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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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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 (Ti6A14V) 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.

The provided text is a 510(k) summary for the DePuy Corail AMT Hip Prosthesis. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel device performance through extensive clinical trials or AI/ML studies.

Therefore, many of the requested criteria (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, effect size of AI assistance, standalone performance, and details about training sets for AI devices) are not applicable to this type of regulatory submission as it does not involve an AI/ML device or a comparative effectiveness study with human readers.

However, the document does describe non-clinical tests conducted to support modifications to an existing device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the format of a typical clinical trial or AI device validation study with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests performed to demonstrate product specifications and safety for changes introduced (new manufacturing site, increased shelf life, alternate manufacturing process). The "performance" is demonstrated by conforming to these established testing standards.

I will attempt to structure this into a table based on the non-clinical tests mentioned.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test. These tests typically involve a limited number of device samples or components subjected to specific mechanical, chemical, or aging conditions. There is no "data provenance" in terms terms of country of origin for patients, as no clinical data was used for this specific 510(k) submission. These are laboratory-based, non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for non-clinical engineering tests is established by documented industry standards (e.g., ISO, ASTM) and internal quality control processes, not by expert consensus in a medical diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring medical adjudication was used.

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 not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria specified by the relevant ISO and ASTM standards cited. For example, a seal strength test has a numerical minimum requirement for a "pass."

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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The DELTA XTEND™ Reverse Shoulder System is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only.

The DELTA XTEND™ Reverse Shoulder System is indicated for use in treatment of a grossly deficient rotator cuff joint with: severe arthropathy and/or; a previous failed joint replacement and/or: fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. DELTA XTEND™ Reverse Shoulder System hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.

The DELTA XTEND™ Reverse Shoulder System is currently cleared and marketed by DePuy Synthes and is comprised of multiple humeral and glenoid implant components. These are provided as separate, standalone devices and may be used in conjunction to form a total shoulder prothesis. This submission is pertinent to only those system components which are HA coated: Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes

The provided text is a 510(k) Summary for the DELTA XTEND™ Reverse Shoulder System. It outlines the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, the primary purpose of this submission (as stated in section 510(K) SUMMARY) is "to extend the current approved shelf life of 5 years to 10 years" of the DELTA XTEND™ Reverse Shoulder System.

Therefore, the performance data provided focuses solely on testing related to shelf-life extension, specifically regarding the HA coating on shelf-aged products. There is no information within this document about acceptance criteria or studies related to AI-powered medical devices, human reader improvements with AI assistance, or algorithm-only performance.

The document explicitly states:
"NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE."

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance), expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device, as this documentation pertains to a traditional medical device (shoulder replacement system) and not an AI/ML device.

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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 dvsplasia.
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, hem-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankvloses.

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 hemiarthroplasty.

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.

This document pertains to a 510(k) premarket notification for a medical device, the DePuy Corail AMT Hip Prosthesis. The purpose of this submission, as stated, is to extend the approved shelf life of the device from 5 years to 10 years.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to demonstrating that the device remains safe and effective for the extended shelf life, specifically focusing on the integrity of the Hydroxyapatite (HA) coating after extended aging.

Based on the provided text, while the document confirms the device's substantial equivalence for its extended shelf life, it does not contain the detailed information typically found in an AI/software as a medical device (SaMD) study regarding performance criteria, sample sizes, expert qualifications, or multi-reader studies. The studies mentioned are primarily non-clinical bench tests focused on material properties after aging.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:

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

The document mentions specific non-clinical tests performed, implying that the acceptance criteria are related to meeting the standards outlined in those test methods. However, the exact quantitative acceptance criteria (e.g., "HA coating adhesion strength > X MPa") and the numerical results of the device performance against those criteria are not explicitly reported in the text. The document only confirms that these tests were performed and conclude substantial equivalence.

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

• Sample sizes for the test set: Not specified in the provided document. The text states "the following tests were performed," but does not mention the number of units tested.
• Data provenance: The tests were performed on "shelf-aged product." The country of origin of the data is not specified, but the applicant is DePuy (Ireland). The studies are inherently prospective in the sense that they are designed to simulate future aging, but performed in a controlled laboratory setting.

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

• Number of experts and qualifications: Not applicable to this type of non-clinical bench testing. Ground truth for these tests is established by adhering to standardized test methods (ISO, ASTM) and using calibrated laboratory equipment and trained technicians/engineers. There is no human interpretation of images or clinical outcomes that would require expert consensus.

4. Adjudication method for the test set

• Adjudication method: Not applicable to this type of non-clinical bench testing. The results are quantitative measurements against established standards, not subjective interpretations requiring 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

• MRMC study: No. This device is a hip prosthesis, not an AI or imaging device. Therefore, MRMC studies are not relevant to its clearance.

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

• Standalone performance: No. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Type of ground truth: For the non-clinical tests, the "ground truth" is defined by the standardized methodologies and specifications outlined in ISO and ASTM standards. For example, the ground truth for HA coating crystallinity would be the measurement obtained by a specified analytical technique (e.g., X-ray diffraction) that meets the criteria of ISO-13779-3.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device does not involve machine learning or a "training set." The tests conducted are to confirm the physical properties of the device over its extended shelf life.

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

• How ground truth was established: Not applicable. As there is no training set involved, this question is not relevant.

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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. 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 ACTISTM DUOFIX™ Hip Prosthesis is indicated for cementless use only.

The ACTIS Duofix™ Hip Prosthesis is identical to the previously cleared ACTIS Duofix™ Hip Prosthesis (K150862 & K160907). The ACTIS Duofix™ Hip prostheses are manufactured from forged titanium alloy (Ti6Al4V), 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 anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-athroplasty and with modular metal or ceramic femoral heads intended for total hip arthroplasty.

The porous coating is applied over the proximal region of the stem. A thin coating of hydroxyapatite (HA) of uniform thickness is sprayed over the porous and distal stem areas 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 used to apply the HA coating to the ACTIS Duofix™ Stem is the same process used to coat the SUMMIT Duofix™ Stem which was cleared in K193398. The HA material used for the ACTIS Duofix™ Stem is the same as the HA material used on the SUMMIT Duofix™ Stem. Thirteen sizes of prostheses are provided to allow high resolution of fit within host femora. Each size is offered in standard and high offset neck options, desired recreation of patient biomechanics in combination with head and liner combinations.

This document describes a 510(k) premarket notification for the ACTIS Duofix Hip Prosthesis, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and human reader performance with AI assistance is not applicable.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through:

• Manufacturing changes: Adding DePuy Ireland as an alternate manufacturing facility for the HA coating process and DePuy Orthopaedics Inc. Warsaw IN as an alternate site for grit-blasting.
• Non-clinical performance data:
  • Biological safety per ISO 10993-1.
  • Characterization testing of Hydroxyapatite Coating per FDA Guidance.
  • Performance Bench Testing - Body (Distal) Fatigue Testing per ISO 7206-4 2010.

No clinical tests were conducted as part of this submission, nor are there any indications of an AI/ML component in the device.

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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.

Ask a specific question about this device

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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