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The One Touch Spiral Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

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This document is a 510(k) clearance letter for the "One Touch Spiral Condom" and describes its indications for use. It outlines administrative details, regulatory compliance information, and contact details for further inquiries regarding FDA regulations. However, this document does not contain information about the acceptance criteria for a device's performance, nor does it detail any study proving a device meets such criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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The One Touch male natural rubber latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The One Touch condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitting membrane. The condom is straight-walled with a reservoir tip, and is silicone lubricated. Condom dimensions are length 210 ± 10 mm, width 60 ± 2 mm, and thickness 0.07 ± 0.01 mm. The condom is designed to conform to the requirements of ASTM D3492:2016 and ISO 4074:2015.

The provided text describes a 510(k) premarket notification for a male natural rubber latex condom called "One Touch." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for an AI/algorithm-driven medical device. Therefore, much of the requested information regarding AI device testing is not applicable.

However, I can extract the relevant information from the document as it pertains to the condom's performance and the testing conducted.

Device Name: One Touch (Male Natural Rubber Latex Condom)
510(k) Number: K181844

The device is a physical product (a condom), not an AI/algorithm-driven device. Therefore, questions 2 through 9 regarding sample sizes, ground truth, expert opinions, adjudication methods, and training sets are not applicable in this context.

Here's the closest information available concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a condom, "acceptance criteria" are typically defined by recognized standards (ASTM, ISO) and specific measurements and performance requirements. The document indicates the device conforms to these standards.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria consists of various performance tests detailed in the "Summary of Performance Testing" section.

• Biocompatibility testing:

  • Cytotoxicity testing per ISO 10993-5:2009
  • Guinea pig maximization sensitization testing per ISO 10993-10:2010
  • Vaginal irritation testing per ISO 10993-10:2010
  • Acute systemic toxicity testing for ISO 10993-11:2006
  • Result: All biocompatibility tests were passed/met requirements.

• Physical Testing Data:

  • Test: Airburst specifications of ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods, and ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms).
  • Result: "Three lots of devices were tested at baseline and met airburst specifications."

• Shelf Life:

  • Test: Stability testing per the requirements of 21 CFR §801.435.
  • Result: Supported a shelf-life of five years.

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

• Physical Testing: "Three lots of devices" were tested for airburst specifications. The exact number of condoms per lot is not specified, nor is the country of origin explicitly stated for the testing data (though the manufacturer is Thai Nippon Rubber Industry Public Company Ltd. in Thailand). The data is retrospective, as it's part of a premarket submission.
• Biocompatibility/Shelf-life: Not specified in terms of sample size, but general statements indicate tests were conducted and met requirements.

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

• Not Applicable. This is a physical device, and its performance is measured against established international and national standards/specifications (e.g., ISO, ASTM, 21 CFR), not by expert consensus on image interpretation or diagnosis.

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

• Not Applicable. The performance tests involve objective physical and chemical measurements rather than subjective expert review 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:

• Not Applicable. This is a physical condom, not an AI or algorithm-driven device.

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

• Not Applicable. This is a physical condom, not an AI or algorithm-driven device.

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

• Ground Truth for Condom Performance: The "ground truth" for condom performance is defined by the objective, measurable requirements specified in established international and national standards such as ISO 4074:2015, ASTM D3492:2016, and FDA regulations like 21 CFR §801.435, as well as specific biocompatibility standards (e.g., ISO 10993 series). These standards provide quantifiable thresholds for properties like burst pressure, tensile strength, and biocompatibility endpoints.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/machine learning model that requires a training set.

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

• Not Applicable. No training set is used for a physical device.

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I am sorry, but the provided text from the FDA letter (K171213) does not contain information about the acceptance criteria or a study that proves the device meets those criteria for the "One Touch Condom with Benzocaine."

The text is a standard FDA 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It outlines the regulatory framework, general controls, and other requirements for the manufacturer. It does not include specific performance data, study designs, or acceptance criteria.

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

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The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The OneTouch® Verio" Blood Glucose Monitoring 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 OneTouch® Verio™ Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv).

The OneTouch® Verio™ Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The OneTouch® Verio" Blood Glucose Monitoring System consists of the OneTouch® Verio" Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio" Control Solutions (mid and high levels), the Lancing Device, Sterile Lancets and Clear Cap (sold separately). The OneTouch® Verio" System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

Here's a breakdown of the acceptance criteria and study information for the OneTouch® Verio™ Blood Glucose Monitoring System, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to testing being done in accordance with ISO 15197:2003(E). While explicit numerical acceptance criteria for each category are not always stated outright, the results presented are the reported device performance and implicitly demonstrate that the device meets the standards of ISO 15197:2003(E).

Detailed Study Information:

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

• System Accuracy:
  • For glucose concentrations <75 mg/dL: 106 samples.
  • For glucose concentrations ≥75 mg/dL: 504 samples.
  • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The phrase "samples were tested in duplicate on three test strip lots" suggests these were controlled laboratory/clinical tests. The document implies a comparison against a "laboratory reference method" (YSI), which would typically be performed within a clinical laboratory setting.
• Precision (Within Run): 300 venous blood tests.
• Total Precision: 600 control solution tests.
• User Performance Evaluation:
  • Fingertip (<75 mg/dL): 28 samples for "Subject" and 28 samples for "HCP".
  • Fingertip (≥75 mg/dL): 128 samples for "Subject" and 125 samples for "HCP".
• Alternate Site Testing:
  • Palm (<75 mg/dL): 8 samples.
  • Forearm (<75 mg/dL): 7 samples.
  • Palm (≥75 mg/dL): 154 samples.
  • Forearm (≥75 mg/dL): 144 samples.
  • Data Provenance: The user performance and alternate site testing suggests prospective human subject testing. The data provenance (e.g., country of origin) is not specified.

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

The document mentions validation against a "laboratory reference method, the Yellow Springs Instrument (YSI)." YSI instruments are highly accurate laboratory analyzers. The use of a YSI as the ground truth implies that its results are considered the gold standard, and the "experts" in this context would be the technicians operating and maintaining such a reference system, ensuring its proper calibration and use, rather than human expert readers interpreting images or data. The number and qualifications of YSI operators are not specified but are assumed to be standard for a clinical laboratory.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth is established by a quantitative laboratory instrument (YSI), not by human interpretation requiring adjudication.

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

No, an MRMC study was not done. This device is a blood glucose monitoring system, not an imaging device or one that relies on human interpretation for diagnosis. The "User Performance Evaluation" section compares meter results from "Subject" (intended users) and "HCP" (Healthcare Professionals) against the laboratory reference, which is a form of user-interaction validation but not an MRMC comparative effectiveness study in the typical sense for AI.

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

Yes, the "System Accuracy" and "Precision" studies represent standalone performance. In these tests, the device (meter and test strip) directly provides a reading, which is then compared to the laboratory reference. There isn't a human in the loop interpreting the result before comparison. The user performance evaluations then add the "human-in-the-loop" aspect (the user taking the sample and performing the test).

7. The Type of Ground Truth Used:

The ground truth used is a laboratory reference method, specifically the Yellow Springs Instrument (YSI), which is an established and highly accurate method for glucose measurement.

8. The Sample Size for the Training Set:

The document does not provide information about a separate "training set" or its size. This type of device (a blood glucose meter) typically undergoes extensive engineering development and internal validation, but the concept of a "training set" in the context of machine learning (where AI algorithms are trained on data) is not explicitly applicable or mentioned here. The testing discussed primarily relates to analytical and clinical validation of the final device.

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

As no explicit "training set" is mentioned in the machine learning sense, this question is not directly applicable. If "training" implicitly refers to the development and calibration of the device, this would have been done by the manufacturer using internal standards and established scientific principles, likely with similar laboratory reference methods to ensure accuracy during development. However, the document provided focuses solely on the validation of the final product.

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The ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips are intended for use with ONE TOUCH ® Brand meters by healthcare professionals and laypersons with diabetes at home to provide a quantitative measurement of glucose in whole blood as an aid in managing their glycemic state.

The ONE TOUCH® Blood Glucose Monitoring System is an in vitro diagnostic product consisting of a test strip impregnated with reagents and a reflectance photometer for the determination of glucose in whole blood. Several different ONE Touch ® Brand reflectance photometers may be used (the ONE TOUCH ® Basic, ONE Touch ® II, or the ONE TOUCH ® Profile Meter). A quality control solution, ancillary devices to aid obtaining a capillary blood sample (lancets and lancing device) as well as data management computer software are also available.

A ONE Touch ® Test Strip is inserted into the meter and a drop of blood applied to the test spot. Glucose oxidase present in the test strip catalyzes the reaction of qlucose in the sample with oxygen to yield gluconic acid and hydrogen peroxide. Hydrogen peroxide subsequently oxidizes dyes in the test strip in the presence of peroxidase, a second enzyme, to produce a blue colored form of the dyes. The intensity of the blue color produced is proportional to the amount of glucose in the sample. The meter measures the amount of light reflected by the blue product and converts it to a glucose concentration that is presented on the meter display. The user adjusts the meter response for each lot of test strips by entering a calibration code that is specific to that lot into the meter.

No modifications to the intended use or to the fundamental scientific technology of the ONE Touch® Blood Glucose Monitoring System are being made. The description above applies to the currently marketed device and will apply equally to the modified device described in this submission.

The provided text is a 510(k) summary for the ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips. It focuses on demonstrating substantial equivalence to a predicate device, primarily through a change in test strip dimensions to allow for a smaller blood drop. The document does not contain the detailed information necessary to answer all the points of your request regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML powered device.

Here's an breakdown of what can be extracted and what is missing, based on the provided text:

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

The document states: "The performance of the modified test strip has been shown to be equivalent to that of the predicate through the acceptable hematocrit range (30% to 55%)."

However, it does not provide a specific table of acceptance criteria (e.g., accuracy metrics like bias, standard deviation, or specific error grid analysis targets commonly used for glucose meters) nor the reported device performance data against those criteria. It only makes a general statement about equivalence regarding hematocrit range.

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

The document does not specify the sample size used for any testing. It also does not provide data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not applicable and not provided in this document. The device is a blood glucose meter, and its 'ground truth' for glucose measurement typically refers to a reference laboratory method, not expert interpretation.

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

This information is not applicable and not provided. Adjudication methods are typically used when human interpretation (e.g., of images) is involved in establishing ground truth.

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 and not provided. This is not an AI/ML powered device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be relevant or conducted.

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

The device is a standalone blood glucose meter. Its performance is inherent in its design and operation. The statement "The performance of the modified test strip has been shown to be equivalent to that of the predicate..." implies a standalone performance comparison. However, specific details about a "standalone study" with detailed methodologies and results are not provided.

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

For a blood glucose meter, the 'ground truth' would typically be reference laboratory glucose measurements (e.g., using a YSI glucose analyzer or a similar laboratory-grade method). However, the document does not explicitly state the type of ground truth used.

8. The sample size for the training set

The document does not mention a "training set" as this is not an AI/ML device. The "training" in the context of a blood glucose meter typically refers to the calibration (entering a code for each lot of test strips), not a machine learning training phase.

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

As there is no "training set" in the AI/ML context, this information is not applicable and not provided.

Summary of what is available from the document:

The provided 510(k) summary focuses on demonstrating that a modification to an existing blood glucose test strip (ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips) does not alter its fundamental performance. The key assertion is that the "performance of the modified test strip has been shown to be equivalent to that of the predicate through the acceptable hematocrit range (30% to 55%)." This implies that the acceptance criteria for equivalence related to hematocrit performance were met, but the specific criteria and corresponding performance data are not detailed in this public summary document.

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The One Touch® Ultra® System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The One Touch® Ultra® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

The One Touch® InDuo™ Blood Glucose Meter is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The InDuo™ Blood Glucose Meter is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

The One Touch® InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.

The One Touch Ultra System consists of the One Touch Ultra Meter. One Touch Ultra Test Strips. One Touch Ultra Control Solution, UltraSoft Lancing Device, UltraClear Cap and UltraSoft lancets. The One Touch Ultra meter, when used with the One Touch Ultra Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The One Touch Ultra Control Solution verifies the performance of the One Touch Ultra Blood Glucose Test Strips.

The One Touch InDuo System consists of the One Touch InDuo Meter (which also functions as a cap for the InDuo Insulin Doser), One Touch Ultra Test Strips, One Touch Ultra Control Solution, UltraSoft Lancing Device, UltraClear Cap and UltraSoft lancets. The One Touch InDuo meter, when used with the One Touch Ultra Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The One Touch Ultra Control Solution verifies the performance of the One Touch Ultra Blood Glucose Test Strips.

The provided documents do not contain information about acceptance criteria or a study that specifically proves the device meets those criteria.

The 510(k) summaries for both the One Touch Ultra and One Touch InDuo Blood Glucose Monitoring Systems state that "There has been no change to the performance characteristics of the device system" and "The modifications to the device system encompass meter software and labeling changes." This implies that the performance characteristics were already established and accepted for the predicate devices, and the current submissions are for minor changes that do not affect those established characteristics.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set details are not present in these documents as they are not new device submissions requiring such detailed performance studies. The 510(k) is based on substantial equivalence to a predicate device, and the changes are described as minor (software and labeling).

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The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart" System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The One Touch® UltraSmari™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.

The One Touch® UltraSmart™ System consists of the One Touch® UltraSmart™ Meter, One Touch® Ultra™ Test Strips, One Touch® Ultra™ Control Solution, UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ lancets. The One Touch® UltraSmart™ Meter, when used with the One Touch® Ultra™ Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The One Touch® Ultra™ Control Solution verifies the performance of the One Touch® Ultra™ Blood Glucose Test Strips.

The UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ lancets are provided to facilitate obtaining a capillary blood sample.

The provided text is a 510(k) summary for the One Touch® UltraSmart™ Blood Glucose Monitoring System. It does not contain detailed acceptance criteria or a study protocol with the specific information requested in the prompt. Instead, it makes a general statement about performance.

Here's what can be extracted based on the provided text, and where information is missing:

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

The document states: "Laboratory studies and clinical studies demonstrate that the One Touch® UltraSmart™ Blood Glucose System provides equivalent performance to the One Touch® Ultra™ Blood Glucose System."

It does not provide explicit numerical acceptance criteria (e.g., specific accuracy percentages, bias limits) or detailed reported device performance against such criteria for the One Touch® UltraSmart™ device itself. It only states equivalence to a predicate device.

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

This information is not provided in the summary.

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 provided in the summary. For a blood glucose monitoring system, the "ground truth" would typically refer to a reference method of glucose measurement (e.g., a laboratory analyzer), not "experts" in the clinical imaging sense.

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

Not applicable for this type of device and not provided in the summary. Adjudication is generally relevant to subjective interpretations, often in imaging studies.

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 for this type of device. The device is a blood glucose monitor, not an AI-assisted diagnostic tool interpreted by human readers. No MRMC study was done.

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

The device itself is a standalone glucose measurement system. The "performance data" mentioned in the summary refers to the device's ability to measure glucose. There's no AI algorithm here in the typical sense of a "standalone" performance study. The device provides a direct measurement.

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

The document implies that the ground truth for performance comparison would be a reference glucose measurement method, likely from a laboratory analyzer, against which the device's readings are compared. However, this is not explicitly stated or detailed in the summary.

8. The sample size for the training set

Not applicable for this type of device. There isn't a "training set" in the context of an AI/machine learning model for this blood glucose monitor.

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

Not applicable for this type of device, as there is no mention of a training set or AI model.

In summary:

The 510(k) summary only states that laboratory and clinical studies demonstrate equivalent performance to a predicate device (One Touch® Ultra™ Blood Glucose System). It does not provide the specific details of these studies that would answer the requested questions about acceptance criteria, sample sizes, ground truth establishment, or study methodologies. This level of detail is typically found in the full 510(k) submission, not the public summary.

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The ONE TOUCH® II Hospital Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in whole blood when monitoring blood glucose levels in hospitals, clinics, and in home settings. ONE TOUCH® Test Strips may be used with the ONE TOUCH® II Hospital Meter to monitor neonates for hypoglycemia in hospital, clinic and home settings. Non-neonatal whole blood glucose measurements may also be reported in terms of approximate plasma/serum equivalents.

The ONE TOUCH® II Hospital Blood Glucose Monitoring System consists of a reagent test strip, a portable, hand-held, battery operated, electronic reflectance photometer (meter) and ancillary devices. The test method employs a dry reagent technology based on the glucose oxidase method and is specific to D-glucose. The intensity of the blue color produced on the strip after applying a drop of whole blood to the ONE TOUCH® Test Strip correlates with the level of glucose in the whole blood sample. The meter measures the reflectance of the reacted test strip at specific wavelengths and displays the corresponding whole blood glucose value or converts the reading to an approximate plasma/serum glucose equivalent.

The provided text for K974451, "ONE TOUCH® II Hospital Blood Glucose Monitoring System 510(k) Submission," does not contain detailed information regarding the specific acceptance criteria for device performance or the study design and results. The document primarily focuses on the device description, intended use, and substantial equivalence to previously marketed devices.

Therefore, I cannot fully answer all the questions as the required details are not present in the provided text.

Based on the available information, here's what can be extracted:

• Device Name: ONE TOUCH® II Hospital Blood Glucose Monitoring System
• Submission Date: November 13, 1997
• Approval Date: January 26, 1998

Missing Information:

The document does not contain critical information needed to answer most of your questions, including:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study, if done, and its effect size.
• Information about a standalone performance study.
• The specific type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set.
• How the ground truth for the training set was established.

General Observations from the Text:

• Substantial Equivalence Claim: The submission states that "No changes to existing technology were required for implementation, so the 'substantial equivalence' of the ONE TOUCH® II Hospital Blood Glucose Monitoring System is unaffected." This implies that the device's performance characteristics were considered substantially equivalent to a predicate device, and thus, detailed new performance studies to establish novel acceptance criteria might not have been a primary focus of this specific summary, but rather referenced existing data or predicate device performance.
• Study Mentioned: The document mentions "summaries of studies demonstrating arterial sample suitability." This indicates that some studies were conducted, but their details (acceptance criteria, sample size, methodology, results) are not provided in this 510(k) summary.
• Intended Use: The device is intended for quantitative measurement of glucose in whole blood in hospital, clinic, and home settings, and can monitor neonates. Non-neonatal results can be reported in whole blood or plasma/serum equivalents.

To answer your questions thoroughly, more detailed performance study reports, which are often part of a 510(k) submission but not always fully summarized in the public-facing 510(k) Summary, would be required.

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