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CaP Spheres Pellet Pack™ is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. CaP Spheres Pellet Pack™ is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. CaP Spheres Pellet Pack™ provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

CaP Spheres Pellet Pack™ is a synthetic, osteoconductive, and resorbable bone void filler device consisting of hollow and microporous biphasic calcium phosphate spheres contained within a resorbable mesh pouch to aid in intraoperative handling. The device may be implanted directly, or hydrated with saline or autologous blood, and is intended to be combined with autograft.

The provided text describes a medical device, CaP Spheres Pellet Pack™, and its FDA 510(k) submission. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML device performance.

The document is a 510(k) clearance letter and summary for a physical medical device (bone void filler), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, test set details, expert involvement, MRMC studies, or standalone algorithm performance, as commonly applied to AI/ML devices, is not present in this text.

The text focuses on:

• Device Description: What the CaP Spheres Pellet Pack™ is.
• Indications for Use: When and how the device should be used.
• Substantial Equivalence: Comparison to existing, legally marketed predicate devices to show it's as safe and effective.
• Performance Testing: Bench testing (physical, chemical, degradation), biological safety, sterilization, shelf-life, and an in vivo animal study.

The closest information related to "acceptance criteria" is the overall demonstration of "substantial equivalence" to predicate devices, and that all performance tests "yielded acceptable results." However, specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, AUC) are not defined, as they are not typically applicable to this type of device in the same way they are for diagnostic AI/ML products.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or answer the subsequent questions, as the input document does not contain this information for an AI/ML device.

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When used as a lumbar intervertebral body fusion device, the Zyston Strut Open Titanium Interbody Spacer System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Zyston Strut Open Titanium Interbody Spacer System is to be implanted via a posterior approach and is to be combined with supplemental fixation. The titanium fusion devices are not indicated for vertebral body replacement.

The Zyston Strut Open Titanium Spacer System implants are intervertebral body fusion devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have an open central area to accommodate autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F2924. The Zyston Strut Open Titanium Spacer System implants incorporate lordotic angles of 0 and 10 degrees. The implants are available in 7 to 16mm heights, 10 and 11mm widths, and 21 to 38mm lengths depending on the implant configuration. The Zyston Strut Open Titanium Spacer System implants are intended to be provided sterile.

This document describes the Zyston Strut Open Titanium Spacer System and its FDA 510(k) clearance, asserting its substantial equivalence to predicate devices. However, it does not contain information related to a study that proves the device meets acceptance criteria for a diagnostic AI/imaging device.

The provided text describes a medical device for spinal fusion, which is a physical implant. The "acceptance criteria" and "study" mentioned in the prompt are typical for AI/ML-based diagnostic devices that process imaging or other data to provide a medical assessment. This document focuses on the mechanical and biological safety and efficacy of an implantable hardware device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document discusses:

• Trade/Device Name: Zyston Strut Open Titanium Spacer System
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Intended Use/Indications for Use: Spinal fusion procedures for degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1.
• Device Description: Implants made of titanium alloy (Ti-6Al-4V ELI) with various sizes and configurations.
• Performance Data: Mechanical testing (ASTM F2077, ASTM F2267) and bacterial endotoxin testing (LAL) to demonstrate substantial equivalence to predicate devices.
• Substantial Equivalence: Comparison to predicate devices (K143258, K162262, K153695) in terms of intended use, indications, technological characteristics, and principles of operation.

All these points relate to the physical implant, its material properties, and its mechanical performance, not to an AI or imaging diagnostic study.

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When used as a cervical intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should have had at least six weeks of non-operative treatment. The Biomet Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s). Implants with 14 degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least one integrated fixation screw. The Biomet Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Biomet Spinal Fixation System. The Biomet SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplement fixation.

When used as vertebral body replacement, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Biomet Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

The subject Biomet Fusion System has the same or similar intended use, indications for use, technological characteristics and principles of operation as the intervertebral body fusion devices which were reclassified as explained in FDA's guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007). The subject Biomet Fusion is substantially equivalent to the previously cleared Biomet Fusion System (K141791).

The Biomet Fusion System is intended for use in intervertebral body fusion or vertebral body replacement. However, the implants included in this application are intended for use in lumbar intervertebral body fusion only. The subject implants are a line extension of those currently available in the Biomet Fusion System. Modifications have been made to the currently available Biomet Fusion System implants to add additional plate heights (18mm and 20mm) in both 1-hole and 2-hole configurations as well as to add a new 14degree spacer option. As a result of these new 18mm and 20mm plates and 14 degree spacers, taller cover plates, implant trials, and implant caddies were developed to correspond to the new implant sizes.

The Biomet Fusion System implants consist of a spacer body and plates with screws for additional fixation. The spacers are made from PEEK-OPTIMA® LT1, a polyaromatic semicrystalline thermoplastic polymer (-CcH4-O-CcH4-O-CcH4-CO-), with tantalum markers. The plates and screw are made from implant grade titanium alloy (Ti-6AI-4V ELI) meeting ASTM F136-08 and ISO 5832-3. The Biomet Fusion System spacers, plates, and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Biomet Fusion System is provided non-sterile.

I'm sorry, but this document does not contain the information required to answer your request. The document describes a medical device, the "Biomet Fusion System," and its indications for use, as well as a comparison to a predicate device. However, it does not include details of a study that establishes acceptance criteria for performance, nor does it present data on reported device performance in the format of acceptance criteria.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Details on standalone algorithm performance.
• The type of ground truth used.
• Sample sizes for training sets.
• How ground truth for training sets was established.

Instead, the document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K141791) based on intended use, indications for use, technological characteristics, and principles of operation, along with a risk analysis.

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