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Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and peripheral vasculature.

The INFINITI Ambi Catheter is a 0.038" guidewire compatible catheter with a 3-staged braided nylon construction. The body is a braided nylon intended for torque responsiveness and stability. The proximal segment is a non-braided nylon for flexibility and shape retention. The Distal Tip is a soft, radiopaque nylon for minimal vessel cannulation. The INFINITI Ambi product line comes in 5F and 6F size and various curve style configurations. The device is a disposable intended for single use only. It is individually packaged and sterilized by ethylene oxide gas.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "INFINITI™ Ambi Angiographic Catheter." It is not a study proving the device meets acceptance criteria for an AI/ML medical device.

The document states that the device is a catheter and its purpose is for "enabling diagnosis of various pathologies by facilitating the positioning of diagnostic devices within the coronary and peripheral vasculature." It is a physical medical device, not a software device or an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable to this document. This submission is for demonstrating "substantial equivalence" of a physical medical device to a predicate device, based on bench testing and biocompatibility testing, not AI/ML performance metrics.

The document explicitly states:

• "No clinical data was required in support of the proposed change to the predicate device cleared under K970854." (Page 9, Section VII. CLINICAL PERFORMANCE)
• The performance data section details Biocompatibility Testing, Sterilization, Packaging, and Bench Testing, which are standard for physical medical devices. (Page 7-8, Section VII. PERFORMANCE DATA)

Since the prompt asks for information about AI/ML device performance and this document concerns a traditional physical medical device, I cannot extract the requested information from the provided text.

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The Cordis 4F Infiniti™ Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Cordis Nylex™ Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Cordis Tempo™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

The 4F Infiniti™ Angiographic Catheter is a single-use device designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Infiniti™ 4F catheter is supplied sterile and is available in various lengths and tip configurations.

The 4F & 5F Tempo "M Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Tempo™ 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.

The 4F & 5F Nylex™ Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a non-braided body. It is compatible with 0.035" guidewire. The Nylex "10 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.

This document is a 510(k) premarket notification for angiographic catheters and does not describe acceptance criteria or a study proving that an AI device meets acceptance criteria. Instead, it describes how the modified devices (4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters) are substantially equivalent to their predicate devices based on design, intended use, and performance testing for biocompatibility, functional performance, and sterilization. Therefore, I cannot generate the requested table and information as it pertains to AI/algorithm performance.

The document specifies the following regarding the testing conducted for the device:

Performance Data:

• Biocompatibility Testing: Conducted on finished and sterilized Tempo 4F Angiographic Catheter in compliance with ISO 10993-1:2009/Cor 1:2010 and FDA guidance.
  • Tests included: In vitro cytotoxicity, Sensitization, Intracutaneous / irritation reactivity, Acute system toxicity, Material mediated pyrogenicity, Hemocompatibility (In vitro hemolysis, Partial thromboplastin time (PTT), Platelets and leukocyte counts, Complement activation (C3a & SC 5b-9), In vivo thrombogenicity).
• Device Functional Testing:
  • Pull force intermediate tip-to-distal tip
  • Pull force tip-to-body
• Sterilization Testing:
  • Bioburden
  • EO residuals
  • Bacterial Endotoxin

Conclusion: The design modifications were verified and validated through a series of tests ensuring that the proposed catheter meets all the required specifications and that the performance and functionality of the proposed devices are substantially equivalent to their predicate devices.

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The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

• Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
• AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells.
• The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, and SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

The INFINITI® Vision System is unchanged from the INFINITI® Vision System (Evergreen II - K112425) and maintains the modular design and incorporated features that include: Power Watch feature, UltraChopper tip, the AquaLase Capsule Wash Tip, the INTREPID® AutoSert™ IOL Injector Handpiece, and the system's associated software.

This 510(k) premarket notification for the INFINITI® Vision System (K120912) is a submission for a device that is largely unchanged from a previously cleared device (K112425). The primary "new" aspect is the expansion of the indications for use of the INTREPID® AutoSert® IOL Injector Handpiece to include additional AcrySof® intraocular lenses (SN6AT3 through SN6AT9). As such, the "study" demonstrating performance is focused on confirming the compatibility of the device with these new lenses, rather than a full de novo study of the entire system's performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of tested lenses. The text indicates "Each AcrySoft lens was tested," implying that at least one of each newly added lens type (SN6AT3 through SN6AT9) was tested.
• Data Provenance: Not specified within the provided document (e.g., country of origin, retrospective or prospective). This information is typically found in the full test report, not usually summarized in the 510(k) itself. The testing would have been prospective to demonstrate compatibility.

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

Not applicable. This type of testing involves mechanical performance standards for medical device components (i.e., whether the IOL injector can successfully inject specific lenses), not interpretation of clinical data where expert consensus for ground truth would be required. The "ground truth" here is compliance with a specified engineering standard.

4. Adjudication Method for the Test Set

Not applicable. See point 3. This was a mechanical engineering performance test against a standard, not a clinical trial with human observers requiring adjudication.

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

No. An MRMC comparative effectiveness study was not done. The submission is for a surgical instrument and a specific component's compatibility (an IOL injector with new lenses), not for an AI-powered diagnostic or assistive tool where human reader performance would be the primary outcome. Therefore, there's no discussion of AI assistance or effect size.

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

No. This device is not an algorithm or AI system. It's a surgical system with a mechanical IOL injector.

7. The Type of Ground Truth Used

The ground truth used was compliance with an established international standard for ophthalmic implants (EN ISO 11979-3:2006, Section 5). This standard outlines mechanical properties and test methods.

8. The Sample Size for the Training Set

Not applicable. There is no mention or indication of a "training set" as this device does not involve machine learning or algorithmic development requiring such a set.

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

Not applicable. See point 8.

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The Infinit® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

• Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
• AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells
• The AutoSert ™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, as well as approved AcrySof lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

The Infinit® Vision System is an enhanced version of the Infinit® Vision System with OZil® IP (K082845) that is modular in design and incorporates the Power Watch feature, along with the Alcon UltraChopper Tip, the AquaLase Capsule Wash Tip, the AutoSert™ IOL Injector, and its associated software.

This is a 510(k) premarket notification for the Infiniti® Vision System. As such, it reports on non-clinical testing to demonstrate substantial equivalence to previously cleared predicate devices, rather than a clinical study with acceptance criteria for a new device's performance.

Therefore, many of the requested categories regarding clinical study design and performance metrics (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable in the context of this 510(k) summary.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-clinical submission focused on substantial equivalence to existing predicate devices, the "acceptance criteria" are compliance with established medical device standards and demonstrating that the new features do not negatively impact safety or effectiveness. The "reported device performance" is essentially that the device meets these standards and maintains equivalent functionality.

• ISO 11135-1:2007 (Sterilization)
• BS EN ISO 11979-3:2006 (Intraocular Lenses Mechanical Properties)
• EN ISO 14971:2007 (Risk Management)
• IEC 60601-1 (General Safety of Medical Electrical Equipment)
• IEC 60601 series (Collateral and Particular Requirements for Medical Electrical Equipment and Ophthalmic Devices)
• BioCompatibility Standards (ISO 10993 series) |
  | Material Biocompatibility | Biocompatibility evaluations of patient fluid path materials performed to ISO 10993 standards (Parts 1, 5, 10, 11, 12). |
  | Sterilization Efficacy | EtO sterilization process for sterile accessories validated per ISO 11135-1:2007. |
  | Reprocessing Instructions | Validated reprocessing instructions (cleaning, sterilization, re-use) provided for reusable handpieces. |
  | Manufacturing and Design Control | Developed and manufactured in compliance with 21 CFR 820 (Quality System Regulation) and ISO 14971:2007 (Risk Management). |
  | Functional Equivalence | Non-clinical testing demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate device. Technological characteristics affecting clinical performance are similar to predicate devices. |

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 510(k) relies on non-clinical testing against established standards and comparison to predicate devices, not on a clinical test set with human 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 the sense of expert consensus on patient data, is not part of this type of submission. The "ground truth" for non-clinical testing relates to objective measurements against standard specifications.

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

• Not Applicable. No clinical test set requiring adjudication of findings is 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:

• Not Applicable. This device is a surgical system, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable. This is a hardware/software medical device used by a human surgeon, not a standalone algorithm.

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

• For non-clinical testing, the "ground truth" is defined by engineering specifications, recognized national and international standards (e.g., ISO, IEC), and established predicate device performance. For biocompatibility, it's the results of standardized biological tests. For sterilization, it's the validation against the specified sterilization cycle.

8. The sample size for the training set:

• Not Applicable. This is a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The development likely involved iterative design and testing, but not a dataset for training an AI model.

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

• Not Applicable. As above, no training set for an AI model is described.

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The INFINITI CYP2C19 Assay is an in vitro diagnostic test for the identification of a patient's CYP450 2C19 genotype in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI CYP2C19 Assay is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.

The INFINITI CYP2C19 Assay is indicated for use as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP450 2C19 gene product, specifically *2, *3, *17.

The INFINITI CYP2C19 Assay is not indicated to be used to predict drug response or non-response.

The INFINITI CYP2C19 Assay is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management, and software technology for the detection and genotyping of the 2C19 *2, *3, and *17 mutations in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples.

The INFINITI CYP2C19 Assay is comprised of the BioFilmChipTM Microarray, the Intellipac Reagent Module and the PCR Amplification Mix. The INFINITI CYP2C19 Assay should be run using the AutoGenomics INFINITI Analyzer.

The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific.

The Intellipac Reagent Module contains up four reservoirs that house the test reagents and has an integrated memory chip. Information on the reagent such as lot number, expiration date and remaining tests, are archived in the memory.

The PCR Amplification Mix consists of the reagents needed for the PCR amplification step of the assay.

The INFINITI CYP2C19 Assay is based on the following processes: (a) DNA extraction (b) PCR amplification of purified DNA from human genomic DNA (c) Labeling of the amplified product (allele specific primer extension) (d) Hybridization of the labeled amplified product to a microarray by signature Tag/Capture probe hybridization under isothermal conditions. (e) Scanning of the microarray (f) Signal detection and analysis Steps (c) through (f) are automated by the INFINITI Analyzer. The INFINITI Analyzer automates the 2C19 assay and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, and results The assays are processed automatically and read by the built-in confocal analysis. microscope. Results are analyzed and presented as genotype calls.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for INFINITI CYP2C19 Assay

The document focuses on the analytical performance of the device rather than clinical efficacy for patient outcomes or human reader improvement, as it is an in vitro diagnostic device for genotyping. Therefore, some of the requested information, such as effect size of human readers with AI assistance, is not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Limit of Detection (LOD) Test Set:

  • Sample Size: A total of 1,560 individual tests were completed across various DNA input levels and sample genotypes.
  • Data Provenance: The document implies these were internally generated samples used for development and characterization of the assay. The genotypes (*1/*1, *1/*17, *2/*2, *2/*17) were determined by bi-directional sequencing. The text refers to "whole blood samples," suggesting human samples, but the country of origin is not specified. It is likely retrospective as these are characterized samples used for method validation.

• Percent Agreement vs. Bi-directional Sequencing (Test Set):

  • Sample Size: 317 patient samples.
  • Data Provenance: The samples were "patient samples" tested at "Three sites." They were "de-identified to protect patient's identity." Country of origin is not specified but generally implies samples obtained where the sites are located, likely within the US given the FDA submission. The nature of these being "patient samples" suggests they are clinical samples, used retrospectively for assay validation.

• Assay Inter-Laboratory Reproducibility (Test Sets):

  • Study 1 Sample Size: 12 whole blood samples, resulting in 430 tests.
  • Study 2 Sample Size: 6 genomic whole blood samples, resulting in 255 tests.
  • Combined Sample Size: Across all reproducibility studies, 18 samples were tested, totaling 685 individual replicates/tests.
  • Data Provenance: The samples were "identical samples comprised of whole blood samples." The sites were blinded to sample identity. Like the previous studies, these imply human samples, but the country of origin is not specified. These are clinical samples likely used retrospectively for method validation.

• Interference Test Set:

  • Sample Size: 8 whole blood samples.
  • Data Provenance: Not explicitly stated, but consistent with other studies, likely human whole blood samples used retrospectively for assay validation.

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

For the genetic assays described, the "ground truth" is established through bi-directional sequencing.

• Number of Experts: The document does not specify the number of individuals involved in performing or interpreting the bi-directional sequencing, nor their explicit qualifications (e.g., molecular geneticists, laboratory technologists). However, bi-directional sequencing is a standard molecular biology technique and its interpretation falls under the expertise of qualified laboratory professionals familiar with genetic sequence analysis.
• Qualifications: "Bi-directional sequencing" itself is the gold standard for defining genetic sequences. Thus, the qualification is implied through the choice of this highly accurate method for ground truth determination.

4. Adjudication Method for the Test Set

• Adjudication Method: The document does not describe an explicit "adjudication method" in the typical sense of multiple expert reviewers resolving discrepancies. Instead, the ground truth was established by bi-directional sequencing. For the "no calls" that occurred with the INFINITI assay, the samples were repeated, and the "repeat test gave the correct call." This indicates an internal re-testing protocol for initial "no calls" rather than a formal expert adjudication of differing results between the device and the ground truth. When an "incorrect call" (1 instance) occurred, the root cause was "not definitively determined," suggesting internal review rather than a formal, pre-defined expert adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable to the INFINITI CYP2C19 Assay. This is an in vitro diagnostic (IVD) device directly measuring genetic material, not an imaging or diagnostic support system where a human "reader" (e.g., radiologist) would interact with AI. The device provides genotype calls directly, without human interpretation in the analytical performance step.

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

• Yes, the performance studies described are essentially standalone (algorithm only). The INFINITI Analyzer automates the entire process from hybridization to signal detection and analysis, presenting "genotype calls." The "Percent Agreement vs. Bi-directional Sequencing" and "Inter-Laboratory Reproducibility" studies specifically evaluate the accuracy and consistency of these automated genotype calls against the gold standard (bi-directional sequencing) and across different operational conditions, respectively. Human involvement is in sample preparation, loading, and interpreting the final report, but the "genotype call" generation is automated.

7. The Type of Ground Truth Used

• The primary ground truth used for all performance validation studies (Limit of Detection, Percent Agreement, Reproducibility) was bi-directional sequencing.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" size for the device's development. This is typical for in vitro diagnostic devices that rely on molecular biology principles and analytical performance rather than machine learning algorithms trained on large datasets. The device's design is based on known genetic sequences and established assay chemistry (PCR, hybridization). The "studies related to specificity were conducted during assay development" (Analytical Specificity section) implies iterative testing and optimization, but not necessarily a distinct, quantified "training set" like in AI/ML applications.

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

• As a formal "training set" is not explicitly mentioned or quantified, this question is largely not applicable in the context of this traditional IVD device.
• For the initial development and optimization of the assay (analogous to internal "training" or development data), the ground truth for samples used would have been established by bi-directional sequencing or other established genotyping methods, as indicated for the LOD studies and as the comparator method for all validation. The "known genomic samples" used for ASP primer specificity determination would also have had their ground truth established by such highly accurate molecular methods.

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The Infiniti® Vision System with OZil® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation.

The Infinitie Vision System with OZit® IP is an enhanced version of the Infinitie Vision System (K021566) that is modular in design and incorporates both the QZile IP feature and the Infiniti® UltraVit" Vitrectomy Probe and its associated software.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Infiniti® Vision System with OZil® IP.

Unfortunately, the provided text does not contain a study that proves the device meets specific performance acceptance criteria in terms of clinical effectiveness or comparison to human performance (AI vs. human).

The document is a 510(k) summary for a medical device seeking substantial equivalence to already marketed devices. The focus is primarily on safety, compliance with standards, and technological similarities to predicates, rather than a clinical performance study with defined acceptance criteria and statistical analysis.

However, I can extract information related to the device's safety and compliance acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a clinical performance study with a "test set" in the context of AI or diagnostic performance. The "tests" mentioned are primarily non-clinical engineering and biocompatibility evaluations, following established standards. Therefore, concepts like sample size for a test set or data provenance (country of origin, retrospective/prospective) are not applicable to the information provided.

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

This information is not provided because, as noted above, there's no mention of a human-centric performance test set requiring expert ground truth establishment for diagnostic or treatment outcomes.

4. Adjudication Method for the Test Set

Not applicable, as no such test set or expert ground truth is described.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided document. The device submission focuses on safety, standard compliance, and substantial equivalence to predicate devices, without presenting data on human reader improvement with or without AI assistance.

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

This device is not an AI algorithm but a surgical system. Therefore, a "standalone algorithm performance" study is not applicable. The device's performance is inherently tied to its operation by a human surgeon. The "functional requirements" are met by the system itself and its components.

7. The Type of Ground Truth Used

For the safety, biocompatibility, and functional evaluations, the "ground truth" used is adherence to established national and international standards (IEC, ISO, AAMI, ANSI, 21 CFR) and successful execution of engineering tests. This is not "expert consensus, pathology, or outcomes data" in a typical clinical study sense, but rather compliance with engineering and manufacturing best practices.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical system, not an AI algorithm that undergoes "training."

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

Not applicable, as no training set for an AI algorithm is involved.

Summary of the document's content regarding acceptance criteria and studies:

The provided 510(k) summary for the Infiniti® Vision System with OZil® IP outlines the device's compliance with a comprehensive set of safety standards (electrical, electromagnetic compatibility, software safety, high-frequency surgical equipment safety), biocompatibility standards for materials in contact with the patient, sterilization validation standards, and adherence to quality system regulations (21 CFR 820) and risk management standards (ISO 14971:2003). The acceptance criteria for these aspects are the successful demonstration of compliance with each listed standard. The study demonstrating this is described as "Non-clinical testing" which "has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate device." This documentation is part of a submission for substantial equivalence to existing legally marketed devices, establishing that the new device is as safe and effective as its predecessors based on technological characteristics and adherence to established regulatory and engineering norms. It does not include clinical performance studies, AI-specific evaluations, or human-in-the-loop performance metrics.

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The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is an in vitro diagnostic test for the detection and genotyping of the *2 and *3 CYP4502C9 genetic variants and the VKORC1 3673 (-1639) intronic variant in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.
The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is indicated for use to identify individuals at risk for sensitivity to warfarin.

The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management, and software technology for the detection and genotyping of the 2C92, 2C93, and VKORC1 3673 (-1639) mutations from EDTA-anticoagulated whole blood samples.

The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is comprised of the BioFilmChip™ Microarray, the Intellipac Reagent Module and the PCR Amplification Mix. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin should be run using the AutoGenomics INFINITI Analyzer.

The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific.

The Intellipac Reagent Module contains up to eight reservoirs that house the test reagents and has an integrated memory chip. Information on the reagent such as lot number, expiration date and volume usage, are archived in the memory.

The PCR Amplification Mix consists of the reagents needed for the PCR amplification step of the assay.

The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is based on the following processes:
(a) DNA extraction
(b) PCR amplification of purified DNA from human genomic DNA
(c) Labeling of the amplified product (allele specific primer extension)
(d) Hybridization of the labeled amplified product to a microarray by signature Tag/Capture probe hybridization under isothermal conditions.
(e) Scanning of the microarray
(f) Signal detection and analysis [determination of the 2C92, 2C93 and VKORC1 3673 (-1639) genotypes]
Steps (c) through (f) are automated by the INFINITI Analyzer.

The INFINITI Analyzer automates the 2C9 and VKORC1 assays and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, detection, and results analysis. The assays are processed automatically and read by the built-in confocal microscope. Results are analyzed and presented as genotype calls.

Here's an analysis of the acceptance criteria and study details for the INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin, based on the provided text:

Acceptance Criteria and Device Performance

The document describes the performance characteristics without explicitly stating pre-defined "acceptance criteria" as pass/fail thresholds. Instead, it presents the "reported device performance" and implies that these results demonstrate the device's suitability. For the purpose of this analysis, I will synthesize the reported performance values as the de facto "acceptance criteria" that the device met.

1. Table of Acceptance Criteria and Reported Device Performance

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

Sample Size for Test Set:

• Agreement with Bi-directional Sequencing:
  • 150 patient samples tested in the initial comparison (first run data for 2C9*2, 2C9*3, VKORC1).
  • Table 2b "by Sample Type" also shows 150 samples, implying these are the same samples analyzed by genotype.
• Inter-Laboratory Reproducibility:
  • 7 genomic DNA samples and 5 whole blood samples (total 12 unique samples).
  • Each unique sample was run in duplicate per day/operator for six days at each of 3 sites.
  • Total tests: 12 samples * 2 replicates/day * 6 days * 3 sites = 432 tests per site, for a total of 1296 tests across all sites for the "first time run" and "final result".

Data Provenance:

• Agreement with Bi-directional Sequencing:
  • Origin: Not explicitly stated, but "patient samples" were used. Given the FDA submission context, it's highly likely these were de-identified samples from the United States.
  • Nature: The description "Each site tested its own patient samples" and that they were "from patients using or have used warfarin" suggests these were retrospective samples, collected from a patient population relevant to the intended use.
• Inter-Laboratory Reproducibility:
  • Origin: Not explicitly stated, but likely from the United States given the submission.
  • Nature: Controlled study using "seven genomic DNA samples and five whole blood samples." These would be prospective in the sense that they were specifically prepared and distributed for this reproducibility study, though the original source of the genetic material might have been retrospective.

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

The document does not mention the use of experts to establish ground truth.

For the Agreement with Bi-directional Sequencing study, the ground truth was established by:

• Bi-directional DNA sequencing. This is a recognized laboratory method for determining genetic sequences and is considered the gold standard for many genetic variants. Thus, the ground truth was established by laboratory method, not expert consensus.
• The document implies that the sequencing results were accepted as the definitive truth without the need for expert adjudication or review.

For the Inter-Laboratory Reproducibility study, the ground truth for the 7 genomic DNA samples and 5 whole blood samples was their known genotypes, which would have been previously determined, presumably also by a method like bi-directional sequencing.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving multiple human reviewers for the test set.

• In the "Agreement with Bi-directional Sequencing" study, "bi-directional sequencing" served as the comparator/ground truth. The device results were directly compared to these sequencing results.
• For the inter-laboratory reproducibility study, device results from different sites and operators were compared to the known genotype of the samples.

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

No MRMC comparative effectiveness study was done. This study assesses the improvement of human readers with AI assistance versus without AI assistance. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is an in vitro diagnostic device for genotype detection, not an imaging or diagnostic support tool that assists human readers. Its output is a genotype call, not an interpretation that radiologists or other human experts would then refine or improve upon.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The entire submission details the performance of the "INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin" as a standalone device. The device automates key steps and provides genotype calls:

• "Steps (c) through (f) are automated by the INFINITI Analyzer."
• "The INFINITI Analyzer automates the 2C9 and VKORC1 assays and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, detection, and results analysis. The assays are processed automatically and read by the built-in confocal microscope. Results are analyzed and presented as genotype calls."
• The performance metrics (agreement with sequencing, reproducibility, LOD, specificity, etc.) are all measures of the algorithm's direct output.

There is no human-in-the-loop component described for its routine operation or performance evaluation.

7. Type of Ground Truth Used

The primary ground truth used for the performance studies was established laboratory method results, specifically bi-directional DNA sequencing. This method is considered highly accurate for determining DNA sequences and genetic variants.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This is typical for in vitro diagnostic devices based on established molecular biology principles (PCR, hybridization, genotyping microarrays) where the design is more mechanistic and less dependent on machine learning models requiring extensive "training data" in the conventional sense. The "development" of the assay mentioned for analytical specificity would involve testing various known samples, but these are generally considered part of the assay development and validation rather than a distinct "training set" for an algorithm in the AI context.

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

Since no explicit training set is detailed, the method for establishing its ground truth is also not described. If one were to consider the samples used during "assay development" as a form of training/optimization, their ground truth would also have been established by known genomic samples (e.g., cell lines with characterized genotypes, or samples sequenced by a gold-standard method).

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The INFINITI™ System Assay for Factor II & Factor V is an in vitro diagnostic device that consists of reagents and instrumentation which includes polymerase chain reaction (PCR) primers, hybridization matrices, a thermal cycler, an imager, and software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI™ System Assay for Factor II & Factor V is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.

The INFINITI" System Assay for detection and genotyping of Factor II & Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

The INFINITI System Assay for Factor II & Factor V is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management and software technology for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation from deoxyribonucleic acid (DNA) isolated from human whole peripheral blood samples.

The INFINITI System Assay for Factor II & Factor V is comprised of the BioFilmChip" Microarray, the Intellipac™ Reagent Module, and the INFINITI Analyzer with the Qmatic" Operating Software.

The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific.

The Intellipac Reagent Module which acts as a communication link contains up to eight reservoirs that house the test reagents and has an integrated memory chip. The assay protocol resides in this memory chip and upon request is loaded to the INFINITI Analyzer. Information such as expiration date of reagents, volume usage, time of use and operation parameters are archived in the memory chip and appear on the worklist (run report).

The INFINITI Analyzer is an instrument used for clinical multiplex systems intended to measure and sort multiple signals from a clinical sample. The INFINITI Analyzer is designed to measure fluorescence signals of labeled DNA target hybridized to BioFilmChip microarrays. The INFINITI Analyzer automates the Factor II and Factor V assays and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, detection, and results analysis. The assays are processed automatically and read by the built-in confocal microscope. Results are analyzed and presented in numerical and graphical format.

The INFINITI Analyzer has two main components: pipetting and optics modules. A variety of electronic components inside the instrument are used for its operation. These include multiple stepper motors, heating and cooling devices, a barcode reader, a photomultiplier tube, and a camera all connected to USB ports.

Pipetting Module - The pipetting module performs all the operations related to dispensing and aspiration of reagent and processing the amplified sample to be dispensed on the microarray. When the sample has been processed and hybridized to the microarray, it is transferred to the optics module for scanning and reading.

Optics Module - The optics module is a lightproof assembly comprised of a 3-axis stage: camera, lasers, and a photo multiplier tube (PMT). It is the enclosed casement into which the microarray is transported automatically prior to being processed on the stringency station. The optics' stage follows X-Y-Z motions that can be stepped at a very precise rate (2.0 micron per step). Using excitation wavelengths of a 760nm laser diode, the camera takes a 1.2x1.2mm picture for each registration spot of a fluorescent die. Analyses of these pictures allow the location of three registration spots to be determined. With respect to the position of the three registration spots, coordinates of all the bio-spots can be located. While scanning, the stage moves along the Z-axis to focus the chip and the X and Y-axes to locate the individual spots on the microarray.

The INFINITI Analyzer hardware is controlled by the Qmatic™ operating software, which is installed with-in the on-board computer and utilizes a LCD screen display. The INFINITI Analyzer modules are controlled by multitasking real time software. The Omatic "M operating software has a schedule manager that is capable of controlling all operations of the INFINITI Analyzer such as assay protocol, fluid handling, robotics, optical detection and result analysis. Results are available for review via the LCD screen. Management reports include results in numerical and graphical format. The operator can also print the displayed results in tabular form (printer not included with INFINITI Analyzer).

Here's a breakdown of the acceptance criteria and the study information for the INFINITI™ System Assay for Factor II & Factor V, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary largely focuses on demonstrating equivalence to predicate devices and detailing performance characteristics rather than explicitly stating pre-defined "acceptance criteria" with specific thresholds for all metrics. However, we can infer the implied acceptance based on the reported results and the comparison to the predicate device.

• Factor V: >95% agreement with predicate device (Roche Factor V Leiden Kit) | - Factor II: 98.6% agreement with predicate
• Factor V: 100.0% agreement with predicate |
  | Limit of Detection (LoD) | Sufficient to detect mutations in typical clinical samples. | 1ng DNA/test. |
  | Assay Precision/Reproducibility | - Chip-to-chip: Low CVs for wild-type calls, 100% correct genotype calls.
• Lot-to-lot: No significant lot-to-lot difference (p>0.05) in RFU, 100% correct genotype calls.
• Day-to-day: Acceptable RFU signal %CV, 100% correct genotype calls. | - Chip-to-chip: CVs for wild-type present calls ranged from 9-12%. All calls were 100% correct.
• Lot-to-lot: Two-way ANOVA on RFU readings did not detect lot-to-lot difference on three of four test runs (p > 0.05). Detected lot-to-lot difference on one test run (0.05 > p > 0.01). Genotype calls were 100% correct.
• Day-to-day: RFU signal %CV ranged from 1.35-14.87 (Day 1), 0.77-19.72 (Day 2), and 0.41-21.2 (Day 3). Genotype calls were 100% correct. |
  | Instrument Reproducibility | - Intra-Instrument: Acceptable %CV, 100% genotype call reproduction.
• Inter-Instrument: Acceptable %CV, 100% correct and reproducible genotype calls. | - Intra-Instrument Reproducibility: %CV using a single chip five times on a single instrument ranged from 0.9 to 28.3%. Genotype calls were 100% reproduced within each instrument.
• Inter-Instrument Reproducibility: %CV using a single chip five times on each of three instruments ranged from 0.5% to 12%. All genotype calls were 100% correct and reproducible.
• Standard Microarray Chip: For three instruments, average %CV for capture probe spots ranged from 3.24% to 4.03%, with ranges per instrument from 1.9-7.5%. |
  | Reagent Stability | Demonstrated stability for adequate shelf life. | - BioFilmChip Microarray: 90 days at RT (25-30 °C)
• Intellipac Reagent Module: 90 days at 4°C
• Amplification Mix: 90 days at 4°C |
  | Interference | No significant interference from common interferents. | No interference with 8mg/dL bilirubin, 70mg/dL cholesterol, and 1333μ/dL heparin. No studies conducted with oral anti-coagulants (no claims made). |
  | Sample Carry-over | No detectable carry-over. | No carry-over detected when a series of positive and negative samples, followed by a "No Template Control," was run six times. |

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

The "test set" here refers to the samples used for the comparative effectiveness study against the predicate device.

• Factor II G20210A mutation: 208 samples
• Factor V Leiden G1691A mutation: 175 samples

The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the given 510(k) summary. The ground truth for the comparison study was based on the results from the predicate devices (Roche Factor II G20210A and Factor V Leiden Kits). It's implied that the predicate devices themselves established the "ground truth" for the samples.

4. Adjudication Method for the Test Set

This information is not provided. The comparison was directly between the new device and the predicate device results. There's no mention of an independent adjudication process for discrepancies.

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 device is an in-vitro diagnostic (IVD) assay system and analyzer, not an AI-powered image analysis or diagnostic aid for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance is not relevant to this submission.

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

Yes, the performance characteristics described, such as Limit of Detection, Assay Precision, Instrument Reproducibility, Reagent Stability, Interference, and Sample Carry-over, represent the standalone performance of the INFINITI™ System Assay for Factor II & Factor V. The comparison to the predicate device also assesses its standalone diagnostic performance.

7. The Type of Ground Truth Used

The ground truth for the comparative effectiveness study was established by the predicate devices: the Roche Factor II G20210A Kit and the Roche Factor V Leiden Kit. This means the device's accuracy was assessed by its agreement with these established, FDA-cleared methods.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" size. As this is a molecular diagnostic assay system, the development process typically involves optimizing reagents and conditions rather than training a machine learning algorithm in the conventional sense. The "training" would be more akin to assay development and validation using various known samples.

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

Since a "training set" for a machine learning algorithm is not explicitly defined or used in the context of this traditional IVD assay, the method for establishing its ground truth is not applicable in the same way. The development of the assay would have relied on known positive and negative controls, synthetic DNA, and clinical samples with previously determined genotypes (likely via Sanger sequencing or other established reference methods during the predicate device's development or the assay's R&D phase). This type of information is generally part of the assay development and validation process rather than a separate "training set" section in a 510(k) summary.

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The MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.

The MyoTrac Infiniti system is also indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention or retardation of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.

The MyoTrac Infiniti device is a non-implanted electrical stimulator for urinary incontinence, it is intended to re-train the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. The device is indicated for treatment of patients with stress incontinence, urge incontinence or mixed incontinence (a combination of stress and urge incontinence). The indications for this use and labeling will be a subset of the overall indications for use. The MyoTrac Infiniti is an electrical muscle stimulator for contraction of muscles as well.

The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle re-education, relaxation and EMG biofeedback.

The provided text describes the MyoTrac Infiniti system and its substantial equivalence to predicate devices, focusing on technical characteristics and intended use. However, it does not include a study that proves the device meets specific acceptance criteria in the way you've outlined for performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the document details a 510(k) premarket notification, which is a regulatory submission to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing technical specifications and intended use rather than conducting new clinical performance studies with acceptance criteria, sample sizes, and ground truth as would be done for a novel or high-risk device.

Therefore, many of your requested points cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

The device described is the MyoTrac Infiniti System, a non-implanted electrical continence device, powered muscle stimulator, and biofeedback device.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of a clinical performance study with specific acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance values. The document focuses on demonstrating substantial equivalence through a comparison of technical characteristics and intended use with predicate devices.

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

• Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical test set or study with human subjects for performance evaluation in the way you've asked. The "performance data" section (page 6) refers to "non-clinical tests" like verification of product specifications, system validation, safety, and EMC testing. Device equivalency is determined by comparing its functional and hardware specifications to predicate devices.
• Data Provenance: Not applicable.

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

• Not applicable/Not provided. No clinical test set with ground truth established by experts is described.

4. Adjudication method for the test set

• Not applicable/Not provided. No clinical test set requiring adjudication is 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

• Not applicable/Not provided. This device is an electrical stimulator/biofeedback device, not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study is not relevant to its function.

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

• Not applicable/Not provided. This is a physical medical device for treatment and biofeedback, not an algorithm. Its performance is inherent in its hardware, software, and physical interaction, not a standalone algorithmic output.

7. The type of ground truth used

• Not applicable/Not provided. For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established safety and efficacy of the predicate devices and the MyoTrac Infiniti's ability to match their intended use and technical specifications. There is no mention of pathology, expert consensus, or outcomes data used to establish ground truth for a performance study of the MyoTrac Infiniti itself.

8. The sample size for the training set

• Not applicable/Not provided. This is not a machine learning or AI-driven device that requires a training set in that context.

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

• Not applicable/Not provided.

Summary of Device Acceptance/Equivalency based on the document:

The MyoTrac Infiniti system's "acceptance criteria" and "proof" are based on its substantial equivalence to existing legally marketed predicate devices, as demonstrated through a comparison of their technical characteristics and intended uses.

• Acceptance Criteria (Implicit for 510(k)): The MyoTrac Infiniti System must have the same intended use and similar technological characteristics as predicate devices such that any differences do not raise new questions of safety or effectiveness.
• Study Proving Acceptance: The main "study" (or rather, the demonstration for regulatory clearance) is the comparison table of technical characteristics and the statement of intended use.
  • "Performance Data": The document explicitly states (page 6): "Non-clinical tests were performed consisted of verification of the product specification, system validation, safety and EMC testing. Device equivalency is determined by a direct comparison of the device functional and hardware specifications of MyoTrac Infiniti system with the legally marketed predicate devices..."
  • Biocompatibility: The related sensors underwent laboratory testing for material safety.
  • Conclusion: "The MyoTrac Infiniti system is safe and effective for its intended use. The MyoTrac Infiniti system is substantially equivalent to the predicate devices." (page 6)

The document lists multiple predicate devices (Pathway CTS 2000, InCare PRS Pelvic Floor Therapy System, Evadri Bladder Control System, K.E.A.T., and Detrusan 500 Incontinence Therapy System) and provides a detailed table comparing various features like frequency, pulse intensity, pulse width, ramp settings, duty cycle, session duration, programmable features, probe types, power density, EMG ranges, bandwidth, signal processing, detection, and feedback modes. The "acceptance" is based on these comparisons demonstrating similarity to devices already cleared by the FDA.

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The MyoTrac Infiniti system is indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Relaxation & Muscle Re-Education purposes.

The MyoTrac Infiniti device is an electrical muscle stimulator for contraction of muscles as indicated below. The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle re-education, relaxation and biofeedback.

Here's an analysis of the provided text regarding the MyoTrac Infiniti System, focusing on acceptance criteria and supporting studies:

This 510(k) premarket notification (K053266) for the MyoTrac Infiniti System does not contain specific acceptance criteria or a dedicated study designed to prove the device meets such criteria in the conventional sense of a clinical trial demonstrating performance metrics against quantitative thresholds.

Instead, the submission focuses on substantial equivalence to predicate devices. The "performance data" section primarily refers to non-clinical tests verifying product specifications, system validation, safety, and EMC testing, along with biocompatibility assessments of electrodes. The core argument for equivalence is a direct comparison of functional and hardware specifications with legally marketed predicate devices.

Therefore, many of the requested categories within your prompt cannot be directly answered from the provided text. I will address what is available and indicate when information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" (e.g., "sensitivity > X%", "accuracy > Y%") are not presented in this 510(k) summary. The "performance" is demonstrated through substantial equivalence to predicate devices based on technical specifications and safety testing.

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

• Sample Size for Test Set: Not applicable. This document describes a 510(k) submission for substantial equivalence based on technical comparisons and non-clinical testing, not a clinical study with a "test set" of patient data.
• Data Provenance: Not applicable for a patient data test set. The data provenance for component testing (e.g., biocompatibility) would be laboratory testing reports.

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

• Not applicable. There is no clinical "test set" with ground truth established by experts discussed in this submission.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical "test set" requiring an adjudication method.

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 biofeedback and muscle stimulation system, not an AI-assisted diagnostic tool that would typically undergo an MRMC study with human readers interpreting results.

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

• This device is not an algorithm-only medical device. It is a physical medical device (stimulator and biofeedback unit) used with human-in-the-loop operation.
• The "standalone performance" is addressed by the comparison of its technical specifications to predicate devices and verification of its own product specifications.

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

• For the purpose of this 510(k) submission, the "ground truth" for proving substantial equivalence is the technical specifications and established safety/effectiveness profiles of the predicate devices, along with the results of internal non-clinical tests (verification, validation, safety, EMC). There is no patient-reported outcomes, pathology, or expert consensus used to establish ground truth for a novel performance claim in this documentation.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ an AI algorithm requiring a "training set" of data.

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

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

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