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• 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 Natural-Hip™ System Porous Stem with HA/CSTi™ is intended only for use without bone cement.

The Natural-Hip System Porous Stem with HA/CSTi is a straight stem manufactured from Ti-6Al-4V alloy conforming to ASTM F-136. The stem is available in both a collared and collarless design. The proximal anterior surface of the stem employs anterior angulation or build-up to match the anatomic angulation of a natural femur. The superior portion of the stem has a built-in anteversion of nine degrees to match the anatomic anteversion of the femur. Circumferential hydroxylapatite coated Cancellous Structured Titanium™ (CSTi™) porous coating provides biological fixation in a cementless application. The distal portion of the Natural-Hip System Porous Stem with HA/CSTi employs ribs and flutes on the anterior and posterior sides to enhance cortical contact, thereby providing rotational stability to the hip stem. In addition, the distal portion of the stem has a flared coronal slot which reduces stiffness of the stem.

This 510(k) submission describes a hip implant device, not an AI/ML-enabled medical device. Therefore, the information typically requested for AI/ML device acceptance criteria and studies (such as sample sizes for test and training sets, expert qualifications, ground truth methods, MRMC studies, and standalone performance) is not applicable in this context.

The document focuses on demonstrating substantial equivalence to predicate devices based on product description, diagnostic indications, and material composition. The FDA's letter (K970300) confirms this substantial equivalence but places limitations on labeling and promotional claims.

Here's an attempt to interpret the request within the context of a traditional medical device submission, focusing on "acceptance criteria" as related to the device's intended use and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

For traditional medical devices like this hip implant, "acceptance criteria" are typically met by demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The "reported device performance" is essentially the determination of substantial equivalence by the FDA.

Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification itself, which presents information to the FDA to demonstrate substantial equivalence to predicate devices. This typically involves:

• Comparison to Predicate Devices: A detailed comparison of the new device's intended use, technological characteristics (materials, design, manufacturing process), and performance data (if applicable, e.g., mechanical testing for implants) to one or more legally marketed predicate devices.
• Performance Data (Non-Clinical): For an implant, this generally involves engineering tests, material characterization, and biocompatibility assessments to ensure the device performs as intended and is safe. The document implies such data were submitted, as the FDA based its decision on "the specific design of stem and coating composition." However, specific test results are not detailed in this summary.

Regarding your specific numbered points (which are more applicable to AI/ML devices):

1. Sample size used for the test set and the data provenance: Not applicable in the AI/ML sense. Mechanical testing or biocompatibility studies would use specific samples of the device and materials, but this isn't "test set" data for an algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant isn't established by experts in this manner. Its performance is evaluated through engineering standards and clinical observation (post-market, often).
3. Adjudication method: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an imaging or diagnostic device that would involve human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant.
6. The type of ground truth used: For a physical implant, "ground truth" relates to its conformity to engineering specifications, material properties, biocompatibility, and mechanical performance under simulated physiological conditions. Ultimately, long-term clinical outcomes (post-market surveillance) provide the most significant "ground truth" regarding its effectiveness in patients.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In summary, for a traditional medical device like a hip implant, the "acceptance criteria" are fundamentally about demonstrating substantial equivalence to pre-existing, legally marketed devices. The "study" is the 510(k) submission itself, supported by non-clinical performance data (e.g., material properties, mechanical testing) rather than clinical studies or AI algorithm performance metrics.

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The Natural-Hip System CoCr Revision Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System CoCr Revision Stem is intended for cemented application only and is intended for single use only. The Natural-Hip System CoCr Revision Stem is intended for use in treatment of the following: Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. Those patients with failed previous surgery where pain, deformity or dysfunction persists. Revision of previously failed arthroplasty.

The Natural-Hip System CoCr Revision Stem is fabricated from either forged or wrought cobalt chromium alloy which conforms to the American Standards for Testing and Materials (ASTM) standards F-799 or F-1537, respectively. The Natural-Hip System CoCr Revision Stem features a threaded Sulzer 12/14 configured neck trunnion for attachment to IOI's currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. The Natural-Hip System CoCr Revision Stem is available in both a collared and collarless design. The proximal one-third of the stem's surface employs normalization steps and is roughened via the process of grit blasting. The normalization steps and grit blasted surface enhance cement compression and bonding for optimal fixation of the hip stem in the femoral canal. The proximal surface of the Natural-Hip System CoCr Revision Stem also employs polymethylmethacrylate (PMMA) cement centralizers to provide even cement mantle when the stem is implanted in the femur. The distal portion of the Natural-Hip System CoCr Revision Stem is bowed to mimic the anatomy of the femur. The Natural-Hip System CoCr Revision Stem employs a hole in the distal portion of the stem to allow the use of a PMMA centralizer for correct distal alignment.

This is a 510(k) summary for a medical device, specifically a hip joint replacement component. It does not describe any AI/ML device or software, therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance.

The document discusses the physical characteristics, intended use, and predicate devices for a "Natural-Hip™ System CoCr Revision Stem." It is purely about the hardware of a hip implant.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment because this document does not pertain to an AI/ML device.

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The Natural-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include: Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, ostooarthritis and inflammatory joint disease (JJD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity or dysfunction persiss. Revision of previously failed arthroplasty. 3.

The Natural-Hip System CoCr Stem is a straight stem employing a proximal wedge shaped design. The stem is available in both a collarless design. The proximal one-third of the stem's surface is grit blasted. Normalization steps are also located on the proximal portion of the stem. The grit blasted surface and normalization steps enhance cement compression and bonding for optimal fixation of the hip stern in the femoral canal. The Natural-Hip System CoCr Stem employs a Sulzer 12/14 configured neck trumion for attachment to Intermedics Orthopedics, Inc.'s femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured bore. The Natural-Hip System CoCr Stem has a hole in the distal portion of the stem to allow the use of a distal centralizer for correct distal alignment. The stern also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. This device is intended for single use only.

This document is a 510(k) summary for a medical device (Natural-Hip™ System CoCr Stem), not a study report or clinical trial outcome document. Therefore, it does not contain the information required to answer your questions about acceptance criteria and study details.

The provided text focuses on:

• Device Description: What the device is, its materials, design features, and intended use.
• Intended Use/Indications: The medical conditions it's designed to address and how it's used (e.g., cemented application).
• Substantial Equivalence: Listing similar devices already on the market to establish that this new device is just as safe and effective.

There is no information in this document about:

1. Acceptance criteria and reported device performance: This document does not describe specific performance metrics or thresholds for success.
2. Sample size and data provenance: No study data is presented.
3. Number and qualifications of experts for ground truth: Not applicable as no ground truth establishment is mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (this device is a physical implant, not an AI algorithm).
9. How ground truth for the training set was established: Not applicable.

In essence, this document is a regulatory submission for a physical orthopedic implant seeking clearance based on its similarity to existing devices, not a report detailing the results of a diagnostic performance study.

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