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Kirschner Wires are used for;
· As guide pins for insertion of other implants
· Bone reconstructions
· Fixation of bone fractures and osteotomies
· Implanted through the skin for traction applied to the skeletal system

Biomet Inc manufactures a variety of internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Biomet Kirschner Wires (K-wires) are rigid yet malleable wires with penetrating tips such that they may be inserted through tissue and into bone to alow for traction of bone fragments as desired or for alignment quides for other bone fixation implants. These wires are available in multiple diameters, same length and unthreaded (smooth) versions.
Biomet Kirschner Wires are single use and provided in both sterile configurations. Unless supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use.

The provided text describes a 510(k) premarket notification for Biomet Kirschner Wires (K-Wires). It states that the device is substantially equivalent to a predicate device based on its indications for use, technological characteristics, and conformance to specific standards.

However, the document does not contain the detailed information requested regarding the acceptance criteria and the study that proves the device meets those criteria, specifically concerning data provenance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, as these aspects are typically relevant for AI/ML-driven medical devices or diagnostic tools. The Biomet Kirschner Wires are described as "rigid yet malleable wires with penetrating tips," implying they are a physical medical device, not a software-based or AI-enabled device.

Therefore, many of the requested categories are not applicable to the information provided in the given text.

Here's a breakdown of the available information based on your request:

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

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

• Sample Size for Test Set: Not specified. Testing for conformance to ASTM standards typically involves a defined sample size as per the specific standard, but this detail is not present in the document.
• Data Provenance: Not applicable in the context of device conformance to ASTM physical/mechanical standards.

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

• Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Conformance to ASTM standards is typically evaluated by technical testing against predefined specifications.

4. Adjudication method for the test set

• Not applicable. Conformance to ASTM standards involves objective measurement and comparison against specified limits, not expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• Not applicable. This is a physical bone fixation device, not a diagnostic imaging or AI-assisted diagnostic tool.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used

• Ground Truth Type: Conformance to established industry standards (ASTM F138-19 for mechanical properties and ASTM F366-17 for dimensional properties). These standards themselves define the "ground truth" or acceptable parameters for such devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and materials science.

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

• Not applicable. Since there is no training set for an algorithm, the method for establishing its ground truth is irrelevant. The "ground truth" for the device's characteristics is inherently defined by the ASTM standards it aims to meet.

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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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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.

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1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.

• 2. Tumor resections.
• 3. Revision of previously failed total joint arthroplasty.
• 4. Trauma.
     The Compress Segmental Femoral Replacement System components are intended for uncemented use.

1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.

• 2. Tumor resections.

3. Revision of previously failed total joint arthroplasty.

• 4. Trauma.
     The Compress Segmental Humeral Replacement System components are intended use.

The Compress and Mini Compress Anti-Rotation Spindles are components of the Compress Segmental Femoral Replacement System and Compress Segmental Humeral Replacement System. The Anti-Rotation Spindles attach to an anchor plug and a proximal/distal femoral/humeral component to serve as a method of fixing a segmental joint replacement to a patient's host bone. The Anti-Rotation Spindles contain several conical washers which allow a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. The Anti-Rotation Spindles also include a series of holes around the spindle collar to allow placement of pins to prevent rotation of the component. The purpose of this submission is the update of the surgical techniques associated with the Compress and Mini Compress Anti-Rotation Spindles to revise the recommended pin selection range for use with the Anti-Rotation Spindles.

This FDA 510(k) premarket notification for the "Compress and Mini Compress Anti-Rotation Spindles" describes a device that is essentially an updated component of existing segmental replacement systems. The submission centers around an update to surgical techniques and therefore does not rely on extensive clinical or performance studies in the way a novel device might.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for an update to surgical techniques for components of an existing device, and not for a new device itself, the typical "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, accuracy) are not applicable. Instead, the acceptance is based on demonstrating that the updated surgical technique does not adversely affect the device or its intended use, and that the devices remain substantially equivalent to predicates.

The "acceptance criteria" here implicitly relate to ensuring functional compatibility and non-inferiority in terms of mechanical properties and surgical application.

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

• Sample Size: Not applicable in the context of typical performance testing. The "test set" in this case appears to be a geometric evaluation of the components in relation to the revised surgical technique.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The geometric evaluation would be internal to the manufacturer (Biomet Inc.).

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

• Not applicable as this was a geometric evaluation, not a clinical study requiring expert ground truth for interpretation. The "ground truth" would be the engineering specifications and physical properties of the device components.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical study with a test set requiring adjudication in the traditional sense.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not provided for the subject devices." This type of study investigates human reader performance, which is not relevant for this engineering-focused submission about surgical technique updates.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no AI component or human-in-the-loop study was involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone (algorithm only) performance study was not done. This device is a mechanical implant, not an algorithm or software.

7. Type of Ground Truth Used

• The implicit "ground truth" for this submission is engineering specifications and verification/validation data related to the geometric fit and function of the Anti-Rotation Spindles with the revised surgical technique, as determined by the "geometric evaluation." There is no clinical or pathology-based ground truth mentioned.

8. Sample Size for the Training Set

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing of the device components would follow standard engineering and quality control processes.

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

• Not applicable, as there was no training set in this context.

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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.

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1. Painful and disabled knee joint resulting from osteoarthritis, and/or traumatic 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 joint replacement procedure.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

Femoral components and tibial tray components with porous coatings are indicated for cemented biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only.

Regenerex components are intended only for uncemented biologic fixation application.

The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.

All-polyethylene patellar components are indicated for cemented use only.

The subject devices are intended for use in total knee arthroplasty.

This document is a 510(k) premarket notification for Biomet Knee Joint Replacement Prostheses, primarily focusing on its MR Labeling. It establishes substantial equivalence to previously cleared predicate devices. The document highlights MR safety testing as the basis for this equivalence. There is no study provided that establishes acceptance criteria for clinical performance or any AI/algorithm-related performance. The document is a regulatory submission for a medical device (knee prostheses), not an AI/ML-driven device, and thus the requested information regarding AI performance will not be found.

However, based on the provided text, I can extract information related to the device's MR safety and the context of the submission.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not applicable or not present:

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

Since this is a submission related to MR Labeling for a physical knee implant, and not a disease detection algorithm, typical performance metrics like sensitivity, specificity, or AUC are not applicable here. The "performance" in this context relates to MR safety.

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

• Sample Size for Test Set: Not applicable in the context of this document. The "tests" refer to non-clinical laboratory MR safety tests on the implants themselves, not a clinical study on patients.
• Data Provenance: Not specified, but likely laboratory testing conducted by or for the manufacturer (Biomet, Inc., located in Warsaw, Indiana, USA). These are non-clinical, in-vitro tests, not patient data.

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. Ground truth in this context would be adherence to ASTM standards for MR safety testing. The "experts" would be the engineers and technicians performing and interpreting the results of the physical MR tests. Their qualifications are not specified but would be implicit in their roles as testers and regulatory affairs personnel.

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

Not applicable. This is not a study involving human interpretation of data requiring adjudication. The assessment is based on physical measurements against established technical standards (ASTM).

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. This document does not describe an AI/ML-driven device or an MRMC study.

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

No. This document does not describe an AI/ML-driven device. It concerns physical knee joint prostheses and their MR safety labeling.

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

The "ground truth" for the non-clinical tests is defined by established engineering and medical device standards, specifically ASTM standards (F2503-13, F2182-11a, F2119-07, ASTM 2052-14) for MR safety and principles of nonpyrogenicity. It is a technical, objective ground truth based on physical measurements and compliance with industry standards.

8. The sample size for the training set

Not applicable. This document is not describing an AI/ML model for which a training set would be required.

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

Not applicable. No AI/ML model or training set is involved.

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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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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.

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