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IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

The IB3D™ PL Spinal System implants are inter-somatic spacers manufactured by additive manufacturing (Direct Laser Metal Sintering) from Titanium alloy Ti-6Al-4V ELI powder, according to ASTM F3001 and ASTM F136.

The IB3D™ PL Spinal System implants are intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach on the lumbar spine only.

The subject IB3D™ PL Spinal System interbody devices are available in a variety of heights and lordosis angles for treatment of lumbar interbody fusion procedure. The implant is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates hexalock macro-rough surface on the superior and inferior surfaces of the device along with angular teeth to prevent expulsion from the interbody space.

This is a medical device submission, not an AI/ML device submission. Therefore, it does not contain information about acceptance criteria, test sets, ground truth, or training sets typical for AI/ML performance evaluation.

The provided document describes the IB3D™ PL Spinal System, an intervertebral body fusion device. The acceptance criteria and supporting studies for this type of device focus on mechanical performance, biocompatibility, and manufacturing quality, not diagnostic accuracy or AI algorithm performance.

Here's a breakdown of the relevant information from the document:

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

The document mentions several non-clinical tests performed to support substantial equivalence. These tests serve as the basis for demonstrating the device meets certain performance criteria. However, explicit "acceptance criteria" presented in a table format with corresponding "reported device performance" values are not detailed in this summary.

Non-clinical tests performed in support of substantial equivalence:

The summary states that these tests were performed on "worst-case constructs" of the IB3D™ PL Spinal System. The implication is that the device met the performance requirements of these standards, demonstrating substantial equivalence to its predicates.

2. Sample size used for the test set and the data provenance:

For mechanical and material tests of this nature, "sample size" typically refers to the number of test articles (implants) subjected to testing. This information is not specified in the provided 510(k) summary. The document does not describe patient data (e.g., country of origin, retrospective/prospective) because no clinical testing was used to support the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the submission is for a medical device (intervertebral body fusion device) and does not involve diagnostic interpretation or AI algorithm evaluation requiring human experts to establish ground truth from medical images or clinical data.

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

This information is not applicable for the same reasons as point 3.

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 information is not applicable as this is not an AI-assisted device. The submission explicitly states: "No clinical testing was used in order to support this submission."

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

This information is not applicable as this is not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the specified test standards (ASTM, ISO). Meeting the criteria outlined in these standards for mechanical strength, fatigue, wear, and biocompatibility constitutes the "ground truth" for proving the device's performance characteristics and safety.

8. The sample size for the training set:

This information is not applicable as this is a medical device, not an AI/ML product that requires a training set.

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

This information is not applicable as this is not an AI/ML product.

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MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

UNID® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device consists of one single implant with specific heights, footprint, lordosis and coronal angle. Patient matched endplates can be added to the implant. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following ASTM F3001 standard, a radio opaque material. As any orthopaedic implants should not be reused. For a complete quide of the system, please refer to the surgical technique manual for specific instructions.

The UNiD® IB3D ALIF cage is designed for a specific patient, it must not be used for another patient.

MATERIALS: Components are manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

Function:
The UNiD® IB3D ALIF was developed as an implant:

• to provide immobilization and stabilization of posterior spinal segments .
• to augment the development of a solid spinal fusion ●
• . to provide stability to ease fusion
• to be mechanically resistant to allow the fusion of the operated level

I apologize, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (UNiD® IB3D ALIF), an intervertebral body fusion device.

It focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than an AI/ML-driven device's performance study against specific acceptance criteria.

The text does not include:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Details about sample sizes used for test sets or data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document discusses mechanical testing (Finite Element Analysis - FEA) of the physical implant, concluding that no new worst-case implant was created, thus no additional physical testing was deemed necessary. This is typical for a physical medical device clearance, not an AI/ML software.

Therefore, I cannot fulfill your request based on the provided input.

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UNiD Patient specific 3D printed TLIF cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

MEDICREA® INTERNATIONAL UNiD Patient specific 3D Printed TLIF cage consists of one single implant with specific heights, length and lordosis angle to the patient. It is intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.

MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

Function:
The UNiD Patient specific 3D printed TLIF cage was developed as an implant:

• To provide immobilization and stabilization of posterior spinal segments ●
• to augment the development of a solid spinal fusion
• to provide stability to ease fusion ●
• to be mechanically resistant to allow the fusion of the operated level

The given text describes a 510(k) summary for the UNiD Patient specific 3D printed TLIF cage, which is an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about studies involving acceptance criteria related to device performance in an AI/algorithm context, nor does it detail a study that proves the device meets such criteria through clinical trials or performance metrics typically associated with AI-driven devices.

Therefore, many of the requested categories of information cannot be extracted from the provided text as they pertain to AI/algorithm performance and clinical study designs which are not present in this regulatory submission for a physical medical device.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria for the device performance that would typically be seen for an AI or algorithm-driven device. Instead, it relies on demonstrating substantial equivalence through material properties and mechanical testing comparisons to predicate devices. The "reported device performance" is essentially that it meets the same mechanical and biocompatibility standards as its predicates.

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. The "test set" and "data provenance" refer to data used in evaluating AI/algorithm performance. This document describes mechanical and biocompatibility testing of a physical implant. The mechanical testing involved evaluating a "worst-case device," but the sample size for these specific tests is not provided.

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 this relates to expert-labeled data for AI/algorithm performance.

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

Not applicable, as this relates to expert adjudication for AI/algorithm ground truth.

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 is a physical medical device (intervertebral cage), not an AI/algorithm.

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

Not applicable. This is a physical medical device.

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

For the mechanical testing, the "ground truth" would be the established engineering standards (ASTM F2077, ASTM F2267) which define acceptable mechanical properties and behaviors of intervertebral body fusion devices. For biocompatibility, the ground truth would be established international standards for the biocompatibility of medical device materials.

8. The sample size for the training set:

Not applicable. There is no AI/algorithm training set.

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

Not applicable. There is no AI/algorithm training set.

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