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The provided text describes the regulatory clearance for the OsOpia Synthetic Bone Void Filler. It does not, however, describe the acceptance criteria of a device (e.g., an AI/ML algorithm or diagnostic tool) in the typical sense of performance metrics like sensitivity, specificity, or F1-score. Instead, it details the criteria and studies used to demonstrate substantial equivalence for a medical device (a bone grafting material) to existing legally marketed predicate devices, as required for a 510(k) submission to the FDA.

Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in the context of this traditional medical device submission, which is not for an AI/ML device.

However, I can extract the relevant information from the provided document regarding how the device (OsOpia Synthetic Bone Void Filler) met the criteria for substantial equivalence.

Here's a breakdown based on the document:

1. Table of "Acceptance Criteria" (for Substantial Equivalence) and Reported Device Performance

Criterion Type	Description of Criterion (as implied by FDA 510(k) process for this device type)	Reported Device Performance (OsOpia)
Biocompatibility	Compliance with ISO 10993-1 and FDA Guidance for biological evaluation of medical devices (including cytotoxicity, irritation/sensitization, systemic toxicity, genotoxicity, implantation, and hemocompatibility, as applicable).	Assessed using ISO 10993-5 (cytotoxicity), ISO 10993-6 (local effects after implantation), ISO 10993-9 (degradation of materials), ISO 10993-10 (irritation and skin sensitization), and ISO 10993-11 (systemic toxicity). Found to be biocompatible per ISO 10993-1.
Sterilization Validation	Sterility Assurance Level (SAL) of 10^-6 for devices sterilized by gamma irradiation.	Validated in accordance with ISO 11137-1 and ISO 11137-2 to a sterility assurance level of 10^-6.
Shelf Life	Demonstration of product and packaging stability over the claimed shelf life, commonly through accelerated and real-time aging studies. Parameters like physical integrity, and product characteristics (e.g., chemical composition, functional properties) should be maintained.	Assigned based on accelerated and real-time aging studies of both packaging and product. Packaging tested with burst (ASTM F1140), peel (ASTM F88), and gross leak (ASTM F2096) tests. Product stability assessed by monitoring color, XRD, SEM, and porosity.
Bioburden/Pyrogenicity	Adherence to specifications for microbial load (bioburden) and absence of pyrogenic substances (bacterial endotoxin).	Verification batches met specifications for bioburden and pyrogenicity. Bacterial endotoxin testing (LAL method, USP) showed the device meets FDA established endotoxin limits.
Material Characterization	Demonstration of equivalent chemical composition, physical properties, and performance characteristics to predicate/reference devices through standardized testing. This typically includes identification of components, structural analysis, and functional assessments relevant to the device's intended use.	Performed in accordance with ASTM F1088. Included: X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR) for chemical composition; inductively coupled plasma/mass spectroscopy (ICP/MS) for trace elemental analysis; dissolution for in vitro calcium release rate; and mercury intrusion porosimetry for porosity. Analytical characterization demonstrated equivalent chemical composition, physical properties, and performance to predicate/reference devices.
Animal Study Performance	Demonstration of suitable performance as a bone grafting material in a relevant animal model for the intended use, showing bone formation and integration.	Evaluated in a sheep model for intraoral maxillary sinus floor augmentation surgery. Results demonstrated suitable performance as a bone grafting material for maxillary sinus augmentation.
Clinical Performance	For bone grafting materials, this often involves demonstrating suitable clinical outcomes such as new bone formation, implant survival rates in procedures where the graft is used, and absence of serious adverse events, to show safety and effectiveness comparable to marketed devices, especially for the stated indications (extraction sockets, maxillary sinus augmentation).	Six clinical studies (all prospective, one randomized, others single-arm) involving 90 patients were used. No serious adverse events reported. Two studies (at 5-6 months post-implantation) showed equal or greater new bone formation than control via bone histology. Four studies evaluated implant placement survival, reporting a survival rate of ≥96%. Demonstrated performance for socket extraction and maxillary sinus augmentation.
Indications for Use	The intended use and indications for use should be substantially equivalent to a predicate device, or any differences should not raise new questions of safety or effectiveness. The range of use (e.g., granule size) should be within or narrower than that of the predicate.	Proposed indications (extraction sockets and maxillary sinus augmentation) are narrower than the primary predicate (which includes root resection, apicoectomy, cystectomy, and periodontal defects in addition to sockets and sinus augmentation), raising no new questions of safety/effectiveness. Granule size range (250-1000 µm) is within the predicate's range (200-2000 µm) and narrower, thus raising no new safety/effectiveness issues.
Composition	The device's composition (e.g., ratio of β-TCP to HA) should be substantially equivalent to or reasonably compared with predicates or reference devices, without raising new safety/effectiveness concerns.	OsOpia: β-TCP >90%, HA 90%, HA

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K Number

K172497

Device Name

NuVasive AttraX Scaffold

Manufacturer

NuVasive, Incorporated

Date Cleared

2017-11-24

(98 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K090641,K151584,K050789

Intended Use

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.

Device Description

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.

AI/ML Overview

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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