(81 days)
The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously. The device is for single use.
The Reflection Acetabular Reinforcement Ring is a device intended to address acetabular defects. The rings are manufactured from titanium in a variety of sizes to accommodate the needs of patients.
This document is a 510(k) summary for a medical device (Reflection Acetabular Reinforcement Rings) submitted in 1996. The information provided is for regulatory clearance based on substantial equivalence to predicate devices already on the market.
It is important to note that this type of submission (510(k)) generally does not involve clinical studies with acceptance criteria, sample sizes, expert ground truth, or comparisons of AI-assisted vs. non-AI-assisted human performance in the way a modern AI/ML device would.
Therefore, I cannot provide the requested information in the format of a typical AI/ML device study. The document focuses on demonstrating similarity to existing devices rather than proving performance against specific acceptance criteria through novel studies.
Here's an explanation based on the provided text, highlighting why the requested information cannot be fully provided:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. For 510(k) submissions of this era for mechanical implants, acceptance criteria would typically revolve around material specifications, dimensional tolerances, and mechanical testing (e.g., fatigue, static strength) to ensure the device performs similarly to predicate devices. These are not detailed in this summary.
- Reported Device Performance: The document states, "The safety and effectiveness of the Reflection Acetabular Reinforcement Rings System is based on the long history of use of these devices in the market place." This implies that the performance is considered equivalent to the predicate devices due to their established clinical use. No specific, quantifiable performance metrics for the Reflection rings themselves are reported from a dedicated study.
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. No clinical "test set" in the context of an AI/ML study is mentioned. The safety and effectiveness are established by reference to the pre-existing market history of similar devices, not through a prospective or retrospective study of the Reflection Acetabular Reinforcement Rings specifically.
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. There is no "test set" requiring expert-established ground truth mentioned in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication 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
- Not applicable. This device is a mechanical implant (acetabular ring), not an AI/ML diagnostic aid. Therefore, no MRMC study, human reader performance, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical implant; it does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this 510(k) clearance is the established safe and effective clinical use of the predicate devices in the market, not a derived ground truth from a specific study for this new device.
8. The sample size for the training set
- Not applicable. This device is a mechanical implant; it does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
In summary: The provided document is a regulatory submission from 1996 for a mechanical implant. It follows the 510(k) pathway, which focuses on demonstrating substantial equivalence to existing devices rather than presenting novel clinical study data with specific acceptance criteria as would be expected for a modern AI/ML medical device.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.