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BioSphere MIS Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere MIS Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine and intervertebral disc space. When used in intervertebral disc space, BioSphere MIS Putty is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. These defects may be surgically created osseous defects or osseous 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.

BioSphere MIS Putty device is composed primarily of medical-grade 45S5 bioactive glass particles. The composition and formula of this material are unchanged and identical to that used in the BioSphere Reference Device (K173301). This submission expands the device's indication to include use in the intervertebral spine and incorporates minor changes to the applicator, delivery gun, and packaging.

The provided text is an FDA 510(k) clearance letter and associated summary for a medical device called "BioSphere MIS Putty." It outlines the device's indications for use, its classification, and its substantial equivalence to predicate devices.

However, the provided document does not contain information regarding specific acceptance criteria for a study demonstrating device performance, nor details of a study setup (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), as would be expected for an AI/software device submission.

The document states:

• "The subject device has been previously cleared under K173301, which serves as a Reference Device. This submission is leveraged to support the device's sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterizations/bench performance as recommended in FDA's Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices."
• "The device's performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies."

This indicates that the submission relies on bench performance, biocompatibility, and prior clinical (potentially animal or human) studies that supported the initial clearance (K173301) and general knowledge of bone grafting materials.

Therefore, I cannot provide the requested information about acceptance criteria and study details (sample size, data origins, expert involvement, ground truth, MRMC, standalone performance) because this document describes a physical medical device (bone void filler) and not an AI or software device that would typically undergo such performance evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the biological and physical properties of the bone putty, not an AI model's diagnostic or predictive performance.

If this were an AI/software device, the 510(k) summary would include sections detailing the clinical validation study with metrics like sensitivity, specificity, AUC, and comparative performance against human readers. This document does not.

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