(57 days)
The Spinal USA Cement Restrictor System is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
The Spinal USA Cement Restrictor is a hollow rounded rectangular frame with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth on two opposing flat sides to prevent migration. The device comes in various sizes and is offered in straight and tapered styles. The device may be made from titanium alloy as specified in ASTM F136 or polyetheretherketone (PEEK) that conforms to ASTM F2026-02.
The provided 510(k) summary does not contain the detailed information necessary to fully answer all of the questions about acceptance criteria and study particulars. This document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with acceptance criteria in the format requested.
However, based on the information provided, here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
The 510(k) summary for the Spinal USA Cement Restrictor System (K060132) does not provide a table of acceptance criteria and reported device performance from a specific study in the way medical device performance studies typically present them (e.g., sensitivity, specificity, accuracy, etc., with associated targets).
Instead, the mechanism for demonstrating acceptable performance is through substantial equivalence to previously cleared predicate devices. The implicit "acceptance criteria" here are that the new device shares fundamental characteristics with predicate devices that have already been deemed safe and effective by the FDA.
The document states:
- "The Spinal USA Cement Restrictor System was demonstrated to be substantially equivalent to previous cleared devices such as the Scient'X Cement Restrictor (K052367), Quantum Cement Restrictor (K040276), and Fortitude Cement Restrictor (K021719)."
- The similarities that establish substantial equivalence are:
- "the same indication for use"
- "the same operating principle"
- "the same basic design"
- "the same materials"
- "implanted using the same surgical techniques and equipment"
Therefore, the reported "performance" is that the device aligns with these characteristics of the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) document does not report on a specific test set, sample size, or data provenance for performance evaluation. This type of information would be relevant if a clinical performance study was conducted, which is not described as the primary pathway for clearance in this summary.
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)
This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document does not describe a study involving expert adjudication for 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
This information is not applicable. The device is a physical cement restrictor, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study or an assessment of human reader improvement with AI would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical cement restrictor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of a "ground truth" as typically used in performance studies is not directly applicable here. The "truth" for substantial equivalence is based on the established safety and effectiveness of the predicate devices and the demonstration that the new device is sufficiently similar to them across key attributes.
8. The sample size for the training set
This information is not applicable. The document does not describe a training set as this is not an AI/ML device or a device requiring a training phase for its function.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.