(451 days)
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No
The document describes a bone graft substitute material and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
Yes
The device is intended as a bone graft substitute to aid in the healing process of bone voids and defects, which is a therapeutic purpose.
No
Explanation: The device is a bone graft substitute used to fill bone voids and is not designed to diagnose medical conditions.
No
The device description explicitly states that PRO-DENSE® is supplied in separate powder and liquid vials along with instruments for mixing and delivering it, indicating it is a physical product, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- PRO-DENSE® Intended Use: The intended use of PRO-DENSE® is to be injected or packed into bone voids/gaps within the body to act as a bone graft substitute and cure in situ. It is a material implanted into the patient.
- No Specimen Examination: The description does not mention the examination of any specimens derived from the human body.
Therefore, PRO-DENSE® is a medical device, specifically a bone graft substitute, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K. Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
PRO-DENSE® is provided sterile for single use only.
Product codes
MQV
Device Description
PRO-DENSE® is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system to cure in-situ. It is supplied in separate powder and liquid vials along with the instruments for mixing it into a paste and delivering it to the defect site. The triphasic resorption of PRO-DENSE® results in a scaffold that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.
PRO-DENSE® is a calcium sulfate - calcium phosphate composite bone graft substitute consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to directions, an injectable paste forms and subsequently hardens via hydration reactions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skeletal system (i.e., the extremities and pelvis)
Indicated Patient Age Range
adults and pediatric patients ≥ 6 years old
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A literature review was conducted to establish the safety and effectiveness of PRO-DENSE® for use in voids resulting from resected benign bone cysts/tumors in both adult and pediatric patients. This evidence was used to change the indications statement to include this patient population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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