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INDEPENDENCE® Spacers (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) are integrated anterior lumbar interbody fusion devices indicated for use at one or more levels of the 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. All INDEPENDENCE® TPS coated spacers are indicated for the same use as nor-coated PEEK versions.

INDEPENDENCE® Spacers are intended to be used with or without three screws which accompany the implants. INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™ Integrated Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when < 25° lordotic implants are used with three screws per implant.

INDEPENDENCE MIS AGX™ Spacers are C-shaped, non-integrated PEEK spacers that are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation). When used in conjunction with the INDEPENDENCE MIS AGX™ Integrated Ti Spacer, these devices become the INDEPENDENCE MIS AGX™ Integrated Spacer.

All INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

HEDRON IA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the 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 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. These devices are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <25° lordotic implants are used with three screws per implant. HEDRON IAT™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The MAGNIFY®-S Spacer is an interbody fusion device indicated for use at one or more levels of the 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 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 at least six (6) months of non-operative treatment.

The MAGNIFY®-S Spacer is to be used with or without three screws which accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when used with three screws per implant. The MAGNIFY®-S Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The MONUMENT® Spacer is an interbody fusion device indicated for use at one or more levels of the lumbosacral spine (1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). 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 nonoperative treatment.

The MONUMENT® Spacer is to be used with four screws that accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The MONUMENT® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices indicated for use at one or more levels of the 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 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. All InterContinental® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

InterContinental® Plate-Spacers are intended to be used with or without two screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). InterContinental® Plate-Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The ELSA® Spacer is an interbody fusion device indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy and/or radiculopathy), spondylolisthesis, 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.

The ELSA® Spacer is intended to be used with or without two screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two screws and/or anchors and supplemental fixation to the two screws and/or anchors. The ELSA®Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

INDEPENDENCE® (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The 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 aid in expulsion resistance. These devices may be used with screws and/or anchors.

HEDRON IA™ Integrated Lumbar Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. These devices may be used with screws and/or anchors.

MAGNIFY® Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The devices are available in various height expansion ranges 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 aid in expulsion resistance. The MAGNIFY®-S Spacers are used with screws.

The MONUMENT® Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The MONUMENT® Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The 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 aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation.

InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. InterContinental® Plate-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 grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Bone screws and/or anchors may be used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation.

ELSA® Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. 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 aid in expulsion resistance. Bone screws and/or anchors may be used to the lateral portion of the adjacent vertebral bodies for bony fixation.

This is a 510(k) premarket notification for a medical device (spinal interbody fusion devices), not an AI/ML device. Therefore, the requested information regarding acceptance criteria for AI/ML performance, study design with human readers, ground truth establishment, training set size, etc., is not applicable and cannot be extracted from this document. The document describes mechanical testing for the devices to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation.

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The INDEPENDENCE® Spacer is a stand-alone 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 nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The INDEPENDENCE® Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws, which accompany the implant.

The INDEPENDENCE® Spacer is a stand-alone anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The 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 aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

The INDEPENDENCE® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

Here's an analysis of the provided text regarding the acceptance criteria and study for the INDEPENDENCE® Spacer, structured as requested:

Acceptance Criteria and Study for INDEPENDENCE® Spacer

This 510(k) submission is for an enhancement to an existing device, the INDEPENDENCE® Spacer (K082252), specifically for the addition of hydroxyapatite (HA) coated screws. As such, the "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to the predicate device and ensuring the new component (HA coating) does not negatively impact performance.

Note: The provided document is a 510(k) summary and the FDA's clearance letter. It does not contain detailed study reports with raw data or comprehensive statistical analyses generally found in a full PMA (Premarket Approval) submission or a clinical trial report. Therefore, some information, particularly regarding specific performance metrics with numerical targets, sample sizes for specific tests, and details on expert ground truth, is limited or not explicitly stated in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "mechanical testing (expulsion)" but does not provide the number of devices or iterations tested.
• Data Provenance: The testing was conducted internally by the manufacturer (Globus Medical Inc.) to support the 510(k) submission. It's a retrospective analysis in the sense that the testing was performed, and the results were compiled for submission. The location of the testing is not specified, but it's presumed to be in a lab setting rather than a clinical trial.

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

• Not applicable / Not specified. This submission focuses on engineering bench testing (mechanical performance, material specifications). It does not involve a clinical test set requiring expert consensus for ground truth for diagnostic accuracy or similar evaluations. The "ground truth" for this device's performance is derived from established engineering test methods and material standards.

4. Adjudication Method for the Test Set

• Not applicable. As the "test set" primarily refers to mechanical testing results against engineering standards and a predicate device, there is no need for expert adjudication. The compliance with standards and equivalence to the predicate is determined by the results of the mechanical tests performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is typically performed for diagnostic imaging devices where human readers interpret medical images. This device is an intervertebral body fusion device, not a diagnostic device, and therefore such a study is not relevant or included.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Yes, effectively. The primary form of "performance" described is standalone. The device's mechanical properties and material composition are assessed independently against established engineering standards and compared to a predicate device. There is no "human-in-the-loop" component in evaluating the expulsion resistance or material characteristics of the spacer itself.

7. Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: The ground truth for this submission is established by:
  • Guidance Document: "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", June 12, 2007, which outlines the expectations for testing intervertebral fusion devices.
  • ASTM Standards: Material specifications (e.g., F2026, F136, F1295, F560, F1185) serve as the ground truth for material properties.
  • Predicate Device Data: The performance of the predicate device (InterContinental® Plate-Spacer, K103382) serves as the benchmark for substantial equivalence, particularly for mechanical properties like expulsion.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As there is no "training set" for an AI/ML algorithm, this question is not relevant.

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The INDEPENDENCE™ Spacer is a stand-alone 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 nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The INDEPENDENCE™ Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws which accompany the implant.

The INDEPENDENCE™ Spacer is a stand-alone anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The 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 aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

The INDEPENDENCE™ Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

The provided text describes the INDEPENDENCE™ Spacer, an intervertebral body fusion device. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.

The document is a 510(k) summary and an FDA clearance letter, which focus on the device's description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The response in the table below reflects the absence of this information in the provided document.

Acceptance Criteria and Device Performance Study Information

The provided document describes the INDEPENDENCE™ Spacer and its FDA 510(k) clearance based on substantial equivalence to predicate devices. However, the document does not contain the specific performance study results, acceptance criteria, or details regarding the methodologies (e.g., sample sizes, ground truth establishment, expert involvement, adjudication) that would typically accompany a clinical or performance study demonstrating that the device meets defined acceptance criteria.

The basis for substantial equivalence is stated as compliance with the "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007. This guidance document would outline the types of tests and considerations for performance, but the results of such tests against specific quantitative acceptance criteria are not presented in this 510(k) summary.

Therefore, the following table and subsequent sections will reflect the absence of this detailed performance study information in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not mentioned in the provided text.
• Data Provenance: Not mentioned in the provided text. The document refers to evaluation against a guidance document, implying a regulatory review process, but not a specific clinical study with a test set.

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

• This information is not mentioned in the provided text.

4. Adjudication method for the test set

• This information is not mentioned in the provided text.

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

• This information is not applicable and not mentioned in the provided text. The device is a physical interbody fusion spacer, not an AI-based diagnostic tool.

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

• This information is not applicable and not mentioned in the provided text. The device is a physical interbody fusion spacer.

7. The type of ground truth used

• This information is not mentioned in the provided text.

8. The sample size for the training set

• This information is not mentioned in the provided text.

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

• This information is not mentioned in the provided text.

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