Search Results

• 1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• Those patients with failed previous 2. surgery where pain, deformity, or dysfunction persists.
• 3. Revision of previously failed arthroplasty.

Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient (see "Warnings and Precautions"), and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate of hip mobility leads to need an expectation of significant improvement in the quality of their lives.

The components of the Natural Hip System employ an IOI 12/14 -Morse Taper configured trunnion, available in either threaded or smooth (non-threaded) configuration, for the attachment of the IOI's femoral bearing heads, including the zirconia bearing heads. The IOI 12/14 Morse Taper configured trunnion has previously been determined substantially equivalent by the FDA via the 510(k) #K913060. In addition, the use of zirconia bearing heads with the IOI 12/14 Morse Taper configured trunnion have also previously been determined substantially equivalent by the FDA via 510(k) #s' K942330 and K942406. Please note that the components of the Natural Hip System with a smooth Morse Taper configured trunnion are not intended to be used with the ceramic bearing heads. Such warning will be clearly stated on the IOI package insert accompanying the component the Natural Hip System (See of IOI's package insert provided proposed in Appendix A of this 510 (k) premarket notification submission).

The components of the Natural Hip System are available with and without a proximal collar. The proximal collar enhances cement pressurization in a cemented total hip arthroplasty. The components of the Natural Hip System incorporate a wedged shaped geometry on the proximal area of the hip stem for enhanced fit of the device in a prepared femoral canal. The wedge shaped geometry is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown. The components of the Natural Hip System are available with or without normalizations in the proximal anterior and posterior regions of the hip stem. Normalizations are series of steps and walls which potentially reduce subsidence and medial migration. In addition, the proximal region of the components of the Natural Hip System are available with or without proximal polymethylmethacryalte (PMMA) spacers which provide an even cement mantle in a cemented total hip arthroplasty.

Surface enhancement via grit blasting is employed on either the proximal third or the entire length of the hip stem below the collar of the components of the Natural -Hip System. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. The grit blasted surfaces provide a surface roughness of 63-149u-inches. In a cemented application, the grit blasted surface provides greater cement interdigitation with bone cement. In a press-fit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface.

The distal portion of the components of the Natural Hip System employs a hole for the attachment of a distal centralizer fabricated from UHMWPe. The distal centralizer has been previously determined substantially equivalent by the FDA via 510(k) #K913208.

The components of the Natural Hip System available in 9 sizes (sizes are 00 through 7).

The components of the Natural Hip System, like the predicate IOI and competitive devices, are intended for cemented application. In addition, the components of the Natural Hip System are intended for cementless application.

This 510(k) premarket notification is for the Natural Hip System, which is a medical device. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than providing new clinical study data with specific acceptance criteria and performance metrics. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, ground truth establishment for a training set, MRMC studies) is not present in this document as it's not required for a 510(k) of this nature.

Here's an analysis based on the provided text, explaining why certain sections of your request cannot be answered and what information is available.

Acceptance Criteria and Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined performance thresholds and a study demonstrating the device meets those thresholds for a novel claim. Instead, the "acceptance criteria" for a 510(k) are informal: the device must be shown to be as safe and effective as a legally marketed predicate device. The "performance" is demonstrated by showing similar materials, intended use, and design characteristics.

Therefore, a table of acceptance criteria and reported device performance, as you've requested for typical AI/diagnostic device studies, is not applicable in this context. The closest analogy would be a comparison of the subject device's characteristics against those of the predicate devices, which is provided in the document.

Table of Substantial Equivalence Comparison (Derived from the document):

Study Details (Not Applicable for this 510(k) Submission)

Given that this is a 510(k) submission for a hip implant, the "study" referred to in the document is a comparative analysis demonstrating substantial equivalence to already cleared predicate devices. It is not an experimental study with a test set, ground truth, experts, or statistical power calculations like those performed for AI/diagnostic devices.

Therefore, the following points cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable. There is no test set in the context of an experimental study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the conventional sense of expert labeling for an experimental study is not established. Substantial equivalence relies on engineering and design comparisons, and regulatory assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. 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 device is a physical hip implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an experimental study. The "ground truth" for substantial equivalence is the regulatory clearance of the predicate devices and the accepted engineering principles for hip implant design and materials.
8. The sample size for the training set: Not applicable. This is a hip implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "proof":

The "proof" in this 510(k) submission revolves around the assertion of substantial equivalence to legally marketed predicate devices. This is achieved by:

• Identifying Predicate Devices: Listing specific, already-cleared hip systems (e.g., Premier Total Hip Stem, Osteonics ODC Cemented Hip Stem).
• Detailed Device Description: Explaining the materials, geometry, surface enhancements, and available options of the Natural Hip System.
• Comparison of Technical Characteristics: A side-by-side tabular comparison (on page 6-7) of the subject device's features (materials, application, design elements like normalizations, wedged design, centralizers, collar, surface enhancement, neck lengths, and sizes) against those of the predicate devices.
• Justification of Equivalence: For each characteristic, the submission argues that the Natural Hip System is either identical, offers equivalent options, or any differences do not raise new questions of safety or effectiveness. For example, while the subject device is for both cemented and cementless applications (predicates only cemented), the document asserts that this difference does not preclude substantial equivalence because they share the same indications for use and the materials are equivalent. The use of specific components (like the IOI 12/14 Morse Taper configured trunnion and zirconia bearing heads) is also supported by previous 510(k) clearances.

In conclusion, this document serves as a regulatory submission demonstrating substantial equivalence for a physical medical device, not a performance study for an AI-based diagnostic tool. Therefore, many of your requested details about acceptance criteria, study design, and ground truth are not relevant to this specific type of document.

Ask a specific question about this device