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The ProLift Pivot Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Pivot Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 15mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-4V ELI) and Cobalt Chrome (CO- 26Cr-6MO) as described by ASTM F136and ASTM F1537. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

The ProLift® Pivot Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 15mm) to suit the individual pathology and anatomical conditions of the patient.

• The ProLift implants are fabricated and manufactured from titanium alloy (Ti-6Al-. 4V ELI) as described by ASTM F136.
  . The ProLift Pivot-U implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 & ASTM F1537.
  The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
  All ProLift Pivot implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Pivot Expandable Spacer System components with components from any other system or manufacturer.

This document pertains to the clearance of a medical device, the ProLift Pivot Expandable Spacer System, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for AI models is not applicable to this submission.

The document discusses the substantial equivalence of the ProLift Pivot Expandable Spacer System to predicate devices based on design, materials, indications for use, sizing, and mechanical performance.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:
   The document does not present a formal table of acceptance criteria with reported performance values in the context of an AI/ML study. Instead, it states that "Performance Data: Static compression shear, Static Axial Compression, Dynamic Compression Shear and Dynamic Axial Compression according to ASTM F2077 was presented to demonstrate the substantial equivalency of the Life Spine ProLift Expandable Spacer System (K190488)." This implies that the acceptance criteria are adherence to the mechanical testing standards outlined in ASTM F2077, and the device performance met these standards to demonstrate substantial equivalence to the predicate device (K190488).

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 this is a medical device clearance based on mechanical testing, not an AI/ML study involving a test dataset of 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): Not applicable. "Ground truth" in the context of this device refers to the mechanical properties and performance standards defined by ASTM F2077 and assessed through engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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, as this is not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device's performance is established by the mechanical testing standards outlined in ASTM F2077. This standard defines the methodologies and expected performance for intervertebral body fusion devices under various loading conditions (static compression shear, static axial compression, dynamic compression shear, dynamic axial compression).

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the document describes the clearance of a physical medical implant (ProLift Pivot Expandable Spacer System) based on its substantial equivalence to previously cleared devices, supported by mechanical performance data against recognized ASTM standards.

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