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CUPTIMIZE™ Advanced is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component.

It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.

The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

CUPTIMIZE™ Advanced is a software as a medical device (SaMD) system that provides acetabular component orientation data for hip replacement surgery. The software guides the user through a workflow that involves positioning digital annotations on preoperative patient radiographic images. CUPTIMIZE™ Advanced utilizes digital annotations to describe the range of motion of the pelvis and provides an orientation of the acetabular component which reduces risk of edge loading and implant impingement. The system also provides warnings for patients with high or low pelvic mobility and high or low pelvic incidence.

CUPTIMIZE™ Advanced will include a pre-operative module that determines spinopelvic tilt relationships and data to provide an implant orientation plan, as well as an intra-operative verification capability that will allow the current implant orientation to be assessed against the plan.

The document provided outlines the K231503 510(k) premarket notification for the "CUPTIMIZE™ Advanced" device. It certifies that the device has undergone non-clinical and/or clinical tests to show its substantial equivalence in safety and efficacy to its predecessor. While the document mentions general categories of tests (model verification, system verification, system validation, and usability evaluation), it does not provide details on specific acceptance criteria or the reported device performance metrics in a table format. It also explicitly states that "Clinical testing was not required to demonstrate substantial equivalence."

Therefore, based solely on the provided text, I cannot complete all sections of your request.

Here's a breakdown of what can and cannot be answered from the provided text:

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

• Cannot be provided. The document states that tests were performed but does not list specific acceptance criteria or quantitative performance metrics.

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

• Cannot be provided. No details on sample sizes, data provenance, or study design are given for any test sets.

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):

• Cannot be provided. No information on expert involvement for ground truth establishment for test sets is present.

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

• Cannot be provided. No details on adjudication methods are given.

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:

• Cannot be provided. The document states "Clinical testing was not required," implying a MRMC comparative effectiveness study was not performed or not deemed necessary for this submission.

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

• Cannot be definitively stated based on the provided text alone. While "system validation tests" are mentioned, there's no explicit confirmation or exclusion of a standalone algorithm-only performance study or its results.

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

• Cannot be provided. The document does not specify the type of ground truth used for any testing.

8. The sample size for the training set:

• Cannot be provided. The document makes no mention of training sets or their sizes.

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

• Cannot be provided. As no training set information is available, how its ground truth was established is also not mentioned.

In summary, the provided FDA 510(k) letter and summary describe the device, its intended use, and its substantial equivalence to a predicate device, noting that non-clinical tests were performed. However, it does not offer the detailed study design, acceptance criteria, and performance results requested.

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The DePuy Attune Total Knee System is intended for cemented use as a total knee replacement system.

Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The subject device is a polyethylene tibial inserts and patella component made from AOX Polyethylene that mates with existing cemented and noncemented femoral and tibial base components

The provided text does not describe an AI medical device or a study involving AI. It is a 510(k) submission for a Total Knee System and specifically concerns an extension of the product's shelf life (from 5 years to 8 years) for certain components made from AOX Polyethylene that are gamma irradiated.

Therefore, I cannot extract information related to:

• Acceptance criteria for an AI device.
• Sample size for a test set or data provenance for an AI study.
• Number of experts for ground truth establishment for an AI study.
• Adjudication method for an AI study.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI.
• Standalone performance for an AI algorithm.
• Type of ground truth for an AI study.
• Sample size for a training set for AI.
• How ground truth for a training set was established for AI.

The document discusses non-clinical testing to support the shelf-life extension, specifically:

• Material Oxidation Index/Resistance Testing (ASTM F2102-17, ASTM F2003)
• Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3, ASTM F1877-05)

It explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patella components and the predicate devices."

In summary, the provided text does not contain the information requested as it pertains to a mechanical medical device (knee implant) and a shelf-life extension, not an AI device or an AI study.

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The TruMatch Patient Specific Instruments are intent-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting. The anatomical landmarks necessary for the TruMatch Patient Specific Instruments must be present and identifiable on CT. The TruMatch Patient Specific Instruments are intended for use with Sigma Total Knee Implants and Attune Total Knee Implants and their cleared indications for use. The TruMatch Patient Specific Instruments are intended for single use only.

Intended for patients with osteoarthritis who: Meet the criteria for primary total knee replacement performed with a measured resection technique. Have mild bone deformities and/or angular deformities less than 15 degrees of fixed varus/valgus, or flexion. Have some previous implants, such as hip implants, ankle implants, and soft tissue anchors. Contralateral knee replacement is acceptable as long as the contralateral knee is flexed away (not within the same medial/lateral axis) from the knee of interest during the CT scan.

The TRUMATCH Personalized Solutions System is comprised of patient-specific instruments and the software utilized to design the patient-specific surgical plans and instruments. The predicate TRUMATCH System creates a surgical plan based on a mechanical axis surgical technique. Changes to the Planning software component allow the surgeon to select a mechanical axis surgical technique or a patient-specific alignment surgical technique. Upon approval of the surgical plan, the TRUMATCH Guides are manufactured according to the plan.

The document describes the DePuy TRUMATCH Personalized Solutions, which are patient-specific surgical instruments for total knee replacement. The 510(k) submission (K193540) is for a modification to the software that enables the TRUMATCH surgical plan and Guides to be designed for a patient-specific alignment surgical technique, in addition to the existing mechanical axis technique.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for the performance of the TRUMATCH Personalized Solutions. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (TRUMATCH Personalized Solutions, K110397). The "performance data" section focuses on non-clinical tests to support this equivalence.

However, based on the described studies, the implied acceptance criteria for the modified software and guides would be:

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

• Test Set Sample Size: The document does not specify the exact sample size for the cadaver lab (how many cadavers or knees were used). For the model creation process verification and software verification testing, no specific sample size (e.g., number of models or software tests) is provided.
• Data Provenance: Not explicitly stated. The studies are non-clinical (cadaver lab, software testing), so country of origin for the data is less relevant than for clinical trials. The description suggests these were internal verification studies.

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

The document does not provide details on the number of experts or their qualifications used to establish ground truth for the non-clinical studies. For the cadaver lab, it's implied that observations and measurements were made, likely by qualified personnel (e.g., orthopedic surgeons or biomechanical engineers), but this is not specified.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1). For non-clinical, objective measurements these methods are often not used as an established "ground truth" might be derived from direct measurements or engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." The studies performed were non-clinical, focusing on the technical performance of the device and software. Therefore, there's no reported effect size regarding human readers improving with AI vs. without AI assistance, as this device does not involve "readers" in the diagnostic sense, nor does it present AI as an assistive tool to human interpretation in the way radiological AI does.

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

The "model creation process verification" and "software verification testing" can be considered evaluations of the standalone performance of the algorithm/software, as they assess its ability to generate models and perform functions independently. However, the TRUMATCH Personalized Solutions is inherently a human-in-the-loop system (the surgeon uses the guides). The software creates the plan, but the surgical execution involves human intervention. The cadaver lab assessed the overall system (guides + human interaction).

7. The Type of Ground Truth Used:

• For the model creation process verification, the ground truth would likely be established based on the accuracy of the generated models against the input CT data and predefined geometric specifications.
• For the cadaver lab, the ground truth for "guide fit, implant alignment and size, and bone resection accuracy analysis" would typically be established through direct measurements using precise instruments (e.g., micrometers, optical tracking systems, or specialized jigs) on the cadaveric specimens, compared to the planned surgical outcomes.
• For software verification testing, the ground truth would be against predetermined software requirements and specifications.

8. The Sample Size for the Training Set:

The document does not specify a training set sample size. This device is related to patient-specific instruments designed from CT imaging. While there might have been internal data used for the development and training of the algorithms within the TRUMATCH software system (prior to this specific modification), this submission does not explicitly detail that "training set" information. It focuses on the verification of the modified software and system.

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

As no training set information is provided in the document for this specific submission, the method for establishing its ground truth is also not described. For systems that use machine learning or AI, training data ground truth is often established by expert annotation or labeling of a large dataset.

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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty

The Summit DuoFix Hip is identical to the previously cleared Titanium Porocoat Hip stem (K170339, K011489, K001911) except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface. The Summit DuoFix Hip is a non-modular, collarless, Titanium, tapered, press-fit femoral stem. The hip stem is manufactured from ASTM F-620-87 forged Titanium (Ti-6Al-4V) and has a sintered commercially pure Titanium bead porous coating (Porocoat®) applied to the stem. The porous coating is applied over the circumferential ridges on the proximal region of the stem. A thin coating of hydroxyapatite (HA) is sprayed over the porous coating in a uniform thickness via a plasma spray process. The HA powder used in the plasma spray process conforms to ASTM F1185-88 and ISO 13779-6 Hydroxyapatite (Ca5(PO4)3OH) ceramic. The plasma spray process to apply the HA coating to the Summit DuoFix Stem is the same process used to coat the Pinnacle Duofix Acetabular Cup which was cleared in K192919. The HA material used for the Summit DuoFix Stem is the same as the HA material used on the Pinnacle Duofix Acetabular Cup. The distal portion of the stem has a grit blast surface finish. The hip stem consists of 10 body sizes ranging in diameter from 7 mm to 18 mm with each body size having two offset options. The design is a medially rounded trapezoid with a longitudinal ridge to optimize distal rotational stability. The Summit DuoFix hip stem uses a 12/14 taper for attachment of femoral ball heads. Femoral ball heads are intended to be used with the Summit DuoFix Hip prosthesis to provide the femoral prosthetic articular surface for the total hip arthroplasty. The femoral head articulates with an acetabular cup prosthesis that functions to restore mobility of the hip.

No acceptance criteria or study information for a device that meets such criteria were provided in the document. The document is a 510(k) premarket notification for a hip implant and discusses non-clinical tests conducted to demonstrate substantial equivalence to predicate devices, but does not present acceptance criteria or reported device performance in the format requested.

The provided text focuses on the substantial equivalence of the "Summit DuoFix™ HA Coating" to predicate devices based on non-clinical tests and manufacturing/packaging changes. It explicitly states: "No clinical tests were necessary to clear the current device and thus no clinical testing was conducted here to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about the training set.

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Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankyloses.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.

2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.

3. Avascular necrosis of the femoral head.

4. Non-union of femoral neck fractures.

5. Certain high subcapital and femoral neck fractures in the elderly.

6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.

7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

HA coated stems of the Corail Hip system are indicated for cementless use only.

The DePuy Corail AMT hip stem family are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles, and with various neck offsets.

Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that this document is for a medical device (hip prosthesis) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI performance, such as MRMC studies, reader improvements, AI-specific ground truth, and training sets, are not applicable.

The submission is a 510(k) for the DePuy Corail AMT Hip Prosthesis, seeking substantial equivalence to already marketed predicate devices. The reason for the submission is a change in manufacturing and sterilization facility and a slight modification to packaging. The core device design, principle of operation, and materials remain the same as the predicate devices.

Acceptance Criteria and Device Performance (for a Hip Prosthesis)

Since this is a non-AI medical device, the "acceptance criteria" are related to established standards for biocompatibility, sterility, and coating characteristics, rather than diagnostic or analytical performance metrics.

Study Details (Not applicable for an AI device in this context)

Since the provided document is for a physical medical device (hip prosthesis) and not an AI/SaMD, most of the requested fields related to AI performance are not available or applicable.

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

   • Not Applicable (N/A) for AI/SaMD. For this physical device, "test sets" would refer to samples used in engineering and biological testing (e.g., specific hip prosthesis components tested for strength, coating adherence, sterility). The document does not specify the number of units tested for each non-clinical test, nor does it detail data provenance beyond the device's manufacturing origin (Ireland).

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

   • N/A for AI/SaMD. Ground truth as defined for AI is not relevant here. For a physical medical device, "ground truth" might refer to established physical properties or biological responses, which are determined by standardized testing methods and scientific consensus, not expert consensus on interpretations.

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

   • N/A for AI/SaMD. Adjudication methods are typically used in clinical studies or human-reader performance evaluations, which are not detailed for this non-clinical submission.

4. 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:

   • N/A. This is a physical hip prosthesis, not an AI system. No MRMC study was conducted or is relevant.

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

   • N/A. This is a physical hip prosthesis, not an AI algorithm.

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

   • N/A for AI/SaMD. For the physical device, the "ground truth" for non-clinical tests would be defined by the specifications of the standards themselves (e.g., a material is "biocompatible" if it passes ISO 10993 tests, a sterilization process is "validated" if it meets the sterility assurance level (SAL) defined by ISO 11137). There is no "pathology" or "outcomes data" specifically mentioned for establishing "ground truth" in this non-clinical submission.

7. The sample size for the training set:

   • N/A. This is a physical hip prosthesis, not an AI system, so there is no "training set."

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

   • N/A. As there is no training set for an AI system, this question is not applicable.

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The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coating applied. The interior of the acetabular cup is designed with a groove and a taper for use with either an ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter. The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support. The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole” (Sector series) configurations.

This document is a 510(k) Premarket Notification for the DePuy Pinnacle Duofix™ HA Acetabular Cup Prosthesis. It aims to demonstrate substantial equivalence to previously cleared devices (K000306 and K031495) rather than proving a specific medical device meets acceptance criteria through clinical studies.

Therefore, the information requested in your prompt for a study proving a device meets acceptance criteria, including specifics about an AI/human reader study, ground truth establishment, and sample sizes for training/test sets, is not present in this document.

This submission is focused on:

• Demonstrating equivalence: The primary purpose is to show that the modified device (manufacturing location, sterilization sites, and packaging change) is as safe and effective as previously cleared predicate devices.
• Non-clinical testing: The performance data listed are non-clinical (biological safety, sterilization validation, HA coating characterization).
• No clinical tests: The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence."

In summary, there is no study described in this document that proves the device meets explicit acceptance criteria through the types of clinical or AI performance studies your prompt asks about.

If you have a document discussing an AI/medical device performance study, please provide that, and I can attempt to extract the relevant information.

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Candidates for total or unicompartmental knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant. In candidates for unicompartmental knee arthroplasty, only one side of the medial or lateral compartment) is affected.

The Sigma® C/R Porocoat® Femoral Components are intended for cementless use as the femoral component of a Total Knee Replacement system.

In the US, all other porous coated components have been cleared for CEMENTED USE ONL Y. Any Non-Porous coated components are intended for CEMENTED USE ONLY.

A total knee prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges. The patella component may be of an all polyethylene design or may be a metal backed polyethylene component.

This 510(k) submission is to provide MRI compatibility labeling for the PFC SIGMA Knee System. No clinical studies were conducted as the submission is based on non-clinical testing for MRI compatibility.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that "worst-case components and constructs" were evaluated for RF Heating and image artifacts. However, a specific numerical sample size for the devices tested is not provided.
• Data Provenance: The data is non-clinical, originating from laboratory testing (often referred to as ex-vivo or in-vitro when applicable to medical devices). The country of origin for the testing itself is not explicitly stated, but it follows US FDA guidance and ASTM standards. The study is retrospective in the sense that the device design already existed and was being evaluated for an additional claim.

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

This section is not applicable. The ground truth for MRI compatibility is established through standardized physical tests and measurements, not through expert consensus on interpretations of images or clinical outcomes. The "ground truth" is whether the device physically behaves safely and predictably in an MR environment according to predefined engineering standards.

4. Adjudication Method for the Test Set

This section is not applicable. As the evaluation involved physical measurements and adherence to engineering standards, there was no need for expert adjudication in the traditional sense of clinical trial data interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for MRI compatibility labeling based on non-clinical testing.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study of an algorithm was not done. This submission pertains to the physical properties of a knee implant system and its interaction with MRI, not an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on results from standardized non-clinical physical and engineering tests (magnetically induced displacement force, torque, RF heating, image artifacts) as defined by FDA guidance and ASTM standards (e.g., ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, ASTM F2219-07, ASTM F2503-13).

8. Sample Size for the Training Set

This section is not applicable. There was no "training set" as this was not a machine learning or AI-based study.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable.

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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.

The Summit Hip System is series of tapered femoral hip stems which may be used in either total or hemi-hip arthroplasty procedures in conjunction with DePuy hip arthroplasty devices.
The Summit Porous Hip Prosthesis is a series of collarless, titanium, tapered, press fit femoral stems The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit DuoFix Porous Hip Prosthesis is a series of collarless, titanium alloy, tapered, press-fit femoral stems. The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem with a thin layer of hydroxyapatite (HA) coating. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit Cemented Hip Prosthesis is series a flanged, collared tapered Cobalt-Chromium femoral stems with a smooth finish. There are seven proportional body sizes with a standard offset, and six proportional body sizes with a high offset. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Cemented Hip Prosthesis is a series of flanged, collared, tapered Cobalt-Chromium-Molybdenum femoral stems with a smooth surface finish. There are seven total sizes with a constant offset. Only six of the seven sizes are available in the high offset option. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Press Fit Hip Prosthesis is a series of collared, tapered Titanium femoral stem with a grit-blasted finish. There are seven sizes with a constant offset and a distal centralizer to assure that the stem is centered in the femoral canal. These stems are intended for uncemented use only.

This is a 510(k) summary for the Summit Hip System, which is a medical device. This document does not describe acceptance criteria for an AI/ML device, nor does it contain information about a study proving such a device meets acceptance criteria. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence of the Summit Hip System to predicate devices.

Therefore, I cannot answer your request based on the provided text as it does not contain the information you are looking for.

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Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

The Actis DuoFix Hip Prosthesis is indicated for cementless use only.

The DePuy Actis DuoFix prostheses are manufactured from forged titanium alloy (Ti-6Al-4V) and have a sintered commercially pure titanium bead porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite (HA) coating.
The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.

This document is a 510(k) premarket notification for the DePuy Actis DuoFix Hip Prosthesis. As such, it focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than establishing new performance criteria for a novel device or AI algorithm.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment, which are typical for assessing new medical devices or AI algorithms, is not explicitly present in the provided text.

Here's why and what information is available:

• Type of Device: The "DePuy Actis DuoFix Hip Prosthesis" is a physical medical device (an uncemented hip implant), not an AI-powered diagnostic or therapeutic tool.
• Purpose of Submission: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing technological characteristics and non-clinical performance data (e.g., mechanical tests, biocompatibility) rather than new clinical effectiveness studies with explicit acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
• No Clinical Tests: The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." This directly negates the possibility of finding information about clinical test sets, ground truth, expert adjudication, or MRMC studies.

However, I can provide the information that is available from the document regarding the non-clinical tests conducted.

Based on the provided document, here's what can be inferred and what information is not present:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the context of comparative performance as would be for an AI device. The acceptance is based on demonstrating substantial equivalence to the predicate devices through non-clinical testing.
   • Reported Device Performance: The document only lists the types of non-clinical tests performed. It does not provide the numerical results of these tests or specific performance metrics against an acceptance criterion. It simply states that these tests were "conducted for determination of substantial equivalence."

   Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
   Mechanical properties (e.g., fatigue strength) comparable to predicate devices.	Non-clinical tests were conducted for: - Distal fatigue - Neck fatigue - Range of motion - Biocompatibility
   Biocompatibility comparable to predicate devices.

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

   • Sample Size: Not specified for any of the non-clinical tests.
   • Data Provenance: Not applicable as no clinical data or test sets are mentioned. The testing would be laboratory-based on the physical devices.

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

   • Not applicable, as no clinical test set or ground truth (in the diagnostic sense) was established. The "truth" for mechanical integrity is inherent in material science and engineering standards.

4. Adjudication method for the test set:

   • Not applicable, as no clinical test set requiring expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence." An MRMC study is a type of clinical study involving human readers.
   • Effect size: Not applicable, as no such study was performed.

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

   • Not applicable. This device is a physical hip prosthesis, not a software algorithm.

7. The type of ground truth used:

   • Not applicable in the context of diagnostic/AI devices. For this physical device, "ground truth" for non-clinical testing would refer to established engineering standards, material properties, and biocompatibility protocols.

8. The sample size for the training set:

   • Not applicable. This is a physical 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 physical device, not an AI model.

Summary of available information:

• Non-Clinical Tests Conducted: Distal fatigue, neck fatigue, range of motion, biocompatibility.
• Clinical Tests Conducted: None.
• Comparison Basis: Substantial equivalence to predicate devices (DePuy Summit DuoFix Hip Prosthesis (K011489) and DePuy Corail AMT Hip Prosthesis (K123991)) based on technological characteristics and non-clinical performance.

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The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.

The DePuy Pinnacle ALTRX Acetabular Liners are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6Al-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter. The subject devices represent additional sizes and style combinations of the predicate acetabular liners.

The DePuy Pinnacle ALTRX Acetabular Liners are a medical device used in total hip replacement procedures. The 510(k) summary provides information on the device's acceptance criteria and the study that proves it meets these criteria.

Acceptance Criteria and Device Performance

The acceptance criteria for the DePuy Pinnacle ALTRX Acetabular Liners are implicitly demonstrated by showing substantial equivalence to legally marketed predicate devices. The study conducted was a non-clinical test that focused on specific performance requirements.

Here's a table summarizing the characteristics of the subject device in comparison to its predicate and reference devices, which effectively serve as the acceptance criteria based on equivalence:

The device performance, as reported, indicates that the subject devices "met the applicable performance requirements and are as safe and effective as a legally marketed device."

Study Details

Given that this is a 510(k) submission for a line extension, the primary "study" is a demonstration of substantial equivalence through non-clinical testing.

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

   • No specific sample sizes for test sets are provided in the document. The testing mentioned (Impingement, High Angle Fatigue, Push-out, and Torque-out) would involve specific numbers of physical samples of the liners and associated components, but these numbers are not detailed here.
   • Data Provenance: The data is from non-clinical tests conducted by the manufacturer, DePuy Orthopaedics. The country of origin of the data is not explicitly stated but is implied to be within the company's testing facilities, likely in the US (Warsaw, IN). The tests are prospective in the sense that they were conducted for the purpose of this submission to demonstrate performance.

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

   • For non-clinical performance testing of medical devices like acetabular liners, the "ground truth" is typically established by engineering standards and validated test methodologies. There isn't a concept of medical "experts" establishing ground truth in the same way as, for example, reviewing medical images. The acceptance criteria for these tests (e.g., maximum force, cycles to failure) are derived from industry standards, regulatory requirements, and historical data from similar, cleared devices. The engineers and technicians who conduct and interpret these tests are qualified in biomechanical testing and materials science, but their specific number or qualifications are not provided here.

3. Adjudication method for the test set:

   • Not applicable in the traditional sense. Non-clinical mechanical tests are generally quantitative, and their outcomes are determined by meeting predefined engineering specifications and statistical analysis, rather than through expert human adjudication.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

   • No, a MRMC comparative effectiveness study was explicitly stated as not conducted. The document states, "No clinical tests were conducted to demonstrate substantial equivalence." This type of study is typically used for diagnostic or screening devices involving human interpretation of data (e.g., radiology images).

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

   • Not applicable. This device is a physical implant (acetabular liner) for hip replacement, not a software algorithm.

6. The type of ground truth used:

   • The ground truth for the non-clinical tests (Impingement, High Angle Fatigue, Push-out, and Torque-out) is based on established engineering performance requirements and industry standards for such orthopedic implants. The reported performance of the subject device was compared against these predefined acceptable limits (derived from the predicate devices and general orthopedic device standards) to ensure it performs "as safe and effective as a legally marketed device."

7. The sample size for the training set:

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

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

   • Not applicable.

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