(30 days)
The indications for the Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems are for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed. This device is to be used with bone cement.
The Rx 90™ Femoral Components have been modified to include, not only a lateralized version to expand its product line, but also additional sizes including a smaller stem, a reduced collar and a "smooth" finish.
The provided text is for a 510(k) premarket notification for a medical device, the Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving device performance against specific clinical acceptance criteria in the way new diagnostic or therapeutic AI devices do.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/diagnostic device is not applicable to this submission.
Here's why and what information is relevant to this document:
- Type of Device and Submission: The Rx 90™ Femoral Stem is a metallic total hip femoral component, a physical implant. The submission is a 510(k), which aims to show the new device is "substantially equivalent" to a legally marketed predicate device (K924028, Rx 90™ Femoral Components).
- Focus of 510(k): For physical medical devices of this nature, substantial equivalence is typically demonstrated through comparisons of materials, design, sizing, indications for use, and mechanical non-clinical testing. Clinical testing is often not required if these similarities are sufficient, as explicitly stated in the document.
Information from the document related to substantial equivalence, which is the "acceptance criteria" for a 510(k) submission:
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Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (for Substantial Equivalence) Reported Device Performance/Evidence from Submission Similarity/Identity to Predicate Device (K924028, Rx 90™ Femoral Components) in: - Materials "The Rx 90™ Femoral Components...the materials, design, sizing, and indications are similar or identical to the predicate devices." - Design "The Rx 90™ Femoral Components...the materials, design, sizing, and indications are similar or identical to the predicate devices." (Modifications mentioned: lateralized version, additional sizes, smaller stem, reduced collar, smooth finish. These modifications are asserted not to affect mechanical properties.) - Sizing "The Rx 90™ Femoral Components...the materials, design, sizing, and indications are similar or identical to the predicate devices." (Additional sizes, including a smaller stem, are noted as modifications.) - Indications for Use "The indications for the Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems are for 1) Non-inflammatory degenerative joint disease... 2) Rheumatoid arthritis... 3) Correction of functional deformity... 4) Treatment of non-union... and 5) Revision procedures..." (These are stated to be "similar or identical" to predicate devices.) Mechanical Properties: Modifications should not adversely affect mechanical properties. "Non-Clinical Testing: Mechanical testing was provided to demonstrate that the modifications do not effect the mechanical properties of the device." (Specific results of this testing are not detailed in the provided summary but are implied to meet equivalence standards.) Clinical Safety and Effectiveness: No new clinical concerns raised by modifications or new device features. "Clinical Testing: No clinical testing was provided as a basis for substantial equivalence." (This indicates that the non-clinical data and similarity to the predicate were sufficient to address safety and effectiveness for substantial equivalence without needing clinical trials.) -
Sample size used for the test set and the data provenance: Not applicable. No clinical test set data was reported. Mechanical testing was performed, but details on sample size for those tests are not provided in this summary.
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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. No clinical test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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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 is a physical implant, not an AI or diagnostic imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This 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. For a physical implant 510(k), "ground truth" is typically established through engineering principles, material science, biomechanical testing standards, and comparison to existing, safe, and effective predicate devices.
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The sample size for the training set: Not applicable. There is no "training set" in the context of this device and submission type.
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How the ground truth for the training set was established: Not applicable. There is no "training set" in the context of this device and submission type.
§ 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.