(35 days)
CELLPLEX™ TCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/ or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEX™ TCP Synthetic Cancellous Bone is intended to be gently packed 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 resorbs and is replaced with bone during the healing process.
CELLPLEX™ TCP Synthetic Cancellous Bone is a porous calcium phosphate bone void filler made from tricalcium phosphate for the repair of bony defects. It is osteoconductive with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile for single patient use. CELLPLEX™ TCP Synthetic Cancellous Bone guides the three-dimensional regeneration of bone in the defect site into which it is implanted. Pores in the device range from 100 to 400 um nominally. When CELLPLEX™ TCP Synthetic Cancellous Bone is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant, filling the pores with new bone. As the implant is bioabsorbed, bone grows into the space previously occupied by the bone graft substitute.
This document is a 510(k) summary for a bone graft substitute, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics described in the prompt.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of specific acceptance criteria (e.g., in terms of sensitivity, specificity, or quantitative measurements for a diagnostic device) and reported device performance against those criteria. Instead, it asserts "substantial equivalence" to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This document refers to substantiating equivalence through a comparison of "intended use, material composition, and design features" and "mechanical properties," along with general "testing results" rather than a clinical study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is not a study involving expert-established ground truth for a diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving adjudication of a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a study of a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a study of a diagnostic AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "proof" of meeting criteria in this context is through substantial equivalence to legally marketed predicate devices, not through a ground truth comparison in a clinical study. The document states:
- "The safety and effectiveness of the CELLPLEX™ TCP Synthetic Cancellous Bone is adequately supported by the substantial equivalence information, and testing results provided within this Premarket Notification."
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that requires a training set.
Summary of what is provided regarding "proving the device meets the acceptance criteria" (in the context of a 510(k) for a bone graft substitute):
The device, CELLPLEX™ TCP Synthetic Cancellous Bone, meets its "acceptance criteria" (which are implicitly defined by the requirements for substantial equivalence) by demonstrating the following:
- Substantial Equivalence:
- To WMT-TCP Bone Graft Substitute (K022629): The intended use, material composition, and design features of CELLPLEX™ TCP are substantially equivalent to this predicate device.
- To VITOSS™ Scaffold Synthetic Cancellous Bone Void Filler (K994337): The mechanical properties of CELLPLEX™ TCP are substantially equivalent to this predicate device.
The "study" or justification for equivalence is based on:
- A comparative analysis of the device's characteristics (intended use, material composition, design features, mechanical properties) against the identified predicate devices.
- "Testing results provided within this Premarket Notification" (the specifics of which are not detailed in this summary, but would be in the full submission).
The regulatory body (FDA) reviewed this information and concluded that the device is "substantially equivalent" to legally marketed predicate devices, thus allowing it to be marketed.
§ 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.