• Patellofemoral contact area and contact stress

No specific numerical acceptance criteria or reported performance values are provided in this summary. The implicit acceptance criterion is likely that the device performs comparably to the predicate devices and meets relevant industry standards for mechanical performance of total knee systems, which are not detailed here.

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

This information is not provided in the summary. The tests mentioned are mechanical performance tests, not clinical studies involving patient data.

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)

This is not applicable. The "ground truth" for mechanical testing is based on engineering principles, material properties, and established test methodologies, not expert consensus on medical images or clinical outcomes.

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

This is not applicable to mechanical performance testing.

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 is not applicable. This is a medical device (knee implant), not an AI/software device requiring an MRMC study.

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

This is not applicable. This is a medical device (knee implant), not an AI/software device.

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

For mechanical performance tests, the "ground truth" refers to the physical properties and performance limits of the materials and design, evaluated against engineering standards and established biomechanical principles. It is not an "expert consensus" or "pathology" in the typical sense of evaluating diagnostic accuracy.

8. The sample size for the training set

This is not applicable. This is a mechanical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as above.

Ask a specific question about this device