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The TRUENESS™ AIR Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ AIR Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ AIR Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.

The TRUENESS™ AIR Blood Glucose Monitoring System is comprised of the TRUENESS™ AIR blood glucose meter and the TRUENESS™ blood glucose test strip.

The TRUENESS™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.

The TRUENESS™ Blood Glucose Monitoring System is comprised of the TRUENESS™ blood glucose meter and the TRUENESS™ blood glucose test strip.

The TRUENESS Blood Glucose Monitoring System and TRUENESS AIR Blood Glucose Monitoring System mainly consist of two parts as below:
(1) TRUENESS Blood Glucose Meter or TRUENESS AIR Blood Glucose Meter (With Bluetooth function)
(2) TRUENESS Blood Glucose Test Strip

A glucose test is based on measurement of electrical current caused by the reaction of glucose with flavin adenine dinucleotide (FAD) glucose dehydrogenase on the electrode of the test strip. The blood or control solution sample is drawn into the tip of the TRUENESS Blood Glucose Test Strip through capillary action. Glucose in the sample reacts with the FAD glucose dehydrogenase and generate electrons. The magnitude of the resultant current is proportional to the concentration of glucose in the blood and is converted to a glucose concentration. The glucose concentration is displayed on the meter display for the user.

The provided text primarily focuses on the FDA's 510(k) clearance for the TRUENESS™ AIR Blood Glucose Monitoring System and the TRUENESS™ Blood Glucose Monitoring System. It outlines the regulatory process, device descriptions, and a high-level summary of testing. However, it does not contain the detailed acceptance criteria or the specific study results in the format requested.

The document indicates that "Design verification and validation testing consisted of performance tests (precision, linearity, interference, flex studies), electrical/mechanical safety tests, as well as disinfection, cleaning, and robustness studies." It also mentions "A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling."

Therefore, I cannot populate the table or answer all your questions with the information given. I can, however, extract the general statement about accuracy.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

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

• Sample Size: Not specified for any of the tests.
• Data Provenance: Not specified.

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 specified. The document mentions a "user evaluation" confirmed system accuracy, but does not detail the nature or qualifications of these users as "experts" for establishing ground truth in a clinical sense.

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

• Not specified.

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/mentioned. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool that involves human readers.

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

• The device performs quantitative measurement of glucose. The "system accuracy" would refer to its standalone performance, confirmed by user evaluation. The specifics of this standalone performance are not detailed in terms of metrics.

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

• Not specified. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings against a laboratory reference method (e.g., YSI analyzer), but this is not explicitly stated in the document provided.

8. The sample size for the training set

• Not applicable/mentioned. Blood glucose monitoring systems typically don't have a "training set" in the machine learning sense. Their performance is validated through defined chemical and user studies against reference methods.

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

• Not applicable/mentioned for the same reason as above.

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The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is a reusable blood lancet holder intended to be used in conjunction with a sterile, single-use blood lancet for obtaining a capillary blood sample for testing purposes from the fingertip and from alternative sites, such as the forearm. TRUEdraw Lancing Device/ Mini Lancing Device is intended for multiple use by a single patient.

This document is a 510(k) Premarket Notification from Trividia Health for their TRUEdraw Lancing Device and Mini Lancing Device. It seeks to demonstrate substantial equivalence to a legally marketed predicate device, the Accu-Chek Softclix Blood Lancing Device (K214022).

The core of the submission revolves around non-clinical bench testing, as clinical testing was deemed not applicable for this device type. Thus, there is no discussion of human-in-the-loop performance, expert ground truth adjudication, or multi-reader multi-case studies typically associated with AI/ML device evaluations.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily based on special controls outlined in 21 CFR 878.4850(c), which focus on design verification and validation testing. The reported performance indicates that the devices passed these tests.

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

Given that this is a mechanical safety and performance evaluation of a lancing device, the "test set" refers to the units of the device that underwent the listed mechanical and cleaning/disinfection tests.

• Sample Size: The document does not specify an exact number of devices tested for each category (e.g., how many TRUEdraw devices for mechanical performance, how many Mini Lancing Devices for cleaning validation). It generally states "Nonclinical bench testing was performed." For cleaning and disinfection validation, it specifies "1,095 cleaning and disinfecting cycles," implying multiple devices or a single device undergoing repeated cycles to simulate 3 years of daily use.
• Data Provenance: The data is generated from bench testing conducted by the manufacturer, Trividia Health. The country of origin for the testing is not explicitly stated, but the company is based in Fort Lauderdale, Florida, United States. The testing is prospective in the sense that it was conducted specifically for this submission.

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

N/A. This is a submission for a mechanical device, not an AI/ML device relying on expert interpretation of medical images. Ground truth is established through engineering and manufacturing specifications, and verification through standard bench testing protocols, rather than expert consensus on retrospective data.

4. Adjudication Method for the Test Set

N/A. As this is not an AI/ML device or a diagnostic device requiring human interpretive ground truth, there is no adjudication method in the context of expert review. Performance is measured against predefined engineering and safety specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A. An MRMC study is not relevant for this type of device (a lancing device). The submission focuses on the mechanical and safety equivalence to a predicate device, not on assessing human reader performance with or without AI assistance.

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

N/A. This is a mechanical lancing device, not an algorithm. There is no software or AI component to evaluate in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this lancing device is based on engineering specifications, design requirements, and established safety and performance standards for lancing devices (e.g., the ability to function mechanically, withstand typical usage, be cleaned effectively, and pose no undue risk of injury or infection). This is verified through objective bench testing.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device; therefore, there is no "training set."

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

N/A. As there is no training set, this question is not applicable.

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Intended use for fixation of complex intra and extra-articular fractures and osteotomies, selective trauma, reconstructive procedures, fusions osteotomies, non-unions, replantations, complex extra articular fractures and fusions of bones of the anatomical regions of the hand, foot and ankle, particularly for osteopenic bone in adults and adolescents.

The Truemed Hand, Foot and Ankle Plates System consist in a variety of plates designed for specific bone areas, with orifices to receive either locking or non- locking screws. The screws can be total or partially threaded, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either Stainless Steel (ASTM 138 - 13a) or Titanium (ASTM F136-12a).

This document is a 510(k) Premarket Notification for a medical device called the "Truemed Hand, Foot and Ankle Plates System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

This document describes a medical device (plates and screws for bone fixation) and its equivalence to other similar devices based on engineering and mechanical testing, NOT an AI/ML powered device, therefore the request regarding acceptance criteria and study proving it meets acceptance criteria for an AI/ML device is not applicable.

However, I can extract the information provided about the device's testing and safety:

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

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

• The document does not specify the sample size used for the mechanical and engineering tests, nor does it mention data provenance (country of origin, retrospective or prospective).

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)

• This information is not applicable and not provided. The "ground truth" in this context is the performance relative to established material standards and predicate devices, assessed through engineering and mechanical testing, not by expert consensus on clinical data.

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

• This information is not applicable and not provided. The "test set" here refers to physical components undergoing mechanical and engineering evaluation, not clinical data requiring adjudication.

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 information is not applicable. This is a medical device for bone fixation, not an AI/ML powered diagnostic or assistance tool.

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

• This information is not applicable. This is a medical device for bone fixation, not an AI/ML powered algorithm.

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

• The "ground truth" for this device's performance is established by engineering analyses, mechanical testing against material standards (ASTM, ISO), and direct comparison to the physical and functional characteristics of legally marketed predicate devices.

8. The sample size for the training set

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

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

• This information is not applicable. There is no "training set."

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The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.

The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes, for neonatal use or for alternative site testing.

The TRUE METRIX Self Monitoring Blood Glucose Test Strips are for use with the TRUE METRIX GO Self Monitoring Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

Not Found

This document is an FDA 510(k) clearance letter for the TRUE METRIX GO Self Monitoring Blood Glucose System. While it states the indications for use, it does not contain detailed acceptance criteria, study data, or information regarding ground truth establishment, expert qualifications, or sample sizes for training and testing as requested. This type of information is typically found in the submission itself, not the clearance letter.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) submission document (K143548) or an equivalent performance study report for the device.

The provided text only includes:

• Device Name: TRUE METRIX GO Self Monitoring Blood Glucose System
• Regulation Number/Name: 21 CFR 862.1345, Glucose test system
• Regulatory Class: II
• Product Code: NBW, LFR
• Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood from the fingertip, for self-testing by people with diabetes at home to monitor diabetes control. Not for diagnosis, screening, neonatal use, or alternative site testing.
• Type of Use: Over-The-Counter Use (21 CFR 801 Subpart C)

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The TRUESPAN Meniscal Repair System is intended for use in meniscal repairs and meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

The proposed device is an all-inside meniscal repair system. The implant consists of two rigid backstops (absorbable PLGA1 or non-absorbable PEEK2), size #2-0 Orthocord suture and UHMWPE braid. The implant system and applier are pre-assembled, and the whole device is sterile, for single patient use only. Compression of the fixation point is accomplished by pulling on the suture post to allow the two suture strands creating the bridge between the implants to lay tight on the surface of the fixation point. *1 PLGA: Poly(lactide-co-glycolide) *2 PEEK: polyaryletherketone

The provided text is a 510(k) summary for the TRUESPAN™ Meniscal Repair System. It describes a medical device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about an AI-powered device or a study proving an AI device meets acceptance criteria.

Specifically, the document discusses:

• Device Name: TRUESPAN™ Meniscal Repair System
• Intended Use: Meniscal repair and meniscal allograft transplant procedures, anchoring the allograft to the meniscal rim.
• Device Description: An all-inside meniscal repair system consisting of rigid backstops (absorbable PLGA or non-absorbable PEEK), #2-0 Orthocord suture, and UHMWPE braid. The system is pre-assembled, sterile, and for single patient use.
• Safety and Performance: States that "Implant system strength was evaluated in vitro and after cyclic (bench top). The testing demonstrated substantial equivalence of performance to the predicate device. Biocompatibility is also confirmed based on biocompatibility data and justification. The proposed device has raised no new issue of safety and efficacy."
• Substantial Equivalence: Concludes that the proposed device is substantially equivalent to the predicate device based on similar technological characteristics and comparable implant system strength.

Since the request asks for details about an AI-powered device and a study proving its acceptance criteria, and the provided text describes a meniscal repair system (a physical medical implant) and its mechanical/biocompatibility testing, I cannot fulfill the request using only the provided text. The information requested (acceptance criteria table, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, training set details) is typical for AI/software as a medical device (SaMD) clearances, not for a physical implant like the TRUESPAN system.

Therefore, I cannot provide the requested table or answer the specific questions about AI device performance and studies based on the given document.

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The True™ Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

The True™ Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The quidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Three radiopaque markers are embedded in the balloon wall. These bands are positioned at the proximal and distal balloon shoulders, and in the middle. These bands are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the True™ Flow Valvuloplasty Perfusion Catheter:

Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report proving a device meets specific clinical acceptance criteria in a human population. Therefore, many of the requested items related to human studies (sample sizes, expert qualifications, adjudication, MRMC) cannot be directly extracted from this document, as the "studies" mentioned are primarily non-clinical (in vitro) performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance data categories and concludes that the device "met all predetermined acceptance criteria of design verification and validation." However, it does not provide a specific table detailing the quantitative acceptance criteria for each test or the exact numerical performance results. It merely states that the criteria were met.

Therefore, the table below reflects what is reported in the document:

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

• Sample Size: The document does not specify the sample sizes used for each individual non-clinical (in vitro) test. It simply lists the types of tests performed.
• Data Provenance: The tests are described as "in vitro tests," meaning they were conducted in a lab environment, not on human subjects. They are non-clinical studies. The country of origin of the data is not specified, but the applicant is "Bard Peripheral Vascular, Inc" located in Tempe, Arizona, USA.

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

This information is not applicable and not provided in this document. Ground truth, in the context of expert consensus, typically refers to clinical data or interpretations by medical professionals. The studies described are primarily engineering and biocompatibility tests, not studies requiring expert clinical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in this document. Adjudication methods (like 2+1 or 3+1) are usually for resolving discrepancies in expert opinions on clinical test data. Since the tests are in vitro performance tests, such a method is not relevant.

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

An MRMC comparative effectiveness study was not done. This document describes a medical device (a catheter), not an artificial intelligence (AI) system or a diagnostic imaging tool that would typically involve human readers.

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

This information is not applicable. The device is a physical medical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the in vitro performance and biocompatibility tests, the "ground truth" would be established by:

• Engineering specifications and design requirements: For mechanical, dimensional, and functional tests (e.g., balloon burst, trackability, inflation/deflation time).
• Standardized test methods and validated analytical techniques: For chemical, material interaction, and biological safety tests (e.g., MEM Elution, Rabbit Pyrogen Test, Thrombogenicity tests).
• Comparison to predicate device performance benchmarks: The overall conclusion relies on demonstrating "substantial equivalence" to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This document describes a physical medical device and its non-clinical testing, not an AI or machine learning product.

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

This information is not applicable. As stated above, there is no "training set" in the context of this device's evaluation.

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The TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX AIR Self-Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. Alternative site testing can only be performed during steady-state blood times (when glucose is not changing rapidly). The TRUE METRIX Self-Monitoring Test Strips are for use with the TRUE METRIX AIR Self-Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

The TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood. The TRUE METRIX AIR PRO Professional Blood Glucose System is intended for multiple patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX AIR PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used for the diagnosis or screening of diabetes. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX AIR PRO Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm or venous whole blood.

Not Found

This document is an FDA 510(k) clearance letter for the TRUE METRIX AIR Self-monitoring Blood Glucose System and the TRUE METRIX AIR PRO Professional Blood Glucose Monitoring System. It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study methodologies commonly found in a clinical study report or a detailed 510(k) submission.

Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on the regulatory clearance for the device, including:

• Device Name: TRUE METRIX AIR Self-monitoring Blood Glucose System and TRUE METRIX AIR PRO Professional Blood Glucose Monitoring System
• Regulation Number and Name: 21 CFR 862.1345, Glucose test system
• Regulatory Class: II
• Product Code: NBW
• Indications for Use: Quantitatively measuring glucose in fresh capillary whole blood (and venous whole blood for the PRO system) for diabetes monitoring, intended for self-testing or professional healthcare settings. It explicitly states it should not be used for diagnosis, screening, or neonate use.
• Type of Use: Over-The-Counter for the standard system; Prescription Use and Over-The-Counter Use for the PRO system.

To answer your questions, I would need a clinical study report, a summary of safety and effectiveness data, or a more detailed section of the 510(k) submission that describes the validation studies.

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The True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

The True™ BAV Balloon Valvuloplasty Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

The provided text describes a medical device, the True™ BAV Balloon Valvuloplasty Catheter, and its substantial equivalence to predicate devices, rather than a study evaluating an AI/ML device. Therefore, much of the requested information regarding acceptance criteria and studies for AI/ML performance (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) is not applicable here.

However, I can extract the information related to device performance and acceptance criteria as presented in the document for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the "True™ BAV Balloon Valvuloplasty Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, specific numerical acceptance criteria and their corresponding reported device performance values are not provided in the text. The document lists the types of in-vitro tests performed, implying that for each of these, acceptance criteria existed and were met.

Here's a table based on the provided text, outlining the tests performed, which inherently means they had acceptance criteria that were met, but the specific numerical criteria and results are not detailed.

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

This information is not provided in the document. The text describes in-vitro (bench) testing, not clinical studies with patients or data sets in the typical sense for AI/ML validation. There's no mention of sample sizes for individual tests or the provenance of any "data."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device submission. There is no mention of experts or ground truth establishment as it typically refers to for AI/ML diagnostic devices. The acceptance criteria for this device are based on engineering specifications and performance standards through in-vitro testing.

4. Adjudication Method

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for reconciling differing expert opinions, which isn't part of this device's testing and validation process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device like a balloon catheter.

6. If a Standalone (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 catheter, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is based on engineering specifications, established performance standards, and internal risk assessment procedures as demonstrated through the in-vitro tests listed. It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device's ground truth would be.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" applies to machine learning algorithms, which is not what this device is.

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

This information is not applicable as there is no "training set" for this device.

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The TrueBeam and Edge Systems are intended to provide stereotactic radiotherapy for lesions, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carvinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear accelerators that integrate the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.

The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.

This document is a 510(k) Premarket Notification for the TrueBeam/Edge Radiotherapy Delivery Systems from Varian Medical Systems, Inc. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

The document states that no changes have been made to the device and no new testing has been performed. This implies that the current submission relies on the performance data and acceptance criteria established for the predicate devices. Therefore, the specific details regarding acceptance criteria and a study proving the device meets them are not explicitly provided for this specific submission. Instead, the submission asserts that the device is substantially equivalent to previously cleared devices which would have undergone such scrutiny.

Based on the provided text, here is what can be inferred and what information is not available:

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

• Not explicitly provided in this document for the current submission. The document states, "No changes have been made to the device and no new testing has been performed." This implies reliance on previous testing and acceptance criteria for predicate devices like K123291 (TrueBeam Radiotherapy System and Accessories).

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

• Not available in this document. Since no new testing was performed for this submission, these details would be found in the documentation for the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not available in this document. As no new testing was performed, this information is not included here. This would have been established during the testing of the predicate devices.

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

• Not available in this document. Similar to the above, this information pertains to the testing of predicate devices, not this specific submission which states no new testing.

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 and not available.
  • This device is a radiation therapy delivery system, not an AI or imaging interpretation device that would involve human readers interpreting AI outputs.
  • The document explicitly states, "No changes have been made to the device and no new testing has been performed."

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

• Not applicable and not available. This is a hardware system for radiation delivery, not an algorithm that would be tested in a standalone manner for performance metrics like sensitivity or specificity.

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

• Not available in this document. This information would be relevant to the performance testing of the predicate devices, which is not detailed here.

8. The sample size for the training set:

• Not applicable and not available. This is a radiation therapy delivery system, not an AI/machine learning algorithm requiring a "training set" in the typical sense.

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

• Not applicable and not available. As above, this is not an AI/machine learning algorithm with a training set.

Summary of what is provided by the document regarding performance and equivalence:

The core of this 510(k) submission is that the TrueBeam and Edge Radiotherapy Delivery Systems are substantially equivalent to their previously cleared predicate devices.

• Predicate Devices: TrueBeam Radiotherapy System and Accessories (K123291), CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems (K102650), Agility™ (K123808).
• Reason for Substantial Equivalence Claim:
  • "The device itself is unchanged from the previous submission K123291."
  • "The principles of operation, technological characteristics and labeling are substantially equivalent."
  • The only change highlighted for this submission is the addition of specific examples of lesions, tumors, and conditions to the Indications for Use statement, which "does not change the therapeutic effect of the device" and "fall within the previously cleared general indication."
  • "No changes have been made to the device and no new testing has been performed."

Therefore, for the current submission (K140528), the "proof" that the device meets acceptance criteria is the argument of substantial equivalence to predicate devices that have already met their respective acceptance criteria through prior studies and FDA clearance. The document explicitly states that no new testing was performed for this specific submission because the device itself is unchanged.

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The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.

The TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The TRUE METRIX Self Monitoring Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.

The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used for neonates or for the diagnosis or screening of diabetes. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or venous whole blood.

Not Found

This document is an FDA 510(k) premarket notification acceptance letter for blood glucose monitoring systems. It does not contain information about the acceptance criteria or a study proving device performance. The sections provided focus on regulatory approval, indications for use, and administrative information related to the FDA submission.

Therefore, I cannot provide the requested information based on the given text.

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