Search Results

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. Inflammatory degenerative joint disease such as rheumatoid arthritis:
• 3. Correction of functional deformity;
• 4. Revision procedures where other treatments or devices have failed; and,
• 5. Treatment of fractures that are unmanageable using other techniques.

The STEM is a modular prosthesis comprising two principal parts:

• Zweymüller style rectangular distal stem and body .
• . Modular neck
  The STEM is available in nine sizes. All distal stems and bodies are rectangular in profile with a heavy grit blast surface finish. The STEM has a specific oblong housing/taper for the insertion of the twelve modular necks, which are available in six versions and two lengths: Neutral, antiversion 8° or 15°, varus/ valgus 8°, or combination of anteverted/ retroverted - varus/ valgus (in both short and long lengths).

The provided document is a 510(k) Summary for the STEM Hip Replacement System, a medical device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with specific acceptance criteria and performance results directly from the device's own testing.

Therefore, many of the requested details about acceptance criteria, performance data, sample sizes, and expert adjudication are not available within this type of regulatory submission. A 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through material data, design comparisons, and mechanical testing, rather than extensive clinical studies with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in this 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific quantitative clinical performance acceptance criteria for the new device as would be seen in a clinical trial report. The "performance" mentioned refers to the overall safety and effectiveness supported by substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/provided. This document describes a medical device seeking market clearance through the 510(k) pathway, which typically does not involve clinical testing on a "test set" of patient data in the way an AI diagnostic algorithm might. Instead, it relies on engineering testing, material data, and comparison to predicate devices. The "study" here is the 510(k) submission process itself, where the safety and effectiveness are established through demonstrating substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth establishment with experts is relevant for diagnostic devices that interpret images or other data. This is a hip replacement system, where ground truth would relate to surgical outcomes or pathology, which are not detailed as part of the 510(k) substantial equivalence argument in this document.

4. Adjudication Method for the Test Set

Not applicable. No "test set" in the context of diagnostic interpretation is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This is not an AI diagnostic algorithm, and no MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (hip implant), not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the conventional sense of a diagnostic algorithm. For a physical implant, "ground truth" would be clinical outcomes (reduction/relief of pain, improved hip function), pathology reports, or explant analysis, but none of these are presented as primary data in this summary. The "ground truth" for the 510(k) process is the safety and effectiveness of the predicate devices and the demonstration that the new device meets those same standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study (510(k) Submission) and its "Acceptance Criteria"

• Acceptance Criteria (Implicit for 510(k)): The primary acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to one or more legally marketed predicate devices. This means the device must be as safe and effective as the predicate(s). This is achieved by comparing:

  • Intended Use
  • Materials
  • Design Features
  • Type of interface (e.g., uncemented total hip arthroplasty)
  • Performance data (e.g., mechanical testing, material characterization – though not explicitly detailed in this summary, it would be part of the full 510(k) submission).

• Reported Device Performance (as per the submission):

  • The "safety and effectiveness of the STEM Hip Replacement System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." (Section C. Substantial Equivalence Information)
  • The FDA concluded that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." (FDA Letter, Page 2)
  • The device is indicated for reduction or relief of pain and/or improved hip function in skeletally mature patients with various degenerative joint conditions, inflammatory conditions, functional deformity, failed revision procedures, and unmanageable fractures.

In essence, the "study" is the 510(k) process itself, and the "acceptance criterion" is the FDA's determination of substantial equivalence based on the provided documentation, material testing, and comparison to existing, legally marketed devices.

Ask a specific question about this device