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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-Knee II Revision Femoral Spacer Lugs are intended for cemented use with the previously cleared Natural-Knee II Revision Femoral Component and associated components (e.g., tibial, patellar, etc.) in the treatment of:

• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular 1. necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• Correctable valgus-varus deformity and moderate flexion contracture. 2.
• Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3.
• Revision of previously failed knee arthroplasty. 4.

The Natural-Knee II Revision Femoral Spacer Lug is in effect a bolt. The threaded portion of the lug screws into blind holes on the inner box of the Natural-Knee II Revision Femoral Component. A large hexagonal head allows the lug to be tightened into place. When used with a femoral spacer, the lug holds the spacer component firmly in place. When used without the spacer, the lug provides medial-lateral stability similar to that of conventionally cast or machined pegs usually found on the inner box of most femoral components.

This 510(k) summary describes a medical device, the Sulzer Orthopedics Inc. Natural-Knee® II Revision Femoral Spacer Lugs, which is a mechanical orthopedic implant. The provided document does not contain information about software, algorithms, or AI. Therefore, it is not possible to answer the questions related to acceptance criteria for an AI/algorithm, study design for AI performance, ground truth establishment, or multi-reader multi-case studies as these concepts are not applicable to the device described.

However, based on the provided text, the closest equivalent to an "acceptance criteria" and "study" for this mechanical device would be the analysis of its shear strength.

Here's an interpretation based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified. The document states "Analysis of the lug shear strength," implying a test was conducted, but the number of lugs tested is not mentioned.
• Data provenance: Not specified. It's likely an in-house laboratory test conducted by the manufacturer, but the location or whether it involved actual patient data (unlikely for shear strength) is not mentioned. It is a prospective test in the sense that it was conducted as part of the device's development/validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a mechanical shear strength test, "ground truth" is typically defined by engineering specifications and physical test standards, not by expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a diagnostic device involving human interpretation.

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 is a mechanical orthopedic implant, not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the shear strength test would be based on engineering standards and established physiological load requirements for implantable devices in the knee joint. The criteria for "survive physiologic loading" would be determined by biomechanical engineers based on expected forces in the human knee during various activities.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a mechanical device.

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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 Select Shoulder Curved-back Pegged All-Poly Glenoids, when used with one of the Select Shoulder Humeral Stems and Humeral Heads, are intended only for use with bone cement in cases of total shoulder arthroplasty for treatment of the following:

• Patient conditions, including but not limited to, noninflammatory degenerative joint > 1. disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-2. union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures.
• Those patients with failed previous surgery where pain, deformity, or dysfunction 3. persists.
• Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the 4. humeral neck, arthrodesis or hemiarthroplasty.
• 5. Cuff tear arthropathy.
• Avascular necrosis or osteonecrosis of the humeral head. 6.
• Tumor resection. 7.

The Curved-back Pegged All-Poly Glenoid is a one piece, polyethylene (ASTM F648) design intended to reproduce the function of the natural glenoid. The design is such that the component may be used in either the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.

This design features a curved articulating surface. The component has two grooved pegs bounded by two dovetail cement grooves which provide translational and rotational stability to the implant as well as to enhance cement fixation. The grooves in the pegs also allow the surgeon to intraoperatively trim the length in the glenoid vault is shallow and prevents the full length from being seated. Titanium (ASTM F136) x-ray marker pins are incorporated in the superior aspects of the component to assist in postoperative evaluation. The lateral surface of the glenoid component accommodates the humeral head. The articulating geometry is nonconstrained for greater range of motion and greater translation.

This is a medical device 510(k) summary, not a study describing acceptance criteria and device performance. The provided text describes the product, its intended use, and claims substantial equivalence to other existing devices.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, and ground truthing methods cannot be extracted from this document.

Here's what can be gathered, with caveats:

1. Table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document states, "Contact area testing indicates that the Curved-back Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction." This is a qualitative statement of performance, not a quantitative report against specific acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable. No test set or study of this nature is described. The "contact area testing" mentioned is likely an internal engineering test, not a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical study with ground truth established by experts is described.

4. Adjudication method for the test set: Not applicable. No test set or adjudication method is described.

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 document describes a physical medical implant (glenoid prosthesis), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical study with a defined ground truth is described.

8. The sample size for the training set: Not applicable. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI or machine learning device requiring a training set.

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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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This device is intended to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific diagnostic indications for use of the MOST include: metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell turnors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; revision cases requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur: and. severe conditions of inflammatory or noninflammatory degenerative joint disease that require extensive resection(s) and replacentent(s) of the proximal and/or distal femur.

The Modular Options for Severe bone loss and Trauma (MOST) System will be used for the replacement of the proximal, distal or total femur. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary, Unlike primary hip and knee systems, this system will be used where the amount of femoral resection and restoration required is extreme (e.g., in oncology cases). The modularity of this system allows for the resection of varying amounts of the femur (and the proximal tibia and patella, if necessary) before implantation. A total replacement is possible in those cases where no part of the femur can be salvaged. The components of the MOST System include: the proximal femoral replacement that is available in two designs to address the presence or absence of the greater rochanter, with sunure holes for soft tissue attachment; the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, allowing 15 degrees of internal and external rountion; intramedullary (I/M) stems with Cancellous Structured Titanium (CSTi) and femoral segments which will be used in conjunction with the proximal and distal replacements, and, an all-poly patella.

This is a description of a medical device (a prosthetic system) and not a diagnostic AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement is not applicable in this context.

The document discusses the product description, diagnostic indications, and substantial equivalence to other existing prosthetic systems based on design and intended use, rather than performance metrics related to diagnostic accuracy or AI model evaluation.

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The general indications associated with the use of Patellofemoral Joint Prosthesis in patellofemoral arthroplasty include:

• 1. Patients with osteoarthritis in the distal femur and patella.
• Patients with a history of patellar dislocation or patellar 2. fracture.
• 3. Those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The design of the Patellofemoral Joint Prosthesis closely replicates the anatomic features of the patellar groove on a femur. In addition, the design of the highly polished concave gliding anterior surface of the Patellofemoral Joint Prosthesis is identical to the proximal anterior surface of the articulating geometry of the Natural Knee II System's femoral component which has been determined substantially equivalent by the FDA via 510(k) K936159. The highly polished concave gliding surface of the Patellofemoral Joint Prosthesis complements the design of the articulating geometry of the IOI's patella components for optimal patellar tracking.

The posterior surface of the Patellofemoral Joint Prosthesis employs two fixation pegs for enhanced stability of the prosthesis when cemented into the femur. In addition, the posterior surface of the Patellofemoral Joint Prosthesis employs a grit blasted roughened surface to facilitate interdigitation with bone cement. The roughness of the grit blasted surface ranges from 175 - 225 uinch.

The Patellofemoral Joint Prosthesis is an asymmetrically designed component and, therefore, is available in both left and right configurations.

This document is a 510(k) premarket notification for a medical device submitted in 1996. It outlines the device's characteristics and compares them to predicate devices to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) notice explicitly states that the device's safety and effectiveness are established through substantial equivalence to predicate devices, rather than through specific performance metrics and acceptance criteria from a clinical study. The "performance" here refers to the device's features and materials matching or being similar to those of previously approved devices.

Study Proving Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is the 510(k) Premarket Notification itself, which acts as a regulatory submission. It does not describe a clinical performance study with specific acceptance criteria that were met with statistical significance. Instead, it argues that the device is "substantially equivalent" to legally marketed predicate devices based on design, materials, and intended use.

2. Sample Size Used for the Test Set and Data Provenance:

This document does not describe a clinical test set with human subjects. The "test" is a comparison of the device's specifications and design features against those of predicate devices. There is no sample size of patients or data provenance in the context of a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and market presence of the predicate devices. There were no experts used to establish ground truth for a clinical test set in this context.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on engineering and design comparisons for substantial equivalence, not clinical effectiveness studies comparing human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device (prosthesis), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" used in this context is the existence and regulatory approval of the predicate devices. The argument for the new device's safety and effectiveness is based on its similarity to these already-approved devices, assuming their safety and effectiveness are established. There is no pathology, expert consensus (in the context of clinical outcomes), or outcomes data presented for the new device itself to establish ground truth.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device requiring a training set. The "training" for this device's development would be engineering design principles and knowledge of existing prostheses.

9. How the Ground Truth for the Training Set was Established:

Not applicable as there is no training set mentioned for this type of device.

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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 InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty).

The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty). This device will be manufactured from either cast, forged, or wrought Cobalt-Chromium (CoCr) alloy conforming to ASTM Standards F75, F799, and F1537, respectively. This straight stem is offered in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a femoral replacement. In addition, the InterMoore Fracture Hip Stem:

• i has a broad collar which wraps around the anterior, medial, and posterior sides.
• I incorporates a stem-neck angle which replicates natural anatomy.
• E is available in a fenestrated design for press-fit applications and a solid design for press-fit and cemented applications.
• 트 has a 12/14 Morse-type male taper making it compatible with any Intermedics Orthopedics, Inc. 12/14 metal femoral head (e.g., modular femoral head, unipolar) or bipolar component which utilizes a 12/14 modular femoral head.
• 트 provides lateral offsets ranging from 32 to 49mm.
• 부 incorporates I-beam grooves along the anterior and posterior surfaces to increase rotational stability in vivo.
• 트 has a roughened/grit-blasted surface below the collar, to enhance fixation in vivo.
• 트 will incorporate a proximal, lateral fin to the fenestrated design. This fin will increase the rotational stability of the implant in vivo.

The provided text is a 510(k) Summary for a medical device (InterMoore Fracture Hip Stem), which is a premarket notification to demonstrate that the device is as safe and effective as a legally marketed predicate device. This type of regulatory submission does not contain information on acceptance criteria or studies that prove a device meets performance acceptance criteria in the way that would typically be seen for an AI/ML medical device, diagnostic test, or clinical trial for a pharmaceutical product.

Instead, the 510(k) submission focuses on demonstrating substantial equivalence to predicate devices. This involves comparing the new device's technological characteristics and indications for use to those of devices already on the market.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods because this type of information is not typically part of a 510(k) summary for a mechanical orthopedic implant. The summary focuses on product description and comparison to existing, legally marketed devices.

If this were an AI/ML device, the requested information would be crucial. However, for a hip stem from 1996, the "proof" is generally based on:

• Material properties: Conformance to ASTM standards (e.g., F75, F799, F1537 for CoCr alloy).
• Design similarities: Comparison of features (collar, stem-neck angle, taper, offsets, I-beam grooves, roughened surface, fin) to predicate devices.
• Intended use: Matching the specified prosthetic replacement of the proximal femur for total hip replacement or hemi-arthroplasty.

The summary explicitly states the device is "substantially equivalent to the Apollo Hip Stem™ offered by Intermedics Orthopedics, Inc., the Modular Austin Moore Hip Stem offered by Zimmer, Inc., the Bio-Moore II Stem offered by Biomet, Inc. and the Hip Fracture Stem offered by Howmedica, Inc." This is the core of the "proof" for a 510(k) submission for this type of device.

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The Select Shoulder Humeral Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use with bone cement in total shoulder arthroplasty. The humeral stem is available in a variety of sizes and features a proximally grit blasted surface (except for the head stem taper) for enhanced cement fixation. The proximal trapezoidal shape tapers in the A-P plane, thus providing for a stable cement mande. The proximal body also features an antirotation fin on the lateral aspect. Suture holes are provided in the medial proximal body and lateral fin to allow for soft tissue/bony fragment attachment and tensioning, thus resulting in a more biomechanically stable construct for repair for proximal fractures. A male IOI morse type taper permits attachment of one of the metallic humeral heads offered by Intermedics Orthopedics. This taper is identical to the taper of the previously cleared Select Shoulder System. Distally, the stem is rounded and fluted to provide enhanced fixation and rotational stability. The distal stem tip is designed to accept a cement centralizer. The humeral stem is designed for use with Intermedics Orthopedics humeral heads and glenoid components in a variety of sizes and heights for increased stability of the glenohumeral joint.

This document is a 510(k) summary for a medical device (Intermedics Orthopedics, Inc. Select® Shoulder System CoCr Humeral Stem) and describes its physical characteristics and intended use. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The provided text focuses on the mechanical and material properties of a humeral stem and its equivalence to other legally marketed devices, rather than on the performance of an AI/ML algorithm.

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