(196 days)
Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing voids in osseous defects or osseous defects or osseous and is from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
Wright Plaster of Paris Bone Vold Finel Kit comment of the mixing bown provided, then placed premeasured quantities, so that when mixed together in the missing bown provided, into the mold provided, the mixute sets to form Wright Plaster of Paris Pellets. The into the mold provided, the mixtite sols to resorbed in 30-60 days when used according to labeling. The kit is provided sterile for single patient use.
This document is a 510(k) summary for a medical device called the "Wright Plaster of Paris Bone Void Filler Kit." It describes the device, its intended use, material, and a brief summary of testing. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria or a study proving device conformance to those criteria.
Here's why and what's missing:
- No Acceptance Criteria or Performance Data: The document does not list any specific performance metrics (e.g., dissolution rate in mg/day, compressive strength in MPa/psi, or specific resorption times) with corresponding acceptance thresholds. It states that "Dissolution studies demonstrate Wright Plaster of Paris Bone Void Filler Litter demonstrated the Dissolution studies demonstrate Wirgit I haste of the bulant to the cast of equivalent dissolution rates to the production in the compressed pellets and to pellets have a compressive innute rate substants of easy volume rato within 15% of the trabecular bone." This is a general statement about equivalence, not a detailed presentation of acceptance criteria or actual performance data.
- No Study Design Details: The document mentions "Dissolution studies" and "Testing indicates the product to be non-pyrogenic." However, there's no information about:
- Sample sizes for these tests.
- Test set data provenance.
- Ground truth establishment (which wouldn't be directly applicable to this type of device, as performance is typically measured against physical/chemical properties or biological responses, not expert consensus on images).
- Adjudication methods.
- MRMC comparative effectiveness studies (these are relevant for diagnostic imaging AI, not a bone void filler).
- Standalone algorithm performance (again, not relevant for this device type).
- Training set information (not applicable as this isn't an AI/ML device).
In summary, based solely on the provided text, I cannot complete the table or provide the requested study details. The document is a high-level summary for regulatory submission, not a detailed technical report of testing.
If this were an AI/ML-driven diagnostic device, the requested information would typically be present in a comprehensive clinical validation study report. For a bone void filler, the "acceptance criteria" would likely be based on physical material properties (e.g., compressive strength, dissolution rate, handling characteristics) and biological performance (e.g., biocompatibility, resorption, bone ingrowth) shown in preclinical or clinical studies. However, the provided text does not elaborate on these thresholds or the studies proving them.
§ 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.