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510(k) Data Aggregation

    K Number
    K141600
    Device Name
    NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I
    Date Cleared
    2014-10-17

    (123 days)

    Product Code
    MQV,MOV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K110561,K100361
    Why did this record match?
    Device Name :

    NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NanOss™ is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

    Device Description

    NanOss™ is a resorbable bone void filler (BVF) consisting of calcium phosphate and a porcine gelatin carrier provided in granular form. The BVF is radiopaque, provided sterile and is intended for single use only. The product is provided pre-filled in a mixing container as NanOss™ or in a mixing chamber/syringe as NanOss™ Loaded.

    The purpose of this submission is to obtain clearance for a merged indications for use statement and new packaging configuration (NanOssTM Loaded Kit). In addition, instrument accessories previously cleared for MIS graft placement in the posterolateral spine through a small incision are now available for graft placement in the skeletal system (i.e., extremities, pelvis).

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called NanOss™, NanOss™ Loaded, and NanOss™ Loaded Kit. It is a resorbable calcium salt bone void filler device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Based on the provided text, the device is cleared based on demonstrating "substantial equivalence" to predicate devices, rather than meeting specific quantifiable performance acceptance criteria in clinical studies. The "testing" section lists non-clinical tests.

    Acceptance Criteria CategorySpecific Acceptance Criteria (Not Explicitly Stated as Numerical)Reported Device Performance (Summary from Submission)
    Substantial EquivalenceThe device should have the same intended uses, operating principles, basic design, and materials as legally marketed predicate devices.The bone void filler has the following similarities to the previously cleared bone void filler product (K110561/K100361):
    • Same intended uses
    • Same operating principles
    • Same basic design
    • Same materials
    • Provided sterile and for single-use. |
      | Packaging & Shelf-Life | Validated according to ASTM D4169-09: DC 13 & 17 and ASTM F1980. | Non-clinical tests were performed to support substantial equivalence. |
      | Sterilization | Validated according to ISO 11137-1. | Non-clinical tests were performed to support substantial equivalence. |
      | Instrument Validation | Validated for instrument accessories. | Non-clinical tests were performed to support substantial equivalence. |

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not describe a clinical study with a "test set" in the context of device performance metrics (e.g., sensitivity, specificity for an AI device). The non-clinical tests mentioned do not specify sample sizes or data provenance in the way a clinical trial would. This submission is for a bone void filler, which typically undergoes biocompatibility, mechanical, and degradation testing, but these details (including sample sizes and provenance) are not provided in this summary. The "testing" section lists only non-clinical tests (packaging, shelf-life, sterilization, instrument validation).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    Not applicable. This is not a study involving expert assessment to establish ground truth (e.g., for image interpretation).

    4. Adjudication Method for the Test Set

    Not applicable.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    Not applicable. This is not an AI/software device undergoing an MRMC study.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Not applicable. This is a medical device (bone void filler), not an algorithm or AI system.

    7. The Type of Ground Truth Used

    The "ground truth" for the substantial equivalence determination for this bone void filler is based on the characteristics and performance of the legally marketed predicate devices (FortrOss Bone Void Filler K110561 and NanOss™ BVF-E K100361), as demonstrated through non-clinical testing. For the non-clinical tests (packaging, sterilization, etc.), the ground truth would be established by the specifications and standards (e.g., ASTM, ISO) they are tested against.

    8. The Sample Size for the Training Set

    Not applicable. This is a bone void filler device, not an AI/machine learning model that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable.

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