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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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The Natural Hip System Porous Stem is identical in design geometry as compared to the predicate IOI Porous Natural Hip Stem, except for the reduction in the neck length. This design change was intended to address various patient population in cases of total hip or hemi-hip arthroplasty. The Natural Hip System Porous Stem employs a Sulzer 12/14 configured neck trunnion for attachment to IOI's femoral heads, including Biolox and Zirconia ceramic heads. featuring a Sulzer 12/14 configured bore. The Natural Hip System Porous Stem is available in both collared and collarless design. The Natural Hip System with Collar employs Cancellous Structured Titanium (CSTi™) porous coating on the inferior surface of the collar. The proximal surface of the Natural Hip System Porous Stem employs anterior angulation to match the anatomic angulation of a natural femur. In addition, the proximal surface of the Natural Hip System Porous Stem employs circumferential CSTi™ porous coating The distal portion of the Natural Hip System Porous Stem employs ribs and flutes on the anterior and posterior sides of the hip stem. In addition, the distal portion of the Natural Hip System Porous Stem employs a flared coronal slot.

This is a 510(k) summary for a medical device (Natural Hip System Porous Stem), not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets that criteria with respect to AI/ML performance is not applicable.

The document describes a orthopedic implant and focuses on demonstrating substantial equivalence to predicate devices, primarily through design comparisons, material specifications, and theoretical stress analysis. There is no mention of any AI or machine learning component in this device or its evaluation.

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The Calcar Replacement Hip Stem is intended for use in treatment of intertrochanteric, comminuted, or femoral neck fracture; trochanteric non-union; erosion of calcar or femoral neck, and; revision total hip arthroplasty involving bone loss in the proximal femur or tumors. In addition, the Calcar Replacement Hip Stem like the predicate IOI and competitive hip stems is intended for cemented application in cases of total hip arthroplasty.

• 1. Patient conditions of intertrochanteric, comminuted or femoral neck fracture
• 2. Trochanteric nonunion
• 3. Erosion of the calcar or femoral neck
• 4. Revision total hip arthroplasty involving bone loss in the proximal femur
• 5. Tumors.

The Calcar Replacement Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to the IOI's femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured threaded bore. The Biolox and Zirconia ceramic heads are available in two sizes, 28mm inner diameter (ID), and 32mm ID. The Biolox and ceramic bearing heads have been determined substantially equivalent by the FDA via 510(k) #'s K923934 and K942330.
The proximal body of the hip stem features an extraction hole in the anterior/posterior direction to facilitate removal of the hip stern if revision becomes necessary. The proximal body of the hip stem features a sloted flange which allows the surgeon the option of wiring the trochanter. The Calcar Replacement Hip Stem employs a keel below the proximal-medial flange for enhanced rotational stability.
The grit blasted distal portion of the hip stem employs two medial longitudinal grooves and is oval shaped. The grit blasted surfaces provide enhanced interdigitation with bone cement. The Calcar Replacement Hip Stem is available with a distal hole for optional use with the PMMA canal centralizer.

This document pertains to the 510(k) Premarket Notification for the Calcar Replacement Hip Stem, a medical device, and therefore does not contain information about software acceptance criteria or studies involving AI/ML performance.

The provided text describes the device's technical characteristics and its intended use, along with a comparison to predicate devices. It does not include any information related to:

• Acceptance criteria for software performance
• Studies proving device meets acceptance criteria related to software
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts for ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used
• How ground truth for a training set was established

The document is a traditional medical device submission, focusing on substantial equivalence to previously cleared devices based on physical design, materials, and intended use, rather than software performance.

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The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty.

The general indications associated with the use of DRG Stem in total hip arthroplasty include:

• 1. Patient conditions of inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
• ni Those patients with failed previous surgery where pain, deformity or dysfunction persists.
• র প Revision of previously failed arthroplasty.

The DRG Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to IOI's femoral bearing heads. The DRG Hip Stem is available with or without a proximal collar. The proximal collar enhances cement pressurization in cases of cemented toral hip arthroplasty. The DRG Hip stem employs a widened or expanded proximal geometty for enhanced fit of the stem in the metaphyseal canal of the femur. The widened or expanded proximal geometry of the hip stem is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown.

Surface enhancement via grit blasting is employed on the entire length of hip stem below the collar. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surfaces provide a greater 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 DRG Hip Stem employs a hole for the attachment of a distal centralizer fabricated from polymethylmethacrylate (PMMA).

This is a 510(k) premarket notification for a hip stem, outlining its intended use, design features, and comparison to predicate devices. It is a medical device submission, not a study describing AI/algorithm performance. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI device.

The provided text describes:

• Device: Natural Hip System - DRG Hip Stem (femoral component of a total hip prosthesis).
• Manufacturer: Intermedics Orthopedics, Inc. (IOI).
• Intended Use: To replace the anatomy of the femur in cases of total hip replacement, for cemented or cementless (press-fit) application in total hip arthroplasty. Indications include inflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis, rheumatoid arthritis), failed previous surgery, and revision of previously failed arthroplasty.
• Technological Characteristics: A detailed comparison of the DRG Hip Stem's material, intended use (cemented/cementless), proximal wedge-shaped design, proximal collar availability, surface enhancement via grit blasting, distal canal centralizer, neck lengths, and sizes against several predicate hip stems.

The document does not contain information on acceptance criteria or a study related to an AI/algorithm device. It is a regulatory submission for a physical medical implant. Therefore, I cannot provide a response for the requested information points, as they are not applicable to the provided text.

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• 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.

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