Search Results

The Born PT-LIF Cage HA is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels of the spine from L2 to S1. These DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted in open surgery via a posterior or transforaminal approach. These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbosacral spine.

The Born PT-LIF Cage HA is an interbody fusion device which is inserted between two lumbar or lumbosacral vertebral bodies to replace a collapsed, damaged, or unstable disc. The cage is manufactured from PEEK-OPTIMA™ HA Enhanced. The cage contains a hollow center to allow for bone graft packing, and radiopaque positioning markers. The cage is designed with a bullet nose for easier insertion and serrated contact surfaces for fixation and stability. The device is available in different lengths (25, 28, 32, 36mm), heights (7-17mm in 1mm increments), and degrees of lordosis (0, 4, 8, 12, 16°). All cages are 10mm wide. The Born PT-LIF Cage HA shall be used with autogenous bone graft and supplemental fixation. The cages are single use devices, which are sterilized via gamma radiation and provided to the user in sterile packages. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use.

The provided document describes a medical device, the Born PT-LIF Cage HA, and its substantial equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about a study proving the device meets acceptance criteria based on clinical performance, nor does it include details typically found in studies involving AI such as sample sizes for test and training sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than efficacy or clinical performance against specific acceptance criteria in the manner described in the prompt.

However, it does describe non-clinical mechanical testing and sets acceptance criteria based on standard ASTM tests for intervertebral body fusion devices.

Here's a breakdown of the available information relevant to your request, adapted to the non-clinical context provided:

Acceptance Criteria and Reported Device Performance (Non-Clinical Mechanical Testing)

The document outlines mechanical testing performed to demonstrate the substantial equivalence of the Born PT-LIF Cage HA. The acceptance criteria for these tests are implicitly that the device performs comparably to or better than the predicate devices and meets the requirements of the referenced ASTM standards.

Regarding the specific points requested for a clinical/AI study, the provided document does NOT contain the following information:

1. Sample sizes used for the test set and the data provenance: Not applicable to this non-clinical mechanical testing report.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 document is for a physical medical implant, not an AI diagnostic/assistive device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is defined by the performance requirements and established methods of the relevant ASTM standards.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary of available non-clinical study information:

• Study Title/Purpose: Non-clinical (Mechanical, Material, Packaging) Testing to support Substantial Equivalence for the Born PT-LIF Cage HA.
• Tests Conducted (Implicit acceptance criteria source):
  • Dynamic Axial Compression (per ASTM F2077)
  • Dynamic Compression Shear (per ASTM F2077)
  • Static Axial Compression (per ASTM F2077)
  • Static Compression Shear (per ASTM F2077)
  • Static Subsidence (per ASTM F2267-04)
  • Expulsion
  • Material stability (thermal transitions, crystallinity, FTIR, density, extractables, leachables)
  • Packaging validation (visual inspection, peel strength, dye leak testing)
• Sample Size for Test Set (Mechanical): The mechanical tests were conducted on the "largest (17mm height) cages," and Dynamic Axial Compression was also done on 8mm height cages. The exact number of units tested per condition is not specified but it implies multiple units were used to meet scientific rigor.
• Data Provenance: The testing was presumably conducted by SpineworxX AG or their contracted labs. The data is retrospective to the submission date.
• Ground Truth (for non-clinical tests): Defined by the referenced ASTM standards (F2077 and F2267-04) and internal specifications for material stability and packaging integrity.
• Training Set: Not applicable as this is not an AI device.

Ask a specific question about this device