(22 days)
The DePuy C-Stem AMT is indicated for cemented use in the treatment of:
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia;
- Avascular necrosis of the femoral head;
- Acute traumatic fracture of the femoral head or neck;
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
- Certain cases of ankylosis.
The subject C-Stem AMT is intended for cemented use as part of the femoral component in a total hip arthroplasty.
The C-Stem AMT hip is a collarless, tapered, cemented femoral stem. It may be used with commercially available modular femoral heads, either metal or ceramic, to form the femoral component of a total hip prosthesis to articulate against either a metal or poly insert.
This 510(k) submission (K082239) is for a medical device called the "DePuy C-Stem AMT," which is a cemented hip stem prosthesis. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (DePuy C-Stem AMT, K042959).
Crucially, this submission does NOT contain acceptance criteria or a study that evaluates the performance of the device against specific acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools. This is a premarket notification for a traditional orthopedic implant, where "acceptance criteria" are generally related to mechanical properties, biocompatibility, and manufacturing quality, and "studies" involve mechanical testing and clinical history based on the predicate device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it's not applicable in the requested format. Similarly, the other points of your request are not directly addressed in the context of this traditional device submission.
However, I can extract the relevant information from the document to explain why these questions are not answered as expected for an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable in the Requested Format: This 510(k) submission is for a physical orthopedic implant (a hip stem prosthesis). "Acceptance criteria" for such a device are typically related to:
- Biocompatibility: Demonstrated through material composition and historical use, or specific biocompatibility testing (which isn't detailed as "acceptance criteria" against numerical performance in this summary).
- Mechanical Strength/Durability: Verified through engineering tests (e.g., fatigue, static strength) to ensure the device can withstand physiological loads over time. These tests are done to industry standards, but specific pass/fail numerical criteria aren't presented as a concise table of "acceptance criteria" in this summary.
- Manufacturing Quality: Adherence to Good Manufacturing Practices (GMP) and sterilization standards.
- Basis for Substantial Equivalence: The document states: "Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject C-Stem AMT is substantially equivalent to the previously cleared DePuy C-Stem AMT, K042959." This indicates that the "performance" is considered equivalent to the predicate device, which has a known clinical history. No new clinical performance data is presented or summarized in this document.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable: There is no "test set" in the context of algorithmic performance for this device. This is a physical implant. The evaluation relies on comparison to a predicate device and engineering principles.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable: There is no "ground truth" to establish for an algorithm in this submission. The "ground truth" for a medical implant like this is its satisfactory performance in patients over time, which would be part of post-market surveillance or clinical studies if required for a novel device. For substantial equivalence, it relies on the predicate's established history.
4. Adjudication Method for the Test Set:
- Not Applicable: No "test set" or algorithmic output requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No: This is not a diagnostic device or an AI-assisted interpretation tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No: This is a physical orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used:
- Not Applicable: As explained for point 3, there's no algorithmic "ground truth" in this context. The "truth" for such a device is its ability to restore function and alleviate pain in patients, which is assessed through clinical outcomes over time, rather than a single "ground truth" label.
8. The Sample Size for the Training Set:
- Not Applicable: No algorithm, no training set.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable: No algorithm, no training set, no ground truth to establish for a training set.
Summary of the K082239 Submission:
This 510(k) submission is a traditional premarket notification for an orthopedic implant. It demonstrates substantial equivalence to a previously cleared device (K042959) based on similarities in:
- Intended Use: Cemented hip stem prosthesis for total hip arthroplasty.
- Indications for Use: Treatment of severely painful/disabled joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture of femoral head/neck, failed previous surgery, and certain cases of ankylosis.
- Materials
- Design
- Method of Manufacture
- Sterilization
- Packaging Methods
The fundamental "study" here is the comparison to the predicate device and the implied reliance on the predicate's established safety and effectiveness, supported by mechanical testing and biocompatibility data (which are not detailed in this summary document but would be part of the full 510(k) submission). The FDA's clearance letter confirms "substantial equivalence" to a legally marketed predicate device, allowing the device to proceed to market.
§ 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.