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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.

• ISO-13779-3 (Chemical analysis, crystallinity, phase purity)
• ASTM F1854 (Stereological evaluation of porous coatings)
• ASTM E2109 (Area percentage porosity in thermal sprayed coatings) | The tests were performed and supported the conclusion of substantial equivalence for the 10-year shelf life, implying the device met the required specifications for HA coating integrity after extended aging. |

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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The DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extraarticular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

The DePuy Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

The DePuy Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically re-adaptation of torn or avulsed ligaments.

The DePuy Synthes 4.0 mm Titanium Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.

The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the femur.

The DePuy Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with DePuy Synthes Locking Plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of nonunions or malunions.

The DePuy Synthes 3.5 mm Conical Screws are intended to be used with existing DePuy Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.

The DePuy Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large (long) bone and bone fragments. In addition, the DePuy Synthes Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).

DePuy Synthes 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

DePuy Synthes 6.5 mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

The DePuy Synthes 1.0mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21 years) when used with the DePuy Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the DePuy Synthes Ti Wrist Fusion Plate (K023879). The DePuy Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or mal unions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis. The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis. The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures, avulsions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bones and bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, nonunions, and malunions of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula, and femur.

The DePuy Synthes Sterile 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot.

The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures in osteopenic bone, and nonunions and malunions.

The 4.0 mm locking screws feature a self-tapping tip, are solid, and have a flat head profile with rounded edges. They are available in lengths ranging from 14 mm to 62 mm. The threads just below the head of each locking screw engage with the threaded holes of the plate. The engagement of the screw to the plate shaft creates a locked fixed angle construct.

The DePuy Synthes Sacral Bar System consists of a threaded bar, washers, and nuts. The bars are fully threaded. One end of the bar has a trocar point to guide the bar through pre-drilled holes. The bars are available in lengths ranging from 120 to 260 mm, in 10 min increments. The washers that are used with this system are oval shaped and are designed to slide freely along the bars. Both rounded and straight nuts are provided with this system; the rounded nuts mate with the washers to create compression, while the straight nuts are then added to wedge against the rounded nuts to maintain compression.

The DePuy Synthes Spiked Washers are made of PEEK Optima™ LT plymer + 6% barium sulfate. There are either six or eight spikes arrayed around a center hole that will accommodate either 2.7, 3.5, 4.0, 4.5 or 6.6 mm screws.

The DePuy Synthes 4.0 mm Titanium (TI) Locking Screws feature a self-tapping tip, stardrive mechanishm, and have a flat head profile with rounded edges. They are available in lengths ranging from 14 mm to 90 mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP plating systems.

The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drilling and self-tapping tips, have a flat head profile with rounded edges with a hex drive recess. They are available in additional lengths ranging from 100 – 145 mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP® plating systems

The DePuy Synthes Peri-Prosthetic Screws feature a self-tapping blunt tip, stardrive mechanism, and have a flat head profile with rounded edges. They are available in lengths ranging from 8 mm to 12 mm. The threads on the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP® plating systems.

The DePuy Synthes 3.5 mm Conical Screws are self-tapping, have a stardrive or hex drive recess, and are manufactured from stainless steel and titanium. The 3.5 mm conical screws are available in various lengths ranging from 40-95 mm.

The DePuy Synthes Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium.

The DePuy Synthes 6.5 mm Cancellous Screws incorporate a fully threaded shaft, 4.0 mm core diameter, and have a flat head profile with rounded edges. They are available in lengths ranging from 60 mm to 130 mm in both Stainless Steel and Titanium Alloy. The screws are provided STERILE and NON STERILE.

The DePuy Synthes 6.5 mm Midfoot Fusion Bolt is a solid metallic fixation bolt which is intended to be used in procedures involving the foot and ankle. The DePuy Synthes 6.5 mm Midfoot Fusion Bolt is partially threaded on both ends and will be available in versions composed of implant quality stainless steel and titanium alloy.

The DePuy Synthes Cortical Screws have self-tapping features, stardrive, or cruciform head recesses, and are manufactured from stainless steel, commercially pure titanium, and/or titanium alloy. Cortex screws are offered both sterile and non sterile and are available in various lengths. Screws may be used independently or with any DePuy Synthes plate which accepts 1.0 mm, 1.3 mm, 2.0 mm, 2.4 mm, 2.7 mm, 4.0 mm, and 4.5 mm cortex screws. The screws, when used in pediatric applications, may be used independently or with compatible Synthes plates which are also indicated for pediatric populations.

The DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The DePuy Synthes Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws.

The DePuy Synthes 2.0 mm Quick Insertion Screws (QI Screws) are twist-off style screws comprised of a screw and post which are intended to separate at a predefined location (the breakpoint) as the screw is implanted into bone. The screws are offered with an external thread diameter of 2.0 mm and in lengths ranging from 11 mm to 18 mm to accommodate varying patient anatomy and fracture patterns in the foot and hand. The screws are made of a titanium alloy (Ti-6Al-7Nb) in accordance with ASTM F1295.

The DePuy Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including (but not limited to) the radius, ulna, humerus, tibia, fibula and femur. The ALPS utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The locking feature consists of conical shaped, threaded screw holes in the plate that correspond wi th the conical-shaped, threaded head of the screw.

The 3.0 mm Cannulated Screw has a 3.0 mm thread diameter and a 4.0 mm head diameter. It is available in short and long thread lengths ranging from 10 mm to 40 mm. It features selfdrillinglself-tapping flutes and cancellous threads for use in cancellous bone. The screw is used in conjunction with a guide wire for precise placement in bone. The Threaded Washer has a 5.5 mm thread diameter and is 3.0 mm in length. It features exterior threads for bone purcbase in the near cortex and is cylindrically shaped to allow passage of the 3.0 mm Cannulated Screw. The washer serves to provide a buttress in the near cortex for which the screw head can compress against.

The DePuy Synthes Cannulated Angle Blade Plate is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal tibia. The blade of the plate is cannulated to fit over a guide wire, allowing for the adjustment of the wire placement several times without adversely affecting the final result. There are cuts in the undersurface of the plate to reduce the surface area of the plate in contact with bone. The plate accepts 4.5 mm and 6.5 mm screws. he Cannulated Angle Blade Plate System is manufactured from stainless steel or commercially pure titanium.

This document describes the FDA's clearance of several DePuy Synthes trauma screws and plates as "MR Conditional" devices. The clearance is based on non-clinical testing demonstrating their safety in an MR environment, not on clinical performance or diagnostic accuracy. Therefore, the questions related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this context.

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

1. Table of acceptance criteria and the reported device performance

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

Not applicable. The study was non-clinical (in-vitro) testing of the devices' physical properties in an MR environment, not a test set using human data.

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

Not applicable. The "ground truth" here is adherence to specific ASTM standards for MR safety, which are technical measurements rather than expert human interpretation.

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

Not applicable. This was non-clinical testing against engineering standards.

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 submission is for the MR Conditional status of medical implants, not for an AI diagnostic device.

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

Not applicable. This submission is for the MR Conditional status of medical implants, not for an AI diagnostic device.

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

The ground truth used was compliance with established ASTM (American Society for Testing and Materials) standards for evaluating the MR safety of medical implants. These standards involve specific experimental setups and measurement methodologies to assess:

• Magnetically induced displacement force (ASTM F2052-14)
• Magnetically induced torque (ASTM F2213-06)
• Radiofrequency (RF) heating (ASTM F2182-11a)
• Image artifacts (ASTM F2119-07)

8. The sample size for the training set

Not applicable. This was non-clinical testing of physical devices. No training set for an algorithm was involved.

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

Not applicable. No training set for an algorithm was involved.

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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