Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
5. Revision of previously failed total hip arthroplasty

The subject devices, Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeves, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

This submission proposes a new bioburden reduction manufacturing process that includes a new contact material for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve.

The provided document is a 510(k) summary for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a study with performance metrics in the way one might expect for a diagnostic AI or imaging device.

Therefore, the requested information, particularly regarding acceptance criteria performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, is not applicable to this type of submission. This submission is for a physical medical device (a hip prosthesis component) and its substantial equivalence is based on technological characteristics and biocompatibility.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity). Instead, they are implied by demonstrating substantial equivalence to a predicate device (K193546 Distal Centralizers). The criteria revolve around showing that the new device shares similar technological characteristics (intended use, indications for use, materials, design features, sterilization) and biocompatibility with the predicate.
• Reported Device Performance:
  • Non-Clinical Tests: A biocompatibility assessment was performed in accordance with ISO 10993-1. The data confirmed the biocompatibility of the candidate manufacturing process flow for the device in long-term contact with patient bone and tissues. No specific numerical performance metrics are provided, as this is a qualitative assessment of biocompatibility.
  • Clinical Tests: None were provided for this submission.

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

• Not Applicable. This submission does not involve a "test set" in the context of evaluating an algorithm or AI. The biocompatibility assessment is a laboratory test on device materials, not a study on a human subject population with a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. Ground truth in the context of expert consensus for diagnostics is not relevant here. Biocompatibility assessment relies on standardized testing procedures and interpretation by qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or expert adjudication is involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. This is a physical device, not an AI or diagnostic tool that would involve human readers.

6. If a Standalone Performance (Algorithm Only) Was Done

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable. For the biocompatibility assessment, "ground truth" would be established by the results of the ISO 10993-1 tests themselves, interpreted against the standard's requirements. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic performance.

8. The Sample Size for the Training Set

• Not Applicable. No training set is involved as this is not an AI/algorithm submission.

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

• Not Applicable. No training set is involved.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic or AI product. Therefore, most of the requested information about "acceptance criteria" and "studies" related to performance metrics, test/training sets, and expert evaluations is not applicable to this specific type of device and submission.

Ask a specific question about this device

The THP™ Hip Fracture Plating System is indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures.

THP Hip Fracture Plating System is a set of metal plates and associated screws designed to affix to the lateral aspect of the proximal femur and provide fracture stabilization for femoral neck fractures and intertrochanteric fractures. The THP 5.0mm Cortical Screws are both locking and non-locking. The locking screws contain external threads that can be used to lock the threaded holes on the plate body, while the non-locking screws do not include the external threads to complete this task.

The provided document is a 510(k) premarket notification for the "THP™ Hip Fracture Plating System" by Biomet, Inc. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily addressing design modifications (specifically related to 5.0mm cortical screws and plate modifications) and confirming that these changes do not adversely affect the device's safety and effectiveness.

Crucially, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the typical performance metrics of sensitivity, specificity, or reader studies. Instead, it describes mechanical and biocompatibility testing of a physical implantable medical device.

Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this submission.

Here's how to address the request based on the provided document:

Acceptance Criteria and Study for the "THP™ Hip Fracture Plating System"

This 510(k) submission for the THP™ Hip Fracture Plating System focuses on demonstrating substantial equivalence to predicate devices, particularly in light of design modifications to address a head breakage issue in previously cleared screws and enhancements to the plates. The "acceptance criteria" in this context are primarily related to the mechanical performance and biocompatibility of the revised components being equivalent or superior to the predicate devices, ensuring no new safety or effectiveness concerns are introduced.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of screws or plates) used for each mechanical test. This level of detail is typically found in the full test reports, which are part of the detailed submission but not typically summarized in the 510(k) summary. However, the studies were sufficient for the FDA to draw conclusions of substantial equivalence.
• Data Provenance: The data is non-clinical performance data generated through mechanical and chemical testing of the device components (screws and plates). The location of the testing is not specified, but it would have been conducted under controlled laboratory conditions, likely by or for the manufacturer (Biomet, Inc., Warsaw, Indiana, USA). This is retrospective testing in the sense that it evaluates manufactured device components against predefined standards or predicate device performance. It is not human clinical data or patient data.

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

• Not Applicable. This is not a diagnostic device or an AI/ML device requiring human expert annotation or ground truth derived from clinical interpretation. The "ground truth" for these mechanical tests is established by published ISO standards (e.g., ISO 11137-2:2013 for sterilization, ISO 10993-1 for biocompatibility) and direct physical measurements/testing against specified engineering parameters or predicate device performance.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication method is relevant for these non-clinical, objective mechanical and chemical tests. The results are quantitative measurements interpreted against pre-defined performance criteria.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This submission is for a physical implantable orthopedic device, not a diagnostic imaging device or an AI component.

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

• Not Applicable. This is not an algorithm or an AI device. The "performance" discussed is the physical, mechanical, and biological performance of an implantable metallic device.

7. The Type of Ground Truth Used:

• Engineering Specifications / Predicate Device Performance / ISO Standards. The "ground truth" for the mechanical tests is the measured performance of the predicate devices or established engineering specifications for strength and fatigue resistance. For biocompatibility and sterilization, the ground truth is adherence to international standards (ISO 10993-1, ISO 11137-2:2013) and cGMP (21 CFR 58 for GLP). It is not expert consensus, pathology, or outcomes data in the sense of clinical studies.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm here. The device itself is the product under evaluation, and its properties are tested directly.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary, the provided FDA 510(k) document is for a traditional physical medical device (an orthopedic implant) and primarily demonstrates substantial equivalence through non-clinical mechanical and biocompatibility testing. The questions posed in the prompt are largely designed for AI/Machine Learning diagnostic devices and therefore do not directly apply to this specific submission.

Ask a specific question about this device

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.

Ask a specific question about this device

Indications for Persona Partial Knee System:

The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;

• traumatic arthritis;

• previous tibial condyle or plateau fractures with loss of anatomy or function;

• varus deformities; and

• revision of the articular surface of a previously implanted Persona Partial Knee Systemknee surgeries providing that the tibial plate locking mechanism is not compromised and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implantation with bone cement.

Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):

• Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

• The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).

• History of patellar dislocation or patella fracture.

• Dysplasia-induced degeneration.

These indications will be used for the combined medial unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.

Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.

The Persona Partial Knee (PPK) System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

The Persona Partial Knee System is compatible with the following devices:

• Zimmer Patellofemoral Joint Prosthesis (K070695)

The provided text is a 510(k) Summary for the Persona Partial Knee System, a medical device. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria and proving performance through a standalone study in the way a de novo or PMA submission might.

Therefore, the typical acceptance criteria and study design for validating an AI/ML device's performance are not applicable here. The device is a physical knee implant, not a software algorithm, and the submission does not describe a clinical study in the traditional sense, but rather non-clinical mechanical testing and engineering analyses.

Here's an breakdown based on the information provided, highlighting why many requested points are not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in a table format and does not represent clinical "performance" in the sense of accuracy, sensitivity, or specificity as would be expected for an AI/ML device. Instead, it lists mechanical tests and analyses performed to demonstrate the physical device's safety and effectiveness compared to predicates.

Acceptance Criteria: The document states that "Results from mechanical tests and engineering analyses demonstrate the proposed PPK components are substantially equivalent to the predicate devices." While specific numerical acceptance criteria (e.g., maximum deflection, minimum fatigue cycles) are implied by performing these tests to a standard or internal method and achieving "substantial equivalence," they are not explicitly listed in this summary. The general acceptance is that the device performs comparably or better than the predicate devices under these conditions.

Regarding other requested information points:

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. This submission focuses on non-clinical mechanical testing and engineering analyses, not human clinical data or AI/ML model performance on a test set. There isn't a "test set" of patient data in this context.

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. This submission relies on engineering and material science principles, not expert consensus on medical images or diagnoses.

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

• Not applicable. No adjudication process is described as there is no clinical test set involved.

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 implant, not an AI/ML diagnostic or assistive device. No MRMC study was performed. The document explicitly states: "No animal or clinical testing was required to support substantial equivalence."

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable / Implied: For the mechanical tests, the "ground truth" would be established engineering standards (like ASTM F2083, ASTM F1223) or validated internal test methods, and the performance of the predicate devices. The aim is to show the new device meets these engineering benchmarks or performs comparably to the predicates.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" for this device.

Conclusion from document:

The Persona Partial Knee System gained 510(k) clearance (K161592) based on demonstrating substantial equivalence to existing legally marketed predicate devices. This was achieved through:

• Similar intended use (limited to medial tibiofemoral compartment, cemented use).
• Use of similar materials (Co-Cr-Mo alloy for femoral, Ti-6Al-4V alloy for tibial, Vivacit-E Vitamin E Highly Crosslinked Polyethylene for articular surfaces), which are already used in predicate/reference devices.
• Similar design features.
• Similar sterilization methods.
• Non-clinical mechanical tests and engineering analyses that showed the device performed comparably or acceptably against established engineering standards and predicate device performance. The specific quantitative acceptance criteria for each test are not detailed in this summary document but would have been part of the full 510(k) submission.

Ask a specific question about this device

Disposable 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 PALACOS® R+G Bone Cement or Refobacin® Bone Cement R. assembled 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 StageOne™ Select 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-hip prosthesis material (PALACOS® R+G Bone and 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 single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are intended to be filled with PALACOS® R+G Bone Cement or Refobacin® Bone Cement R* by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-hip prosthesis is to be removed from the molds with the reinforcement remaining as the core of the hemi-hip prosthesis, assembled using the neck length adapter and placed into the joint space. The hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.

This document is a 510(k) premarket notification for a medical device, the StageOne™ Select Disposable Cement Spacer Molds for Making Temporary Hemi-Hip Prosthesis with Reinforcement Stem. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device.

The "acceptance criteria" discussed in this document revolve around the concept of "substantial equivalence" to a legally marketed predicate device (K080979 - StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement). The study described is a non-clinical performance comparison to demonstrate this equivalence.

Here's the information broken down based on your request, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the mechanical performance testing, gentamicin elution testing, or bacterial endotoxin testing. It only states that these tests were performed and demonstrated equivalence.

The data provenance is not explicitly detailed beyond being "Non-Clinical Tests" presented by Biomet Inc. It is retrospective in the sense that it's a comparison to existing, defined characteristics of a predicate device. The country of origin of the data is not specified.

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

Not applicable. This submission relies on non-clinical comparative testing against a predicate device and established specifications (like pyrogen limits). There is no mention of experts being used to establish ground truth for a test set in the context of diagnostic accuracy or similar applications.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no diagnostic test set with human interpretation requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention any MRMC study. The device is a physical medical device (spacer molds), not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the non-clinical tests performed are "standalone" in that they assess the physical characteristics and performance of the device itself (or the prosthesis molded from it) against predefined specifications and a predicate device, without direct human interaction as part of the "performance" measurement. However, this is not an "algorithm-only" standalone performance as typically discussed for AI devices.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

• Predicate Device Performance: The established mechanical and elution characteristics of the legally marketed predicate device (K080979).
• Established Specifications: Pyrogen limit specifications for bacterial endotoxin testing.
• Material Properties: The known properties of PALACOS® R+G Bone Cement and Refobacin® Bone Cement R.

8. The Sample Size for the Training Set

Not applicable. This is a medical device for physical implantation, not an AI model that requires a training set.

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

Not applicable, as there is no training set for an AI model.

Ask a specific question about this device

Disposable 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 Palacos® R+G Bone Cement or 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 antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from the StageOne™ 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 (Palacos® R-G Bone Cement and 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 single-use cement spacer molds 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 by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-shoulder prosthesis is to be removed from the mold and placed into the joint space. The hemi-shoulder prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional shoulder joint prosthesis.

The document describes the StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis and its substantial equivalence to predicate devices, but it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-enabled medical device.

This document is a 510(k) premarket notification for a medical device (a cement spacer mold), which is a physical product, not an AI/ML diagnostic or therapeutic tool. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, and associated sample sizes for training and testing are not applicable to the information provided.

The performance data mentioned (mechanical performance and gentamicin elution testing) is for the physical characteristics of the cement spacer and the bone cement combination, comparing it to an existing predicate device.

Here's a breakdown of the information that is available, and why the requested information is largely absent based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative targets for performance (e.g., sensitivity, specificity, accuracy) for an AI/ML system. For this physical device, "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices in terms of mechanical and elution characteristics.
• Reported Device Performance:
  • Mechanical performance testing: "StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin® Bone Cement R were compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess mechanical... characteristics comparable to those of the predicate device."
  • Gentamicin Elution testing: "...and Gentamicin Elution testing of StageOne™ ... compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess... elution characteristics comparable to those of the predicate device."
  • Design validation: "Design validation test results confirm that the StageOne™ Shoulder Spacer Molds utilized with Palacos® R+G Bone Cement and Refobacin® Bone Cement R meet design requirements for 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 mentioned. The "test set" here refers to the physical samples of the cement spacers and bone cement used for mechanical and elution testing, not a dataset for an AI/ML model. The document does not specify the number of samples tested or the provenance of these physical samples.

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. This question pertains to expert review for AI/ML model ground truth. The "ground truth" for this device is based on laboratory testing of physical properties (mechanical strength, drug elution) and comparison to a predicate device, not expert interpretation of medical images or data.

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

• Not applicable. This is relevant for resolving discrepancies in expert opinions for AI/ML ground truth. Not relevant for physical device 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 study type is specific to evaluating AI/ML's impact on human performance in diagnostic tasks. The StageOne™ device is a physical medical device.

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

• Not applicable. This refers to the standalone performance of an AI/ML algorithm.

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

• Ground Truth (for the physical device): The "ground truth" for this device's performance is established by objective, quantitative laboratory measurements of mechanical properties (e.g., strength, stiffness) and drug elution profiles, compared against established standards or performance of a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. There is no AI/ML training set for this device.

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

• Not applicable. There is no AI/ML training set for this device.

In summary, the provided document is a 510(k) submission for a physical medical device. The questions posed are primarily designed for AI/ML-enabled medical devices, and thus, most of them are not relevant to the information presented in this document.

Ask a specific question about this device

The Vanguard XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component.

• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic 1. arthritis where one or more compartments are involved.
• 2. Correction of varus, valgus, or posttraumatic deformity.
• 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.

*where available

The subject Vanguard XP Knee System line extension introduces the 59mm XP-XP Tibial Tray, modifications to corresponding 59mm XP-XP and XP-AS bearings, implant-specific instrumentation, differential bearing (thickness and/or articulation) compatibility and MR conditional labeling for the system.

The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of Co-Cr-Mo, two styles of tibial trays manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of E1 poly. Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP-XP tibial components are available in Biomet's Interlok coarse blasted finish for cemented fixation.

This document is a 510(k) premarket notification for the "Vanguard XP Knee System". It focuses on a line extension, specifically the introduction of a 59mm XP-XP Tibial Tray and related components. The document describes the device, its intended use, and provides a summary of performance data (non-clinical tests) used to demonstrate substantial equivalence to existing predicate devices.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way one might expect for a new artificial intelligence (AI) device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the performance of the new device (Vanguard XP Knee System line extension) is comparable or equivalent to the predicate devices.

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

This document does not describe a clinical study or a study involving a "test set" of patient data in the context of an AI device. The "tests" described are non-clinical (mechanical and MR compatibility) and would involve physical devices or components, not a patient data set. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable or provided in this document as it pertains to a traditional medical device, not an AI/software device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a knee implant, not an AI diagnostic or prognostic tool. "Ground truth" in the context of expert consensus on patient data is not relevant to the non-clinical mechanical testing and MR compatibility testing described.

4. Adjudication Method

Not applicable, as this is not a study involving expert review or a patient data test set.

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

No. This is a traditional medical device (knee implant) premarket notification, not an AI device. An MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

No. This document is for a physical medical device (knee implant), not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described would be based on established engineering principles, material science standards (e.g., ASTM standards for MR compatibility, fatigue testing), and comparison to the performance of legally marketed predicate devices. The "truth" is determined by whether the device meets specific physical and performance characteristics as defined by these standards and comparison.

8. Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set of data.

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

Not applicable for the same reason as above.

Ask a specific question about this device