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The Stryker Spine AVS® AL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® AL Peek Spacers are to be implanted via an anterior or anterolateral approach.

The AVS® AL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The AVS® AL Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The Stryker Spine AVS® AL PEEK Spacer is a ring shaped, hollow frame implant with lateral fenestrations, machined from medical grade PEEK OPTIMATM LT1 that is radiolucent and incorporates three (3) Tantalum marker pins to aid in radiographic visualization. The upper and lower aspects of the subject device are open, and the superior and inferior surfaces have serrations that assist in the anchorage and seating of the device.

The subject devices are manufactured out of the following materials:
Spacers: Polyetheretherketone (PEEK) OPTIMA™ LT1 (ASTM F2026)
Marker Pins: Tantalum (ASTM F560).

The Stryker Spine AVS™ AL PEEK Spacer family is comprised of six (6) different heights (10, 12, 14, 16, 18 and 20mm), two (2) lengths (22 mm and 28 mm), two (2) widths (28 mm and 33 mm) and lordotic angles of 4° and 8 °, which allows the surgeon to best choose the size suited to the patient's anatomy and pathology.

The provided text describes the Stryker Spine AVS® AL PEEK Spacers and their intended use, but it does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies based on the provided text. The document refers to "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed... and demonstrated substantial equivalent performance characteristics", but the details of these tests, acceptance criteria, and specific performance results are not included in this summary.

Therefore, the requested information (points 1-9) cannot be extracted from the provided text.

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