(156 days)
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists.
- Revision of previously failed arthroplasty. 3.
The Precedent Revision Hip System is manufactured from either wrought or forged titanium alloy. The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. Precedent Revision Hip System is available in both a collared and collarless design to address surgeon preference. The entire length of the Precedent Revision Hip System, except the neck region and the distal tip, is roughened via the process of grit blasting. The grit blasted proximal surface of the stem is coated with hydroxylapatite (HA). The distal portion of the Precedent Revision Hip System employs flutes which cut into the distal cortices of the prepared femoral canal, thereby providing rotational stability to the hip stem. In addition, the Precedent Revision Hip System employs a coronal slot which potentially reduces bending stiffness of the distal stem and thigh pain. The distal tip of the Precedent Revision Hip System is polished to a machined finish to provide ease of insertion during surgery.
This 510(k) summary for the Precedent Revision Hip System does not contain the kind of detailed study data, acceptance criteria, and specific performance metrics that would allow for a comprehensive answer to your request.
Medical device submissions from 1997, particularly for orthopedic implants like hip stems, typically did not include formal clinical studies or detailed performance data as would be expected for AI/software-as-a-medical-device (SaMD) products today. The clearance for such devices was primarily based on demonstrating substantial equivalence to already legally marketed predicate devices, focusing on material properties, design features, and intended use.
Here's a breakdown of why this document doesn't provide the requested information and what it does provide:
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Acceptance Criteria and Reported Device Performance: This document does not list any specific quantitative acceptance criteria or provide reported device performance metrics in the way you've described (e.g., sensitivity, specificity, AUC). Instead, the "performance" demonstrated for this device is primarily its substantial equivalence to existing hip stems.
- Implicit Acceptance Criteria: The implicit acceptance criteria are that the device's design, materials, and indications for use are similar enough to predicate devices to not raise new questions of safety and effectiveness.
- "Reported Device Performance": The document states: "The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." This is the closest it comes to a "performance" statement, indicating its mechanical fixation is comparable to existing press-fit prostheses, but explicitly denying claims of "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation."
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Sample Size used for the test set and the data provenance: Not applicable. There was no "test set" in the context of an AI/SaMD study. The evaluation was a comparison to predicate devices, likely based on engineering principles (material science, biomechanics where applicable) and regulatory review of existing device performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There was no "ground truth" to establish in the context of an AI/SaMD study. The "truth" in this submission is the established safety and effectiveness of the predicate devices.
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Adjudication method: Not applicable. No clinical or performance adjudication process is described.
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Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not a software or imaging device where human reader improvement with AI assistance would be relevant.
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Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable. This is a physical orthopedic implant.
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Type of ground truth used: Not applicable. No "ground truth" as typically understood in AI/SaMD studies was used.
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Sample size for the training set: Not applicable. There was no AI model or "training set."
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How the ground truth for the training set was established: Not applicable.
Summary of Information Provided in the Document Relevant to Device Evaluation (not directly answering your AI/SaMD specific questions):
- Product Description: Details materials (titanium alloy), features (threaded neck trunnion, collared/collarless design, grit blasting, HA coating, flutes, coronal slot, polished distal tip).
- Intended Use/Indications: Primarily for femoral bone deficiencies from failed primary arthroplasties, and for cementless application in total hip arthroplasty for NIDJD, IJD, failed previous surgery, and revision.
- Substantial Equivalence: Lists five predicate devices:
- Restoration HA Hip Stem: Osteonics Corporation.
- Sentry Femoral Component: Howmedica Inc.
- S-ROM® Femoral Prosthesis: Joint Medical Product Corporation.
- Stability Hip Stem: DePuy Inc.
- Wagner Revision Stem: Protek Inc.
Conclusion:
This 510(k) pertains to a physical medical implant (a hip stem) from 1997. The regulatory process and documentation standards for such devices at that time were fundamentally different from those for AI/SaMD products, which your questions are tailored to. Therefore, the detailed performance study information, including acceptance criteria, sample sizes, expert ground truth, and AI-specific metrics, is not present in this document. The device's clearance was based on demonstrating substantial equivalence to pre-existing, legally marketed devices, primarily through comparison of design, materials, and intended use.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.