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INDEPENDENCE® (including INDEPENDENCE® TPS, INDEPENDENCE MIS™, INDEPENDENCE MIS™ TPS, INDEPENDENCE MIS AGX™, and INDEPENDENCE MIS AGX™ TPS) Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacal 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 at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/ or corticocancellous bone.

INDEPENDENCE® and INDEPENDENCE® TPS Spacers are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants.

INDEPENDENCE MIS™ and INDEPENDENCE MIS™ TPS Spacers are interbody fusion devices intended to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Integrated Spacer, INDEPENDENCE MIS AGX™ TPS Integrated Spacer, and INDEPENDENCE MIS AGX™ Integrated Ti Spacer are interbody fusion devices that may be used with three titanium allov screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Soacer and INDEPENDENCE MIS AGX™ TPS Spacer 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.

INDEPENDENCE MIS AGX™ Spacers are 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 the device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. INDEPENDENCE MIS AGX™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. INDEPENDENCE MIS AGX™ Integrated Spacers may be used with three titanium alloy screws and/or anchors which accompany the implants.

The INDEPENDENCE MIS AGX™ Integrated Ti Spacer is made from titanium alloy as specified in ASTM F136, F1295, and F1472. INDEPENDENCE MIS AGX™ Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. All PEEK implants are additionally available with a commercially pure titanium plasma spray coating, as specified in ASTM F67 and ASTM F1580.

The mating screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and the screws and anchors are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

The provided document is a 510(k) summary for the INDEPENDENCE® Spacers, which are intervertebral body fusion devices. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical sense.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets these criteria in the context of diagnostic or assistive AI devices.

More specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on mechanical testing standards for this type of medical implant.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device and submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for these implants would be their ability to facilitate fusion and provide stability in vivo, which is assessed through clinical follow-up in post-market studies, not pre-market mechanical testing.
8. The sample size for the training set: Not applicable. This is a medical implant, not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide:

The document describes the performance data as follows:

• Mechanical testing: "Mechanical testing (static and dynamic compression and compression-shear, subsidence, and expulsion) was conducted in accordance with the 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device,' June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate spacers."
• Bacterial endotoxin testing (BET): "Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."

These tests and standards serve as the basis for demonstrating that the device is substantially equivalent to existing devices and functions as intended for an intervertebral body fusion device. They are not "acceptance criteria" in the sense of a performance study for an AI or diagnostic device, but rather engineering and biocompatibility standards for implantable medical devices.

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