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The Vanquard® Cruciate Molded Poly Tibia is intended for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved; 2. Failure of a previous joint replacement procedure 3. Correction of varus, valgus, or post traumatic deformity; 4. Correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.

The Vanguard® Removable Molded Poly Tibia (also referred to as the Vanguard® Mono-Lock) is intended to replace the tibial articulating surface in a joint replacement and works in conjunction with previously cleared Vanguard® Knee Systems. There are three parts to the Vanguard® Removable Cruciate Molded Polyethylene Tibia component: the tibial plate (Co-Cr-Mo), tibial bearing (UHMWPE) and an insert (Ti-6AL-4V). The profile of the tibial plate is identical to that of the predicates. The stem geometry of the Vanguard® Removable Molded Poly Tibia is non modular and does not include the conical core geometry to house the female taper as the predicate K915132. The articulation surface is identical to the surface cleared in K060525.

This document describes a 510(k) premarket notification for a medical device, the Vanguard® Removable Molded Poly Tibia, which is a knee prosthesis. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The primary "acceptance criteria" in a 510(k) submission for a device like this are centered around demonstrating substantial equivalence to existing legally marketed predicate devices. This means proving that the new device is as safe and effective as a predicate device. For this specific device, the key performance aspects relate to the mechanical properties and design.

Since this is a knee prosthesis, "performance" is largely assessed through non-clinical mechanical testing and comparison to predicates. There are no clinical performance metrics in terms of patient outcomes or diagnostic accuracy in the same way one might have for an AI/ML device.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is primarily non-clinical mechanical testing and a demonstration of design and material equivalence to predicate devices.

Specific Information Requested:

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

   • This submission relies on non-clinical mechanical testing rather than clinical data from human subjects. The "test set" would consist of physical device samples.
   • The document lists several "test reports" such as "CoCr I-Beam Tray 80/20 Fatique Test Report," "Removable Molded Tibia PS Post Fatigue Strength," etc.
   • The sample sizes for these specific mechanical tests are not explicitly stated in the provided text.
   • Data Provenance: The tests are indicated as having been "previously performed" (for predicates) and some new tests (e.g., CoCr Cruciate Plate 80/20 Fatigue Test Report) were "provided to further indicate the devices are functional within its intended use." This implies the testing was likely conducted in a lab setting by the manufacturer, Biomet Manufacturing Corp., or a contract lab. The country of origin for the testing data is not specified but would presumably be related to Biomet's operations (USA, given the address in Indiana). The data is retrospective in the sense that many tests leverage previous data from predicate devices.

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

   • This question is less applicable to a mechanical device 510(k) submission based on substantial equivalence and non-clinical testing.
   • There is no "ground truth" in the clinical diagnostic sense established by human experts for a test set of patient data.
   • The "ground truth" for mechanical testing is established by engineering standards and specifications (e.g., ISO, ASTM standards for medical device mechanically), often with verification by qualified engineers and testing technicians. The number and qualifications of these individuals are not specified in the document.

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

   • Not applicable. This is a concept used in clinical trials or studies with human reader performance assessment, not for mechanical device testing for substantial equivalence. The "adjudication" of mechanical test results would typically refer to review by quality control/engineering personnel to ensure adherence to protocols and standards.

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

   • Not applicable. This is a mechanical device, not an AI/ML diagnostic tool. No MRMC study was performed.

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

   • Not applicable. This is a mechanical device, not an AI/ML algorithm.

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

   • The "ground truth" is based on engineering specifications, mechanical performance standards (e.g., fatigue strength, retention strength), and comparison to the proven performance of predicate devices. It's about demonstrating mechanical integrity and functional equivalence, not clinical diagnostic accuracy or patient outcomes data directly.

7. The sample size for the training set:

   • Not applicable in the context of an AI/ML device. For a traditional mechanical device, there isn't a "training set" in the machine learning sense. The "training" for such devices involves design iterations, material selection, and internal testing to optimize the product before formal verification tests.

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

   • Not applicable for the reasons stated above. Design and R&D involve iterative testing, but not a formally defined "training set" with ground truth in the AI/ML context.

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

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Ligament deficiencies. Tumor Resection. Revision of previously failed total joint arthroplasty. Trauma. These are single use implants. These devices are for cemented use only.

The Regenerex™ Ultra Porous Construct- Titanium Knee Augments are designed for attachment to selected commercially available Biomet® tibial base plates and femoral components using bolts, cement or a combination of both (depending on the augment). The augments are manufactured to interface with selected femoral and tibial Biomet® components. The femoral augments come in nine (9) different sizes that correspond with the sizes of the femoral components. The thickness options for the femoral augments vary from 5mm to 15mm. The tibial augments are available in 10° wedge and block form. The block augments are available in three (3) thicknesses for nine (9) tibial sizes. The OSS femoral augments are available in a 3,5mm thick anterior flange augment. The OSS tibial augments are available in monoblock and block form. The monoblocks are only available in 10mm thicknesses for three tibial sizes, while the block augments are available in 10mm and 20 mm sizes for three tibial sizes.

The provided document is a 510(k) premarket notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments. The content primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing a detailed study proving the device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study design, and performance metrics are not present in this document. The document states:

"Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." (Page 1)
"Clinical Testing: None provided as a basis for substantial equivalence." (Page 1)

This means the submission relies on non-clinical testing and comparison to predicates, not specific clinical performance studies with detailed acceptance criteria as one might find for a novel device requiring more extensive validation.

Given the information provided, here's what can be inferred and what cannot:

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

Missing: Specific quantifiable acceptance criteria (e.g., tensile strength, fatigue life, wear rate thresholds) and the exact numerical performance results for these criteria. The document only provides a general statement of functionality.

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

Not provided. The document mentions "non-clinical laboratory testing" but does not specify the sample size, type of test specimens, or the provenance of any data used for these tests. It is implied these were laboratory tests on the device itself, not patient data.

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

Not applicable/Not provided. Since the testing was non-clinical and no clinical data was presented, there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical test set requiring adjudication by experts was presented.

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 device is a medical implant (knee augments), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

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

No. As mentioned above, this is a physical implant, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by standard engineering and material science specifications, predicate device performance data, and regulatory standards for mechanical and material properties of implants. However, the document does not detail these specific standards or how the device's performance compared against them. It only states it was "functional within its intended use."

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission as it is not a machine learning/AI device.

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

Not applicable/Not provided. As above, no training set was involved.

In summary: The provided 510(k) notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments relies heavily on a comparison to predicate devices and general non-clinical laboratory testing to assert substantial equivalence. It does not contain the detailed performance data, acceptance criteria, sample sizes for patient data, or expert review methodologies that would be typical for clinical studies validating a new diagnostic or AI-driven device. The statement "Clinical Testing: None provided as a basis for substantial equivalence" is key in understanding the limited scope of detailed performance data in this particular document.

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• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid l. arthritis, traumatic arthritis where one or more compartments are involved;
• correction of varus, valgus or posttraumatic deformity; 2.
• correction of revision of unsuccessful osteotomy, arthrodesis, or failure of 3. previous joint replacement procedure.
  Femoral components and tibial tray components with porous coating are indicated for cemented and uncemented biological fixation application. Non-coated amiliation only cemented and uncemented blological fixation upprication.
  and all polyethylene patellar components are indicated for cemented application only.

The Vanguard™ Anterior Stabilized Tibial Bearings are intended for use in the Device Description. "The Valleula "The knee joint. They offer increased anterior and posterior replacement on the articular portions of they are to be used with the Vanguard™ CR femoral stablization and the with grouter sagtas components cleared in K915132, both of which were Components citation in 10259 10 the title the new learners and withing any Biomet commercially available patella button.

This document is a 510(k) summary for the Biomet Vanguard™ Anterior Stabilized Tibial Bearings. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:

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

Based on the provided document, there are no explicit acceptance criteria or reported device performance metrics in the format of a table related to clinical outcomes. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting clinical trial results against specific performance criteria.

The document states:

• "Risk analysis has demonstrated equivalence between the modified and predicate devices."
• "No clinical testing was necessary to support the claim of substantial equivalence."

This indicates that the equivalence was demonstrated through non-clinical testing and risk analysis, not through performance metrics against pre-defined clinical acceptance criteria.

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

The document explicitly states: "No clinical testing was necessary to support the claim of substantial equivalence."

Therefore, there was no clinical test set, no sample size, and no data provenance from human subjects or patient data. The evaluation was based on non-clinical testing and comparison to predicate devices.

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 "No clinical testing was necessary," there was no clinical test set requiring ground truth established by experts.

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

Since "No clinical testing was necessary," there was no clinical test set and thus no adjudication method for establishing ground truth from clinical data.

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

The document is for a knee prosthesis, not an AI or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

This is a physical medical device (knee prosthesis), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

For a physical device like a knee prosthesis, ground truth in design and engineering typically refers to established biomechanical principles, material science properties, and comparison to existing, cleared devices. The document mentions "Risk analysis has demonstrated equivalence between the modified and predicate devices" and that the device "have the same intended use, are made of the same materials and have the same or similar design and sizing as the predicate bearings." This suggests the ground truth was based on:

• Engineering and design specifications: Conforming to established design principles for knee prostheses.
• Material properties: Verifying that the materials meet established standards and are equivalent to those used in predicate devices.
• Biomechanical testing: Although not detailed, "non-clinical testing" would typically include mechanical and fatigue testing to ensure the device performs as expected under simulated physiological conditions. This implicitly relies on an 'engineered' ground truth derived from industry standards and previous device performance.
• Predicate device characteristics: The fundamental premise of a 510(k) is demonstrating substantial equivalence to a device already on the market, meaning the predicate device's safety and effectiveness implicitly serve as a form of "ground truth" for comparison.

8. The sample size for the training set

This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning. The design and manufacturing of the device would follow established engineering and quality control processes.

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

As there is no training set for an AI/ML model, this question is not applicable. The design and validation of the device rely on engineering principles, material science, and comparison to predicate devices, not on data-driven "ground truth" for a training set in the AI sense.

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Total hip and knee joint replacement in cases of:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis
2. Correction of varus, valgus or post traumatic deformity
3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
4. Ligament deficiencies
5. Tumor resections
6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
7. Revision of previously failed total joint replacement
8. Trauma

The IM Total Femur is, in simplest terms, an intramedullary (IM) rod which connects a proximal hip replacement component to a knee femoral replacement component.

The IM rods are slightly bowed to mimic the natural femur and find appropriate alignment. Both ends of the rod have a male taper for connection to the hip proximal femur and a knee femoral component. Following impaction, a locking screw further secures the parts. Two types of IM rods are available based on the tapers of the distal knee component selected by the surgeon. IM total femur rods with an "Impact" taper at one end and an "OSS" taper at the other come in 1cm increments for replacements of 35cm to 45cm. The second type of rod have an "Impact" taper at both ends and come in 3cm increments for replacement from 34 to 46cm.

Femoral knee components are available with both "OSS" and "Impact" taper bores. The femoral knee components articulate with previously cleared tibial bearings, base-plates and femoral components. The device is compatible with any of Biomet's proximal modular hip components.

The provided text describes the 510(k) summary for the Biomet IM Total Femur device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The document is a regulatory submission for a medical device (an intramedullary rod connecting hip and knee replacement components), and its primary purpose is to demonstrate substantial equivalence to previously marketed devices. It focuses on device description, intended use, and a summary of technologies.

The "Non-Clinical Testing" section
{1} states: "Mechanical testing has shown the tapers capable of withstanding expected loading conditions." This is a very generalized statement and does not provide specific acceptance criteria or detailed study results.

The "Clinical Testing" section
{1} explicitly states: "None provided."

Therefore, based on the input provided, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them because this information is not present in the given text.

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The Maxim Knee System is indicated for:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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.
   This device is for use with bone cement

The Maxim Knee femorals are composed of Co-Cr-Mo conforming to ASTM F-75 standards. The posterior stabilized femoral components provide stabilization in knees with soft tissue deficiencies. The devices achieve stability against posterior tibial subluxation through the posterior flange of the femoral component meeting a central polyethylene post on the tibial component. This configuration allows for minimal femoral femoral roll back and rotational instability. The modifications made to the anterior flange were the increase in height and the decrease in angle. The femoral augment holes are now threaded instead of unthreaded and material was removed from the anterior flange in the form of retinaculum relief.
There are six sizes available in both right and left configurations for the Maxim PS V-II femoral components as well as the Maxim PS w/ Retinacular Relief femoral components. The femoral articulation is the same as the Maximum Congruent Knee (K915132). The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur. The femoral component has an Interlok finish for use in cemented applications.

This is a medical device submission (K993159) for the Maxim Knee System, a knee replacement prosthesis. The document does not describe acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new performance studies against predefined acceptance criteria.

Therefore, I cannot provide the requested information from the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is a regulatory filing for a physical medical device (knee implant), not an AI/software as a medical device (SaMD) where such performance metrics and study designs would be typically found.

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• Osteoarthritis, rheumatoid arthritis or traumatic arthritis 1.
• Failure of a previously failed joint replacement procedure 2.
• Correction of varus, valgus or post-traumatic deformity 3.
• Correction or revision of unsuccessful osteotomy or arthrodesis 4 .
  The device is intended for use with bone cement (USA)

The AGC V2 Revision Knee System is an extension of Biomet's knee families. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates with a one-piece tibial component. The AGC V2 system employs Biomet's standard all polyethylene patella button.
Unique features of the AGC V2 System included the femoral stem angle being built into the stem itself rather than the boss of the femoral component like other systems. The device expands Biomet's existing AGC product line by providing a device with more constraint than current components and additional augments for the femoral component.
The AGC V2 tibial component provides a one-piece molded component with a high post posterior stabilized option. Pegs on the bottom of the tray provide stability for the augmentations.

This document focuses on the substantial equivalence of the AGC V2 Revision Knee System to previously cleared devices, rather than presenting a study with specific acceptance criteria and performance data. The FDA 510(k) approval process for devices like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on new clinical performance studies with predefined acceptance criteria.

Therefore, many of the requested elements for a detailed study description are not available in the provided text.

Based on the provided text, here's what can be inferred:

1. Table of acceptance criteria and reported device performance:

This information is not provided in the document. The document primarily focuses on establishing "substantial equivalence" to predicate devices, not on presenting specific performance metrics against defined acceptance criteria.

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

This information is not provided. The document does not describe a "test set" in the context of a performance study.

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

This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to this type of submission.

4. Adjudication method for the test set:

This information is not provided.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a knee implant, not an AI-assisted diagnostic tool.

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

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

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

The concept of "ground truth" as it relates to evaluating an algorithm's performance is not applicable here. Instead, the "truth" for this regulatory submission is the established safety and effectiveness of the predicate devices to which the AGC V2 Revision Knee System is compared.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" in the context of a machine learning model.

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

This information is not applicable as there is no training set for a machine learning model.

Summary regarding acceptance criteria and studies:

The provided K984054 document is a 510(k) premarket notification for a medical device (AGC V2 Revision Knee System). The core of a 510(k) submission is to demonstrate substantial equivalence to a device already legally marketed in the U.S. (a predicate device). This process typically involves:

• Comparison of technological characteristics: Showing that the new device has similar design, materials, and operational principles to the predicate.
• Discussion of intended use: Confirming the new device's indications for use are the same as or comparable to the predicate.
• Performance data (often non-clinical): This might include bench testing, mechanical testing, or material characterization to show that the device performs as intended and is as safe and effective as the predicate. In this case, the document states, "In function and overall design, Biomet's AGC V2 Revision Knee System is equivalent to almost all knee components on the market."

The document lists several Biomet knee systems as comparators (predicate devices):

• AGC 2000 Total Knee Prosthesis (K833921)
• AGC Revision Knee Prosthesis (K912245)
• MCK (Maxim) Knee System (K915132)

The "study" in this context is the comparison to these predicate devices to establish substantial equivalence. Specific quantitative acceptance criteria for clinical performance are generally not a requirement for this type of 510(k) pathway, as the safety and effectiveness are established by reference to the predicate.

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Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.

The Maxim Removable Molded Poly Tibia is intended to replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132. This device is a CoCr tibial plate with a removable molded UHMWPE tibial bearing that can be used with previously cleared modular Maxim tibial bearings.

This document is a 510(k) summary for the Biomet, Inc. Maxim Removable Molded Poly Tibia Device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria. Therefore, the requested information about acceptance criteria and a study proving the device meets them cannot be fully provided from the given text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of acceptance criteria or reported device performance metrics in the way typically found in a clinical or performance study report (e.g., sensitivity, specificity, accuracy, mechanical failure rates, etc.).

Instead, the document details the intended use and potential risks of the device, and discusses its substantial equivalence to existing devices on the market. The FDA's letter further clarifies specific limitations and conditions for marketing the device.

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

The document does not report on a specific "test set" or a clinical study with associated sample sizes to demonstrate performance against acceptance criteria. The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than extensive new clinical performance data unless a new technological claim or significant difference warrants it.

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

Not applicable, as no such test set or ground truth establishment is described in the provided document.

4. Adjudication method for the test set

Not applicable, as no such test set or adjudication process is described in the provided document.

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

No, an MRMC study was not done or reported in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices assessing human-in-the-loop performance, not mechanical implants.

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

No, a "standalone algorithm only" performance study was not done or relevant. This device is a physical knee joint implant, not an algorithm.

7. The type of ground truth used

Not applicable, as the document focuses on substantial equivalence based on design, materials, and intended use, rather than a performance study requiring a "ground truth."

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI algorithm that requires a training set.

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

Not applicable.

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Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include ternoral, titbial and patellar replacement in a wide size range of patients who require implantation due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, pseudo-gout or complications from a falled prosthesis.

The Kirschner Knee Modified encompasses the Kirschner Performance Total Knee System, Kirschner TC-IV Total Condylar Knee System and Kirschner HybridFit Total Knee.

Kirschner Performance Total Knee System features an anatomically designed cast cobalt chromium femoral component whose geometry allows for maximum range of motion and size interchangeability. It comes with a non-porous coated proximal supracondylar flange and two non-porous coated fixation pegs to minimize stress shielding and permit compression between the porous coated surface and bone. Five sizes in left/right anatomic configurations are available to better match the patient's anatomy. The modular titanium tibial component has four screw holes and comes with either a cruciate or round Available is an all polv tibial component. There are femoral and tibial stem. augmentations to fill cavitary defects.

Kirschner TC-IV Total Condylar Knee Svstem features a cobalt chromium femoral component with a "waffled" non-porous coated proximal flange and two non-porous fixation peas. The one-piece cobalt chromium tibled component has a posterior recess allowing for the retention of the posterior cruciate ligament.

The UHMWPE patellar component for both the Performance and TC-IV knee systems come in porous-coated metal-backed or all UHMWPE options.

The HybridFit cobalt chrome tibial tray accepts the TC-IV or Performance bearing inserts and can be used with either the Performance or the TC-IV femoral component.

These knee devices are intended for use with bone cement.

The major changes are in material and method of the porous coating and in the manufacturing process of the Ultra High Molecular Weight Polyethylene.

Porous coated Kirschner Knees Modified features plasma spray coating of titanium alloy powder. The integrity of this coating has been proven in the performance of many Biomet joint prosthesis previously reviewed by the FDA. There have been no reported incidents of coating failure.

The polyethylene components are of ArCom UHMWPE, Biomet's improved polyethylene components.

This document describes a medical device, the Kirschner® Knee Modified, which is a total knee replacement system. It details the device's components, indications for use, and potential risks, as well as asserting its substantial equivalence to other legally marketed devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way an AI/ML medical device would. The information is typical of a 510(k) submission for a traditional, non-software medical device.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, or ground truth establishment, as this information is not present in the provided text.

The closest relevant statements are:

• "The integrity of this coating has been proven in the performance of many Biomet joint prosthesis previously reviewed by the FDA. There have been no reported incidents of coating failure." This refers to previous FDA reviews and lack of reported incidents, but not a specific, controlled study with defined acceptance criteria and performance metrics for this specific modified device.
• The comparison to other "substantially equivalent" devices (Maxim Total Knee System, AGC 2000 Total Knee Prosthesis) is a regulatory pathway, not a performance study against acceptance criteria.

In summary, the provided text does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested.

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