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The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two 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 up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.

The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136. The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand in both height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.

This document describes the FDA's 510(k) clearance for the Spectrum Spine Expandable Titanium PLIF/TLIF System, an interbody fusion device. The focus of the provided text is on demonstrating the substantial equivalence of the new device to existing predicate devices, primarily through mechanical performance testing, rather than an AI/ML-based device requiring a study proving its performance against acceptance criteria for diagnostic or prognostic tasks.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these in the context of AI/ML performance (e.g., sensitivity, specificity, reader improvement, ground truth establishment) is not applicable to this submission.

The document primarily provides the following:

1. A table of acceptance criteria and the reported device performance:
This is described in terms of mechanical testing for intervertebral fusion devices, not diagnostic performance.

• Acceptance Criteria (Testing Modes):

  • Static axial compression per ASTM F2077
  • Static compression shear per ASTM F2077
  • Dynamic axial compression per ASTM F2077
  • Dynamic compression shear per ASTM F2077
  • Subsidence per ASTM F2267

• Reported Device Performance:
  "The results of this non-clinical testing show that the strength of the Expandable Titanium PLIF/TLIF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
  (Specific numerical results are not provided in this summary, but the conclusion of substantial equivalence based on these tests is stated.)

The remaining points (2-9) are not relevant as this is not an AI/ML device that requires a diagnostic or prognostic performance study:

• Sample size used for the test set and the data provenance: Not applicable to a mechanical device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is based on engineering standards and performance in stress tests, not expert interpretation of medical images or data.
• Adjudication method for the test set: Not applicable.
• 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 implant, not a diagnostic AI tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is its ability to withstand mechanical forces according to established ASTM standards, indicating its structural integrity and safety for its intended use, as compared to predicate devices.
• The sample size for the training set: Not applicable. No AI model involved.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a Class II medical device (surgical implant) based on substantial equivalence through mechanical testing, not an AI/ML device requiring clinical performance evaluation against specific diagnostic or prognostic metrics.

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The Spectrum Spine Expandable Cages (SSEC) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two 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 up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The Spectrum Spine Expandable Cages (SSEC) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SSEC are provided in different shapes to accommodate a lateral surgical approach to the lumbar spine and can expand to the desired height and varying degrees of lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SSEC implants are manufactured from radiolucent PEEK (per ASTM 2026), titanium alloy (per ASTM F136), and tantalum markers (per ASTM F560).

The provided document is a 510(k) summary for a medical device called "Spectrum Spine Expandable Cages (SSEC)". This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study for AI performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and study data for an AI-powered device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI
• Sample size and data provenance for an AI test set
• Number and qualifications of experts for AI ground truth establishment
• Adjudication methods for AI test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results
• Standalone AI performance
• Type of ground truth used for AI
• Training set sample size and ground truth establishment for AI

The information within the document pertains to mechanical and material testing of an intervertebral fusion device (implants), which are entirely different types of tests than those required for an AI-based medical device. The "Performance Data" section discusses:

• Static Axial Compression per ASTM F2077
• Static Compressive Shear per ASTM F2077
• Static Subsidence per ASTM F2267 and ASTM F2077
• Static Expulsion
• Dynamic Axial Compression per ASTM F2077
• Dynamic Compressive Shear per ASTM F2077

These are all mechanical tests to ensure the physical integrity and durability of the spinal implant, not performance metrics for an AI algorithm.

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The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.

The SS Fenestrated Facet Screw System (FFS) is a permanent implant device made from Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from the posterior approach. The device is provided in one diameter and multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The SS Fenestrated Facet Screw System is cannulated and fenestrated which allows it to be used as a delivery system for bone graft. The system is not to be used with bone cement.

The provided text describes the regulatory submission for a medical device called the "SS Fenestrated Facet Screw System." It does not contain information about a study involving software or AI. Therefore, I cannot extract details about acceptance criteria or a study proving device performance in the context of AI.

The document discusses the substantial equivalence of the SS Fenestrated Facet Screw System to predicate devices based on performance testing for mechanical properties. However, this is for a physical implantable device, not an AI software.

Here's a breakdown of what is present in the document related to performance and testing for the physical device:

Device: SS Fenestrated Facet Screw System (FFS)

Acceptance Criteria and Reported Device Performance (for the physical device):

The document states:

• "Testing of the FFS to demonstrate substantial equivalence included static and dynamic 3-point bending, screw axial pullout, and torque to failure."
• "The testing standards utilized were, ASTM F543-07 'Standard Specification and Test Methods for Metallic Medical Bone Screws', F2193-02, 'Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System,' and ASTM F1264-03 'Standard Specification and Test Methods for Intrameduliary Fixation Devices.'"

While the specific numerical acceptance criteria and reported performance values are not detailed in the provided text, the successful 510(k) clearance implies that the device met the requirements outlined in these ASTM standards and was deemed substantially equivalent to its predicate devices in terms of safety and effectiveness.

Regarding your specific questions related to AI/Software:

1. A table of acceptance criteria and the reported device performance: This information is not present for an AI/software device. The document describes mechanical testing of a physical implant.
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/software study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/software study.
4. Adjudication method: Not applicable for an AI/software study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for an AI/software study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/software study.
7. The type of ground truth used: Not applicable for an AI/software study.
8. The sample size for the training set: Not applicable for an AI/software study.
9. How the ground truth for the training set was established: Not applicable for an AI/software study.

In summary, the provided text is a 510(k) summary for a physical medical implant (a facet screw system) and does not describe an AI or software device, nor does it contain the type of study data you are asking for regarding AI acceptance criteria and performance.

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The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The Spectrum Spine Laminoplasty Plating System is comprised of various sized, pre-bent plates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at both ends of the plate to allow for attachment to the bone. The screws intended for use with the plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.

The provided text describes the Spectrum Spine Laminoplasty Plating System and its performance data for a 510(k) submission. However, it does not contain specific acceptance criteria, reported device performance in those terms (apart from passing certain ASTM standards), or details about a study that would address most of the requested information.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical testing according to established ASTM standards. It does not describe a clinical study or a study comparing the device's performance against specific, quantifiable acceptance criteria in a clinical context.

Therefore, for many of your requested points, the information is not available in the provided text.

Here is the information that can be extracted or deduced from the provided text, and where the information is not available, it is stated as such:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Reported Device Performance": The document states that the device "was tested" according to specific ASTM standards and that the data "lead to the conclusion that Spectrum Spine Laminoplasty Plating System is substantially equivalent to the predicate devices." This implicitly means the device met the requirements of these tests, but the specific numerical results or thresholds (acceptance criteria) for those tests are not detailed in this summary.

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

• Sample Size: Not specified. The testing described is mechanical (physical hardware testing), not clinical or involving human subjects/cases in the traditional sense of a "test set" for performance evaluation.
• Data Provenance: The "performance data" refers to mechanical testing.
  • Country of origin: Not specified, but likely performed in a certified lab in the USA, given the FDA submission.
  • Retrospective or Prospective: Not applicable, as this refers to mechanical bench testing, not clinical data collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The "ground truth" for this device's performance evaluation is based on established engineering standards (ASTM F543-07 and ASTM F2193-02) and material specifications (ASTM F136), not expert consensus from clinical cases. There's no mention of experts establishing a ground truth in the context of device performance as one would for an AI/diagnostic device.

4. Adjudication Method for the Test Set

• Not applicable. This concept typically applies to clinical studies where expert reviewers independently assess cases and then reconcile discrepancies. The reported testing is mechanical bench testing.

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

• No. An MRMC study is not relevant for this type of mechanical implant device. This type of study is typically performed for diagnostic or AI-assisted interpretation devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Engineering Standards and Material Specifications: The ground truth for evaluating the device's safety and effectiveness for a 510(k) submission is based on adherence to established ASTM standards for mechanical properties (e.g., strength, durability) and material composition (titanium alloy as per ASTM F136), demonstrating substantial equivalence to previously marketed devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical surgical implant. There is no training set in the context of machine learning or AI.

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

• Not applicable. See point 8.

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