(185 days)
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No
The summary describes a bone void filler material and its physical properties, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
A therapeutic device is typically one that treats or cures a disease or condition. This device is described as a "bone void filler" that facilitates the body's natural healing process by being replaced with bone, rather than actively treating a condition itself.
No
The device, Norian SRS Bone Void Filler, is described as a bone void filler intended to be placed or injected into bony voids or gaps. Its function is to resorb and be replaced with bone during the healing process, not to diagnose a condition.
No
The device description clearly states it is an injectable, moldable bone void filler composed of sterile powder and solution components, which are physical substances, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Norian SRS Bone Void Filler's Intended Use: The intended use of Norian SRS Bone Void Filler is to be placed or injected into bony voids or defects within the skeletal system. It is a material that is implanted into the body to fill a physical space and support bone growth.
- No Specimen Examination: The device does not examine any specimens derived from the human body in vitro. It is used directly on the patient's bone.
Therefore, based on the provided information, Norian SRS Bone Void Filler is a medical device, but it falls under a different category than In Vitro Diagnostics. It is a bone void filler intended for surgical implantation.
N/A
Intended Use / Indications for Use
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). 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.
Product codes
MQV
Device Description
Norian SRS Bone Void Filler is an injectable, moldable and biocompatible bone void filler. The reactants pack contains sterile powder (calcium phosphate) and solution (dilute sodium phosphate) components. The reactants pack is designed to be placed in a reusable mixer where the two components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18 - 23°C. Norian SRS Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes at body temperature (37°C). Norian SRS Bone Void Filler is slowly resorbed over a period of years. The 3cc, 5cc, and 10 cc reactants packs are provided sterile and are for single use only.
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
the extremities, spine and pelvis
Indicated Patient Age Range
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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)
Pre-clinical animal data demonstrate that Norian SRS Bone Void Filler supports bone growth into a metaphyseal defect. These data show that the materials compared resorb over a period of time, accompanied by bone ingrowth and bone remodeling. These results, in conjunction with biocompatibility data, demonstrate that Norian SRS Bone Void Filler is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler, Pro Osteon® 500R Resorbable Bone Graft Substitute
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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