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The Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The SHARK implant (PLIF) consists of rectangular blocks with a tapered nose. The BULLSHARK implant (PLIF) is rectangular in shape with a conical nose. Both devices have parallel configurations of various heights.

The TIGER implant (TLIF) consists of banana shaped blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft and facilitate fusion.

The GREAT WHITE implants (ALIF) are oval shaped blocks, which are available in a two lordotic configurations (7° and 13°) of various heights. The hollow cylinders allow for placement of bone graft and facilitate fusion.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.

The provided text is a 510(k) summary for the "Spine 360 Interbody Fusion System," which is a medical device. This document focuses on demonstrating substantial equivalence to previously approved devices, not on proving that the device meets specific performance criteria through clinical studies or extensive testing that would generate acceptance criteria and reported performance in the way an AI/software device would.

Therefore, many of the requested elements for an AI or software device (like sample size for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, etc.) are not applicable to this type of device submission.

However, I can extract the information that is relevant to the provided document:

Acceptance Criteria and Device Performance (for Substantial Equivalence)

The core "acceptance criteria" for a 510(k) submission like this is substantial equivalence to predicate devices. This means demonstrating that the new device is as safe and effective as a legally marketed device that is already on the market. The reported "performance" is primarily a comparison of key features and the results of non-clinical (bench) testing against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This is a non-clinical device. The "test set" consists of the physical devices themselves and test coupons for material characterization. The document does not specify a numerical sample size for the mechanical testing, but these tests are typically performed on a statistically relevant number of units.
• Data Provenance: The mechanical tests (static compression, dynamic compression, subsidence) are bench tests conducted in a laboratory setting, not on patient data. The origin of the data is therefore the testing facility. The document does not specify the country of origin of the testing.

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. For a physical implant device, ground truth as it pertains to AI/software evaluation (e.g., expert consensus on medical images) is not relevant. The "ground truth" for material properties and mechanical performance is established by recognized ASTM standards and physical measurements.

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

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of medical data, which is not part of this device submission.

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

• No. This is a physical interbody fusion system, not an AI or imaging software. MRMC studies are not applicable.

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

• Not Applicable. This is a physical implant.

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

• The "ground truth" for this device's performance is derived from:
  • Material Specifications: Compliance with ASTM F2026 (for PEEK) and ASTM F560 (for Tantalum) standards.
  • Mechanical Testing Standards: Adherence to ASTM F2077 (static and dynamic compression) and ASTM F2267 (subsidence) test methods and their implied performance requirements.
  • Substantial Equivalence: Comparison against the design, materials, intended use, and performance of legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This device does not use machine learning, so there is no training set.

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

• Not Applicable. As there is no training set, this question is not applicable.

Summary of the Study (or Basis for Clearance):

The "study" in this context is the non-clinical testing and comparison to predicate devices for demonstrating substantial equivalence.

• Non-Clinical Test Summary: The application included non-clinical tests:
  • Static and dynamic compression testing according to ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices."
  • Subsidence testing according to ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression."
• Clinical Test Summary: "No clinical studies were performed."
• Basis for Clearance: The Spine 360 Interbody Fusion System was found "substantially equivalent" to predicate devices (BRANTIGAN I/F CAGE (P960025) and Lucent Straight Intervertebral Body Fusion Device (K072120)) based on:
  • Identical intended use (intervertebral body fusion for DDD in lumbar spine).
  • Similar design, materials (predominantly PEEK Optima LT1 and tantalum markers), and function.
  • Successful completion of non-clinical mechanical testing demonstrating performance comparable to what is expected for such devices and predicates.

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The Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing applications.

The Black Widow Anterior Buttress Plate is designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Specific system features include: Plate uniquely shaped to conform to anterior spine anatomy. Two peas which engage the vertebral body and prevent rotation. An extremely low profile plate with a full radius around the perimeter and a screw that sits flush with the anterior surface of the staple. A self-tapping screw in multiple lengths. The devices are manufactured from Ti6Al4V per ASTM F136. The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.

The provided text describes a medical device submission (K081770 for the Black Widow Anterior Buttress Plate System) to the FDA. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria, expert adjudication, or AI performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and AI performance is not applicable to this document because it describes a mechanical device that underwent mechanical testing for substantial equivalence, not a machine learning or AI-driven diagnostic device.

Here's why the specific questions cannot be answered from the provided text:

• Acceptance Criteria & Reported Performance: The document states that "Mechanical test results, conducted in accordance with ASTM F1717, demonstrate that the Black Widow Anterior Buttress Plate System is substantially equivalent to the predicate device." It does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or exact device performance values from these mechanical tests. It only states the conclusion of substantial equivalence.
• Sample Size (Test Set) & Data Provenance: This pertains to clinical or imaging data. As this is a mechanical device, no such "test set" of clinical data was used for evaluation in this submission.
• Number of Experts, Qualifications & Adjudication Method: These are relevant for studies involving human interpretation or clinical outcomes. They are not applicable to the mechanical testing performed for this device.
• MRMC Comparative Effectiveness Study: This is specific to AI or diagnostic imaging studies comparing human reader performance with and without AI. Not applicable here.
• Standalone Performance (Algorithm Only): This refers to AI algorithm performance without human intervention. Not applicable as no AI is involved.
• Type of Ground Truth: Ground truth (e.g., pathology, expert consensus) is established for clinical conditions or diagnostic accuracy. For a mechanical device, the "ground truth" would be engineering specifications and physical properties, which are evaluated through mechanical tests (like ASTM F1717).
• Sample Size (Training Set): This refers to data used to train AI models. Not applicable as no AI is involved.
• How Ground Truth for Training Set was Established: Again, not applicable as no AI training occurred.

In summary, the provided document from a 510(k) premarket notification for a spinal implant describes mechanical testing for substantial equivalence, not an evaluation of an AI or diagnostic device that would involve the specific criteria outlined in your request.

Ask a specific question about this device