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The LOGIC Stand-Alone Intervertebral Body Fusion Device is indicated for stand-alone intervertebral body fusion in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment.

In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The LOGIC Stand-Alone Intervertebral Body Fusion Device is to be used with autogenous bone graft material.

The LOGIC system consists of a PEEK spacer with titanium bone screws for intervertebral body fusion. Screws are available in a variety of diameter-length combinations. Spacers are available in a variety of widths. depths, and heights. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the lumbar spine. The screws are intended to be used as integrated fixation for stand-alone use of the device.

The provided regulatory document describes a 510(k) premarket notification for the "LOGIC Stand-Alone Intervertebral Body Fusion Device." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials for efficacy and safety from scratch.

Therefore, the information regarding acceptance criteria and a study proving device performance, as typically understood for AI/software-as-a-medical-device (SaMD) or novel device submissions, is not present in this document. Instead, the "performance data" refers to non-clinical bench testing to demonstrate mechanical equivalence.

Here's the breakdown of what can be extracted based on your request, explicitly stating what information is not available due to the nature of a 510(k) for this type of device:

Acceptance Criteria and Device Performance for the LOGIC Stand-Alone Intervertebral Body Fusion Device

The LOGIC Stand-Alone Intervertebral Body Fusion Device, a Class II medical device, demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing. The acceptance criteria for this type of device are primarily tied to meeting established ASTM standards for intervertebral body fusion devices, ensuring the device's mechanical integrity and performance under simulated physiological conditions.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Test Set Sample Size: Not applicable. The "test set" here refers to the physical devices subjected to mechanical bench testing, not a dataset of patient images or clinical outcomes. Specific numbers of devices tested per standard are not provided in this summary, but typically multiple samples are used for each test.
   • Data Provenance: The data is generated from in vitro mechanical testing performed on the device itself.
   • Retrospective or Prospective: Not applicable, as this is bench testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on objective measurements against engineering standards, not expert clinical interpretation.

3. Adjudication method for the test set: Not applicable. Mechanical test results are quantitative and do not require expert adjudication in the same way clinical diagnoses do.

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 device is a physical implant, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.

6. The type of ground truth used: For mechanical testing, the "ground truth" is defined by the objective measurements obtained from standardized tests (e.g., force applied, displacement, cycles to failure) and comparison to the performance of predicate devices or established minimum thresholds set by the ASTM standards.

7. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Summary of Substantial Equivalence:

The submission highlights that the LOGIC device is substantially equivalent to its predicates (Biomet Solitaire PEEK Anterior Spinal System, Binder Intervertebral Body Fusion Device, Synthes Synfix-LR system, Centinel Spine STALIF system) in terms of:

• Intended use
• Design
• Materials (PEEK-OPTIMA®, tantalum markers, titanium alloy screws)
• Processing
• Operational principles

The non-clinical mechanical performance data further supports this claim of substantial equivalence.

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The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is intended to be used for intervertebral body fusion.

The Binder Intervertebral Body Fusion Device is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.

The Binder Fusion System is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Binder Fusion System also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Binder Fusion System is provided non-sterile.

The provided text describes a 510(k) summary for a medical device, the Binder Intervertebral Body Fusion Device. It outlines the device's intended use, technological characteristics, and a statement about performance data. However, it does not contain the detailed acceptance criteria or a specific study proving the device met those criteria in the way a clinical or AI-based performance study would.

Instead, the document focuses on the regulatory submission process for substantial equivalence to predicate devices, primarily through mechanical testing.

Here's the breakdown of the information requested, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "In all instances, the Binder Fusion System functioned as intended and specified requirements were met." but does not provide the specific numerical acceptance criteria or the quantitative results from the tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data or AI model evaluation. The "performance data" refers to mechanical testing.

• Sample Size for Mechanical Testing: Not specified.
• Data Provenance: Not applicable in the context of clinical patient data or AI data. The "data" refers to engineering test results.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable to the information provided. The performance testing described is mechanical, not involving expert interpretation of patient data.

4. Adjudication Method for the Test Set

This is not applicable to the information provided, as there is no "test set" in the context of human or AI interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document describes mechanical performance testing, not a clinical study involving human readers or AI assistance.

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

No. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be the engineering specifications and performance standards defined by ASTM F2077-03 and ASTM F2267-04.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary of Missing Information in Relation to AI/Clinical Study Criteria:

The provided document is a 510(k) summary focusing on a physical medical device (intervertebral body fusion device) and its mechanical performance testing for regulatory clearance. It does not provide information relevant to the performance evaluation of an AI algorithm, clinical trials with human readers, or detailed patient data analysis that would typically involve many of the criteria you asked for (e.g., test set size, expert ground truth, adjudication, MRMC studies, training sets). The "acceptance criteria" discussed are for the physical properties of the implant based on recognized ASTM standards.

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