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The Whistler Modular 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 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 Whistler Modular Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136). The Whistler Modular Pedicle Screw System is provided in both non-sterile and sterile forms. All implants are intended for single use only.

The provided document is a 510(k) Premarket Notification from the FDA for the Whistler Modular Pedicle Screw System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information regarding an AI/ML-driven device or studies proving its performance against acceptance criteria in the context of diagnostic accuracy, image analysis, or similar AI-related applications.

Instead, this document focuses on a physical medical device (pedicle screw system) and its mechanical performance testing to demonstrate substantial equivalence to existing devices. The performance data listed (Static Axial Compression Bending, Static Torsion, Dynamic Axial Compression Bending, Static A-P load) are standard mechanical tests for spinal implants, not AI performance metrics.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves a device meets acceptance criteria in an AI/ML context using the provided text. The document is entirely about a hardware implant.

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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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