(132 days)
The KMI Cement Restrictor Implant is intended to be implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug. The safety and effectiveness of this device for use in the spine have not been established.
The KMI Cement Restrictor Implant is a flexible, bio-resorbable restrictor designed to provide a quick and effective method of plugging the intramedullary canal with an easy-to-place absorbable bone plug. Based on the size of the canal and reamer used to form the channel, the appropriate size cement restrictor is selected and is guided into the canal to the desired depth. The KMI Cement Restrictors are malleable to take on the irregular shape of the canal, effectively sealing them at the desired friction-fit position. There are a variety of sizes and shapes offered, including cylindrical and cube versions. Each device can be custom shaped either by manual manipulation, by using a scalpel at the time of surgery, or by press-fitting into the canal.
This prompt describes a 510(k) premarket notification for a medical device and not a study that proves the device meets specific acceptance criteria via performance data. Therefore, many of the requested fields cannot be filled as they pertain to clinical trial design and results.
However, I can extract the information relevant to the device and its intended use, as well as the FDA's acceptance of its substantial equivalence.
Here's a breakdown of the provided information, noting what can (and cannot) be answered based on the input:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance for the KMI Cement Restrictor. It is a 510(k) summary, which demonstrates substantial equivalence to a predicate device rather than providing performance data against predefined criteria. The FDA's letter states they have "reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent." This implies the device met the regulatory requirements for showing substantial equivalence, which is the "acceptance criteria" in this context, but no specific performance data is provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission, not a study report with a test set of data. Substantial equivalence is typically demonstrated through comparison of design, materials, and intended use to a predicate device, sometimes supported by non-clinical testing (e.g., biocompatibility, mechanical testing) but not necessarily a "test set" of clinical data for performance metrics.
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. No ground truth establishment for a test set is described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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 document pertains to a cement restrictor, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described in the context of device performance testing. The "ground truth" for a 510(k) itself is the existing legal market status and safety/effectiveness profile of the predicate device.
8. The sample size for the training set
Not applicable. This is not a study involving a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
Summary of Device Information (from the provided text):
- Device Name: KMI Cement Restrictor
- Common Name: Bone Plug
- Classification Name: Cement Obturator
- Product Code: LZN (initially), later determined to be JDK (Surgical mesh) by FDA.
- Submitter: Kinetikos Medical, Inc.
- Predicate Device: Improve Absorabale Cement Flow Restrictor (K011943)
- Description: Flexible, bio-resorbable restrictor designed to plug the intramedullary canal as an absorbable bone plug. Malleable, can be custom shaped.
- Materials: L,D-L Lactic Acid Polymer
- Shelf Life: Two (2) years
- Intended Use: Implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug.
- Contraindications: Active local infection, allergic reaction to foreign bodies, poor/insufficient bone stock, clinical/functional abnormalities precluding good results, other patient risks, and spinal applications.
Key FDA Determination/Acceptance:
- Determination: The device is "substantially equivalent" to legally marketed predicate devices.
- Limitations/Warnings:
- "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS."
- "WARNING: THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."
- These warnings must be prominently displayed in all labeling and promotional materials.
In conclusion, this document serves as a regulatory approval notice based on substantial equivalence to a predicate device, not a performance study detailing acceptance criteria and their fulfillment through specific test results.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.