(24 days)
Porous Biologic Scaffold is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Porous Biologic Scaffold is indicated to be packed gently into bony voids or gaps of the pelvis, intervertebral disc space, and posterolateral spine and is used combined with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Porous Biologic Scaffold must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Porous Biologic Scaffold is a resorbable bone void filler that is available in two versions:
Version 1 is comprised of a porous collagen mesh that is either prefilled or separately packaged with human demineralized allograft bone matrix. In the prefilled format, the demineralized bone matrix is completely enclosed inside the collagen mesh. In the separately packaged format, an open-ended collagen mesh bag is supplied with separately packaged demineralized bone matrix and is filled and sewn closed with absorbable suture by the clinician. Version 1 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation.
Version 2 is comprised of a porous resorbable collagen mesh bag either prefilled or separately packaged with activated biphasic ceramic granules. In the prefilled format, the biphasic granules are completely enclosed inside the collagen mesh. In the separately packaged format, an openended collagen mesh bag is supplied with separately packaged biphasic granules and is filled and sewn closed with absorbable suture by the clinician. Version 2 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation.
Both formats of the Porous Biologic Scaffold are supplied terminally sterile and are available in sizes of 18 x 50 mm, 18 x 100 mm, 24 x 50 mm, and 24 x 100 mm.
This document is an FDA 510(k) clearance letter for a medical device called "Porous Biologic Scaffold." It's important to note that this document primarily focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating acceptance criteria for an AI/software-based medical device.
Therefore, I cannot extract the information required for an AI/software-based medical device's performance study acceptance criteria, as this document describes a physical medical device (bone void filler) and its regulatory clearance process, which relies on demonstrating equivalence to previously cleared devices rather than extensive new clinical performance studies with acceptance criteria like those for AI.
The document states:
- "The subject device has been previously cleared under K240775, 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."
- "Based on the clinical analysis, the device is substantially equivalent to the predicates."
These statements indicate that the "performance" demonstrated is primarily based on established characteristics (sterility, biocompatibility, material properties) and leveraging prior studies on similar devices or the same device from a previous submission, rather than a new, detailed clinical trial with specific acceptance criteria that would be typical for an AI software.
Therefore, I cannot fill out the requested table and answer the detailed questions about acceptance criteria specific to an AI/software study because the provided text describes a physical medical device and its substantial equivalence clearance, not an AI/software performance study.
§ 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.