(26 days)
The ProxiLock Hip Prosthesis is intended for use where severe degeneration of the hip joint is necessary due to osteoarthritis, rheumatoid arthritis, trauma, revision of previously failed total hip arthroplasty or other pathology.
The ProxilLock Hip Prosthesis offers the surgeon a cementless option in reconstructing the hip joint on the femoral side. The stem is intended for use in the relatively younger, moderate and higher demand patient in hybrid or cementless hip arthroplasty. The Implex ProxiLock Hip Prosthesis is compatible with all Implex acetabular Hip components. The ProxiLock Hip Prosthesis is available in an array of sizes to fit a patient size range. The stem system is available without a distal slotted stem. The ProxiLock Stem is intended to be used as a cementless stem only, and is intended to cooperate with Implex Femoral Bearing Heads via a tapered locking mechanism between the neck of the ProxiLock Hip Prosthesis and the Modular Bearing Head. Implex Modular Bearing Heads are compatible with all Implex Femoral Stems.
The provided 510(k) summary does not contain information about the acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or accuracy, and details about a test set, ground truth establishment, or expert involvement).
Instead, this document focuses on the substantial equivalence of the ProxiLock Hip Prosthesis to a predicate device based on mechanical testing and material changes.
Here's a breakdown of the information that is available, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Strength Criteria (implicitly, for mechanical properties) | Passed strength criteria (mechanical testing, similar to predicate device) |
| Fatigue Criteria (implicitly, for mechanical properties) | Passed fatigue criteria (mechanical testing) |
| Tolerances (implicitly, for mechanical properties) | Passed tolerance requirements (mechanical testing) |
| Sterility Testing | Test data provided in predicate submission; device presumably meets sterility standards. |
| Package Integrity | Test data provided in predicate submission; device presumably meets integrity standards. |
| HA Integrity in Saline | Test data provided in predicate submission; device presumably meets integrity standards. |
| Dissolution Characteristics of HA Coating | Test data provided in predicate submission; device presumably meets dissolution standards. |
| Modular Locking Head Test | Test data provided in predicate submission; device presumably meets locking standards. |
Missing Information: The document does not specify quantitative acceptance criteria for "strength," "fatigue," or "tolerances" (e.g., "must withstand X N of force," or "fatigue life of Y cycles"). It only states that the device "passed the strength criteria" and that testing showed the manufacturing change "does not adversely influence the strength, fatigue, or tolerances."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "mechanical testing" and "test data" but does not give sample sizes for these tests.
- Data Provenance: The tests are "conducted... in a manner similar to the predicate device." The location or nature of these tests (e.g., in-house, third-party lab) is not specified, nor is whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable / Not specified. This type of information is relevant for studies involving human interpretation (e.g., medical imaging devices). For a mechanical device like a hip prosthesis, the "ground truth" for performance is typically established through engineering standards and validated physical testing methods, not expert clinical consensus in the way a diagnostic device would. No experts are mentioned in the context of establishing performance ground truth.
4. Adjudication Method for the Test Set
- Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in tasks like image interpretation. This is not relevant for the mechanical testing described for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a mechanical hip prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or analysis of human reader improvement with AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device does not involve an algorithm. Mechanical testing was performed on the device itself.
7. The Type of Ground Truth Used
- For the described performance, the "ground truth" would be established by engineering standards and validated mechanical testing protocols (e.g., ASTM standards for fatigue, strength, etc.). The document refers to "strength criteria," but the specific quantifiable metrics are not provided.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI models, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
In summary: The provided 510(k) emphasizes a comparison to a predicate device and mechanical testing to demonstrate substantial equivalence, rather than meeting specific, quantitatively defined acceptance criteria through a clinical study with human data interpretation. The evaluation framework used for this device is typical for a mechanical implant seeking 510(k) clearance, focusing on engineering performance and material properties.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.