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The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.

The provided document is a 510(k) summary for a spinal implant device (Curiteva Laminoplasty System), not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML device.

Specifically, the document discusses:

• Acceptance Criteria & Performance: The performance data section (page 4, section F) states that "Non-clinical testing performed on the Curiteva Laminoplasty System supports substantial equivalence to predicate devices." The tests performed are:
  • Static four-point bending per ASTM F2193
  • Dynamic four-point bending per ASTM F2193
  • Axial screw pullout per ASTM F543
    It concludes that the strength and performance are sufficient for intended use and substantially equivalent to the primary predicate device (K032534). However, this refers to mechanical testing of a physical implant, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the following information which is relevant to AI/ML device studies:

1. Table of acceptance criteria and reported device performance (for AI/ML): Not applicable.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth establishment for training set: None of this information is present as the document describes a physical medical device, not an AI/ML algorithm.

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The Blustone Synergy cervical (Slate Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.

The Blustone Synergy lumbar (Lavaflow) implants are intervertebral body fusion devices indicated for use with autograff and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion 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 non- operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scolosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Blustone Synergy Interbody Fusion System is composed of cervical and lumbar interbody fusion devices. The BluStone Synergy Slate Lavaflow System is a Titanium Plasma Coated cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach. The Blustone Synergy Lumbar Interbody Lavaflow System is a Titanium Plasma Coated lumbar interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: bi-laterally in pairs via a posterior (PLIF) approach; as a single device via a transverse (T-PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via a lateral (LLIF) approach.

All Blustone Synergy Interbody Fusion System implant components are made of polyether-ether-ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

This Traditional 510(k) submission seeks to expand the sizes offered for the MAGMA LLIF cages as well as add commercially pure (CP) titanium plasma coating per ASTM F1580 to the subject new MAGMA cages as well as all previously cleared cervical and lumber interbody fusion devices. Plasma-coated implant options will be denoted as the LAVAFLOW subfamily. Finally, this submission seeks to offer all implants as sterile devices via sterilization by ethylene oxide (EO) in addition to the previously cleared non-sterile, non-coated options.

The provided text is a 510(k) summary for the Blustone Synergy Interbody Fusion System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria with statistical data, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document primarily focuses on demonstrating substantial equivalence to previously cleared devices through:

• Comparison of Indications for Use, Materials, and Geometry: Stating that these aspects are "all-inclusive of the subject device" compared to predicates.
• Performance Testing: Mentioning that mechanical testing (expulsion, dynamic compression per ASTM F2077, and wear debris analysis per ASTM F1877) has been performed and "the results have shown them to be substantially equivalent to the predicate interbody devices." It also notes an "engineering rationale" for new MAGMA small IBDs.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth details, adjudication methods, MRMC study information, or standalone algorithm performance, as this information is not present in the provided text.

The document concludes that "Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices," which is the central finding of a 510(k) submission. However, the specifics of these "test results" in terms of statistical metrics against predefined acceptance criteria are not detailed.

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