(223 days)
The Hedrocel® Acetabular Restrictor is a device intended for restriction of effusion of bone cement, allograft bone, and/or autograft bone into the pelvis if defects in the acetabulum are encountered.
The Hedrocel® Acetabular Restrictor is manufactured as a surgical mesh fabricated from Hedrocel® porous metal. The tantalum lattice mesh device is available in three (3) sizes. The Hedrocel® material is a tantalum deposited upon vitreous carbon construct which possesses dodecahedron shaped, fully interconnecting pores resulting in a relatively high bulk volume porosity, approximately 80%. Cement restrictors are classified as Surgical Meshes.
This document is a 510(k) summary for the Hedrocel® Acetabular Restrictor, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a performance study to meet specific acceptance criteria in the way an AI/ML device would. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not applicable or available in this document.
However, I can extract information related to the device and its claimed equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a physical medical device (a cement restrictor), there aren't "acceptance criteria" and "reported device performance" in the sense of an AI/ML diagnostic algorithm (e.g., sensitivity, specificity, accuracy against a numerical threshold). Instead, the "acceptance criteria" are implied by the requirement to demonstrate substantial equivalence to predicate devices in terms of:
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance/Comparison to Predicate |
|---|---|
| Intended Use (Restriction of effusion of bone cement into the pelvis) | The Hedrocel® Acetabular Restrictor's intended use is identical to the predicate devices. |
| Technological Characteristics (Design features, materials) | Design features (open lattice) are identical to predicate devices. Fabricated from metallic alloys, similar to predicates. Specific alloy (tantalum on RVC) varies, but this is presented as a material difference, not a functional difference that would negate equivalence. |
| Safety | Claimed to be substantially equivalent. Implicitly, the material (tantalum on carbon) is considered biocompatible and safe for this application, similar to other metallic implants. |
| Effectiveness | Claimed to be substantially equivalent. Implicitly, its ability to restrict cement effusion is considered equivalent to predicate devices based on design and intended use. |
2. Sample Size Used for the Test Set and the Data Provenance
- Not applicable. This submission doesn't involve a test set for performance evaluation in the way an AI/ML algorithm would. The demonstration of equivalence relies on comparison of device characteristics and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No test set or independent ground truth establishment is described for this type of device submission.
4. Adjudication Method for the Test Set
- Not applicable. No test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a physical device, not an AI/ML software. No MRMC study was conducted or is relevant for this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Not applicable. For this type of submission, "ground truth" refers to the established safety and effectiveness of the predicate devices based on their prior clearance and clinical use, which the new device aims to match through substantial equivalence. There is no independent "ground truth" established for the Hedrocel® Acetabular Restrictor itself as part of this submission, other than the inherent properties of its materials and design.
8. Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set is described.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.