(18 days)
ReBOSSIS is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ReBOSSIS is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, posterolateral spine, and intervertebral disc space). In the extremities and pelvis ReBOSSIS may be used without hydration or hydrated with blood. In the posterolateral spine and intervertebral disc space, ReBOSSIS is to be used hydrated with bone marrow aspirate and mixed with autograft bone. When used in intervertebral body fusion procedures, ReBOSSIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
ReBOSSIS is composite material consisting of beta-tricalcium phosphate (B-TCP), siloxanecontaining vaterite (a form of calcium carbonate, CaCO3), and a resorbable scaffold of poly(Llactide-co-glycolide), or PLGa. The electrospinning process used in manufacturing ReBOSSIS results in a glass wool-like (or cotton ball-like) physical form. Due to its physical form, ReBOSSIS is flexible and can easily adapt to and fill in defects in appropriate amounts.
The provided FDA 510(k) clearance document for ReBOSSIS (K240453) does not contain the detailed information necessary to fill out a table of acceptance criteria and the extensive study details commonly associated with AI/ML device evaluations. This document pertains to a resorbable calcium salt bone void filler and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance criteria for an AI algorithm.
Therefore, I cannot provide a table of acceptance criteria or populate the detailed study information as requested, because this information is not present in the provided text. The document mainly discusses:
- Device Type: Resorbable Calcium Salt Bone Void Filler (not an AI/ML device).
- Purpose of Submission: To expand the indications for use of the existing ReBOSSIS device (K172573) to include intervertebral disc space.
- Demonstration of Equivalence: Primarily relied on non-clinical testing data and animal testing data from the prior clearance (K172573), supplemented with a clinical rationale.
Specifically, the document states:
- "As the subject device is identical to the previously cleared reference device (K172573), it was determined that the non-clinical testing data and the animal testing data provided in the prior submission is adequate to support the expanded indications proposed in the current submission."
- "Non-clinical testing data and animal testing data, supplemented with a clinical rationale, are referenced to demonstrate the performance of the subject device is substantially equivalent to that of the predicate device."
Given this, the requested information points (especially those related to AI/ML device testing like MRMC studies, standalone algorithm performance, expert consensus for ground truth involving multiple readers, training set details) are irrelevant to the content of this 510(k) summary.
If this were an AI/ML device, the detailed information would be crucial. However, for this specific bone void filler, the focus is on physical, chemical, and biological performance (biocompatibility, resorption, mechanical properties, etc.) typically demonstrated through bench testing and animal studies.
Therefore, I will state that the information requested is not available in the provided text, as the device is not an AI/ML device and the 510(k) is for an expanded indication for a non-AI bone void filler.
§ 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.