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The InterSpace GV Hip Spacer is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).

The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The InterSpace GV Hip Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

The InterSpace GV Hip Spacer is manufactured from PMMA with gentamicin and vancomycin and includes a stainless-steel core as well as a tapered wedge design. The InterSpace GV Hip Spacer is single-use, disposable, and provided sterile. The InterSpace GV Hip Spacer is inserted into the femoral medullary canal and acetabular cavity following the removal of the existing femoral and acetabular implants and debridement as part of a two-stage procedure due to a septic process. The device is protected from bacterial colonization due to the presence of gentamicin and vancomycin.

The provided text is a 510(k) clearance letter for a medical device called the "InterSpace GV Hip Spacer." This type of document is a regulatory approval and outlines the device's intended use, regulatory classification, and a summary of the reasons for its clearance (often by showing substantial equivalence to a predicate device).

However, this document does not contain the specific information required to answer your detailed questions about acceptance criteria and the study that proves the device meets those criteria, particularly regarding AI/algorithm performance and clinical validation.

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the subject InterSpace GV Hip Spacer met the pre-determined acceptance criteria for the verification activities." It then lists the types of performance tests conducted (Mechanical Testing, Analysis of Antibiotic Content, Biocompatibility Assessment, Sterilization Validation, Shelf-Life Validation, Packaging Validation).

These tests are standard for a physical medical device (a hip spacer) to ensure its mechanical integrity, material compatibility, and sterile delivery, which are critical for its safety and function. They are not related to the performance of an AI/algorithm.

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance, ground truth establishment, sample sizes for AI training/testing, or MRMC studies, as the provided text does not describe a study involving an AI or algorithm.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only generically states that "pre-determined acceptance criteria" were met for these categories. It does not provide the specific numerical or qualitative criteria themselves, nor the detailed results for each test.

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

• Not applicable / Not provided. This document does not describe a study involving a "test set" in the context of an AI/algorithm. The "tests" mentioned are physical and chemical characterizations of the device itself.

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

• Not applicable / Not provided. No AI/algorithm study is described where ground truth would be established by experts.

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

• Not applicable / Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was not done for this device. This is a physical hip spacer, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant.

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

• Not applicable / Not provided. The "ground truth" for this device's performance would be engineering specifications, material science standards, and in-vitro or in-vivo testing results to confirm physical and biological properties.

8. The sample size for the training set:

• Not applicable / Not provided. No AI/algorithm training set is mentioned.

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

• Not applicable / Not provided. No AI/algorithm training set is mentioned.

In summary: The provided FDA clearance letter pertains to a conventional medical device (a hip spacer) and its physical and material properties, not a software or AI-driven device. Therefore, the questions related to AI/algorithm performance and clinical validation through sophisticated study designs (like MRMC) are not relevant to this document.

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The Hip Spacer with gentamicin preserves the joint space and the length of the affected limb, which results in the maintenance of the entire abductor and stabilizer apparatus of the hip. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Hip Spacer is implanted after the removal of the infected implant, as a regular Hemiarthroplasty. The spacer is inserted into the femoral canal, and a handmade ring of PMMA bone cement with antibiotic may be added to the base of the spacer's neck in order to increase stability. The spacer is kept "in place" until it is replaced by the final prosthesis according to medical criteria. The Hip Spacer must not remain implanted for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Knee Spacer with gentamicin maintains the articular space, the length of the affected limb, and the ligament apparatus of the knee. Its use is indicated for a limited period, in patients who require a Two stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Knee Spacer is placed like a regular arthroplasty, after the removal of the original implant. This knee spacer consists of two independent parts: a tibial plate and a femoral component. The first has a flat base where the femoral component articulates. It is recommended that both components be adapted to the bone by means of a small amount of bone cement with antibiotic. The Knee Spacer must not remain implanted more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Shoulder Spacer with gentamicin preserves joint space and length of the affected limb, resulting in maintenance of the entire shoulder muscle and stabilizer complex. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Shoulder Spacer is placed as a hemiarthroplasty after the original implant has been removed. The spacer is inserted into the humeral canal and a ring of bone cement with antibiotic can be added to the base of the neck of the spacer for added stability. The Shoulder Spacer should not remain in place for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Synicem Hip, Knee, and Shoulder Spacers are combination products made from fully formed polymethylmethacrylate (bone cement) with gentamicin. The bone cement is prepared from a powder component and a liquid component. The hip and shoulder spacers contain a stainless steel core of 316L in accordance with ASTM F138. The spacers are temporary implants utilized to maintain the joint space during two-stage revision arthroplasties. The spacer implant is placed as part of the first stage of the two-stage revision when the original prostheses are removed due to joint infection. Once the infection is cleared, the spacers are removed and replaced with a permanent prosthesis as part of the second stage of the revision process. The joint spacers are not intended to be implanted for longer than 6 months. They are a single use device and supplied sterile.

This document is a 510(k) clearance letter for the Synicem Hip, Knee, and Shoulder Spacers. These are medical devices, specifically temporary implants used in two-stage revision arthroplasties following joint infections.

The information provided outlines the substantial equivalence of the Synicem Spacers to previously cleared predicate devices. It describes the device, its intended use, technological characteristics, material composition, sizes, and various performance tests conducted.

However, a critical point to understand is that this document DOES NOT describe an AI/ML-based device. It is a clearance for a traditional medical device (joint spacers). Therefore, many of the requested criteria related to AI/ML systems (such as test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The document focuses on demonstrating that the new Synicem Spacers are "substantially equivalent" to existing, legally marketed predicate devices in terms of safety and effectiveness, based on non-clinical performance testing (mechanical, antibiotic elution), biocompatibility, and MRI safety.

Here's an analysis based on the provided document, addressing the applicable criteria and explicitly stating where information is not available due to the nature of the device:

Device: Synicem Hip Spacer, Synicem Knee Spacer, Synicem Shoulder Spacer
Type of Device: Traditional Medical Device (Non-AI/ML)

Acceptance Criteria and Reported Device Performance

Given that this is a traditional medical device (joint spacer) and not an AI/ML algorithm, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices through various non-clinical performance tests and adherence to relevant standards. There isn't a "performance metric" in the sense of accuracy, sensitivity, or specificity as one would expect for a diagnostic AI.

The acceptance criteria are implicitly met by demonstrating that the Synicem Spacers "met performance requirements and is substantially equivalent to the predicate device" across several categories.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

• Knee Spacers: Fatigue performance and wear testing performed. Results showed equivalence to predicate.
• Shoulder Spacers: Static and dynamic fatigue testing performed. Results showed equivalence to predicate. |
  | Antibiotic Elution Profile | Elution kinetics of gentamicin are equivalent to predicate devices. | Antibiotic Elution Kinetics testing conducted. Results demonstrated elution kinetics equivalent to predicate spacers. |
  | Biocompatibility | Biological safety suitable for intended use, in accordance with ISO 10993 standards and FDA guidance. | - Cytotoxicity (ISO 10993-5)
• Sensitization (ISO 10993-10)
• Irritation (ISO 10993-23)
• Acute systemic toxicity (ISO 10993-11)
• Material mediated pyrogenicity (ISO 10993-11)
• Genotoxicity (ISO 10993-3)
• Intramuscular implantation (ISO 10993-6)
• Local Effects after Bone Implantation / Subchronic Systemic Toxicity (ISO 10993-6 and ISO 10993-11)
• Chemical characterization (ISO 10993-18)
• Toxicological risk assessment (ISO 10993-17)
  Conclusion: Materials are biologically safe and suitable for intended use. |
  | MRI Safety | Meet MR safety classifications as "MR Safe" or "MR Conditional" as determined by testing. | - Synicem Knee Spacer: "MR Safe"
• Synicem Hip and Shoulder Spacers: "MR Conditional"
  (Testing conducted according to FDA guidance) |
  | Sterilization & Shelf Life | Sterilization methods validated according to international standards and FDA guidance; packaging maintains functionality and safety. | Sterilized using well-established methods; validations performed following international standards and FDA guidance. Compatibility between packaging and sterilization ensured; packaging preserves functionality and safety throughout declared shelf-life. |

Study Details (Applicability to AI/ML context)

Since this is a non-AI/ML device submission, most of the requested study details pertinent to AI/ML performance validation are not applicable (N/A). The "study" here refers to the non-clinical performance testing done to establish substantial equivalence.

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

   • N/A. This is not an AI/ML device. The "test set" would refer to the physical samples of the spacers used for mechanical, biocompatibility, and elution testing. The provenance would be the manufacturing site (United Kingdom).

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

   • N/A. This is not an AI/ML device requiring expert-labeled ground truth data. Performance for this device is based on objective measurements from mechanical and chemical tests, and biological assays.

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

   • N/A. Not applicable for objective non-clinical performance testing of a physical device.

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:

   • No. This is a physical medical device (joint spacer), not an AI system designed to assist human readers. MRMC studies are not relevant.

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

   • N/A. There is no "algorithm" in this device. Its performance is inherent in its physical and chemical properties.

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

   • N/A. The "ground truth" for this device's performance is established by validated engineering and scientific test methods (e.g., ASTM standards for material properties, ISO standards for biocompatibility, gravimetric analysis for elution profiles). It's based on physical measurements and biological reactions, not subjective interpretation requiring "expert consensus" in the diagnostic sense.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device; there is no "training set."

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

   • N/A. Not an AI/ML device; no "training set" or "ground truth for training."

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COPAL® exchange G hip spacer (polymethy)methacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

COPAL® G+V (gentamicin and vancomycin) is a PMMA bone cement intended for fixation of COPAL® exchange G hip spacer to the host bone.

COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.

COPAL® exchange G hip spacer is made of fully formed polymethyImethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).

COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methy) methacrylate)-based (PMMA) bone cement, containing gentamicin and vancomycin, designed for fixation of COPAL® exchange G hip spacer to the host bone. COPAL® G+V is intended for single-use and is supplied sterile.

The provided text is a 510(k) summary for the COPAL® exchange G hip spacer and COPAL® G+V. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device. The section "VII. PERFORMANCE DATA" primarily focuses on mechanical testing, biocompatibility, packaging, sterilization, and shelf life for a physical medical device (hip spacer and bone cement). It also mentions a "Clinical evaluation" but clarifies it was to "analyze the existing clinical data of predicate device and legally marketed U.S. devices" and "no unknown complications that have not yet been described in the instructions for use were found." Crucially, it explicitly states, "No clinical tests were performed to demonstrate substantial equivalence."

Therefore, I cannot extract the information required to answer your prompt, as the prompt's assumptions (acceptance criteria, test set, ground truth, MRMC study, standalone performance for an algorithm) are not applicable to the content of this 510(k) summary for a physical orthopedic device.

If you have a document describing an AI/algorithm-driven medical device and its performance studies, please provide that document, and I will be happy to attempt to extract the requested information.

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UHR Bipolar:
· Femoral head/neck fractures or non-unions.
· Aseptic necrosis of the femoral head.
· Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
· Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

Restoration GAP II Acetabular Shell:
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
· Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.

The devices covered by this submission are Stryker Hip System components:

• UHR Bipolar femoral head
• Restoration GAP II Acetabular Shell
  These devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available.
  The purpose of this submission is to modify the labeling of these Stryker Hip System components to add MR Conditional labeling.

This document is a 510(k) summary for medical devices (UHR Bipolar Implants and Restoration GAP II Implants) and focuses on the modification of labeling to include MR Conditional information. It does not describe an AI medical device or a study involving human readers or ground truth determination in the context one would typically find for AI/diagnostic devices.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert qualifications, and study designs are not applicable to the content of this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not applicable:

1. Table of acceptance criteria and the reported device performance

   This document is a 510(k) submission for an existing medical device, primarily focused on updating labeling to include MR Conditional information. It does not describe performance metrics in the way an AI diagnostic device would (e.g., sensitivity, specificity). The "acceptance criteria" here are related to proving safety in an MR environment.

   Acceptance Criteria (for MR Safety)	Reported Device Performance (Compliance)
   Magnetically Induced Displacement Force (per ASTM F2052-15)	Tests performed, results indicate MR Conditional status is appropriate
   Magnetically Induced Torque (per ASTM F2213-17)	Tests performed, results indicate MR Conditional status is appropriate
   Image Artifact (per ASTM F2119-07)	Tests performed, results indicate MR Conditional status is appropriate
   Heating by RF Fields (per ASTM F2182-19)	Tests performed, results indicate MR Conditional status is appropriate

   Note: The document states "The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned," implying that the devices met the acceptance criteria for the MR safety tests performed.

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

   This document describes non-clinical laboratory testing on the device itself for MR compatibility. It does not involve a "test set" of patient data or clinical images. Therefore, questions of sample size for a test set, country of origin, or retrospective/prospective nature are not applicable. The tests were performed on the device components.

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)

   Not applicable. No "ground truth" establishment by experts is described as this is non-clinical device testing, not a diagnostic or AI performance study.

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

   Not applicable. No "test set" of cases or adjudication of expert opinions is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   Not applicable. This is not a study involving human readers or AI assistance.

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

   Not applicable. This document does not describe an algorithm or AI device.

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

   Not applicable. The "ground truth" in this context is the physical properties and behavior of the device components under MR conditions, as measured by standardized tests (e.g., compliance with ASTM standards).

8. The sample size for the training set

   Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

   Not applicable. There is no training set and therefore no ground truth described for a training set.

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The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM GV components include gentamicin and vancomycin.

The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin or gentamicin vancomycin are the most appropriate antibiotics based on the infecting micro-organism(s).

Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medulary canal and can mate directly with the native actabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The OsteoRemedies Hip Spacer System is not intended for use than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

The OsteoRemedies Hip Spacer System is a modular temporary spacer device inclusive of femoral stems, femoral heads, and acetabular cups. The OsteoRemedies Hip Spacer System is sterile and single-use, intended for temporary use (maximum 180 days) for joint replacement. This submission expands the existing system to include additional sizes of the acetabular cup and femoral head. The system components are made of fully formed polymethylmethacrylate (PMMA) with gentamicin (REMEDY®) and gentamicin with vancomycin (REMEDY SPECTRUM® GV).

The OsteoRemedies Hip Spacer System provides a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The REMEDY® components are protected from bacterial adhesion due to the presence of gentamicin. The REMEDY SPECTRUM® GV components are protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

This document is a 510(k) premarket notification for the OsteoRemedies Hip Spacer System, specifically focusing on expanding the system to include additional sizes of acetabular cups and femoral heads (XS REMEDY Modular Head, XS REMEDY SPECTRUM GV Modular Head, and XS REMEDY Acetabular Cup). This document does not describe an AI/ML powered device, therefore, many of the requested fields are not applicable.

Here's an analysis of the provided information, focusing on the acceptance criteria and study details for this medical device, with N/A for fields not applicable to this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific tests within this summary document. For mechanical testing (fatigue, disassembly), standard practices involve testing a statistically representative number of samples for each design variant to ensure robustness. For antibiotic elution, multiple samples would also be tested.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are primarily lab-based performance tests for mechanical properties and material characteristics. Clinical data is mentioned as having been performed on "predicate devices," implying existing data. The context is a US FDA submission, so industry standards are applied. Retrospective or prospective is not applicable for these engineering tests.

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

• N/A. This document describes engineering performance testing and material characterization, not studies requiring expert interpretation of medical images or patient outcomes for ground truth establishment. The "ground truth" for these tests is defined by established engineering and material science standards (e.g., ISO, ASTM).

4. Adjudication method for the test set:

• N/A. As above, this is not an AI/ML clinical validation study involving human interpretation and adjudication. The tests involve objective measurements against predefined criteria.

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:

• N/A. This device is a physical hip spacer, not an AI/ML software device.

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

• N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Engineering Standards and Material Specifications: For mechanical properties (fatigue, strength, disassembly, wear, range of motion), the ground truth is established by recognized international standards (e.g., ISO 7206 series) and material specifications for PMMA.
• Biocompatibility Standards: For biocompatibility, the ground truth is established by ISO 10993 series.
• Pharmacokinetic/Pharmacodynamic Principles: For antibiotic elution kinetics, the ground truth is based on established principles of drug release and achieving therapeutic concentrations, typically supported by in vitro or in vivo studies on the predicate device.
• Sterilization Validation Standards: For sterility, pyrogenicity, and endotoxin, the ground truth is established by relevant sterilization and quality control standards.

8. The sample size for the training set:

• N/A. This is not an AI/ML device, so there is no "training set."

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

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

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The REMEDY Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The REMEDY Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with the REMEDY Hip Spacer using the REMEDY 46mm Modular Head when gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s), or the REMEDY SPECTRUM GV Hip Spacer using the REMEDY SPECTRUM GV 46mm Modular Head when gentamicin and vancomycin are the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The REMEDY Acetabular Cup 46mm ID/54mm OD is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, etc.).

The REMEDY Acetabular Cup is a temporary spacer device available in a single size, intended to be combined with either the REMEDY Hip Spacer with 46mm Modular Head or the REMEDY SPECTRUM GV Hip Spacer using its 46 mm Modular Head.

The REMEDY Acetabular Cup is a sterile, single-use device intended for temporary use (maximum 180 days) as joint replacement. The device is made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin.

The REMEDY Acetabular Cup and REMEDY or REMEDY SPECTRUM GV Hip Spacers provide a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The REMEDY Acetabular Cup is protected from bacterial adhesion due to the presence of gentamicin.

This is a 510(k) premarket notification for a medical device called the "REMEDY Acetabular Cup." This document does not describe a study that validates an AI/ML powered medical device. It instead details the equivalency of the REMEDY Acetabular Cup to predicate devices through physical performance testing and engineering analysis, not through a clinical or algorithmic performance study involving a test set, ground truth, or expert readers.

Therefore, I cannot provide the information requested in the format of acceptance criteria and study proving device meets the criteria, as this document does not contain that type of information for a device that relies on algorithmic performance.

The document discusses:

• Device Name: REMEDY Acetabular Cup
• Regulation: 21 CFR 888.3360 (Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis)
• Product Codes: KWL, KWY
• Indications for Use: Temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. It requires combination with specific Hip Spacers (REMEDY Hip Spacer or REMEDY SPECTRUM GV Hip Spacer) depending on the appropriate antibiotic (gentamicin or gentamicin and vancomycin).
• Device Description: Sterile, single-use, made of polymethylmethacrylate (PMMA), radio-opaque, contains gentamicin. Provides functional-mechanical mode of action, allows natural range of motion and partial weight-bearing.
• Predicate Devices: REMEDY Acetabular Cup (K173967) and REMEDY SPECTRUM GV Hip Spacer (K172906).
• Substantial Equivalence: Demonstrated through performance testing (static and fatigue strength of resin, range of motion, surface roughness, antibiotic release kinetics) and engineering analysis of wear. Endotoxin testing also performed.

The relevant section regarding acceptance criteria and performance would be "Performance testing... to support its substantial equivalence" on page 5. However, this refers to mechanical and material performance, not the performance of an AI/ML algorithm.

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The REMEDY PLUS Hip Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).
The head and stem components are inserted into the acetabular cavity and femoral medullary canal, respectively, following removal of the existing acetabular and femoral components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The REMEDY PLUS Hip Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

The UNITE PLUS Bone Cement is intended for the fixation of a REMEDY PLUS spacer device to the host bone.

The REMEDY PLUS Hip Spacer is comprised of modular components, which are available in different sizes to accommodate variations in patient anatomy. The REMEDY PLUS Hip Spacer includes stems in various sizes and lengths, and femoral heads in various diameters. The modular design of the REMEDY PLUS Hip Spacer allows the surgeon to choose a femoral head offset which best matches the patient's anatomy.

The REMEDY PLUS Hip Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as a joint replacement. The implants are made of fully formed polymethylmethacrylate (PMMA), which is radiopaque, and contains gentamicin and vancomycin. The hip device has an inner stainless steel (AISI 316 ESR stainless steel) reinforcing structure.

The UNITE PLUS Bone Cement is a PMMA, radiopaque bone cement, containing gentamicin and vancomycin, designed for the fixation of prosthesis to the living bone. The UNITE PLUS Bone Cement is provided sterile.

Here's an analysis of the acceptance criteria and study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria for device performance. However, based on the clinical study, the implicit "acceptance criteria" appear to be similar or superior clinical outcomes compared to the predicate device and literature.

| Acceptance Criteria (Implicit) | Reported Device Performance (REMEDY PLUS Hip Spacer / GV Spacer) |
| Mechanical Performance: * Similar mechanical performance as predicate devices. | Performance testing included: * Stem fatigue per ISO 7206-4 * Neck fatigue per ISO 7206-6 * Femoral head/stem disassembly based on ISO 7206-13 * Chemical and physical properties of cement (for UNITE PLUS Bone Cement) |
| Biocompatibility: * Biocompatible materials. | Biocompatibility data was collected (details not provided in the summary). |
| Sterilization & Shelf Life: * Device capable of being sterilized and maintaining function over shelf life. | Sterilization, pyrogenicity, bacterial endotoxin, and shelf life testing were performed. |
| Antibiotic Elution: * Appropriate and sustained antibiotic elution kinetics. | Antibiotic elution kinetics were performed (details not provided in the summary). |
| Clinical Efficacy (Composite Success): * Comparable or superior composite success rate (Stage 1 and Stage 2 success) as compared to the G Spacer and existing literature. Stage 1 success: absence of Girdlestone, arthrodesis, amputation, or spacer-related death. Stage 2 success: absence of two or more positive cultures of microorganisms at reimplantation. | * All Subjects: GV Spacer: 89.6% (N=48), G Spacer: 71.6% (N=81). GV Spacer significantly higher (p=0.01262). * Hip Subjects: GV Spacer: 84% (N=25), G Spacer: 66.7% (N=51). GV Spacer 17.3% higher. * Comparison to Predicate: Predicate success rate (82.2%) comparable to GV Spacer. * Comparison to Rothman Institute Literature: Rothman (71.3%) lower than GV Spacer. |
| Clinical Efficacy (Stage 1 Outcomes): * Comparable or superior Stage 1 success rate as compared to the G Spacer and existing literature. | * All Subjects: GV Spacer: 91.7% (N=48), G Spacer: 85.2% (N=81). GV Spacer higher, but not statistically significant (p=0.213). * Hip Subjects: GV Spacer: 88% (N=25), G Spacer: 84.3% (N=51). GV Spacer 3.7% higher. * Comparison to Predicate: Predicate Girdlestone (4.4%), deep infections (8.9%). * Comparison to Rothman Institute Literature: Rothman (89.5%) comparable to GV Spacer. |
| Clinical Efficacy (Stage 2 Outcomes): * Comparable or superior Stage 2 success rate as compared to the G Spacer and existing literature. | * All Subjects: GV Spacer: 97.7% (N=43), G Spacer: 84.1% (N=69). GV Spacer statistically superior (p=0.0198). * Hip Subjects: GV Spacer: 95.5%, G Spacer: 79.1%. GV Spacer 16.4% higher. * Comparison to Predicate: Predicate treatment success 83% (N=116). * Comparison to Rothman Institute Literature: Rothman (80.7%). GV Spacer compares favorably. |
| Safety - Inter-Stage Reoperations: * Similar rates of inter-stage reoperations (spacer exchanges, debridements) as compared to the G Spacer, predicate, and literature. | * All Subjects - Spacer Exchange: GV Spacer: 10.4% (N=48), G Spacer: 9.9% (N=81). Similar rates. * All Subjects - Spacer Debridement: GV Spacer: 6.25% (N=48), G Spacer: 0% (N=81). GV Spacer higher. * Hip Subjects - Spacer Exchange: GV Spacer: 12% (N=25), G Spacer: 11.8% (N=51). Similar rates. * Comparison to Predicate/Literature: Similar to reported rates (e.g., Predicate spacer exchange 6.8%, Gomez 11.9% for spacer exchange, Cancienne 10.8% for debridement). |
| Safety - Acute Kidney Injury (AKI): * AKI rates within the range reported in literature for PJI patients with antibiotic-loaded spacers. | * All Subjects: GV Spacer: 10.2% (N=49), G Spacer: 3.7% (N=81). Both within literature range (8.5% to 20%). * Hip Subjects: GV Spacer: 16% (N=25), G Spacer: 5.9% (N=51). Both within literature range. * Mention of literature suggesting high-dose, intra-operatively molded spacers may have higher risk than preformed, low-dose spacers like GV Spacer. |

2. Sample Size and Data Provenance:

• Test Set (Clinical Study):
  • GV Spacer (REMEDY PLUS Hip Spacer): 49 subjects (26 hips, 23 knees).
  • G Spacer (REMEDY Hip Spacer): 81 subjects (51 hips, 31 knees).
  • Data Provenance: The data was collected outside of the United States.
    • GV Spacer data: Prospectively collected.
    • G Spacer data: Majority retrospectively collected, some prospectively.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the clinical study. It refers to diagnoses of "periprosthetic joint infection (PJI)" and assessment of "positive cultures of microorganisms," which implies involvement of medical professionals (e.g., infectious disease specialists, microbiologists, surgeons) in these determinations as part of standard clinical practice. However, no specific details are provided about their experience or roles in adjudicating the study outcomes.

4. Adjudication Method for Test Set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The outcomes (e.g., absence of positive cultures, Girdlestone procedure, amputation) are presented as direct observations or clinical determinations. It's implied that these outcomes were part of the standard reporting and assessment within the clinical studies, but specific adjudication by a panel is not mentioned.

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

No, an MRMC comparative effectiveness study involving human readers assisting AI or vice versa was not conducted. The clinical study compares two different types of spacers (GV Spacer vs. G Spacer) and compares these to predicate devices and literature, focusing on the clinical outcomes of the devices themselves, not on the effectiveness of human readers or AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was done in the sense that the clinical study evaluated the performance of the device only (REMEDY PLUS Hip Spacer / GV Spacer) without explicit human-in-the-loop assistance for interpretation or decision-making beyond standard surgical practice. The results presented are the direct outcomes observed in patients treated with these spacers.

7. Type of Ground Truth Used:

The ground truth for the clinical study outcomes was based on:

• Clinical Outcomes/Events:
  • Absence of Girdlestone (hip fusion), arthrodesis (knee fusion), amputation, or spacer-related death (for Stage 1 success).
  • Absence of two or more positive cultures of microorganisms at the time of reimplantation (for Stage 2 success).
  • Observation of inter-stage reoperations (spacer exchanges, debridements).
  • Diagnosis of Acute Kidney Injury (AKI).
• Microbiological Data: Positive cultures of microorganisms.

This essentially constitutes a combination of clinical outcomes data and laboratory (microbiological) data.

8. Sample Size for the Training Set:

The document does not mention a training set. The study described is a clinical evaluation of the devices, not an AI or machine learning model that would require a distinct training set. The "samples" referred to are human subjects in a clinical study for device efficacy and safety.

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

Since no training set for an AI/ML model is mentioned, this information is not applicable. The ground truth for the clinical evaluation (as discussed in point 7) was established through standard clinical diagnostic procedures, surgical interventions, and microbiological testing within the context of the prospective and retrospective studies.

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The REMEDY® Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).

The REMEDY® Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with REMEDY® Hip Spacer using REMEDY® Modular Head 46 mm. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The REMEDY® Acetabular Cup 46mm ID/54mm OD is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, etc.).

The Remedy® Acetabular Cup is a temporary spacer device available in a single size, intended to be combined with Remedy Hip Spacer using Remedy® Modular Head 46 mm.

The Remedy® Acetabular Cup is sterile, single-use device intended for temporary use (maximum 180 days) as joint replacement. The device is made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liguid components. The liquid component consists of methylmethacrylate (MMA), N, N dimethylp-toluidine and hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.

The Remedy® Hip Spacer and Acetabular Cup provide a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The Remedy® Acetabular Cup is protected from bacterial adhesion due to the presence of gentamicin, similar to other spacers devices made from antibiotic loaded PMMA currently on the US market.

The provided text describes a 510(k) premarket notification for a medical device called the "Remedy® Acetabular Cup." This documentation is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical efficacy or diagnostic performance as one might for an AI/ML medical device.

Therefore, the information required to answer your questions about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets for an AI/ML device is not present in the provided document. The document primarily details:

• Device Description: What the Remedy® Acetabular Cup is (a temporary acetabular cup spacer with gentamicin).
• Intended Use: Its temporary use (max 180 days) as an adjunct to total hip replacement in a two-stage procedure due to a septic process.
• Comparison to Predicate Device: How it is similar and different from its predicate (Remedy® Hip Spacer) in terms of materials, design, and performance characteristics.
• Performance Data (Non-Clinical): Summaries of sterilization, shelf life, biocompatibility, and mechanical performance testing (static, fatigue, surface roughness, wear, antibiotic elution).

In the context of the provided text, there are no "acceptance criteria" or "study" described that would prove an AI/ML device meets certain performance metrics. The "performance data" referred to in section 8 are bench and lab tests demonstrating the physical and material properties of the implant, not clinical or diagnostic performance evaluated against a ground truth dataset in the way an AI/ML model would be.

To directly answer your request based on the absence of this information in the provided text:

1. A table of acceptance criteria and the reported device performance:
   • No such table exists for an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC). The document lists mechanical and material performance attributes, but not against quantitative "acceptance criteria" in a table format relatable to AI.
2. Sample sized used for the test set and the data provenance:
   • Not applicable/Not provided. There is no test set of patient data for AI model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Not applicable/Not provided. Ground truth establishment for an AI/ML model is not mentioned.
4. Adjudication method for the test set:
   • Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
   • No. This is a physical implant, not a diagnostic AI tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable.
7. The type of ground truth used:
   • Not applicable.
8. The sample size for the training set:
   • Not applicable.
9. How the ground truth for the training set was established:
   • Not applicable.

Summary of what is provided about "performance data" (non-AI related):

The document states in section 8, "PERFORMANCE DATA":

• Sterilization and Shelf Life: Validated using international standards. Endotoxins tested via LAL test, meeting

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Signature Orthopaedics' Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• . Fracture dislocation of the hip
• Avascular necrosis of the femoral head ●
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly ●
• . Degenerative arthritis involving only the femoral head

The Evolve™ UniPolar Head is a metallic (per ISO 5832-12) ball with a tapered bore. The head connects to a femoral stem from Signature Orthopaedics' range via taper sleeve. The taper sleeve is manufactured from cobalt-chromium alloy per ISO 5832-12, and includes a 12/14 taper. The head's outer surface is highly polished to articulate against the patient's natural acetabulum as part of a hip hemi-arthroplasty.

This document is a 510(k) premarket notification for the Evolve™ UniPolar Head, a hip prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a novel device requiring extensive clinical studies with acceptance criteria and ground truth evaluations typically seen for AI/ML devices or new technologies.

Therefore, many of the requested items related to acceptance criteria, ground truth, expert adjudication, MRMC studies, and standalone performance for AI/ML are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is a series of non-clinical tests and engineering evaluations. These are outlined in the "Performance Testing" section:

• Range of motion analysis
• Component connection strength and fretting corrosion testing
• Femoral stem fatigue testing

The report states that these tests were conducted "to verify that the performance of the Evolve™ UniPolar Head is adequate for anticipated in-vivo use." The conclusion is that "Non-clinical testing results support the substantial equivalence claim. The Evolve UniPolar Head is expected to perform adequately during clinical use."

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

• Not applicable / Not provided. This document details a 510(k) submission for a traditional medical device (hip prosthesis) based on mechanical and material engineering testing, not a data-driven device like AI/ML. There is no "test set" in the sense of a dataset for an algorithm. The "data" provenance would refer to the origin of the materials and manufacturing, and the engineering tests are conducted in a lab setting.

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)

• Not applicable / Not provided. Ground truth, in the context of expert consensus, is not relevant for the mechanical and material testing performed for this device. The "ground truth" for these tests is the physical measurement and observation of the device's behavior under simulated conditions.

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

• Not applicable / Not provided. Adjudication methods are used to resolve discrepancies in human expert labeling or diagnosis for ground truth establishment, which is not part of this device's testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a physical medical device, not an AI/ML diagnostic aid. MRMC studies are not relevant.

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

• Not applicable. This is a physical medical device. There is no algorithm to evaluate in standalone mode.

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

• Engineering/Physical Ground Truth: The "ground truth" for the performance testing is based on established engineering principles, material science standards (e.g., ISO 5832-12), and physical measurements obtained from laboratory testing (e.g., range of motion, connection strength, fretting corrosion, fatigue). Outcomes data might be considered relevant in post-market surveillance for long-term device performance but is not part of this premarket submission.

8. The sample size for the training set

• Not applicable / Not provided. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering development, which could be seen as an iterative "training" process in product design, but not through statistical learning from a data set.

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

• Not applicable / Not provided. As there is no "training set" in the ML sense, there is no ground truth needing establishment for it. The "ground truth" for design decisions and manufacturing quality would be established through engineering specifications, material standards, and quality control processes.

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Hip Modular Spacer: The Hip Modular Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms. The head and stem components are inserted into the acetabular cavity and femoral medullary canal, respectively, following removal of the existing acetabular and femoral components and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The Hip Modular Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Knee Modular Spacer: The Knee Modular Spacer, which consists of a modular femoral, tibial insert component, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the tibial insert component is optional, when a large tibial defect is present. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The Knee Modular Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.

The Modular Spacers are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacements. The Hip Modular Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary hip spacer; the components are available in a range of sizes. The Knee Modular Spacer is composed of three independent components (a femoral component, a tibial component and a tibial insert component) that are intended to be used together to form a temporary knee spacer; the components are available in a range of sizes. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radioopaque, and contains gentamicin and color additives to give a green color. The Modular Spacers provide a functional-mechanical mode of action; they provide patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. They are designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

The provided text describes a medical device, the Garventis Modular Spacer (Hip and Knee), and its premarket notification (510(k)) to the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices through various tests rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories related to clinical study design, human readers, and expert ground truth are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines several types of tests performed to demonstrate the device's safety and effectiveness compared to predicate devices. The acceptance criteria are generally implied to be meeting the standards of the referenced ISO and ASTM guidelines.

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

• Test Set Sample Size: Not applicable. The studies conducted are primarily non-clinical performance tests on the device itself (materials, mechanical properties, drug elution) rather than clinical studies on patient data.
• Data Provenance: Not applicable for device performance testing. These are laboratory-based 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 these types of engineering and materials tests is established by adhering to recognized international standards (ISO, ASTM) and measuring physical, chemical, and mechanical properties.

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

• Not applicable. This is not a diagnostic device requiring expert adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/imaging device.

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

• Not applicable. This is not an algorithm-based device.

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

• For the non-clinical performance tests, the "ground truth" is based on established engineering and material science standards (e.g., ISO 10993 for biocompatibility, ISO 5833 for static testing, ASTM F2118 for fatigue testing). The device performance is compared against the requirements and specifications defined by these standards.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

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