(165 days)
BioSet™ XCh is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g., the extremities, spine, ilium and/or 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.
BioSet™ XCh is a combination of bovine bone chips processed with the BioCleanse Tissue Sterilization Process, human demineralized bone matrix, and a carrier derived from DBM from the same donor. BioSet™ XCh is available in volumes from 1 to 32cc.
The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
This document is a 510(k) summary for a medical device (BioSet™ XCh), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance acceptance criteria or results from a dedicated study.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria/Device Performance: These are typically quantitative metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility test results) that the device must meet. The document only describes the device's components and intended use.
- Study Details: There's no mention of a clinical trial, in-vitro study, or any other type of study designed to evaluate the BioSet™ XCh's performance against specific endpoints.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: All of these relate to the methodology and results of a performance study, which is absent from this 510(k) summary.
Instead, the document focuses on:
- Substantial Equivalence: Stating that "Data demonstrating substantial equivalence of BioSet™ XCh to predicate devices has been submitted."
- Technological Characteristics Comparison: Highlighting that "The DBM and bovine bone chips are processed in the same manner as the predicate BioSet™ XC. BioSet™ XCh is simply a substitution of human DBM-derived carrier for the porcine gelatin carrier in the BioSet™ XC product."
- Safety Aspects: Mentioning "Viral inactivation studies of the manufacturing process demonstrate a significant reduction of a representative panel of viruses." (While this is a study, it's specific to viral inactivation, not overall device performance or acceptance criteria in the context of efficacy or clinical outcomes).
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text.
§ 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.