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SPECTRUM® GV Bone Cement is indicated for the fixation of the REMEDY® & REMEDY SPECTRUM® GV Spacers, and for the fixation of prostheses to living bone in the second stage of a two-stage revision of a total joint arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

This FDA 510(k) clearance letter is for a bone cement, not a medical device that utilizes AI or requires complex studies to demonstrate performance through acceptance criteria in the way you've described.

The document indicates that SPECTRUM® GV Bone Cement is substantially equivalent to a previously cleared predicate device (K231556), and therefore, extensive new studies to prove acceptance criteria in the context of device performance metrics (like sensitivity, specificity, or reader improvement with AI) were not required.

Here's why and what information is provided:

• Device Type: This is a Polymethylmethacrylate (PMMA) bone cement, a physical material used for fixation. It's not a diagnostic imaging device, a software as a medical device (SaMD), or an AI algorithm.
• Substantial Equivalence: The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device. This means the FDA has determined it is as safe and effective as the predicate, often due to identical or very similar technological characteristics and intended use.
• No New Performance Data (for the requested criteria): The document explicitly states: "Non-clinical testing was not required as the subject device is identical to that of the predicate." This confirms that specific performance metrics, sample sizes for test sets, expert adjudication, or AI-related studies were not performed for this specific submission because the device itself hasn't changed.

Therefore, I cannot provide the detailed information requested in your prompt because the provided 510(k) letter does not contain the type of acceptance criteria and study analysis that would be relevant for an AI-powered diagnostic device. The questions about sensitivity, specificity, MRMC studies, ground truth establishment, and training/test set sizes are pertinent to AI/software device clearances, not to the material science and manufacturing consistency demonstrated for a bone cement via substantial equivalence.

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The REMEDY Stemmed Knee Spacer, which consists of Modular Femoral, Tibial, and Stem Extension Components, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process where gentamicin is the most appropriate antibiotic based on the susceptibility of the infecting micro-organism(s).

The REMEDY Stemmed Femoral Component can be used with a PMMA Tibial Component or an All-Poly tibial component. 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 Stem Extension Component is optional to replace the space occupied by the previous femoral and/or tibial stem (dead space management). Stem Extensions may be used with the Femoral and Tibial components. Moreover, if necessary, the Tibial Component could be coupled with the REMEDY Tibial Insert Wedge 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 device is intended for use with antibiotic (gentamicin) bone cement.

The REMEDY Stemmed Knee 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, the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.

The OsteoRemedies' REMEDY Stemmed Knee Spacer (K183017, K223650) are legally marketed devices that are used in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The 510(k)-cleared REMEDY Stemmed Knee Spacer is a temporary knee spacer device consisting of independent components (femoral component, tibial component and stem extension components) that can be combined with each other and the optional insert wedge depending on the anatomy of the patient. All components are manufactured from PMMA with gentamicin; the stems are structurally reinforced with a stainless steel core.

The subject REMEDY All-Poly Tibial Component is intended to be a line extension to the REMEDY Stemmed Knee Spacer ( K183017, and K223650). The REMEDY All-Poly Tibial Component may be used in lieu of the currently cleared PMMA tibial component.

The provided text is a 510(k) summary for the REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices.

However, the document does NOT contain the specific details required to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria Table: The document does not provide a table outlining specific numerical or qualitative acceptance criteria for the device's performance.
• No Reported Device Performance Data: While it lists categories of performance testing (Fatigue, Wear, Elution, Range of Motion, Interconnection), it does not present the actual results or data points from these tests that would demonstrate how the device performed against any criteria.
• No Details on Study Design for Performance Testing: The summary mentions "Performance Testing" but provides no information on the methodology, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods for these tests. It merely states that "The following performance characteristics of the device have been assessed." These are likely in vitro bench tests, not clinical studies with human subjects or AI algorithm testing.
• No Mention of AI/ML or Software: The entire document refers to a physical medical device (knee spacer system) and its components, made of materials like PMMA and stainless steel. There is absolutely no mention of any AI algorithm, machine learning, software performance, human-in-the-loop studies (MRMC), or standalone AI performance.

Therefore, since the provided text relates to a physical orthopedic implant and not an AI/ML-driven device, the questions about acceptance criteria for AI algorithms, sample sizes for AI test sets, expert involvement in ground truth for AI, MRMC studies, or standalone AI performance are not applicable to this document.

In summary, the provided document does not contain the information requested in your prompt as it pertains to a traditional physical medical device, not an AI/ML powered one.

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SPECTRUM® GV Bone Cement is indicated for the fixation of a REMEDY SPECTRUM® GV Spacer, and for the fixation of prostheses to living bone in the second stage revision of a total hip arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

The provided text describes a 510(k) premarket notification for a medical device called "SPECTRUM® GV Bone Cement." This document focuses on the substantial equivalence of the new bone cement to a legally marketed predicate device (SPECTRUM® GV Bone Cement, K172906).

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria in the context of an AI/Machine Learning (ML) enabled medical device.

The content details the regulatory clearance process for a traditional medical device (bone cement) and the performance testing conducted to demonstrate its physical, chemical, and biological properties, as well as its substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to provide information about acceptance criteria for an AI/ML device, sample sizes for test sets, expert ground truth, MRMC studies, or training set details from the provided text.

The closest relevant sections in the provided text are "Performance Testing of Subject SPECTRUM® GV Bone Cement," which lists the types of tests performed (mechanical, elution, biocompatibility, sterilization, shelf life), but these are for a physical substance, not a software algorithm.

In summary, the provided document is not about an AI/ML medical device, and thus does not contain the information requested regarding AI/ML device acceptance criteria and validation studies.

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The REMEDY Stemmed Knee Spacer, which consists of a modular femoral, tibial and stem extension components, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) 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 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 stem extension component is optional to replace the space occupied by the previous femoral and/or tibial stem (dead space management). Moreover, if necessary, the tibial component could be coupled with the OsteoRemedies REMEDY Tibial Insert Wedge 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 REMEDY Stemmed Knee 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, allowing basic joint mobility.

The REMEDY Stemmed Knee Spacer System is a temporary knee spacer system consisting of femoral, tibial, and tibial wedge components, and stem extensions which can be combined to address dead space management following explantation of an infected total knee arthroplasty device. These components are available in different sizes to generally match the sizes of the explanted components and to accommodate variations in patient anatomy.

The stem extension components can be coupled with the femoral and tibial implant components to address dead space management in the femoral and tibial intramedullary canals following removal of infected stemmed prostheses.

The components of the REMEDY Stemmed Knee Spacer System are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacement. The components are made of fully formed polymethylmethacrylate (PMMA), which is radiopaque and contains gentamicin. The stem components have a stainless steel core.

The REMEDY Stemmed Knee Spacer System provides patients a temporary complete knee implant that allows for a natural range of motion and partial weight-bearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection. The components of the REMEDY Stemmed Knee Spacer System are protected from bacterial adhesion due to the presence of gentamicin.

The provided text describes a medical device, the REMEDY Stemmed Knee Spacer, and its FDA 510(k) clearance. This type of clearance is based on demonstrating "substantial equivalence" to a predicate device, rather than a full pre-market approval (PMA) which would require extensive clinical efficacy and safety studies.

Therefore, the information you've requested regarding acceptance criteria for an AI/algorithm-based device and the study that proves it meets those criteria is not applicable to this document. This document pertains to a physical medical device (a knee spacer) and its mechanical, material, and biological properties, not a software-based AI device.

The "Performance Data" section describes:

• Sterilization and Shelf Life: Validation of sterilization cycles and stability studies for shelf life.
• Biocompatibility: Evaluation conforming to ISO 10993 and FDA guidance.
• Performance Testing of Subject REMEDY Stemmed Knee Spacer: This specifically mentions "Antibiotic elution testing," "Fatigue behavior of the stem extensions," and "Interconnection strength." These are all physical and chemical performance characteristics of the knee spacer itself.

Since the request asks for details related to AI/algorithm performance and ground truth, which are not relevant to this physical device's clearance, I cannot fill out the requested table or answer the specific questions about AI/algorithm study design using the provided text.

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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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