(211 days)
The Modular Revision Femoral Hip Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
The Modular Revision Hip stem is made up of a modular stem coupled with a proper neck by means of a "Morse" taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur. The modular system allows achievement of the required stability and the good distal fit of the stem within the femoral canal, regardless of the bone loss or the femur anatomy. In some particular cases the stem fixation can be enhanced by using bone cement. The stems are made of titanium alloy (ASTM F1472). The stem has a 1°50' tapered profile, with round finned section and typical diameters ranging from 14 to 24 mm. The diameter increases by 2 mm. The neck design, made of titanium alloy (ASTM F1472), includes a single CCD configuration of 135°, thus performing a unique offset of 35mm. An additional neck offset of 40mm of 131℃ of CCD configuration is also available. Both the neck versions are available in 7 different lengths from 50 to 110 mm. in 10 mm increments. The correct length of the final implant can thus be obtained by coupling the stem to a modular neck.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
Disclaimer: The provided document is a 510(k) summary for a medical device (Modular Revision Hip Stem). 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, rather than detailed clinical effectiveness studies with specific acceptance criteria in the manner you describe for algorithm performance. Therefore, many of your requested points related to AI/algorithm testing will not be present in this type of document.
Acceptance Criteria and Device Performance for Modular Revision Hip Stem
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided K092331 summary, the device is a Class III medical device (prosthesis) which likely has stringent performance requirements. However, this 510(k) summary does not explicitly define numerical "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable by meeting this equivalence and passing non-clinical mechanical testing.
| Acceptance Criteria Category | Specific Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|---|
| Material Equivalence | Same materials as predicate devices | Made of titanium alloy (ASTM F1472), same as predicate devices. |
| Indications for Use (IFU) Equivalence | Comparable IFU to predicate devices | Intended for cementless revision hip arthroplasty, comparable to predicate devices. |
| Mechanical Performance | Ability to perform under expected clinical conditions | "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." (No specific metrics or thresholds provided in this summary) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical "test set" in the context of an algorithm or diagnostic study was performed or reported in this 510(k) summary. This submission relies on substantial equivalence and non-clinical mechanical testing, not a clinical trial with a patient test set.
- Data Provenance: Not applicable. No clinical data from patients were used for a "test set."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No clinical "test set" requiring ground truth establishment by experts was conducted or reported.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As no clinical test set was performed, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is not typically required or presented in a 510(k) submission for an orthopedic implant. MRMC studies are more common for diagnostic imaging devices or AI-powered analytical tools.
- Effect Size: Not applicable, as no such study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This device is an orthopedic implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for a clinical study on this device. For the mechanical testing performed, the "ground truth" would be the engineering specifications and performance limits established by the manufacturer, often based on industry standards and predicate device performance.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as no training set was used.
Summary of the K092331 Document's Approach:
The K092331 submission for the Modular Revision Hip Stem demonstrates safety and effectiveness through the 510(k) substantial equivalence pathway. This pathway primarily involves:
- Comparison to Predicate Devices: Showing that the new device has the same intended use, fundamental technological characteristics, and (where applicable) similar materials as legally marketed predicate devices.
- Predicate Devices Identified: ZMR 1M Hip System, Modular REACH Hip, Modular Femoral Revision System, Modular-Plus Revision System.
- Comparable Features: Same materials (titanium alloy) and indications for use.
- Non-Clinical Testing: Performance testing (e.g., mechanical testing) to ensure the device meets engineering specifications and can perform under expected clinical conditions. The summary states, "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions."
- Clinical Testing: The document explicitly states: "Clinical Testing: None provided." This is common for 510(k) submissions where substantial equivalence can be adequately demonstrated without new clinical study data.
In essence, the "acceptance criteria" for this specific submission were met by successfully demonstrating its substantial equivalence to previously cleared devices and confirming its mechanical integrity through non-clinical means.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.