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Noninflammatory degenerative (oint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory (out disease (IJD), e.g., rheumatoid arthritis.
Failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed hip arthroplasty.

The Subject CoCr Heads are intended to be used as a modular head component for articulation in total hip arthroplasty. A system consisting of a femoral stem, a ball head and a cup or a shell with an insert is used for replacement of the proximal femur in total hip arthroplasty. The articulation is comprised of a modular femoral head and a corresponding cup or acetabular insert. CoCr Heads are to be used in combination with polyethylene cups or inserts. It is also possible to use CoCr Heads in revision cases (unless subsequent to a broken ceramic component) where the stem remains in place.
The Subject CoCr Heads have a head diameter of 38 mm and are provided with 5 different neck lengths (from -8 to +8) to allow an individual adaptation of leg length and offset. A 12/14 taper, incorporated in the design of the head, interlocks with the femoral stem. The CoCr Heads are made from Protasul®-20 (CoCrMo alloy).

This is a good question! However, the provided document is a 510(k) summary for a medical device (CoCr Head) that is a hip prosthesis, not an AI/ML-enabled medical device.

Therefore, the requested information about acceptance criteria and studies demonstrating AI performance (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Non-Clinical Performance Data: Engineering analyses, wear justification, material equivalence testing (ISO and ASTM standards), and Range of Motion testing (ISO 21535).
• MR Conditional Labeling: Evaluation in accordance with ASTM F2503-13 for RF-induced heating, static magnetic field interactions, and image artifact generation in MRI environments.

It explicitly states: "Clinical data and conclusions were not needed for this device."

In summary, as this document is not for an AI/ML medical device, none of the requested information regarding AI acceptance criteria and performance studies can be extracted.

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The AFFIXUS® Natural Nail® System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preiniured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.

The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as:

• · Proximal fractures (proximal short and long nails only)
• · Diaphyseal fractures (proximal long, antegrade/retrograde nails)
• · Open and closed fractures
• · Comminuted fractures
• · Nonunions and malunions
• · Pathologic fractures

The Affixus Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs.

Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. Nails and nail caps are made from Tivanium® Ti-6Al-4V alloy. Screws are also made from Tivanium alloy. Package labels indicate the material of each component.

Selected components of the Affixus Natural Nail System are colour coded to aid in identifying which components should be used together. Refer to the colour coding chart and/or surgical technique for more detailed instructions on the use of Affixus Natural Nail System components.

The provided text is an FDA 510(k) clearance letter and a 510(k) Summary for the Affixus® Natural Nail® System Humeral Nail. This device is an intramedullary fixation rod, which is a physical device used for stabilizing fractures.

The requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically associated with the evaluation of AI/ML-based medical devices or diagnostic tools, where performance is measured against a ground truth and often involves human reader studies.

For the Affixus® Natural Nail® System Humeral Nail, an intramedullary fixation rod, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested is not applicable in the same way it would be for an AI diagnostic device.

Here's why and how to interpret the provided document:

• This is a physical medical device clearance, not an AI/ML device clearance. The FDA document is about a Class II medical device (intramedullary fixation rod) for fixing humeral fractures not a software.
• Substantial Equivalence: The clearance is based on substantial equivalence to a previously cleared predicate device (K181827). This means the FDA determined the new device is as safe and effective as the predicate without raising new questions of safety or effectiveness.
• Performance Data: The 510(k) Summary explicitly states:
  • "Non-clinical performance and conclusions were not needed for this device."
  • "Clinical data and conclusions were not needed for this device."
  • This is because the device is largely identical to its predicate, and any minor modifications did not warrant new performance data.
• Acceptance Criteria for Physical Devices: For physical devices like this, acceptance criteria typically involve engineering specifications, biocompatibility, mechanical testing (e.g., fatigue, torsional strength, bending strength), and sterilization validation, rather than diagnostic performance metrics like sensitivity, specificity, or AUC against a ground truth. These tests ensure the device meets required functional and safety standards. However, the document states "performance testing" was done to address differences, but it doesn't detail these tests or criteria because no new questions of safety/effectiveness were raised.

Therefore, it is not possible to extract the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document for the following reasons:

1. Nature of the Device: It's a physical implant, not a diagnostic AI.
2. Regulatory Pathway: 510(k) clearance based on substantial equivalence, especially for minor modifications, often relies on existing data for the predicate device and does not always require new extensive performance studies for the modified device if no new questions of safety or effectiveness are raised.
3. Explicit Statement: The document clearly states that non-clinical and clinical performance data were not needed for this submission.

In summary, the provided document does not contain the specific type of acceptance criteria and study details (especially related to human-in-the-loop, MRMC, or standalone performance against a ground truth) that would be relevant for an AI/ML diagnostic device. The "performance data" mentioned in the document refers to the demonstration that "any differences do not raise new questions of safety and effectiveness as established with performance testing" and that the devices are "at least as safe and effective as the legally marketed predicate devices." This implies that prior engineering and safety testing for the predicate device were sufficient, and no new, extensive clinical or non-clinical performance studies were required for this specific 510(k) submission to prove substantial equivalence.

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Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:
· Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

• · Failed previous surgery where pain, deformity, or dysfunction persists.
  · Revision of previously failed hip arthroplasty

The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:

• · Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases

• · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, or total hip replacement (THR)

• · Acute traumatic fracture of the femoral head or neck

• · Avascular necrosis of the femoral head.

• · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.

• · Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.

• · Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

• · Acute traumatic fracture of the femoral head or neck.

• · Avascular necrosis of the femoral head.

The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,
polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
· Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
· Patients with acute femoral neck fractures.

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,
polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.

• · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.

• · Patients suffering from disability due to previous fusion.

• · Patients with previously failed endoprostheses and/or total hip components in the operative extremity.

• · Patients with acute neck fractures.

• This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:

• Noninflammatory degenerative joint disease (NID), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.

• · Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.

• · Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.

• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

· Revision of previously failed hip arthroplasty

Zimmer Hip Joint Replacement Prostheses are hip replacement system components. A femoral stem component is used in conjunction with a femoral head component for replacement of the proximal femur in total hip arthroplasty. Femoral stems are available in different designs, materials, sizes, neck lengths and taper sizes. A taper is incorporated in the design of the stem to interlock it with the femoral head. Femoral head components are available in a variety of sizes and neck lengths for reconstruction of the natural head center of the femur. The purpose of this submission is the addition of MR conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging, or sterilization.

The provided document is a 510(k) premarket notification for Zimmer Hip Joint Replacement devices. The submission focuses on adding MR conditional information to the labeling for existing predicate devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" pertain specifically to the MR Conditional safety of the implants and not to the efficacy of the hip replacements themselves.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical values for MR Conditional testing results. Instead, it states that the devices have been determined to be MR Conditional based on specific testing. The acceptance criteria are implied by adherence to the standard ASTM F2503-13.

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

The document does not specify the sample size of the devices tested for MR compatibility. It refers to "Zimmer Hip Joint Replacement implants" in general. The data provenance is not mentioned, but given the nature of the testing (evaluating physical interactions with magnetic fields), it would likely be laboratory-generated data rather than patient data. The country of origin of the data is not specified, but the applicant is Zimmer GmbH, Switzerland.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For MR compatibility testing, the "ground truth" is typically established by physical measurements and adherence to engineering standards, rather than expert consensus on diagnostic images. The expertise would lie in the engineers and physicists conducting the testing and interpreting the results according to ASTM F2503-13.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers evaluate medical images or data. This document describes a technical evaluation of device interaction with MRI fields. Therefore, an adjudication method in this sense is not applicable or described. The "adjudication" is essentially the determination of compliance with the ASTM F2503-13 standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is about the MR compatibility of hip implants, not about diagnostic AI or human reader performance.

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

This question is not applicable. The device is a physical medical implant, not an algorithm. The testing performed was related to the physical properties of the implant in an MRI environment.

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

The "ground truth" for MR Conditional testing is based on physical measurements and adherence to the technical requirements and thresholds defined in the ASTM F2503-13 standard. This includes measurements of RF-induced heating, static magnetic field interactions (e.g., deflection force, torque), and image artifact size.

8. The sample size for the training set

This question is not applicable. This is not an AI/algorithm-based device that requires a training set. The study is a technical evaluation of physical implants.

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

This question is not applicable, as there is no training set for this type of device and study.

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Hemi- or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for:
• Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate.
• Avascular necrosis.
• Conditions consequent to earlier operations.
• Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure).
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
• The Anatomical Shoulder Reverse System and the ASHCOM Shoulder system are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
• The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.
Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi- and fracture shoulder arthroplasty in treatment of the following:
• Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment.
• Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment.
• Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment.
• Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus.
• Posttraumatic necrosis of the humeral head.
• Posttraumatic arthrosis after humeral head fracture.
The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only.
Anatomical Shoulder Combined System
Advanced destruction of the shoulder joint resulting from:
• Omarthrosis
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head
• Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
• Conditions following earlier operations
The Anatomical Shoulder Combined System is intended for cemented or cementless use.
When used with the following humeral stems the Anatomical System is intended for cemented use.
• Anatomical Shoulder Standard Cemented Humeral Stem
• Anatomical Shoulder Long Stem
When used with the following humeral stem the Anatomical System is intended for cementless use:
• Anatomical Shoulder Standard Uncemented Stem.
When used with the following humeral stems the Anatomical System is intended for cemented or cementless use:
• Anatomical Shoulder Fracture Stem.
• Anatomical Shoulder Fracture Long Stem.
When used with the following glenoids the Anatomical System is intended for cemented use:
• Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.

The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision (Reverse Shoulder Arthroplasty), total or hemi- shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
The proposed Anatomical Shoulder System is comprised of the following families of products:
Anatomical Shoulder Humeral Stems (Cemented, Uncemented)
Anatomical Shoulder Reverse System (Cups, PE-inlays, Glenoid Fixation, Screws, Glenospheres)
Anatomical Shoulder Fracture System (Stems, Heads)
Anatomical Shoulder Combined system (Bigliani / Flatow® Adaptors)
Anaverse™ Anatomical Shoulder Pegged Glenoid
Anatomical Shoulder Domelock® System (Heads, Dome Centric, T-Domes)
Anatomical Shoulder ASHCOM® Shoulder System (ASHCOM Shoulder AC-Connector)

This document is a 510(k) premarket notification for the Zimmer GmbH Anatomical Shoulder System. It details the device, its indications for use, and its substantial equivalence to previously cleared predicate devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present explicit "acceptance criteria" in a quantitative table for a new device's diagnostic performance, as this is a medical device (shoulder prosthesis) rather than an AI/diagnostic software. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various non-clinical performance tests.

2. Sample size used for the test set and the data provenance:

• Test Set (Non-clinical Performance Data): The document does not specify a "sample size" in the context of patients or clinical cases for a test set. The tests performed are non-clinical (MR compatibility, mechanical integrity of instruments, packaging performance).
  • For MR compatibility, it states "MR compatibility evaluation on the Anatomical Shoulder™ System," but no specific number of implants or tests is given. It clarifies that no new MRI performance testing or simulations were completed for the implant devices, but existing reports were reviewed.
  • For Mechanical integrity and resistance, it states testing was performed "for instrument groups of mechanically loaded devices." No specific number of instruments or tests is provided.
  • For Packaging performance, it states "Packaging Configuration testing was conducted by representative worst-case products." No specific number of packages or products is provided.
• Data Provenance: Not applicable in the traditional sense of patient data. The provenance for the non-clinical tests would be Zimmer GmbH's internal testing facilities or contracted labs.

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

• Not applicable. This is not a study requiring expert readers to establish ground truth from medical images or clinical data. The "ground truth" for non-clinical tests is established by objective engineering and material science standards (e.g., ISO standards for packaging, mechanical test specifications).

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

• Not applicable. This is not a study requiring adjudication of expert readings.

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 an application for a shoulder prosthesis, not an AI-assisted diagnostic device. No MRMC study was performed.

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

• Not applicable. This is a physical medical device (shoulder prosthesis), not a standalone algorithm.

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

• For the non-clinical performance tests, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 11607-1:2006, ISO 11607-2:2006 for packaging, relevant mechanical testing standards for device integrity, and MRI compatibility standards).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. No training set for an algorithm was used.

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Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:

• Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

· Failed previous surgery where pain, deformity, or dysfunction persists.

• Revision of previously failed hip arthroplasty

The Alloclassic® Zweymüller® SL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. The general design of the Alloclassic Zweymüller SL Femoral Stem comprises a slim neck and a short taper. Alloclassic Zweymüller SL Femoral Stems are available in 14 sizes and can be implanted to achieve primary stability in cases of unexpected poor bone quality. Distally the stem is anchored primarily by its edges; proximally the surfaces anchor against the bone cortex. The Alloclassic Zweymüller SL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM 1295-16). The entire stem below the neck of the hip stem is grit basted to provide enhanced bone/prosthesis interface.

The design of Alloclassic® Zweymüller® SL Offset Femoral Stem is very similar to the previously cleared Alloclassic Zweymüller SL Femoral Stems (K962101, K030373), and identical to the previously cleared Alloclassic Zweymüller SL Offset Femoral Stem (K033664). Similar to the Alloclassic Zweymüller SL Femoral Stem, the Alloclassic Zweymüller SL Offset Femoral Stem is a conically shaped straight stem with a rectangular cross section for rotational stability. The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface. The stem is available in 14 sizes and is manufactured from the wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM 1295-16). In contrast to the Alloclassic Zweymüller SL Femoral Stem, the Alloclassic Zweymüller SL Offset Femoral Stem provides an additional 6.25 mm of offset (per size) and has a CCD/neck angle of 121° (vs 131° for SL stem). Overall the Alloclassic Zweymüller SL Offset Femoral Stem design provides a higher offset sometimes needed for correcting insufficient soft tissue balancing, restoration of leg length, and sufficient joint stability following total hip arthroplasty.

The provided text is a 510(k) summary for the Alloclassic® Zweymüller® SL Femoral Stem and Alloclassic® Zweymüller® SL Offset Femoral Stem. It does not describe an acceptance criteria table or a study proving the device meets an established acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and modifications to packaging and instrument classification.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to performance studies with specific metrics, sample sizes, ground truth establishment, and expert involvement, which are not detailed here.

However, I can extract the following relevant information:

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

This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than reporting against specific acceptance criteria for performance.

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

No specific test set or data provenance for performance evaluation is mentioned. The document states that "Packaging Configuration testing was conducted by representative worst-case products," but it does not specify the sample size or provenance for this testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document, as it does not detail a study involving expert-established ground truth.

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

This information is not provided in the document, as it does not detail a study involving adjudication.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a hip implant, not an AI-assisted diagnostic tool.

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

This information is not applicable, as the device is a hip implant, not an algorithm.

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

This information is not applicable as there is no mention of ground truth establishment for performance evaluation. The document focuses on demonstrating equivalence through design, materials, and mechanical integrity rather than clinical outcomes data for the modified components.

8. The sample size for the training set:

This information is not applicable as there is no mention of a training set for an algorithm.

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

This information is not applicable as there is no mention of a training set for an algorithm.

Summary of available information regarding compliance/testing:

The document mentions two types of non-clinical performance activities:

• Packaging configuration change: Testing was performed to verify package integrity (sterile barrier, protection during sterilization, handling, distribution, and storage) according to ISO 11607-1:2006 and ISO 11607-2:2006. This testing was conducted on "representative worst-case products."
• Correction of instrument classification from Class I to Class II: This involved an "Amendment of Design Controls with verification of mechanical integrity and resistance."

The document explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that no clinical studies were performed to demonstrate performance or meet specific acceptance criteria in a clinical setting. The justification for clearance is based on substantial equivalence to predicate devices and non-clinical testing for specific modifications.

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Avenir® Müller Stem is intended for:
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.Acute traumatic fracture of the femoral head or neck.Avascular necrosis of the femoral head.
Avenir® Müller Stems are for cementless use only.

The Avenir® Cemented Hip Stem is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseasesFailed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)Acute traumatic fracture of the femoral head or neckAvascular necrosis of the femoral head.

The Avenir® Müller Stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit and the stem features proximal ribs on the anterior and posterior surfaces which are designed to increase stability. Except for the polished neck area, the surface of the stem is coated with Ti-6Al-4V titanium alloy plasma spray and oversprayed by a hydroxyapatite coating. The stem is available as both a lateralized and standard version.

The Avenir® Cemented Hip Stem is a stainless steel alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit. The stem is highly polished and available as both a lateralized and standard version.

This document, K193030, is a 510(k) premarket notification for Zimmer GmbH's Avenir Müller Stem and Avenir Cemented Hip Stem. It's a submission for hip prostheses, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance as would be expected for a software-based device.

Based on the provided text, the device in question is a medical implant (hip stem), not an AI/software device. Therefore, the questions about "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only without human-in-the-loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission. The "acceptance criteria" here relate to the physical and mechanical properties of the implant and its packaging.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:

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

• any differences (modifications) do not raise new questions of safety and effectiveness as established with performance testing; and
• the subject devices are at least as safe and effective as the legally marketed predicate device. The devices have the same intended use and similar indications for use, use the same operating principle, incorporate the same basic design and labeling, and are manufactured and sterilized using the same materials and processes as the predicate device. |

2. Sample sized used for the test set and the data provenance

• Sample Size:
  • For Packaging Configuration testing: "Packaging Configuration testing was conducted by representative worst-case products." A specific number is not provided, but the approach indicates a focus on challenging scenarios to ensure robustness.
  • For Instrument Classification (mechanical integrity and resistance): Not explicitly stated, but implies testing of the instruments.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, as these are non-clinical (laboratory/engineering) tests rather than human subject studies. Such tests are typically conducted in a controlled lab environment.

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

This question is not applicable as this submission is for a physical medical device (hip stem) and its associated instruments and packaging, not an AI/software device that requires expert-established ground truth from medical images. The "ground truth" here is compliance with engineering standards and performance specifications.

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

This question is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation (e.g., of medical images) where there might be disagreements among human readers. This submission describes non-clinical engineering and packaging tests.

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

This question is not applicable. This describes a physical medical device, not an AI-assisted diagnostic or treatment planning tool.

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

This question is not applicable. This describes a physical medical device, not a software algorithm.

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

The "ground truth" for this device's acceptance criteria is based on established engineering standards and regulatory requirements for the performance of medical device packaging (e.g., ISO 11607-1:2006 and ISO 11607-2:2006) and the mechanical integrity of instruments. These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device. This term is relevant to AI/machine learning models.

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

This question is not applicable for the same reason as point 8.

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This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
• Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
• Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
• Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.

The Fitmore® Hip Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The component is an uncemented stem which is coated proximally with Titanium Vacuum Plasma Spray and rough-blasted distally for primary stability. The stem design is curved and features a trapezoidal cross-section.
The 12/14 femoral stem is available in multiple sizes, consisting of three stem families. The different family designs were developed in order to meet various patients' anatomic needs. As the anatomic offset varies considerably between individuals, the Fitmore® Hip Stem offers a wide range of offset options. Each family is designed with a CCD angle of 140°, 137°, 129° and 127°.

This document is a 510(k) premarket notification for a medical device called the "Fitmore Hip Stem." It concerns the substantial equivalence of the device to legally marketed predicate devices.

Based on the provided text, the device is a hip implant, and the performance data described is focused on non-clinical aspects like packaging and sterilization, not on the clinical performance or diagnostic accuracy of an AI or software-as-a-medical-device (SaMD) product.

Therefore, most of the requested information regarding acceptance criteria, study methodologies (sample size, expert ground truth, adjudication, MRMC, standalone performance), and training set details for AI/SaMD devices is not applicable to this document. This document is for a physical orthopedic implant.

Here's what can be extracted and what cannot:

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

The document describes non-clinical performance testing for packaging and labeling integrity. It does not provide specific quantitative acceptance criteria or performance metrics in a table format that would be typical for an AI/SaMD product.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document mentions "representative worst-case products" were used for packaging configuration testing, but no specific sample size (N) is provided.
• Data Provenance: Not applicable in the context of clinical data for a physical implant. The testing was conducted by the manufacturer (Zimmer GmbH). The document implies the tests are laboratory-based, not patient-derived data.

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

This information is not applicable. The "ground truth" for a physical implant's packaging integrity is based on testing against ISO standards, not expert medical opinion on imaging or diagnostic accuracy.

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

This information is not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., radiologist reads) in clinical studies, not for objective engineering tests of packaging.

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:

This information is not applicable. This device is a physical hip stem, not an AI or software product. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable. This is not an algorithm or software device.

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

The "ground truth" for the non-clinical performance (packaging) was based on compliance with international standards (ISO 11607-1:2009 and ISO 11607-2:2006) and physical integrity. No expert consensus, pathology, or outcomes data were used for this type of testing.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This information is not applicable for the same reason as above.

In summary: The provided document is an FDA 510(k) clearance letter for a conventional medical device (a hip stem), not a software or AI-driven diagnostic/therapeutic device. Therefore, the questions related to AI/SaMD performance metrics and study methodologies are generally not relevant to the content of this document.

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The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Cephalomedullary nails include:

• Compound and simple shaft fractures
• Proximal, metaphyseal and distal shaft fractures
• Segmental fractures
• Comminuted fractures
• Fractures involving osteopenic and osteoporotic bone
• Pathological fractures
• Fractures with bone loss
• Pseudoarthrosis, non-union, mal-union and delayed union
• Periprosthetic fractures
• Surgically created defects such as osteotomies
• Intertrochanteric and subtrochanteric fractures

The Zimmer® Natural Nail® System Cephalomedullary Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. A set screw (with a polyethylene peg) allows guided rotational stability of the lag screw. Nails, nail caps and screws are made from Tivanium Ti-6Al-4V Alloy. Set screws are made from Tivanium Ti-6Al-4V Alloy and Polyethylene (PE). Selected components of the Zimmer Natural Nail System are color coded to aid in identifying which components should be used together. The package label for each of the nails indicates which screw sizes should be used with that nail. A screw case that holds unused screws intended for resterilization is available and contains designated sections for each screw size. Each section contains the color name that matches the color/color name on the label of the appropriate screw size for that section. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Zimmer Natural Nail System components.

The provided document, K192312, is a 510(k) premarket notification for a medical device: the Zimmer Natural Nail System Cephalomedullary Nails. It details the substantial equivalence of the device to existing predicate devices.

Based on the provided text, there is no information about an AI/algorithm-driven device or its performance criteria. The document exclusively discusses an intramedullary fixation rod for fracture fixation and stabilization of the bone.

Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample sizes for test sets or data provenance for an AI/algorithm.
• Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
• Adjudication methods for an AI/algorithm's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for an AI/algorithm.
• Standalone AI/algorithm performance.
• Type of ground truth used for AI/algorithm.
• Sample size for training set or how ground truth was established for an AI/algorithm and its training set.

The document explicitly states under "Performance Data (Nonclinical and/or Clinical)":

• "Non-Clinical Performance and Conclusions: Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
• "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

This indicates that the clearance was based on mechanical integrity testing and design control amendments, not on a clinical performance study involving AI or human interpretation of images.

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The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute femoral neck fractures.

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion.
• Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

The BIOLOX OPTION Ceramic Femoral Head System consist of a ceramic head fabricated from an alumina matrix composite available in diameters of 28, 32, 36, and 40 mm and a titanium adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision total hip arthroplasty.

This appears to be a 510(k) summary for a medical device (BIOLOX Delta Ceramic Femoral Heads and BIOLOX Option Ceramic Femoral Head System), not a study describing acceptance criteria and performance of a device based on AI/ML or image analysis. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through engineering analyses and material equivalence, rather than a clinical study with a test set, ground truth, or human reader involvement.

Therefore, many of the requested fields cannot be extracted directly from this document as they are not applicable to this type of regulatory submission. This document does not describe an AI/ML-based device that would typically have the requested performance metrics.

However, I can extract information related to the performance data presented within the context of a 510(k) submission for mechanical/material equivalence.

Here's a breakdown of what can and cannot be answered 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

• Not Applicable in the way implied by the request for an AI/ML study.
• The performance data relies on engineering analyses and material testing, not a "test set" of clinical cases or images. The "samples" would refer to test articles/components used in the mechanical and material tests. The document does not specify the number of individual components tested but refers to the completion of the tests.
• Data Provenance: The tests are likely conducted in a controlled laboratory environment by the manufacturer or a third-party testing facility, adhering to specified ISO/ASTM standards. The country of origin of these tests is not explicitly stated but would typically be where the manufacturer (Zimmer GmbH, Switzerland) conducts or commissions such testing.

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

• Not Applicable in the way implied by the request for an AI/ML study.
• This device is a mechanical implant. "Ground truth" in this context would refer to the validated standards and specifications (e.g., ISO standards) used for material and mechanical properties, not expert consensus on clinical cases. The interpretation of test results would be done by engineers and scientists (who are experts in their field) in accordance with these standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth, especially with image interpretation. For mechanical testing, adherence to standardized test protocols and data analysis governs the results.

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 implant device, not an AI/ML diagnostic aid that involves human readers interpreting cases.

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

• Not Applicable. This is a mechanical implant device, not an AI/ML algorithm.

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

• For this type of device, the "ground truth" (or reference standard) is primarily international standards and specifications (e.g., ISO, ASTM) for mechanical properties, material composition, and performance under specific simulated conditions (like wear and range of motion). There is no "pathology" or "outcomes data" ground truth directly described for the performance testing in this summary for substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is a mechanical implant device, not an AI/ML algorithm, so there is no "training set."

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

• Not Applicable. No training set exists for this type of device.

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The NCB Plating System is indicated for temporary internal fixation of fractures and osteotomies of long bones.

The NCB Plating System is an extramedullary internal fixation plate system to be used for either distal femoral or proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.

The provided text is a 510(k) summary for the Zimmer GmbH NCB® Plating System. This document describes a medical device, specifically a bone fixation system, and its premarket notification to the FDA.

Based on the content of the document, the device described is a mechanical implant, not an AI/software-based medical device. The "Performance Data (Nonclinical and/or Clinical)" section explicitly states:

• Non-Clinical Performance and Conclusions: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This means the clearance for this device was based on mechanical testing and verification of design controls, not on a study proving performance against acceptance criteria for an AI or software algorithm. There is no mention of an algorithm, AI assistance, human readers, or ground truth establishment in the context of device performance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details for an AI/software device, as this document is about a physical orthopedic implant.

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