(29 days)
The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. Examples of specific indications for use of the Restoration® Modular System include, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Restoration® Modular Hip System is a modular hip system comprised of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing Restoration® Modular Bowed Plasma Stem to create a line extension called the Restoration® Modular Bowed Plasma Trislot Stem. The subject components are for use with the previously cleared Restoration® Modular Distal Stem components.
The provided text describes a Special 510(k) Premarket Notification for a line extension to the Restoration® Modular Hip System, specifically the Restoration® Modular Bowed Plasma Trislot Stem. This is a submission for a medical device (hip prosthesis) and the document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo performance criteria for a new type of device or an AI/software as a medical device.
Therefore, the requested information about acceptance criteria and the study proving the device meets them (especially those related to AI/software performance, ground truth, experts, and training sets) is not applicable to this type of regulatory submission.
Here's why and what information is relevant from the provided text:
Key Takeaways from the Document:
- Device Type: This is a physical medical device (femoral hip prosthesis components), not an AI/software-based diagnostic or therapeutic device.
- Regulatory Path: It's a "Special 510(k) Premarket Notification" for a "line extension." This path is used for modifications to a manufacturer's own legally marketed device where the modification does not affect the intended use or the fundamental scientific technology of the device. The primary goal is to demonstrate substantial equivalence to the predicate device.
- Proof of Equivalence: The document states: "Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical."
Answer to the specific questions (modified for context):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Substantial Equivalence (Implicit): The device (Restoration® Modular Bowed Plasma Trislot Stem) must demonstrate equivalent mechanical strength, intended use, material, manufacturing methods, packaging, and sterilization to its predicate devices (Restoration® Modular Bowed Plasma Stem and other Restoration® Modular Distal Stem components).
- Reported Device Performance: "Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength." The document does not provide specific quantifiable performance metrics (e.g., fatigue life numbers, stress data) in this summary, but asserts that the testing showed equivalence.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable in the context of an AI/software device. For a physical device like a hip implant, "sample size" usually refers to the number of components tested in mechanical studies (e.g., fatigue or tensile tests). This specific information (number of components tested) is not detailed in the summary. Data provenance is not a typical concern for this type of mechanical testing.
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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. "Ground truth" established by experts is relevant for diagnostic or AI systems. For mechanical testing of an implant, the "ground truth" is determined by established engineering standards and physical measurements, not expert human interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to expert review for diagnostic accuracy, not mechanical testing.
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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 study design is specifically for evaluating diagnostic AI or image interpretation systems.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. As noted above, the "ground truth" for demonstrating substantial equivalence for a mechanical implant would be established through engineering measurement against established performance standards and predicate device data.
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The sample size for the training set:
- Not applicable. This concept pertains to machine learning models, not physical devices.
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How the ground truth for the training set was established:
- Not applicable. This concept pertains to machine learning models, not physical devices.
In summary, this document is a regulatory submission for a physical hip implant. The "study" referenced is mechanical testing and analysis, which determined that the new components are "substantially equivalent" to predicate devices, thereby meeting the regulatory requirement for market clearance. The detailed specifics of those mechanical tests (e.g., number of samples, specific loads, quantifiable results) are not provided in this summary but are implicit in the FDA's clearance decision.
§ 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.