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Indications:

Indications for Total Knee Replacement:

• 1. Rheumatoid arthritis,
• 2. Correction of functional deformity.
• 3. Osteoarthritis.

4. Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result.

5. Failed osteotomies, unicompartmental replacement, or total knee replacement.

The femoral component and tibial tray are for cemented use (biological fixation).

The patellar component and metaphyseal stem (K080199) are for cemented use only.

Indications for Posterior Stabilized Knee Replacement:

Posterior stabilized knee systems with a deep articular surface are designed for use in patients in primary and revision surgery, where the anterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Total Knee indications still apply.

Indications for Constrained Knee Replacement:

Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/ or lateral collateral ligament) are absent or incompetent. Total Knee indications still apply.

The Agility Symmetric™ Total Knee System is intended for the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem previously cleared in K080199) and a potellar component (also cleared in K080199).

The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/ molybdenum (CoCrMo). The femoral component is available in five sizes (3-7) and will have two condylar pegs to aid in rotational stability. It is mesh coated with ASTM F67 titanium.

The TIBIAL TRAY is a symmetric designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti6Al4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside providing rotational stabilization and increased tray strew holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting an ultra-high polyethylene (UHMWPE) tibial insert to be snapped into place. The tibial tray has 5 sizes (3-7) and is mesh coated with ASTM F67 titanium.

Mating geometries for the previously cleared (K080199) TIBIAL INSERT, METAPHYSEAL STEM, REVISION STEM, and PATELLAR COMPONENT have not changed from the predicate devices.

The prompt asks to describe the acceptance criteria and the study proving a device meets them, but the provided text is a 510(k) clearance letter for a total knee replacement system (Agility Symmetric Total Knee System). This document does not describe acceptance criteria for an AI/ML medical device, nor does it detail a clinical study with human readers or AI assistance.

Instead, it's a premarket notification for a medical implant and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot fulfill the request as it pertains to an AI/ML medical device's acceptance criteria and study, based on the provided text. The text outlines:

• Device Name: Agility Symmetric™ Total Knee System
• Regulation Number/Name: 21 CFR 888.3565 / Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
• Product Codes: MBH, JWH
• Indications for Use: Total Knee Replacement, Posterior Stabilized Knee Replacement, Constrained Knee Replacement (details specific conditions like rheumatoid arthritis, osteoarthritis, failed osteotomies, ligament integrity, etc.).
• Predicate Devices: K080199 (Symmetric™ Total Knee System - primary), K141635 (Arthrex iBalance® TKA System - secondary)
• Device Description: Components (femoral, tibial tray, patellar, metaphyseal stem), materials (CoCrMo, Ti6Al4V), and coating (ASTM F67 titanium mesh).
• Technological Comparison: Differences from predicates in coating material and bone interface features (e.g., removal of central post/gussets, addition of condylar pegs), but deemed to not raise new questions of safety and effectiveness.
• Non-Clinical Tests Summary & Conclusions:
  • Fatigue testing per ASTM F3210 (femoral knee) and ASTM F1800 (tibial tray, tibial tray and modular stem).
  • Wear testing per ISO 14243-1.
  • Particle characterization per ASTM F1877-16.
  • Shear-off testing for tibial locking mechanism per ASTM 1814.
  • Cleaning validation per ISO 19227.
  • Biocompatibility assessment per ISO 10993-1.
  • Sterilization assessment per ISO 11135 and AAMI TIR28.
  • Uncemented design validation per ISO 21536.
  • Morse taper modular connection assessment per ISO 21536 and ASTM F1814.
  • Constraint and contact area assessment per ASTM F1223 and ISO 21536.
• Clinical Testing: Not Applicable. This further confirms that no human-in-the-loop or standalone AI/ML performance study was conducted.

In summary, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and study data for an AI/ML medical device.

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The AGILITY® Steerable Guidewires are intended for selective placement of microcathers and other devices in the neuro and peripheral vasculature.

The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The hydrophilically coated AGILITY® and NEUROSCOUT® Steerable Guidewires consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the AGILITY® and NEUROSCOUT® Guidewires.

The provided text describes a 510(k) submission (K133625) for a packaging change to the AGILITY® and NEUROSCOUT® Steerable Guidewires. It largely focuses on demonstrating that the packaging changes only do not alter the fundamental technology or intended use of the previously cleared predicate devices (K121776).

Therefore, the study described is not for the performance of the guidewires themselves in their intended clinical use, but rather for the integrity and safety of the new packaging. The acceptance criteria and "device performance" consequently pertain to packaging validation, sterilization validation, and biocompatibility, not to the clinical efficacy or accuracy of an AI or medical device for which such metrics usually apply.

Given this context, the request cannot be fully answered as it typically would for a device demonstrating clinical performance or AI algorithm performance. Many of the requested fields (e.g., multi-reader multi-case study, effect size of human readers with AI, training set size, ground truth for training set) are not applicable to this type of submission focused on packaging changes for a steerable guidewire.

However, I will extract the information that is present concerning the validation of the packaging changes.

Acceptance Criteria and Study for Packaging Modifications of AGILITY® and NEUROSCOUT® Steerable Guidewires (K133625)

The study described in this 510(k) submission (K133625) is not for the device's functional performance in a clinical setting, but rather for the packaging modifications to the AGILITY® and NEUROSCOUT® Steerable Guidewires, demonstrating substantial equivalence to the predicate device. The primary objective was to ensure that the new packaging maintained sterility, integrity, and safety.

1. Table of Acceptance Criteria and Reported Device Performance (Packaging)

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

• Sample Size for Test Set: Not explicitly stated in the document. The text indicates "appropriate testing was identified" and "all testing was performed on final sterile product" for packaging validation, sterilization validation, and shelf-life stability. Specific numbers of units tested are not provided.
• Data Provenance: The studies were prospective bench tests performed by the manufacturer, Codman & Shurtleff, Inc. The country of origin for the data is not specified but is presumably where the manufacturing and testing facilities of Codman & Shurtleff, Inc. are located (e.g., USA, as the company is based in Raynham, MA).

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

• This information is not applicable to this submission concerning packaging modifications. "Ground truth" in the requested sense (e.g., expert consensus on medical images or diagnoses) is not relevant for testing packaging integrity, sterilization residuals, or biocompatibility.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for clinical endpoints or image interpretations where multiple experts assess a case. The tests performed here (e.g., dye leak, seal strength, chemical residuals) are objective, quantitative measurements that do not require expert adjudication in that manner.

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

• No, an MRMC study was not done. This type of study is for evaluating the clinical performance of a diagnostic or therapeutic device by comparing human reader performance with and without AI assistance. This submission is for packaging changes to a guidewire, not an AI-enabled diagnostic device.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, this is not applicable. The device is a steerable guidewire; it does not involve an algorithm or AI.

7. Type of Ground Truth Used

• For the packaging validation, the "ground truth" would be established by objective technical standards and specifications (e.g., dye penetration not exceeding a certain limit, seal strength within a defined range, chemical residuals below a specified ppm). These are based on recognized industry standards (listed in Table 4) and regulatory requirements for medical device packaging and sterilization.

8. Sample Size for the Training Set

• This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• This is not applicable.

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The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

The associated Integrity R3.1 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation.

Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated.

The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of radiation for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

This Traditional 510(k) describes changes to the Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator and associated Integrity linac control system. Items added are; High Dose Rate mode x-rays, specific clinical indications for use, and the Response™ gating interface that enables the linac treatment beam to be automatically turned on and off by signals from an external gating device.

High Dose Rate mode x-rays are provided by changes to the filtering arrangement to reduce wasteful attenuation of the beam.

The Elekta Agility Multileaf Collimator system, including the Agility MLC, Integrity R3.1 software, High Dose Rate mode, and Response™ gating interface, underwent non-clinical performance testing to demonstrate substantial equivalence to predicate devices and conformance to applicable technical design specifications, assuring safety and effectiveness.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

*with validated external gating device which has 510(k) clearance
**other methods are not supported with the RPM interface

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

The document does not explicitly state a specific numerical sample size for a "test set" in the context of patient data or clinical images. The testing described is "non-clinical performance testing" which involved:

• "module, integration and system level verification"
• "regression testing"
• "Validation of the system under clinically representative conditions"
• "Testing has been undertaken on production equivalent systems both at Elekta and at hospital sites."

This suggests testing was performed on a sufficient number of hardware and software configurations to ensure functionality and safety, but not on a specific number of patient cases or images for diagnostic performance.

The data provenance is from non-clinical performance testing performed at Elekta and hospital sites. It is not based on retrospective or prospective patient data for an AI-specific algorithm performance evaluation. It's focused on the physical and software performance of the medical device components.

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 in the document. Given that the testing is non-clinical performance testing of a medical linear accelerator accessory, the concept of "ground truth" as established by medical experts (e.g., radiologists) for image interpretation or diagnosis would not typically apply. Instead, the acceptance criteria relate to physics performance metrics and software functionality, which would be verified against engineering specifications by qualified engineers and physicists. The document mentions "competent and professionally qualified personnel" for validation, but does not specify their number or exact qualifications.

4. Adjudication method for the test set:

This information is not provided and is not applicable in the context of this type of non-clinical device performance testing. Adjudication methods are typically used when multiple experts are interpreting data to establish a consensus ground truth for classification or detection tasks, which is not the nature of the testing described.

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 done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiologists interpreting images with or without AI assistance). The device
(a multileaf collimator and control system for radiation therapy) is not an AI-powered diagnostic tool, but rather a treatment delivery system for which the performance is measured by physical and software parameters, not human reader interpretation.

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

While the device itself is an "algorithm" in the sense of software control, the term "standalone" in this context usually refers to an AI algorithm processing data (e.g., images) independently of human intervention for diagnostic or analytical purposes. This device is a component of a larger system (radiation therapy) where human practitioners make clinical decisions.

The document describes comprehensive testing of the device's components and integrated system to ensure they meet performance specifications. This is "standalone" in the sense that the device performs its functions as designed, but it's not an AI performing an independent diagnostic task. The validation focused on the technical performance of radiation delivery and control.

7. The type of ground truth used:

The "ground truth" for the non-clinical performance testing described would be the engineering design specifications and recognized international standards (e.g., IEC 60601-1, IEC 60601-2-1, IEC 62366, ISO 14971). The device's measured physics performance (e.g., transmission, leakage, dose rates) and software functionality were compared against these predetermined, quantitative criteria.

8. The sample size for the training set:

Not applicable. The device is not an AI algorithm that learns from a training set of data. It's a hardware and software system designed and programmed to perform specific functions.

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

Not applicable. As stated above, there is no "training set" in the context of AI model development for this traditional medical device submission. The device's functionality is based on engineering design and rigorous testing against established specifications and standards.

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The AGILITY® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The hydrophilically coated AGILITY® and NEUROSCOUT® Steerable Guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The basic principle of the guidewires is to act as a monorail that catheters can track over to reach a particular area of the neuro and peripheral vasculature. They have a nominal outside diameter range of 0.012 to 0.016 inches and overall length of up to 350 cm. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the guidewires.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:

This 510(k) summary describes a modification to existing AGILITY® and NEUROSCOUT® Steerable Guidewires, specifically material changes and related manufacturing process changes. The submission asserts substantial equivalence to predicate devices, meaning that clinical testing was not required. Therefore, the acceptance criteria and studies are focused on non-clinical (bench and biocompatibility) performance rather than clinical outcomes or human reader performance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes various tests conducted to verify the modified design. The acceptance criteria for these tests are generally implied to be meeting the performance of the predicate devices or established engineering specifications, but explicit numerical acceptance criteria are not provided in this summary. The reported device performance is stated as "performed according to their description, intended use and the established performance characteristics" and "meet all the same biocompatibility requirements as the predicate devices."

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

The document does not specify the exact sample sizes used for each individual bench test (e.g., number of guidewires tested for tensile strength, number of samples for coating adherence). It indicates "Design Verification testing" was conducted.

The data provenance is internal laboratory testing conducted by Codman & Shurtleff, Inc. "Bench testing data demonstrated..." and "Full biocompatibility testing... was conducted." This is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

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

Not applicable. This submission is for a medical device (guidewire) and relies on objective, quantifiable engineering and biological tests rather than expert interpretation of medical images or records. The "ground truth" for the bench tests is defined by the established test methods and specifications, often derived from industry standards (FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995 and ISO 11070:1998, ISO 10993-1). No human experts are involved in establishing ground truth for these types of device performance tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting data (e.g., medical images) to establish a consensus ground truth. For the bench and biocompatibility tests conducted here, the "adjudication" is inherent in the test method itself – a pass/fail criterion based on objective measurements or observations.

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 product is a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool. Clinical studies involving human reader performance or AI assistance are not relevant to its regulatory pathway or the provided testing summary.

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

Not applicable. This product is a physical guidewire, not an algorithm or software. "Standalone performance" in this context refers to the device's inherent physical and biological properties. The bench and biocompatibility tests assess this standalone performance against predefined standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench tests, the "ground truth" refers to the established performance specifications (e.g., minimum tensile strength, acceptable coating integrity, specific torque response values) that the guidewire must meet. These specifications are derived from:

• FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995
• ISO 11070:1998 Sterile Single-Use Intravascular Catheter Introducers (though the device is a guidewire, this standard was cited, likely for relevant general requirements for intravascular devices)
• Internal engineering specifications designed to ensure the device performs as intended and is equivalent to the predicate.

For biocompatibility tests, the "ground truth" is defined by international standards and regulatory guidance:

• ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)
• General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices

The device is deemed to meet these "ground truths" if it passes the tests within the defined acceptable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "training set" concept does not apply to the regulatory submission for this physical medical device.

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

Not applicable. As explained above, there is no training set for this device.

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The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

This Traditional 510(k) describes the addition of the new Agility multileaf collimator beam limiting device and its associated control software to the Elekta medical linear accelerator. The new device has 160 leaves of 5mm width at isocenter, a fast leaf speed of up to 65 mm/s, low leakage (<0.5%) and is capable of interdigitation within a maximum field size of 40 x 40 cm. Control is by extension to the existing Elekta linear accelerator control system software. Synchronization of the movement of the dynamic leaf guides with individual leaf movements achieves enhanced leaf speed and removes the need for a split field.

The Agility includes dynamic leaf guides, fluorescing ruby leaf markers ('Rubicon') for improved leaf tracking by the optics system, the elimination of backup diaphragms by providing low interleaf leakage, sculpted field defining diaphragms, separate lighting systems for patient plane illumination and movement control using LEDs, and a new control cabinet on which the Integrity user interface and machine control software is executed including a hardware firewall to provide safe network connection.

The provided document is a 510(k) premarket notification for a medical device called "Agility™," a multileaf collimator, and its associated control software, Integrity R3.0. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than a detailed comparative effectiveness study of AI versus human readers or standalone AI performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance are not applicable or cannot be extracted from this specific document.

However, I can provide information based on the engineering and performance specifications detailed in the 510(k) summary.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance of the device and its predicate, primarily focusing on mechanical and physics performance characteristics to demonstrate substantial equivalence. The "study" proving the device meets these criteria is described as "module, integration and system level verification," "regression testing," and "validation... under clinically representative conditions."

Table of Acceptance Criteria and Reported Device Performance:

Note: The "Acceptance Criterion" column reflects the performance of the predicate device (MLCi2), as the submission aims to demonstrate substantial equivalence and often improved performance. The acceptance for the new device is typically meeting or exceeding these established benchmarks.

Study Details (as inferable from the document):

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

   • The document does not specify a "test set" in the context of patient data or clinical images for performance testing like an AI algorithm would.
   • Performance testing was conducted on "production equivalent systems both at Elekta and at hospital sites." No specific sample size (e.g., number of machines, number of tests) is provided, nor is the country of origin of the data explicitly stated other than Elekta Limited being based in the UK.
   • The testing described is engineering verification and validation, not a clinical trial with patient data.

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

   • This question is not applicable. The device is a hardware component (multileaf collimator) and its control software. "Ground truth" in the clinical sense (e.g., definitive diagnosis from experts) is not relevant to its performance testing.
   • Validation was performed by "competent and professionally qualified personnel," but their specific number or detailed qualifications (e.g., radiologist with X years of experience) are not provided as it's not a diagnostic AI device.

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

   • This is not applicable. Adjudication methods are used to establish ground truth in clinical studies, particularly for diagnostic devices or AI algorithms. This device's testing involves engineering and physics measurements.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a component of a linear accelerator used for radiation therapy, not a diagnostic AI system that assists human readers.

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

   • This is not applicable in the context of an AI algorithm's standalone performance. The device is hardware with control software. Its "standalone" performance refers to its mechanical and physics capabilities as documented in the table, without direct human intervention in the moment-to-moment leaf movement (which is automated by the software). However, it is explicitly designed to assist a "licensed practitioner" in delivering radiation, meaning it is ultimately human-in-the-loop for treatment planning and oversight.

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

   • The concept of "ground truth" as pathology or outcomes data is not applicable here. The "ground truth" for the device's performance is typically established by:
     • Technical specifications: Design requirements for leaf width, speed, accuracy, leakage, etc.
     • Physics measurements: Using dosimeters, films, or other calibrated instruments to verify radiation beam shaping, dose delivery accuracy, leakage, etc.
     • Mechanical measurements: Calibrated tools to verify physical dimensions, movements, and resolutions.

7. The sample size for the training set:

   • This is not applicable. This device is not an AI algorithm trained on a dataset in the conventional sense. The "control software" is developed through traditional software engineering processes, not machine learning model training.

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

   • This is not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the software's functionality would be its design requirements and specifications, validated through formal verification and validation protocols.

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Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis in elderly individuals with reduced activity levels.

CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

The Agility™ LP Total Ankle Prosthesis proposed in this submission are a line extension to the Agility™ Total Ankle system components (cleared as DePuy Alvine Total Ankle Prosthesis under K920802, December 17, 1992). The Agility LP Ankle is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a talar component.

The provided text is a 510(k) summary for the Agility™ LP Total Ankle Prosthesis. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria for device performance, nor details of a study demonstrating such performance.

The 510(k) process for this type of medical device (an ankle prosthesis) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria in the same way a diagnostic AI device or novel therapeutic might.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

Specifically, the document states:

• "The substantial equivalence of the Agility LP Ankle Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to the Agility Ankle cleared in K920802 (formerly called the Alvine Ankle)."

This statement indicates that the regulatory clearance was based on similarity to a previously approved device, not on specific performance metrics established through a new study with acceptance criteria.

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Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis.

The Agility Ankle Revision Prosthesis is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

The Agility Ankle Revision Prosthesis is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a revision talar component. The Agility Ankle revision talar component is designed to replace the Agility Ankle primary talar component in revision ankle arthroplasty. It is designed for use with the existing Agility Ankle tibial tray and either the existing polyethylene tibial insert or revision (+2) tibial insert.

The distal surface of the Agility Ankle revision talar component is a rectangular shape and is designed with a fin in the anterior-posterior plane to be cemented into the bone. This distal surface and fin are porous coated with Porocoat. The superior surface is a convex shaped and highly polished to articulate with the polyethylene tibial insert.

The Agility Ankle revision (+2) tibial insert component is manufactured from Ultra High Molecular Weight Polyethylene. It is designed to slide into the existing Agility Ankle tibial tray and is designed to articulate with either the primary or revision Agility Ankle talar components. As with the current tibial insert, the revision insert is designed with lateral and medial ears that slide into the grooves of the tibial tray. The only difference is that the revision insert is 2mm thicker to allow the insert to be used in revision cases and in primary cases where the soft tissues surrounding the ankle are lax.

The provided text is a 510(k) summary for the Agility Ankle Revision Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific acceptance criteria through a study. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study to prove device performance.

Specifically:

• No table of acceptance criteria and reported device performance is present. The document focuses on demonstrating equivalence to a previously cleared device (K920802, the Agility Ankle).
• No study data related to sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set information is included.
• The document explicitly states that "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards," rather than a new clinical or performance study demonstrating novel acceptance criteria.

The 510(k) process primarily relies on comparing a new device to an existing, legally marketed predicate device to establish that the new device is as safe and effective as the predicate. It generally does not require new clinical trials or studies to establish performance against novel acceptance criteria unless the device has significant differences in technological characteristics or indications for use from the predicate.

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The Cordis AGILITY™ Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

The hydrophilically coated AGILITY Steerable Guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the AGILITY Guidewire.

The provided 510(k) summary (K991646) describes the Cordis AGILITY™ Steerable Guidewires, a Class II device intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

However, it is important to note that this document does not contain specific acceptance criteria for performance metrics in a numerical form nor does it present a detailed study proving the device meets said criteria in the way typically expected for AI/ML medical devices.

Instead, for this type of medical device (guidewire), "acceptance criteria" are implied by the comparative testing against predicate devices to establish substantial equivalence. The "study" in this context refers to the in-vitro and animal testing performed to demonstrate that the AGILITY Guidewire performs "as well or better than" the predicate devices.

Here's an attempt to structure the information based on the provided text, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the in-vitro comparative tests (e.g., number of guidewires tested for tensile strength).
For the animal study, the sample size is not mentioned.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated, but these are typically prospective laboratory and animal studies conducted by the manufacturer.

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

This information is not applicable in the context of this device and study type. Ground truth for mechanical and biological performance of a guidewire is established by standardized testing methods, not expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. Mechanical and biocompatibility tests have objective pass/fail or quantitative measurements, not expert adjudication.

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

No. This is a medical device (guidewire), not an AI/ML system for image interpretation, so an MRMC study is not relevant.

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

Yes, in a way relevant to this device type. The in-vitro and animal studies assess the device's inherent performance and safety characteristics independently of a human operator's specific skill set beyond standard surgical handling. The performance is of the physical device itself.

7. The Type of Ground Truth Used

• For in-vitro tests: The "ground truth" is based on objective, quantifiable measurements of physical properties (e.g., force required for tensile break, torque applied, coefficient of friction for lubricity) as defined by established engineering and material science standards and compared against predicate devices.
• For biocompatibility: Ground truth is established by adherence to recognized standards for material safety, often involving cell culture tests, sensitization tests, and toxicity tests.
• For animal study: The "ground truth" for intended function (e.g., steerability, ability to navigate vasculature, lack of adverse tissue reaction) is observed and assessed in a live biological system.

8. The Sample Size for the Training Set

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

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

Not applicable. As above, this device does not utilize a "training set" in the context of AI/ML.

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