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GENTAFIX is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Teknimed's GENTAFIX® cements with gentamicin are a family of surgical cements of various viscosities, each containing the antibiotic gentamicin. GENTAFIX® bone cements are intended for fixation of prosthetic components into bone medullar cavity in cemented arthroplasty procedures. GENTAFIX® can be used with the Teknimed's own Class I 510(k) exempt accessories: bowl and spatula, and a Vacuukit® vacuum mixing and injection system. Following are the GENTAFIX models identified based on their viscosities:

• o GENTAFIX® 1 is a high viscosity bone cement intended for digital use.
• . GENTAFIX® 3 is a low viscosity bone cement intended for syringe application.
• GENTAFIX® 3 MV is a medium viscosity bone cement intended for syringe application.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called Gentafix, a bone cement. It focuses on demonstrating substantial equivalence to a predicate device, primarily through material composition, technological characteristics, and performance testing.

However, this document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-based medical device. The product is a physical bone cement, and the testing described (physical, chemical, mechanical, sterilization, biocompatibility) are standard tests for such a material, not for an AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request based on the provided text, as it does not describe:

• Acceptance criteria for an AI/ML device.
• The reported device performance for an AI/ML device.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document is entirely about the regulatory clearance for a bone cement, not an AI/ML system.

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Hip Spacer Molds with stainless-steel reinforcement stems, centralizers and Hip Head Inserts are indicated for use to mold a temporary hemi-hip spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-hip spacer is molded using Cemex Genta LV, and inserted into 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 antibiotic therapy (standard treatment approach to an infection). The temporary hemi-hip spacer made from Hip Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the temporary hemi-hip spacer material (Cemex Genta LV) the temporary hemi-hip spacers is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.

Femoral Knee Spacer Molds and Tibial Knee Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cemex Genta LV and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The temporary total knee spacer made from the Femoral Knee Spacer Molds and Tibial Knee Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty fusion, etc.). Due to the inherent mechanical limitations of the temporary total knee spacer material (Cemex Genta LV), the temporary total knee spacer is only indicated for patients who will consistently use traditional mobility devices (e.q., crutches, walkers) throughout the implant period.

Shoulder Spacer Molds with stainless-steel reinforcement stems, centralizers and Shoulder Head Inserts are indicated for use to mold a temporary hemi-shoulder spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-shoulder spacer is molded using Cemex Genta LV, and inserted into 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 antibiotic therapy (standard treatment approach to an infection). The temporary hemi-shoulder spacer made from Shoulder Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of hemi-shoulder prothesis material (Cemex Genta LV) the temporary hemi-shoulder prothesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The Hip Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemi-hip spacers in a two-stage septic hip joint endoprosthesis. The Hip Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Femoral and Tibial Knee Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary knee spacers in a two-stage septic knee joint endoprosthesis. The Knee Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Shoulder Spacer Molds are sterile, sinqle use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemishoulder spacers in a two-stage septic glenohumeral joint endoprosthesis. The Shoulder Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

This FDA 510(k) clearance letter pertains to medical device molds (Hip, Knee, Shoulder Spacer Molds) used to create temporary orthopedic spacers. The submission does not describe an AI/ML powered device and therefore, the information requested about acceptance criteria and studies proving the device meets the criteria in the context of AI/ML is not available in the provided text.

The document discusses performance data related to the physical characteristics of the molds and the resulting spacers, but not in the context of an AI/ML algorithm's performance. Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for an AI/ML test set.
• Number and qualifications of experts for AI/ML ground truth.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size and ground truth establishment for an AI/ML training set.

The performance data mentioned in the document relates to:

• Sterilization and Shelf Life: Validation according to ISO 11135, shelf life of 2 years.
• Biocompatibility: Categorized per ISO 10993-1, with tests performed including Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous reactivity (ISO 10993-23), Pyrogenicity (ISO 10993-11), and Acute systemic toxicity (ISO 10993-11).
• Mechanical Performance Testing:
  • Endurance properties of stemmed femoral hip components according to ISO 7206-4 and ISO 7206-6.
  • Wear of total knee-joint prosthesis according to ISO 14243-1.
  • Endurance properties of tibial trays according to ASTM F1800.
  • Endurance properties of shoulder spacer stem and neck region based on ISO 7206-4 and ISO 7206-6.
  • Antibiotic (gentamicin) elution testing.

These tests are designed to demonstrate the physical and biological safety and effectiveness of the medical device molds and the spacers they produce, showing substantial equivalence to predicate devices, rather than evaluating the performance of an AI/ML algorithm.

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StageOne™ Select Hip Cement Spacer Molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin Bone Cement R, assembled and inserted into the femoral medullary cavity following removal of the existing femoral and acetabular replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-hip prosthesis made from the StageOne™ Select Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (Refobacin Bone Cement R), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

The StageOne™ Select Hip Cement Spacer Molds are sterile, single use medical devices made of silicone with a stainless steel reinforcement stem, head insert and neck length adapter. The device is used to create a temporary hip implant component made from antibiotic bone cement, Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After removal of the initial femoral and acetabular implants, the prepared cement spacers are assembled using the neck length adapter and placed into the femoral joint space using Refobacin® Bone Cement R as the first stage of a two-stage revision surgical procedure. The temporary hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage revision procedure is performed to implant a conventional hip joint prosthesis.

The provided text is related to an FDA 510(k) premarket notification for a medical device called "StageOne™ Select Hip Cement Spacer Molds." It details the device's purpose, indications for use, and a comparison to predicate and reference devices to establish substantial equivalence.

However, the document DOES NOT contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML medical device submission. This document pertains to a physical medical device (cement molds) and the testing described is non-clinical (biocompatibility, packaging, shelf-life, sterilization, MRI analysis, fatigue performance, antibiotic elution, BET, and pyrogenicity testing) and does not involve AI/ML performance evaluation.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of AI/ML, as the provided text does not contain such information.

If you have a different document related to an AI/ML medical device, please provide it, and I will be happy to assist.

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StageOne™ Shoulder Cement Spacer Molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from StageOne™ Shoulder Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The subject device is a sterile, single use device made of silicone and is used to create a temporary hemi-shoulder implant component made from antibiotic bone cement, Refobacin® Bone Cement R. After removal of the initial implant the prepared cement spacer is placed into the glenohumeral

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "StageOne™ Shoulder Cement Spacer Molds." It describes the device's intended use, indications for use, and a summary of performance data (nonclinical).

However, the document does not contain information about:

• Acceptance criteria for an AI/ML device.
• A study that proves the device meets AI/ML acceptance criteria.
• Details about the test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, or training ground truth establishment.

The document explicitly states that Clinical Testing was deemed not necessary to establish substantial equivalence for the proposed device modifications, and the focus was on non-clinical performance testing for a physical medical device (molds for bone cement).

Therefore, based on the provided text, I cannot describe the acceptance criteria or a study proving an AI/ML device meets those criteria because this document does not pertain to an AI/ML device.

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StageOne™ Knee Cement Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The knee prosthesis made from the StageOne™ Knee Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the knee prosthesis material (Refobacin® Bone Cement R), the temporary knee prosthesis is only indicated for patients who will consistently use traditional mobility devices (e.g. crutches, walkers) throughout the implant period.

The subject device is a sterile, single use device made of silicone and is used to create temporary tibial and femoral implant components made from antibiotic bone cement, Refobacin® Bone Cement R. After removal of the initial implant the prepared cement spacers are placed into the tibiofemoral joint space using Refobacin® Bone Cement R as the first stage of a two-stage revision surgical procedure. The temporary spacers remain in place (180 days or less) until the second stage of the two-stage revision procedure is performed to implant a conventional knee joint prosthesis.

This document describes the StageOne™ Knee Cement Spacer Molds, a device used to mold temporary total knee replacements in a two-stage revision procedure due to a septic process.

Here's an analysis based on your request:

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

The provided text does not contain a specific table of acceptance criteria with corresponding performance results. Instead, it lists various non-clinical performance tests conducted to support the modifications and establish substantial equivalence to a predicate device. The underlying assumption is that the device met the acceptance criteria for these tests, as the FDA concluded substantial equivalence.

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

The document focuses on non-clinical performance testing. Therefore, there is no patient-specific test set sample size or provenance information (country of origin, retrospective/prospective) for clinical data provided. The testing relates to the physical and chemical properties of the device and its molded cement.

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)

Since this is a non-clinical device, there were no clinical experts used to establish ground truth for a test set in the traditional sense (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would have been based on established standards, protocols, and scientific principles followed by engineers, material scientists, and microbiologists involved in the testing. The document does not specify the number or specific qualifications of these individuals, but it's understood that qualified personnel would conduct such tests.

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

No adjudication method was used for a test set because this was entirely non-clinical testing. Adjudication methods are typically relevant for clinical studies involving human interpretation or decision-making.

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 MRMC comparative effectiveness study was done. This device is a cement spacer mold, not an AI or imaging-related device that would involve human readers or AI assistance.

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

No standalone algorithm performance study was done. This device is a physical medical device, not a software algorithm.

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

For the non-clinical tests, the "ground truth" was established by recognized industry standards, scientific principles, and internal specifications for biocompatibility, packaging, sterilization, wear, and antibiotic elution. For example, biocompatibility testing would adhere to ISO 10993 standards, and sterilization validation would follow established guidelines to ensure a certain sterility assurance level (SAL).

8. The sample size for the training set

There is no "training set" as this is a physical medical device and not a machine learning model.

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

As there is no training set, this question is not applicable.

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Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemishoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process.

The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.

The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patiently follow activity limitation throughout the implant period.

The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.

For what concerns the modes of the bone cement potentially loaded with antibiotics, see the instructions for use of the selected bone cement.

Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process.

The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.

The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, tusion, etc.).

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period.

The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.

For what concerns the modes of usage of the bone cement potentially loaded with antibiotics, see the instructions for use of the selected bone cement.

This document is a 510(k) Premarket Notification from the FDA regarding the SpaceFlex Shoulder device. It contains information about the device's intended use, comparison to predicate devices, and performance data. However, it does not describe an AI/ML-driven medical device or a study involving human readers and AI assistance for diagnostic purposes.

Therefore, I cannot extract the information required to populate the tables and answer the questions about acceptance criteria, study details, human reader performance, or ground truth establishment as it pertains to an AI/ML device.

The document discusses:

• A physical medical device: SpaceFlex Shoulder, which is a disposable cement spacer mold for temporary hemi-shoulder replacement.
• Its intended use in a two-stage revision procedure due to a septic process, where it's molded with bone cement to create a temporary prosthesis.
• Performance testing for mechanical properties (Fatigue, Visual Inspection, Usability, Gentamicin Elution), demonstrating equivalence to predicate devices. This testing is for the physical product, not an AI algorithm.

In summary, there is no information in the provided text to fulfill the request concerning acceptance criteria for an AI/ML device, study design, expert involvement, or MRMC studies.

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SpaceFlex Knee disposable cement spacer molds are indicated for use to mold a temporary Total Knee Replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (G3A Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

G21 SpaceFlex Knee system are disposable cement spacer molds made of polypropylene (PP) intended to be filled with low-viscosity polymethyl methacrylate bone cement directly in the operating room. Once the bone cement has hardened, the SpaceFlex Knee system creates a polymethyl methacrylate based bone cement spacer for patients undergoing a two-stage procedure following a periprosthetic joint infection. The device can be used in either the left or right knee joint. The SpaceFlex Knee molds are single-use and cannot be re-used or re-sterilized.

This document is a 510(k) summary for a medical device called "SpaceFlex Knee - 80mm Size." It aims to demonstrate that this new device is substantially equivalent to existing predicate devices.

1. Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size for the test set. It mentions "The mechanical properties of the SpaceFlex knee System 80mm size were tested in accordance with applicable international standards," implying that a sufficient number of samples were tested to meet the requirements of those standards.

The provenance of the data is directly from the manufacturer, G21 S.r.l., whose address is in Italy. The testing described appears to be prospective performance testing conducted on the device itself, rather than retrospective analysis of patient data.

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

This type of study does not involve establishing ground truth through expert review in the way a diagnostic AI study would. The performance data presented here relates to mechanical and material properties of the device, not clinical diagnostic accuracy. Therefore, the concept of "experts" establishing ground truth in this context is not applicable. The "ground truth" for these tests would be the established international standards and engineering specifications.

4. Adjudication Method for the Test Set:

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there might be disagreements among expert reviewers. This document describes laboratory-based mechanical and material performance testing of a physical device. Therefore, adjudication methods are not applicable here. The results of these tests are objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This study is focused on the mechanical and material performance of a physical medical device (a cement spacer mold for knee replacement), not on the diagnostic accuracy or effectiveness of an AI algorithm interpreted by human readers.

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

No, a standalone (algorithm only) performance study was not done. This document is about the physical characteristics and performance of a medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this study is based on predefined international standards and engineering specifications for the mechanical properties and material characteristics of medical devices, specifically those for knee joint prostheses and bone cement. The tests (Dimensional and Visual Characterization, Rupture Test, Fatigue Test, Elution Test) verify that the device meets these established physical and material requirements.

8. The Sample Size for the Training Set:

This document describes the performance testing of a physical medical device, not the development or training of an AI algorithm. Therefore, the concept of a "training set" and its sample size is not applicable.

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

As this study does not involve an AI algorithm with a training set, the question of how ground truth for a training set was established is not applicable.

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Disposable cement spacer molds with titanium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and 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 hemi-hip prosthesis made from the SpaceFlex Hip disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatmy performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Disposable cement spacer molds with titanium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement.

This document describes the G21 SpaceFlex Hip, a medical device for temporary hemi-hip replacement, and provides information regarding its FDA clearance.

Here's an analysis of the provided text with respect to your questions:

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

The document mentions that the device was tested against "applicable international standards" and that "all results were satisfactory and met all performance specifications." However, it does not provide a specific table of acceptance criteria with corresponding performance outcomes. It lists the types of tests performed:

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

The document mentions "performance testing - mechanical/bench testing," but it does not specify the sample size for any of these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. These were likely benchtop (laboratory) studies, not human or animal studies.

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)

This question is not applicable to the information provided. The document describes mechanical/bench testing, which typically does not involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" here would be the physical properties and performance characteristics measured by engineering and scientific methods against established standards.

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

This question is not applicable for the same reasons as point 3. Adjudication methods are relevant for interpretation of clinical data or images, not for objective measurements in bench 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

This question is not applicable. The G21 SpaceFlex Hip is a physical medical device (cement molds for temporary hip replacement), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance are not relevant.

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

This question is not applicable, as the device is a physical medical product, not an algorithm.

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

For the performance testing mentioned, the "ground truth" would be established by engineering and scientific standards (e.g., ISO, ASTM, USP) for mechanical properties, material properties, and biocompatibility. For instance, the pyrogen testing refers to USP 38: NF33 , which defines the method and acceptance criteria for pyrogenicity.

8. The sample size for the training set

This question is not applicable as the device is a physical product and not an AI algorithm that requires a training set.

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

This question is not applicable for the same reason as point 8.

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SpaceFlex Knee disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (G3A Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

G21 SpaceFlex Knee system are disposable cement spacer molds made of polypropylene (PP) intended to be filled with low-viscosity polymethyl methacrylate bone cement directly in the operating room. Once the bone cement has hardened, the SpaceFlex Knee system creates a polymethyl methacrylate based bone cement spacer for patients undergoing a two-stage procedure following a periprosthetic joint infection. The device can be used in either the left or right knee joint. The SpaceFlex Knee molds are single-use and cannot be re-sterilized.

The provided text describes the regulatory clearance of the G21 s.r.l SpaceFlex Knee, a disposable cement spacer mold. This device is classified as Class II and is indicated for use in molding a temporary total knee replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process.

However, the provided document does not contain information about an AI/ML-based medical device study. Instead, it focuses on the substantial equivalence of a physical medical device (a knee spacer mold) to existing predicate devices, based on typical mechanical and material performance testing.

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving an AI/ML device meets those criteria, as the document details a different type of medical device and a different type of clearance process.

To answer your request, I would need a document describing the study and acceptance criteria for an AI/ML-driven medical device, not a physical orthopedic device.

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Disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G Bone Cement and Refobacin® Bone Cement R), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

The disposable cement spacer molds (femoral and tibial) are sterile disposables made of medical grade silicone. They are intended to be filled with PALACOS® R+G Bone Cement or Refobacin® Bone Cement R*, either by injecting with a dispenser/gun, or by pouring the prepared cement into the mold. After the cement cures, the temporary spacers are to be removed from the molds and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional knee joint prosthesis.

The provided document is a 510(k) premarket notification for a medical device (StageOne™ Disposable Cement Spacer Molds for Temporary Knee Prosthesis). It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or algorithm validation study would.

This FDA letter and the associated 510(k) summary primarily focus on demonstrating substantial equivalence to a previously legally marketed predicate device. This regulatory pathway generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a predicate device, rather than requiring extensive clinical trials to prove efficacy against "acceptance criteria" in the sense of an AI/ML or diagnostic study.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The device is a "Disposable Cement Spacer Mold" used to create temporary knee prostheses from bone cement. It's a manufacturing aid, not a diagnostic tool or an AI/ML algorithm.
• Regulatory Pathway: The document clearly states it's a 510(k) submission, specifically demonstrating "substantial equivalence." This means the manufacturer is arguing their device is similar enough to an existing one that it doesn't need a full Premarket Approval (PMA), which would typically involve extensive clinical trials and pre-defined acceptance criteria for performance.
• Performance Data: The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states:
  • Non-Clinical Tests: "Mechanical performance testing and Gentamicin Elution testing... was conducted. The results demonstrated that StageOne® Knee Spacers fabricated with PALACOS® R+G Bone Cement and Refobacin® Bone Cement R possess mechanical and elution characteristics equivalent to those of the predicate device." This is about equivalence to a predicate, not meeting a new set of performance thresholds.
  • Clinical Tests: "Clinical data was not required to establish substantial equivalence between the subject StageOne™ Knee Spacer Molds and the predicate device." This is the most crucial point – no clinical study (and therefore no acceptance criteria or human reader studies) was required or conducted for this 510(k) clearance.

Therefore, I cannot provide the requested table and study details because the provided document does not contain them. The 510(k) process for this type of device (a Class II device based on the regulation number) typically emphasizes bench testing, material compatibility, and comparison to a predicate, rather than human performance studies with specific accuracy/sensitivity/specificity targets or MRMC studies.

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