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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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AttraX Scaffold is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. AttraX Scaffold resorbs and is replaced with bone during the healing process.

The subject AttraX Scaffold, is an osteoconductive and resorbable bone void filler designed for use in the skeletal system. AttraX Scaffold consists of ceramic granules premixed with purified type I bovine collagen. The ceramic granules are identical to those cleared as CuriOs (K090641; herein after referred to by the commercial name as AttraX Granules) and identical to the granules within AttraX Putty (K151584). The collagen binder used in AttraX Scaffold is manufactured from the same source material as that of the primary predicate Formagraft Collagen Bone Graft Matrix (K050789). AttraX Scaffold will be provided sterile in singleuse packages. Once hydrated with biological fluids or saline, AttraX Scaffold can be applied directly to bone defects or molded to fit the contours of complex bone defects.

This document is a 510(k) summary for the NuVasive® AttraX® Scaffold, a resorbable calcium salt bone void filler device. It establishes substantial equivalence to predicate devices, but it does not describe a study involving device performance against acceptance criteria in the context of an AI or diagnostic device. Therefore, I cannot provide the requested information about acceptance criteria or a study that proves the device meets those criteria from this document.

The document discusses:

• Device Name: NuVasive® AttraX® Scaffold
• Regulation Number/Name: 21 CFR 888.3045, Resorbable calcium salt bone void filler device
• Regulatory Class: Class II, Product Code MQV
• Predicate Devices: NuVasive Formagraft™ Collagen Bone Graft Matrix (K050789), NuVasive AttraX Putty (K151584), NuVasive AttraX Granules (K090641).
• Device Description: An osteoconductive and resorbable bone void filler made of ceramic granules (identical to AttraX Granules) premixed with purified type I bovine collagen (from the same source as Formagraft Collagen Bone Graft Matrix).
• Indications for Use: Fills bony voids or gaps of the skeletal system (posterolateral spine and pelvis), must be used with autogenous bone or bone marrow aspirate in the posterolateral spine. Resorbs and is replaced with bone.
• Performance Data: Mentions bench-top testing for physicochemical and crystallographic characteristics, in vivo animal data for intended use, ISO 10993 for biocompatibility, and bacterial endotoxin testing. These are conducted to support substantial equivalence, not to demonstrate performance against specific, quantifiable acceptance criteria for an AI or diagnostic device.

The questions you've asked (about sample sizes, experts, ground truth, MRMC studies, standalone performance) are highly relevant for the evaluation of AI/ML or diagnostic devices where performance metrics like sensitivity, specificity, AUC, etc., are established and compared against acceptance criteria. This document, however, pertains to a bone void filler and focuses on demonstrating substantial equivalence based on material composition, intended use, and existing predicate devices, rather than a diagnostic performance study.

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