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The EmPro™ EPS/Nanoparasol™ EPS is indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the filter placement should be between 3.0 and 6.5 mm.

MicroVention's Embolic Protection System (EPS) is marketed under two names: EmPro™ Embolic Protection System and Nanoparasol™ Embolic Protection System. The Embolic Protection System (EPS) is designed to capture and remove dislodged debris during a carotid interventional procedure. It consists of three basic components and additional accessories:

1. An Embolic Protection Device (EPD) consisting of a nitinol braided mesh filter with an atraumatic distal tip built on an integrated .014" PTFE coated stainless steel capture delivery wire.
2. A 3.5F delivery catheter with 150 cm length.
3. A 5F retrieval catheter with 150 cm working length. Accessories include a wire introducer, EPD loading cover, sheath introducer and a torque device. Catheters are provided in two separate dispenser coils.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the EmPro™ EPS/Nanoparasol™ EPS. This device is an embolic protection system indicated for use as a guidewire to contain and remove embolic material during angioplasty and stenting procedures in carotid arteries.

Here's the 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 the data provenance

• Sample Size for Clinical Study (Test Set): 256 patients (n=256) in the Intent-To-Treat (ITT) population.
• Data Provenance: The study was a "multicenter, single-arm, interventional study" called the CONFIDENCE study (IDE G140249). While the specific countries are not mentioned, FDA submissions typically involve studies conducted in the US or under equivalent international standards. The study design is prospective.
• Sample Size for Animal Study: 6 animals (porcine model).

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study's endpoint definitions (MAE, technical success). Clinical trials typically involve a clinical events committee (CEC) composed of expert physicians to independently adjudicate events like death, stroke, and MI, but this level of detail is not provided in this regulatory summary.

For the animal study, the document mentions "histological analysis" and "neurological assessments" were performed, implying expert evaluation, but the number and specific qualifications of the experts are not detailed.

4. Adjudication method for the test set

The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the clinical study's primary and secondary endpoints. For a multi-center clinical study with composite endpoints like MAE, it is standard practice to have a Clinical Events Committee (CEC) adjudicate events, often with multiple readers and a pre-defined adjudication process, but the specifics are not provided here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an embolic protection system, not an AI-powered diagnostic tool, so such a study would not be applicable. The performance evaluated relates to the mechanical and clinical outcomes of the device itself and its ability to capture emboli, not human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (an embolic protection system), not an algorithm or AI system. Its performance is evaluated in vivo (animal and human clinical studies) and in vitro (bench testing), not as a standalone algorithm.

7. The type of ground truth used

• Clinical Study (CONFIDENCE study): The ground truth for the primary endpoint (MAE) was based on clinical outcomes: death, stroke, and myocardial infarction (MI), confirmed by medical records and follow-up. For secondary endpoints like technical success (e.g., EPS successfully inserted, deployed, retrieved), the ground truth would be based on procedural observations and documentation. This represents outcomes data and procedural success data.
• Animal Study: Ground truth was established through direct observation during intervention (e.g., tracking, deployment, retrieval), post-intervention assessment (thrombus formation, particulate capture, device damage, neurological dysfunction), and post-explantation histopathology/histology to evaluate tissue response.

8. The sample size for the training set

This document does not describe a "training set" in the context of an AI/ML model. The studies described are for the validation and performance evaluation of a physical medical device. Therefore, a training set sample size, as understood in AI/ML development, is not applicable or provided.

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

As there is no mention of a "training set" for an AI/ML model, this question is not applicable. The device's design and engineering would have been informed by a vast amount of existing medical knowledge, material science, and prior device development, rather than a specific "training set" with established ground truth in the AI/ML sense.

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The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes, GI flexible endoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50-57°C HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfects up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

• The Reliance Endoscope Processor is an electromechanical washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
• Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
• Optional washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner during the wash phase of the cycle.
• CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is used in one of the two self-decontamination cycles provided by the processor.
• Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
• VERIFY Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.

The provided document is a 510(k) summary for the STERIS Reliance Endoscope Processing System. It outlines the device's indications for use, technological characteristics, and a summary of non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Key takeaway for your request: This document primarily focuses on showing the equivalence of a slightly modified device (due to a raw material change) to an already cleared predicate device. It is not a study demonstrating the initial performance acceptance criteria for the original device for the purpose of a device efficacy study in terms of AI performance. The device in question is an endoscope reprocessing system, not an AI-powered diagnostic device. Therefore, a significant portion of your requested information, particularly relating to AI performance, ground truth, expert readers, and MRMC studies, is not applicable to this document.

However, I can extract the acceptance criteria and performance results directly from the provided Table 3, which summarizes the new testing performed for this 510(k) submission (related to a raw material change).

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify quantitative sample sizes for the "Fit test," "Technical specifications," or "Biocompatibility and Chemical Compatibility" evaluations. These typically involve material evaluations, bench testing, and potentially a limited number of device assemblies rather than large-scale patient-based test sets as would be seen for an AI diagnostic.
• Data Provenance: The document does not explicitly state the country of origin for this specific testing data beyond it being a submission to the U.S. FDA by a company based in Mentor, Ohio, USA. The testing would have been conducted by or for STERIS Corporation. The nature of these tests (material properties, component fit, chemical compatibility) suggests laboratory or manufacturing facility-based evaluations, not clinical data. The document indicates this was non-clinical testing (Page 12, Section 6).

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

• Not Applicable. This document pertains to the mechanical, chemical, and material compatibility performance of an endoscope processing system, not an AI diagnostic device that requires expert-established ground truth from images or other medical data.

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

• Not Applicable. As above, this type of adjudication is relevant for human interpretation of medical data (e.g., radiology reads), not for the engineering and material performance tests 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 an automated endoscope reprocessing system, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

• Not Applicable. This device does not involve an AI algorithm; it is a physical system for high-level disinfection of endoscopes.

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

• For the tests conducted (Fit test, Technical specifications, Biocompatibility/Chemical Compatibility), the acceptance criteria inherently define the "truth." For example, for "Fit test," the ground truth is simply whether the components physically fit and function as intended without interference, consistent with the original design. For "Technical specifications," it's comparison to established material specifications. For "Biocompatibility/Chemical Compatibility," it's compliance with ISO standard requirements for non-cytotoxicity and resistance to the processing chemicals. These are not clinical "ground truths" in the diagnostic sense.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

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

In summary, the provided document is a regulatory submission for an endoscope reprocessing system, focusing on demonstrating substantial equivalence after a minor material change. It does not involve AI or diagnostic imaging, and therefore, most of the requested information regarding AI performance testing (MRMC, standalone performance, expert ground truth) is outside the scope of this document.

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The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

The provided text is a 510(k) Summary for the STERIS Reliance Endoscope Processing System. This document details the device, its intended use, and a comparison to a predicate device, along with a summary of non-clinical testing performed to demonstrate substantial equivalence.

Based on the provided information, I will answer the questions regarding acceptance criteria and the study that proves the device meets them.

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

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

The document does not specify the exact sample sizes for the "selected worst-case duodenoscope models" or the number of medical devices used in biocompatibility testing. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. However, based on the context of a 510(k) submission for a medical device and the type of tests performed (e.g., efficacy, biocompatibility, stability), these would typically be controlled laboratory studies conducted prospectively.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth in these non-clinical tests. These types of tests (disinfection efficacy, biocompatibility, stability) are generally conducted by laboratory technicians and scientists following established protocols (e.g., ISO standards, AOAC methods) and do not typically involve human expert consensus for "ground truth" in the way a diagnostic AI system would. The "ground truth" for these tests is based on the measurable outcomes of the chemical and biological assays.

4. Adjudication method for the test set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers. For the non-clinical laboratory tests described here (efficacy, biocompatibility, stability), an adjudication method is not applicable as the results are quantitative and based on predefined measurement thresholds.

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, an MRMC comparative effectiveness study was not done. The device in question is an automated endoscope processing system, which performs automated cleaning and high-level disinfection. It is not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply here.

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

The primary tests reported are for the performance of the automated system itself (efficacy of disinfection, biocompatibility of the germicide, stability of the germicide). In this context, the "standalone" performance is precisely what was evaluated. The device functions automatically without a human actively making decisions based on its output during the disinfection process.

7. The type of ground truth used

For the efficacy test, the ground truth is the microbiological log reduction of Mycobacterium terrae following the disinfection process. For biocompatibility, the ground truth is cellular response (e.g., non-cytotoxicity) based on ISO 10993-5 standards. For stability, the ground truth is the chemical and functional properties of the germicide maintaining within acceptance criteria over time. These are all objective, measurable laboratory outcomes.

8. The sample size for the training set

The document describes non-clinical performance testing for a physical device (an automated endoscope reprocessor and its germicide). It does not involve machine learning or AI models with "training sets." Therefore, the concept of a training set size is not applicable.

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

As there is no training set involved for this type of device, this question is not applicable.

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The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The holds and guides a standard FDA-cleared powered bone cutting instrument.

The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS provides haptic feedback to the surgeon by constraining the motion of the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan.

The patient tracking portion of the NGS is comprised of linkages from the NGS, which for partially edentulous patients include the Chairside Patient Splint (CPS) (K173402) or the Clamped Chairside Patient Splint (CCPS) (K202100), the End Effector (EE) and the Patient Tracker (PT). The CPS or CCPS is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the splint prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The subject of this submission is a design change to the sleeves in our Edentulous Patient Splint (EPS) (K200805). The EPS enables use of the NGS in fully edentulous patients. It is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS and CCPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The provided text discusses the Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS) and a design change to its sleeves. However, it does not contain a detailed study proving the device meets acceptance criteria for performance, especially not in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Neocis Guidance System (NGS) with Patient Splints, K200805) after a design change to the EPS sleeves. The "Performance Testing" section lists various tests conducted, primarily related to the physical and biological aspects of the device, rather than a clinical performance study.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not available in the provided text for a clinical performance study.

Here's what can be extracted and inferred from the text, focusing on the design change and the tests mentioned:

Acceptance Criteria and Device Performance (Design Change Validation)

The document describes a design change to the sleeves within the Edentulous Patient Splint (EPS) component of the Neocis Guidance System (NGS). The acceptance criteria are implicitly related to ensuring this design change does not negatively impact the safety and effectiveness of the device, and that it remains substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for performance tests like "EPS Weighted Deflection Test" or "Total System Accuracy". These are typically engineering verification tests, and the "sample size" would refer to the number of units tested.
• Data Provenance: Not specified for these engineering tests. "Sawbones®" is mentioned, indicating laboratory testing on synthetic bone models. This is not clinical data.

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

• Not applicable for the reported tests. The tests are engineering verification tests, not diagnostic accuracy studies requiring expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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

• No MRMC study was mentioned or conducted. The device is a surgical guidance system, not a diagnostic AI tool for human readers.

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

• Not explicitly described as a standalone algorithm performance study. The "Total System Accuracy" test would assess the device's accuracy in guiding the surgical instrument, which is its primary function (albeit with a human surgeon operating the instrument under guidance). The text focuses on the mechanical and system accuracy of the guidance mechanism itself, not a diagnostic algorithm.

7. The type of ground truth used:

• For mechanical tests: Engineering specifications, precision measurements, or established physical benchmarks are the "ground truth."
• For biological tests: Standards (e.g., ISO 10993) and established laboratory protocols define the "ground truth" for material properties and effects.

8. The sample size for the training set:

• Not applicable. The document does not describe the development or training of an AI algorithm in the context of a "training set" for diagnostic performance.

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

• Not applicable. See point 8.

Summary of Device Performance (from the document's conclusion):
The primary conclusion is that "The design changes to the EPS sleeves have been verified using well established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate." This implies that all the listed performance tests were successfully passed, ensuring that the modified device remains as safe and effective as its predecessor.

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alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent institus of in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

alpha-AMYLASE PANCREATIC: Reagent for the measurement of pancreatic c-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronin pancreatitis. This reagentis for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

BILIRUBIN DIRECT: Reagent for the measurement of direct bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.

BILIRUBIN TOTAL: Reagent for the measurement of total bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, herrytological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for nuse in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.

Not Found

This 510(k) summary provides information about the substantial equivalence of several Biosystems S.A. reagents (alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL) to legally marketed predicate devices. It states that the devices are intended for in vitro diagnostic use in the clinical laboratory for measuring specific analyte concentrations in human serum, plasma, or urine, which are useful as aids in the diagnosis and treatment of certain medical conditions. However, the document does not contain any data, studies, or information regarding acceptance criteria or device performance statistics. It is a regulatory clearance letter, not a performance study report.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

To answer your request, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the validation and performance characteristics of these reagent systems.

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The VERIFY Process Indicator for Reliance Endoscope Processing Systems is intended for routine monitoring of the Reliance Endoscope Processing System (EPS) and the Reliance Advance EPS employing Reliance DG Dry Germicide. The device is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.

The VERIFY Process Indicator for Reliance Endoscope Processing Systems is a single-use chemical indicator strip with indicator ink printed on one end that monitors the peracetic acid (PAA) dose at the point of use in a Reliance EPS Endoscope Processing System or a Reliance Advance Endoscope Processing System employing Reliance DG Dry Germicide.

The process indicator shows an incomplete color change when exposed to peracetic acid at a dose of ≤ 9000 mg/L PAA min. in an Endoscope Processing Cycle. It shows a complete color change from orange to white (colorless) when exposed to peracetic acid at a dose of ≥ 11,500 mg/L PAA min. in an Endoscope Processing Cycle.

The chemical indicator performs equivalently in Reliance Endoscope Processing System (EPS) and in Reliance Advance Endoscope Processing System.

Acceptance Criteria and Study for VERIFY™ Process Indicator for Reliance TM Endoscope Processing Systems

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the specific "sample size" for the test set in terms of number of individual indicators or test runs. It describes repeated testing ("re-opened repeatedly for 6 months and tested," "each of three test environments"). The data provenance is not specified regarding country of origin, but the testing was conducted to support a submission to the US FDA, implying internal testing by STERIS Corporation. The study appears to be prospective, as it involves testing the device's performance under various conditions, including stability and use life.

3. Number of Experts used to establish Ground Truth and Qualifications

The document does not provide information on the number of experts used to establish a ground truth or their qualifications. The evaluation of the indicator's color change (Pass/Fail) is based on a predefined visual criterion ("Colorless1: Pass" and "Incomplete color change2: Fail"). This suggests that the ground truth is established by the intrinsic design of the indicator and its expected color response to specific Peracetic Acid (PAA) doses, rather than interpretation by human experts.

4. Adjudication Method

The document does not describe an adjudication method for the test set. The determination of "Pass" or "Fail" is based on the visual color change of the indicator in relation to specified PAA dose levels and a reference color block. This implies a direct, objective assessment against predetermined criteria rather than a consensus-based adjudication process.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with AI assistance. This device is a chemical indicator, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The device is a chemical indicator, not an algorithm, so a "standalone algorithm only" performance study was not conducted.

7. Type of Ground Truth Used

The ground truth used is based on predetermined physical and chemical responses to specific concentrations of peracetic acid. The "Pass" and "Fail" states are defined by the visual color change of the indicator relative to known PAA dose levels (≥ 11,500 mg/L PAA min. for Pass and ≤ 9000 mg/L PAA min. for Fail) and a reference "start" color. This is an objective, mechanism-based ground truth.

8. Sample Size for the Training Set

The document does not mention a "training set." The device is a chemical indicator, not a machine learning model, and therefore does not undergo a training process in the conventional sense.

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

This question is not applicable, as there is no training set for this type of device.

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The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal / Laryngology, and Head & Neck procedures.

Specific procedures and applications would include: Sinus / Rhinology:

• FESS (Functional Endoscopic Sinus Surgery) .
• Including Endoscopic approaches to: Polypectomy, Ethmoidectomy, o
• Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
• Septal Spur removal ●
• Endoscopic DCR .
• Trans-sphenoidal procedures specifically to create access through the sinuses to the . Pituitary, Skull base, and CSF leak repair
• . Turbinate Reduction / Turbinoplasty
• o Including sub mucosal resection

Nasopharyngeal / Laryngeal:

• Adenoidectomy / Tonsillectomy .
• Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, . Polypectomy

Head & Neck:

• Soft tissue shaving .

The DIEGO ELITE system is the second generation of the RF Diego® system cleared under K034004. The second generation system offers many improvements over the previous system. The DIEGO ELITE includes a power console with touchscreen, footswitch, reusable handpiece, image guided surgery compatibility, an optional powered suction pump, single use disposable accessories and interchangeable burrs / blades and electrosurgical blades. This second generation device adds monopolar capability, disposable sensing technology, improved blades. improved fluid pathway, a more durable reusable handpiece, a premium tubeset with a declog feature and IGS connector, and a powered suction pump that is an optional accessory that can be used to replace the standard facility suction.

The provided 510(k) summary for the DIEGO ELITE device (K123429) lists performance testing, but it does not express these in terms of specific, quantifiable acceptance criteria or provide a detailed study that measures the device's performance against such criteria. Instead, it describes various types of tests performed to ensure the device functions as intended and meets design specifications, relying on comparative performance to predicate devices for substantial equivalence.

Here's an attempt to extract and infer the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a surgical device like an electrosurgical drill/shaver, formal acceptance criteria with specific numerical targets and measured performance values are typically not explicitly stated in the public summary. The performance is primarily demonstrated through compliance with recognized standards and comparison to predicate devices.

However, based on the "Summary of Performance Testing," we can infer the intent of the acceptance criteria as substantial equivalence to predicate devices and meeting design specifications.

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

• Sample Sizes: The document does not specify exact sample sizes for any of the non-clinical or preclinical tests (e.g., number of bench tissue samples, number of cadavers, number of animals). It only refers to "Representative samples" for stability testing.
• Data Provenance:
  • Bench Tissue: Ex vivo using bovine tissue.
  • Cadaver: In vivo (though cadaver tissue is technically ex vivo in a surgical context, it implies human anatomy simulation). The country of origin is not specified.
  • Animal: In vivo using porcine models. The country of origin is not specified.
  • Non-Clinical (electrical, mechanical, functional): Performed in a lab setting; provenance not specified.
  • Retrospective or Prospective: These appear to be prospective tests specifically conducted for the 510(k) submission to demonstrate device performance.

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

• The document does not specify the number of experts or their qualifications for establishing ground truth for the test sets.
• It mentions "surgeon input" was used to confirm appropriate tissue medium for simulated use and bench testing. This suggests expert involvement, but details are absent.
• For preclinical studies, outcomes like "Overall design confidence" were evaluated, implying expert assessment, but again, no specifics on the experts.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for evaluating the test set results. The tests are primarily functional and comparative, with "ground truth" established by the design specifications, recognized standards, and direct observation of performance against predicate devices.

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

• No, an MRMC comparative effectiveness study was not done. The device being a surgical tool (drill/shaver/electrosurgical unit) means its performance is assessed directly on tissue/cadavers/animals, not through human reader interpretation of images or data.
• Therefore, there is no effect size reported for how human readers improve with or without AI assistance, as AI assistance in this context is not applicable in the way it is for diagnostic imaging devices.

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

• This question is framed for AI/software devices. In the context of this electrosurgical and drill system, the "standalone" performance refers to the device's intrinsic functional capabilities.
• Yes, standalone performance (without a human-in-the-loop in an interpretive sense) was extensively tested. All the non-clinical/preclinical tests described (electrical, mechanical, functional, biocompatibility, stability, cutting, coagulation, tissue removal, suction, thermal impact) represent the device's standalone performance characteristics. The human operator is integral to using the device, but the device's performance itself is evaluated directly.

7. The Type of Ground Truth Used

The ground truth for this device's performance testing appears to be based on:

• Compliance with Recognized Standards: Meeting the requirements outlined in standards such as IEC 60601-1, IEC 60601-2-2, ISO 10993-1, ISO 14971, etc.
• Design Specifications: The device's ability to "function as intended and met design specifications."
• Comparative Performance to Predicate Devices: "performs substantially equivalent to the predicate devices" and "exhibited comparable performance characteristics to the predicates."
• Direct Observation/Measurement: For aspects like cutting efficiency, coagulation effect, tissue removal, suction efficacy, thermal margins, and mechanical properties.
• Surgeon Input: Used to confirm appropriateness of tissue models and likely for evaluation of usability aspects.

8. The Sample Size for the Training Set

• Not applicable. This device is a surgical instrument, not an AI or machine learning model that requires a "training set." The concept of a training set is relevant for data-driven algorithms.

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

• Not applicable. As there is no "training set" for this type of medical device, the establishment of ground truth for a training set is not relevant. The device's design and functionality are based on engineering principles, material science, and established medical knowledge, not on learning from a data set.

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The EasyMax T1 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood qlucose conditions.

The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.

The EasyMax T1 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.

The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.

The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.

Acceptance Criteria and Study for EasyMax TI Self Monitoring Blood Glucose System

1. Table of Acceptance Criteria and Reported Device Performance

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The EG V1 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The system consists of the EG V1 Pro meter and the EG Pro Test Strips. The EG V1 Pro meter only is used with the EG Pro Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip.

EG Glucose Control Solution: For use with the EG V1 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The EG V1 (BL) Self Monitoring Blood Glucose Test System is intended for the quantiatative measurement of glucose in fresh capillary whole blood from the fingertip, palm or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter[OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.

The system consists of the EG V1 (BL) meter and the EG V1 Test Strips. The EG V1 (BL) meter only is used with the EG V1 Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip, palm, or forearm.

EG Glucose Control Solution: For use with the EG V1 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The EG V1 Pro Self-Monitoring Blood Glucose System consists of the EG V1 Pro Blood Glucose Meter, EG Pro Glucose Test Strips, single-use Lancing Device and EG Level 2 Control Solution.

The EG V1 (BL) Self-Monitoring Blood Glucose System consists of the EG V1 (BL) Blood Glucose Meter, EG Glucose Test Strips, Auto-Lancet Device and EG Level 2 Control Solution.

Here's an analysis of the acceptance criteria and study details for the EG V1 Pro Self-Monitoring Glucose Test System and the EG V1 (BL) Self Monitoring Glucose Test System, based on the provided 510(k) Summary.

Key Observation: The document contains two separate 510(k) summaries for two devices:

1. EG V1 Pro Self Monitoring Glucose Test System: Intended for professional use, measuring glucose in venous or capillary whole blood from the fingertip.
2. EG V1 (BL) Self Monitoring Glucose Test System: Intended for Over-The-Counter (OTC) / home use, measuring glucose in capillary whole blood from fingertip, palm, or forearm.

Both summaries reference the same performance characteristics data, indicating that the underlying technology and analytical performance studies likely apply to both, with clinical accuracy studies differing based on professional vs. patient use and anatomical sites. I will present the acceptance criteria and study details as they apply to the respective devices and their specific accuracy studies.

EG V1 Pro Self Monitoring Glucose Test System (Professional Use)

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

The acceptance criteria for system accuracy are based on ISO 15197:2003.

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The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius and ulna.

The EVOLVE® EPS OTHOLOC™ System is extended to offer two longer screw lengths and four shorter plates. The driver-screw interface is also being modified. The plates are identical to the predicate in hole/slot placement and depth, plate shape and material. The subject screws have identical profile and thread form. The screws may be used with or without the plates.

The provided text indicates that the EVOLVE® EPS ORTHOLOC™ System is a bone plate and screw system, and the submission is for an extension of the existing system (K100146) to include longer screw lengths, shorter plates, and a modified driver-screw interface. The study performed is a non-clinical, mechanical study, not a clinical study involving human or animal subjects. Therefore, many of the requested categories are not applicable.

Here's the information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated in terms of number of screws/plates tested, but the study refers to "ultimate torque testing, pull-out data, and off-axis locking comparison." It's common in mechanical testing to test multiple samples to ensure repeatability and statistical significance, but the exact number isn't provided here.
• Data Provenance: The data is from non-clinical laboratory testing performed by Wright Medical Technology, Inc.

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

• Not Applicable. This was a non-clinical, mechanical performance study. "Ground truth" in the context of expert review is not relevant for this type of testing. The acceptance criteria were based on predefined mechanical engineering standards and comparison to a predicate device.

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

• Not Applicable. As a non-clinical engineering study, an adjudication method for case evaluation is not relevant. The performance metrics (e.g., torque values, pull-out forces) were direct measurements.

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

• Not Applicable. This is a mechanical device, not an AI or diagnostic imaging device. No MRMC study was conducted.

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

• Not Applicable. This is a mechanical device. No algorithm or standalone performance testing was performed.

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

• Not Applicable (or "Predicate Device Performance Data"). For this non-clinical study, the "ground truth" for comparison was the established mechanical performance of the predicate EVOLVE® EPS ORTHOLOC™ System (K100146) and relevant engineering standards for bone fixation devices. The goal was to demonstrate that the modified device performed "at least as well as" the predicate.

8. The sample size for the training set:

• Not Applicable. This documentation does not describe a machine learning algorithm, and thus there is no training set in that context. The "training" for such a device involves design and manufacturing processes, not data for an AI model.

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

• Not Applicable. No training set for an AI model was used.

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