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PATRIOT® Spacers (including CONSTITUTION®, SIGNATURE®, CONTINENTAL®, TransContinental®, and TransContinental® M) are interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and had at least six (6) months of non-operative treatment. PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as thoracolumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R. SUSTAIN®-IR, and SUSTAIN®-RT) are indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy), soondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous, and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® (including CONSTITUTION®. SIGNATURE®. Spacers TransContinental®, CONTINENTAL®, TransContinental® and M) are thoracolumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the spine. CONSTITUTION® PLIF Spacers are inserted using a posterior or transforaminal approach. SIGNATURE® TLIF Spacers are inserted using a transforaminal or lateral approach. CONTINENTAL® ALIF Spacers are inserted using an anterior, anterolateral, or lateral approach. TransContinental® and TransContinental® M Spacers are inserted using an anterior, anterolateral, or lateral approach. All approaches may be used in the lumbar spine; only anterior, anterolateral, or lateral approaches may be used in the thoracic spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

SUSTAIN® Spacers (including SUSTAIN® R, SUSTAIN®-IR, and SUSTAIN®-RT) are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. When used as interbody fusion devices, each of the spacers provides a different shape to accommodate various surgical approaches to the spine. SUSTAIN Small, SUSTAIN-R, and SUSTAIN-RT Spacers are inserted using a posterior or transforaminal approach. SUSTAIN Arch Spacers are inserted using a transforaminal or lateral approach. SUSTAIN Large Spacers are inserted using an anterior, anterolateral, or lateral approach. SUSTAIN Oblique and SUSTAIN G Spacers are inserted using a posterior, transforaminal, or lateral approach. These spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). All approaches may be used in the lumbar spine; only the anterior, anterolateral, or lateral approach may be used in the thoracic spine.

This document describes the premarket notification (510(k)) for two medical devices: PATRIOT® Lumbar Spacers and SUSTAIN® Spacers. It seeks clearance for additional implants and indications for these devices.

Based on the provided text, the acceptance criteria and the study that proves the device meets the acceptance criteria primarily revolve around demonstrating substantial equivalence to already legally marketed predicate devices, rather than a de novo clinical trial with specific performance metrics for the AI component. This is typical for 510(k) submissions for Class II medical devices like intervertebral body fusion devices, where the focus is on a comparison to existing cleared products.

Therefore, the table for "acceptance criteria and reported device performance" will be framed differently than for a typical AI/ML medical device, as the "performance" here is primarily about mechanical and physical characteristics matching predicates, and clinical support comes from literature rather than a new study with specific metrics.

Here's a breakdown of the information requested, as extractable from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Dynamic Compression
• Static Compression
• Compression-Shear
• Subsidence resistance
• Expulsion resistance | Mechanical testing conducted in accordance with:
• "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007
• ASTM F2077 (Dynamic and Static Compression and Compression-Shear)
• ASTM F2267 (Subsidence)
• Expulsion testing
  Result: Demonstrated substantial equivalence to the predicate spacers. |
  | Technological Characteristics Equivalence:
• Design
• Intended Use
• Material Composition
• Range of Sizes | Subject implants have the same technological characteristics as the predicate devices. |
  | Clinical Equivalence for Additional Indications:
• Safety and effectiveness for treating disc herniation, spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, or failed previous fusion (pseudarthrosis). | Published clinical data for interbody fusion devices provided.
  Result: The clinical data demonstrates that the use of interbody fusion devices for these conditions does not pose new risks to patients. |

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

This document describes a 510(k) submission based on substantial equivalence and mechanical testing, not a clinical study with a "test set" of patients in the typical sense for AI/ML device validation.

• Sample Size for Test Set: Not applicable in the context of a prospective clinical trial. The "testing" referred to is mechanical testing of the devices themselves, on samples of the physical product. The number of samples for these mechanical tests is not specified in the document but would follow the requirements of the ASTM standards.
• Data Provenance: The mechanical testing is performed in a lab setting. The clinical support data is "published clinical data" for interbody fusion devices, implying retrospective analysis of existing medical literature. The specific country of origin for this literature is not stated but would typically encompass international studies.

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

• Number of Experts: Not applicable. For this type of 510(k) submission, ground truth isn't established by expert consensus on a test set of patient cases in the way it is for diagnostic AI. The "ground truth" for mechanical testing is derived from adherence to engineering standards. The rationale for clinical safety and effectiveness for new indications relies on a review of existing clinical literature by the manufacturer and the FDA.
• Qualifications of Experts: Not applicable in this context. The FDA's review committee would consist of qualified experts in orthopedic devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This wasn't a clinical test set requiring adjudication of patient cases.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission does not involve an AI component that assists human readers.

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

• Standalone Study: Not applicable. This device is an intervertebral body fusion device, not a software algorithm.

7. The Type of Ground Truth Used

• Ground Truth:
  • For Mechanical Performance: Engineering standards (e.g., ASTM F2077, ASTM F2267) define the "ground truth" for mechanical properties and performance.
  • For Clinical Efficacy/Safety: Published clinical literature and established medical understanding of interbody fusion devices (for the new indications) serve as the "ground truth" for safety and effectiveness.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The "training" in the context of device development would involve engineering design, prototyping, and iterative mechanical testing, not data-driven machine learning.

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

• Ground Truth for Training Set: Not applicable. As there is no AI/ML component, there's no "training set" or establishment of ground truth for such a set in the machine learning sense.

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