(80 days)
The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty.
The Implex Modular Elliptical Porous Acetabular Cup is intended for use with 6.5 mm diameter cancellous bone screws in 20 to 65 mm lengths, in 5 mm increments. A titanium alloy dome hole plug is available for sealing the central dome hole.
The provided text describes a 510(k) summary for "The Implex Modular Elliptical Porous Acetabular Cup," an orthopedic implant. The information primarily focuses on establishing substantial equivalence to predicate devices based on material, design, and intended use, rather than presenting a performance study with detailed acceptance criteria and results as would be typical for an AI/software device.
Therefore, many of the requested elements for a study proving device adherence to acceptance criteria, especially those pertaining to AI/software performance validation, are not applicable or cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured and the target value) | Reported Device Performance (Achieved value in test) |
|---|---|
| Mechanical Performance: | |
| Push-out strength (per FDA Guidance and ASTM Standards) | Possesses performance characteristics similar to several legally marketed devices. |
| Lever-out strength (per FDA Guidance and ASTM Standards) | Possesses performance characteristics similar to several legally marketed devices. |
| Torsion strength (per FDA Guidance and ASTM Standards) | Possesses performance characteristics similar to several legally marketed devices. |
| Material Equivalence: | |
| Manufactured from similar materials to predicate devices | Yes, manufactured from similar materials. |
| Design Equivalence: | |
| Similar insert locking mechanisms to predicate devices | Yes, similar insert locking mechanisms. |
| Intended Use Equivalence: | |
| Similar or the same indications for use as predicate devices | Yes, similar or the same indications for use. |
| Surgical Technique Equivalence: | |
| Utilizes similar surgical techniques and instrumentation | Yes, utilizes similar surgical techniques and instrumentation. |
Note: The document states the device "possesses performance characteristics similar to several legally marketed devices" for the mechanical tests. It does not provide specific numerical acceptance criteria or numerical reported performance values. The acceptance criterion is implicitly being "similar to legally marketed predicate devices" as evaluated against FDA Guidance Documents and ASTM Standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not specified in the document. The document refers to "testing" but does not give the number of samples tested for push-out, lever-out, or torsion.
- Data provenance: Not applicable in the context of an orthopedic implant's mechanical testing as described here. The data would originate from laboratory testing of the manufactured devices. It is not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is an orthopedic implant, and its performance is evaluated through mechanical testing, not by expert interpretation of data or images. Ground truth for mechanical properties would be established by physical measurements using standardized equipment and methods.
4. Adjudication Method for the Test Set
Not applicable. This concept (e.g., 2+1, 3+1) is relevant for clinical studies involving human interpretation or consensus, not for mechanical laboratory testing of an implant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is for evaluating the performance of diagnostic devices or AI systems, often in comparison to human readers. It is not relevant for an orthopedic implant's mechanical performance assessment as described here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No. This concept applies to AI algorithms. The device described is a physical orthopedic implant. Its performance is inherent to its design and manufacturing, evaluated through mechanical testing.
7. The Type of Ground Truth Used
For the mechanical performance data (push-out, lever-out, torsion), the ground truth is established through physical measurement of the device's properties according to established ASTM Standards and FDA Guidance Documents. It is not based on expert consensus, pathology, or outcomes data in the traditional sense. The "similarity" to predicate devices serves as the benchmark for "truth."
8. The Sample Size for the Training Set
Not applicable. This device is an orthopedic implant, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is an orthopedic implant, not an AI model requiring a training set.
§ 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.