(332 days)
The IM C-Ment Acetabular Cup will be used in indications which are the same as that for other acetabular components of cemented total hip replacement systems. Specifically, the IM C-Ment Acetabular Cup is intended to resurface the acetabular socket in cases of femoral head and neck fractures, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed prostheses.
The IM C-Ment Acetabular Cup is intended to be used in cemented applications only.
The IM C-Ment Acetabular Cup is an all-polyethylene, hemispherical acetabular component with three (3) concentric grooves on the outer diameter and 3 circular indentations equally-spaced around the circumference near the middle of the cup. It is provided in eleven (11) sizes for the 28mm inner diameter, ranging from outer diameters of 40mm to 60mm.
Here's an analysis of the provided text in the context of acceptance criteria and a study demonstrating device performance, as requested.
However, it's crucial to point out that the provided document is a 510(k) Summary for a medical device (acetabular cup), not a software algorithm or AI device. Therefore, many of the requested fields related to AI study design (like ground truth, expert adjudication, MRMC studies, training sets, etc.) are not applicable to this type of submission.
I will populate the table and answer the questions based on the information available in the 510(k) summary, explicitly stating when a requested piece of information is not present or not relevant to this type of device.
Acceptance Criteria and Device Performance Study (for IM C-Ment Acetabular Cup)
Given that the provided document is a 510(k) Summary for a physical medical device (acetabular hip cup), the "acceptance criteria" discussed are primarily related to safety, effectiveness, and substantial equivalence to existing predicate devices, rather than performance metrics typically associated with AI or diagnostic algorithms. The "study" proving acceptance is the submission itself, which demonstrates this substantial equivalence through comparison of materials, design, and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (typically implied by predicate device comparison) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Material Composition | Use of materials with a history of demonstrated success as implant materials. | Uses UHMWPE (Ultra High Molecular Weight Polyethylene) and Stainless Steel, materials also used by predicate devices, indicating a history of demonstrated success. |
| Intended Use | Intended use consistent with predicate devices for resurfacing the acetabular socket in specific conditions. | Intended for the same indications as other acetabular components of cemented total hip replacement systems (e.g., fractures, aseptic necrosis, arthritis, revision). |
| Device Configuration/Design | Hemispherical shape, concentric I.D., cement grooves, circular x-ray wires (general design). | Hemispherical, with three concentric grooves on the outer diameter and 3 circular indentations. This is generally consistent with predicate devices, with noted exceptions. |
| Sizing (Inner Diameter) | Inner diameter within or comparable to the range of predicate devices. | Available in a 28mm inner diameter. Predicates have 22mm and 32mm inner diameters, indicating a comparable functional range. |
| Sizing (Outer Diameter) | Outer diameter within or comparable to the range of predicate devices. | Available in outer diameters from 40mm to 60mm. Predicates range from 36mm to 65mm, indicating the IM C-Ment Cup is within this range. |
| Application Method | Intended for cemented applications. | Intended for cemented applications only, consistent with predicate devices. |
| Biocompatibility/Safety | (Implied by use of established materials and substantial equivalence, not explicitly detailed). | Uses materials and design comparable to legally marketed predicate devices, implying similar safety profiles. |
| Mechanical Performance/Durability | (Implied by use of established materials and substantial equivalence, not explicitly detailed). | Not explicitly stated in this summary, but substantial equivalence implies similar mechanical performance to a device that has already proven safe and effective. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a physical medical device, not an AI/software algorithm that would involve a "test set" of data in the sense of patient-derived information. The "testing" involves comparing the device's physical specifications and intended use against predicate devices' established safety and efficacy.
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)
- Not Applicable. As above, there is no "test set" of patient data requiring expert ground truth in this context. The "ground truth" for a 510(k) submission for a physical device is generally the established safety and effectiveness of the identified predicate devices, based on their clinical history and regulatory clearance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication process for data is described.
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
- No, not applicable. MRMC studies are specific to evaluating diagnostic accuracy, especially for AI-assisted interpretation, which is not relevant to this physical hip component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional sense of AI/diagnostic algorithms. For a 510(k) for a physical device, the "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness of the identified predicate devices based on their regulatory history, clinical use, and performance data available from their previous clearances.
8. The sample size for the training set
- Not Applicable. There is no "training set" for a physical device like an acetabular cup. The design and manufacturing are based on established engineering principles and materials science, often informed by decades of clinical experience with similar devices, rather than machine learning training.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.