Search Results

The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Atlas Spine Expandable Cervical Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft post expansion.

The implants components are manufactured from implantable grade Ti6AI4V per ASTM F136 alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.

The provided documentation describes a medical device, the "Atlas Spine Expandable Cervical Interbody System," and its 510(k) premarket notification for substantial equivalence, not an AI/ML device. Therefore, the specific questions regarding acceptance criteria, study details, and performance metrics for AI/ML devices are not applicable.

However, I can extract the relevant information from the document concerning the device's evaluation and its deemed "acceptance criteria" for regulatory clearance based on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are not reported as quantitative performance metrics for an AI/ML algorithm. Instead, they refer to the device meeting the requirements for substantial equivalence to predicate devices. The performance is demonstrated through non-clinical (bench) testing.

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

Not applicable for this type of medical device (physical implant). The "test set" refers to the specific implants tested during the non-clinical bench studies. The document does not specify the exact number of implants tested, only the types of tests performed. Data provenance is not mentioned beyond the tests being conducted according to ASTM standards.

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

Not applicable. Ground truth as typically defined for AI/ML studies by experts is not relevant here. The "ground truth" for a physical implant's mechanical properties is derived from the physical testing against established ASTM standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling or diagnoses for AI/ML 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 not an AI/ML device that assists human readers.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device's performance is established by physical mechanical testing against recognized industry standards (ASTM F2077 and ASTM F2267), demonstrating that the device meets or exceeds the performance criteria for intervertebral body fusion devices, and is comparable to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The PILLAR SA PTC is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR SA PTC is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.

The PILLAR SA PTC is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Firebird Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR SA PTC.

The PILLAR SA PTC in a standalone intervertebral body implant that is comprised of a PEEK OPTIMA LT1 core material as described by ASTM F-2026, with two integrated porous titanium alloy (Ti-6Al-4V) endplates as described by ASTM F1580 or ASTM F136. The PILLAR SA PTC device is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

The PILLAR SA PTC is designed to be used as a standalone device, when implanted with accompanying stabilizing screws. The PILLAR SA PTC spacers are provided sterile.

This document is a 510(k) summary for the PILLAR® SA PTC, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study with a test set, ground truth, and expert adjudication as typically described for AI/ML device evaluations.

Therefore, many of the requested categories are not applicable or cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document states that the performance of PILLAR SA PTC was assessed through various mechanical and material tests. It doesn't present explicit "acceptance criteria" in a numerical sense but rather aims to show that the device performs similarly to predicate devices and meets relevant ASTM standards.

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 document. The "tests" described are primarily mechanical and material characterization, not clinical studies with patients or data sets in the typical sense of AI/ML evaluation.

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 as the "ground truth" for mechanical properties would be derived from physical measurements and material specifications, not expert consensus on interpretations.

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. This is a medical device for spinal fusion, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. The "device" is a physical implant.

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

For the mechanical and material tests, the ground truth would be established by:

• ASTM standards: Defined methodologies and acceptance ranges for mechanical properties (e.g., strength, wear).
• Material specifications: Chemical composition, microstructure, and physical properties of the PEEK OPTIMA LT1 and Ti-6Al-4V as described by ASTM F-2026, ASTM F1580, or ASTM F136.
• Sterility standards: Endotoxin limits as per ANSI/AAMI ST-72:2011.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device's evaluation.

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

Not applicable.

Ask a specific question about this device

The FORZA® PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZA® PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA® PTC Spacer System.

The FORZA® PTC Spacer System is comprised of a variety of implants that have a PEEK core as described by ASTM F-2026 with two integrated porous Titanium alloy (Ti-6Al-4V) endplates as described by ASTM F1580. The FORZA PTC Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

The FORZA® PTC Spacer System is not intended to be used as a standalone device. The FORZA® PTC Spacer System must be used with a supplemental fixation system. The FORZA® PTC Spacer System implants are provided sterile.

The provided text describes a 510(k) premarket notification for a medical device called the FORZA® PTC Spacer System. This submission aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

However, the document focuses on non-clinical performance data (mechanical and material testing) to establish substantial equivalence for a medical implant, not on a study proving a device meets acceptance criteria in the context of an AI/software device that needs performance metrics like accuracy, sensitivity, or specificity.

Therefore, based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving device performance in the manner requested.

The questions you've asked (about sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are typically relevant for evaluating the performance of AI/Machine Learning-based medical devices or diagnostic tools. The document describes a traditional medical device (an intervertebral body fusion device) and its premarket submission process, which relies on demonstrating mechanical, material, and design equivalence to previously approved devices, rather than clinical performance metrics from a human-in-the-loop or standalone AI study.

To directly address your request, I will state that the information is not present in the provided text.

Here's an explanation of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: The document reports mechanical test results (Static and Dynamic Axial Compression, Static and Dynamic Compression Shear, Static Torsion, Subsidence, Expulsion, Taber abrasion, tensile testing, coating shear strength, wear test). It states that these results "demonstrated that FORZA® PTC Spacer System is substantially equivalent to the predicate FORZA Spacer System K103111." However, specific numerical acceptance criteria (e.g., "must achieve > X% compression strength") and the exact numerical performance values are not provided, nor are they presented in a table. The primary acceptance criterion here seems to be "substantially equivalent" to predicates based on these tests.

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 or not provided. The "test set" here refers to the physical devices undergoing mechanical testing, not a dataset of patient information. The number of physical units tested is not specified, nor is "data provenance" in the sense 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 this context would refer to material properties or mechanical performance, which are established through standardized ASTM tests, not expert consensus on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of patient data, which is not what this document describes.

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 an implant, not an AI diagnostic tool that would be evaluated with an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the mechanical performance is the established standards and specifications for material properties and mechanical strength as defined by ASTM standards (e.g., ASTM F2077-11, ASTM F2267-04, ASTM F1978, ASTM F1147, ASTM F1044, ASTM F1877).

8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of medical device's performance evaluation.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the document provides information about a regulatory submission for a physical medical device (intervertebral spacer) and its evaluation through non-clinical, mechanical, and material testing to demonstrate substantial equivalence. It does not contain the type of clinical or AI performance study data that your questions are designed to ascertain.

Ask a specific question about this device