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VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Charger: The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Charger: The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:

• Intraoperative (Microvascular and Vascular)
• Intraoperative Neurological
• Transrectal and Peripheral Vascular.

VascuChek® Surgical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.

VascuChek® Clinical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.

The VascuChek® device follows Track 1.

A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

The provided text is a 510(k) summary for a medical device called VascuChek®. It outlines the device description, indications for use, comparison to predicate devices, and a summary of non-clinical performance testing.

However, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: While it mentions electrical safety, EMC, firmware verification, and biocompatibility testing, these are general device safety and performance criteria, not specific performance metrics for an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Sample size and data provenance for a test set: No information regarding a test set, its size, or where the data came from (country, retrospective/prospective) is provided.
• Number and qualifications of experts for ground truth: There's no mention of experts, how many, or their qualifications, as the device doesn't appear to rely on such ground truth establishment for its performance claims.
• Adjudication method: Not applicable as there's no mention of expert review or ground truth establishment in this context.
• MRMC comparative effectiveness study: There is no indication of such a study being performed or any effect size for human reader improvement with AI assistance.
• Standalone (algorithm only) performance: The device described is a blood flowmeter, a hardware device with firmware, not an AI/ML algorithm that would have standalone performance metrics like sensitivity/specificity.
• Type of ground truth used: Not applicable for a non-AI/ML device that measures physiological parameters.
• Sample size for training set: Not applicable as it's not an AI/ML device.
• How ground truth for training set was established: Not applicable.

Explanation Based on the Provided Document:

The VascuChek® device is a cardiovascular blood flowmeter that uses ultrasonic technology to detect blood flow and convert frequency differences into an audible tone. It's a hardware device with integrated firmware, not an AI/ML-driven diagnostic or assistive tool. The performance studies mentioned are related to:

• Electrical Safety Testing (ANSI AAMI ES60601-1): Ensures the device is electrically safe.
• EMC Testing (IEC 60601-1-2, IEC 60601-2-37): Ensures the device operates correctly in its electromagnetic environment and doesn't interfere with other devices.
• Firmware Verification Testing: Confirms the embedded software functions as intended.
• Biocompatibility information: Addresses the safety of the materials in contact with the patient.

These are standard regulatory requirements for medical devices but are not related to the performance evaluation of an AI/ML algorithm. The document explicitly states that the device employs "identical technology" and "identical firmware requirements and performance" to its predicate devices, indicating that its performance is established through equivalence to existing, cleared devices, rather than through complex AI/ML validation studies.

Conclusion:

The provided 510(k) summary does not contain the information requested regarding acceptance criteria and study details for an AI/ML device because the VascuChek® device is an ultrasonic blood flowmeter and not an AI/ML-based medical device. Therefore, a study demonstrating AI/ML performance metrics (e.g., sensitivity, specificity, reader studies) was not conducted or reported for this submission.

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Remington Medical, Inc. VascuChek™ device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:

• · Intraoperative (Microvascular and Vascular)
• · Intraoperative Neurological
• · Transrectal and Peripheral Vascular

VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.

The VascuChek™ device follows Track 1.

A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

Here's a summary of the acceptance criteria and study information for the VascuChek™ device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing acceptance criteria with numerical performance targets and reported values. Instead, it describes a series of non-clinical and in vivo tests performed. The "reported device performance" is essentially that the device passed these tests and was found to be "substantially equivalent" to the predicate.

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

• Sample Size: Not explicitly stated for each test beyond "the subject device and predicate device" for the in vivo test. It implies a sufficient number of units or test scenarios were used to generate data for each performance test.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/engineering) and in vivo (likely animal or simulated human models for the blood flow assessment, although this is not explicitly stated). The report does not mention human clinical trials. All studies are presumably prospective as they were conducted to support the 510(k) submission.

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

This information is not provided in the document. For the in vivo simulated use test comparing audio quality, it would typically involve trained personnel for evaluation, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (engineering, biocompatibility, in vivo simulation), formal adjudication methods like 2+1 or 3+1 typically used in image interpretation studies are unlikely to be directly applicable. The test results would be assessed against pre-defined engineering or biological standards.

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. The document explicitly states: "No clinical testing was required." The in vivo test was a "simulated use" assessment comparing the subject device to the predicate in terms of audio quality for blood flow measurement, not a clinical study involving human readers/interpreters.

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

This concept is not directly applicable in the context of the VascuChek™ device. This device is a cardiovascular blood flowmeter that produces an audible tone based on the Doppler effect. Its performance is evaluated on its ability to generate an accurate audible signal representing blood flow, which is inherently designed for human interpretation (listening to the audio). There is no "algorithm only" component that would operate without human input in its intended use.

7. The Type of Ground Truth Used

The ground truth for the various non-clinical tests would be established by:

• Engineering Standards/Specifications: For mechanical, electrical, EMC, and software performance.
• Regulatory Standards/Guidelines: For biocompatibility (e.g., ISO 10993), pyrogenicity, sterility, and reprocessing.
• Predicate Device Performance: For the in vivo simulated use test, the performance of the predicate device serves as the comparative "ground truth" or benchmark, implying that the subject device should produce similar (substantially equivalent) audio quality and blood flow detection capabilities.

8. The Sample Size for the Training Set

This information is not applicable as the VascuChek™ device, as described, does not appear to be an AI/machine learning device that requires a "training set." It is a hardware device based on the Doppler effect for real-time blood flow detection.

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

This information is not applicable for the same reason as point 8; there is no "training set" for this type of device.

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The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile, single-use VascuChek™ Clinical Probe which connects to the reusable, nonsterile VascuChek™ Transceiver.

The VascuChek™ device follows Track 1.

A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.

The provided document is a 510(k) summary for the Remington Medical, Inc. VascuChek™ Clinical Device. The product is a cardiovascular blood flowmeter intended for non-invasive transcutaneous evaluation of blood flow in peripheral vasculature. The submission demonstrates substantial equivalence to the predicate device, Vascular Technology Incorporated (VTI) Surgical Doppler (K082870).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner (e.g., minimum sensitivity or specificity). Instead, the performance evaluation is based on demonstrating substantial equivalence to a predicate device through various non-clinical and an in vivo simulated use test. The criteria for acceptance are implied by the successful completion of these tests and a conclusion of substantial equivalence.

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

The document mentions an "in vivo Simulated Use" test. However, it does not specify the sample size used for this test (e.g., number of subjects, number of measurements). It also does not provide details about the data provenance beyond stating it was an in vivo test. Therefore, information regarding country of origin of the data or whether it was retrospective or prospective is not available in the provided text.

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

The document does not mention the use of experts to establish ground truth for any test set. The in vivo simulated use test focused on assessing audio quality and comparing performance to the predicate device, implying that the predicate's output or a direct measurement was used as a reference rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set:

Since the document does not describe the use of multiple experts or a diagnostic task requiring consensus, there is no mention of an adjudication method (e.g., 2+1, 3+1).

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on demonstrating substantial equivalence of the device's technical characteristics and performance to a predicate device, not on how human readers' performance might improve with or without AI assistance. The device itself is a blood flowmeter, not an AI-assisted diagnostic tool for interpretation by human readers in the traditional sense of an MRMC study.

6. Standalone Performance:

The primary focus of the performance data section is on the standalone performance of the VascuChek™ Clinical Device, both through non-clinical bench testing and the in vivo simulated use test. The purpose was to show that the device itself performs comparably to the predicate device.

7. Type of Ground Truth Used:

For the in vivo simulated use test, the ground truth appears to be established by comparison to the predicate device in terms of measuring the velocity of blood flow. The phrasing "compare performance of the new device to its predicate" suggests the predicate's output served as the reference for evaluating the subject device's audio quality in measuring blood flow velocity. There is no indication of pathology, outcomes data, or expert consensus being used as ground truth for this device's specific function.

8. Sample Size for the Training Set:

The document does not mention a training set because the VascuChek™ Clinical Device is a cardiovascular blood flowmeter, not a device that employs machine learning or artificial intelligence requiring a training set in the typical sense.

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

As there is no mention of a training set, there is no information on how its ground truth might have been established.

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Remington Medical, Inc. Automatic Cutting Needle (NAC) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The Remington Medical Inc. Automatic Cutting Needle (NAC) is a device used for obtaining biopsies from soft tissues such as liver, kidnev, prostate, spleen, lymph nodes and various soft tissue tumors in combination with compatible commercial biopsy instrument(s)/gun(s) which are FDA cleared and distributed in the US Market. The Automatic Cutting Needles (NAC) are available in five qauges (differentiated by color) and seven needle lengths. The Automatic Cutting Needle (NAC) is advanced via the compatible commercial biopsy instrument/gun into the desired tissue to obtain a sample for histological examination. The Automatic Cutting Needle (NAC) is a sterile, single patient use and non-pyrogenic device.

The provided text describes a 510(k) premarket notification for the Remington Medical, Inc. Automatic Cutting Needle (NAC). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study or AI model evaluation.

Therefore, many of the requested details, such as those related to AI algorithm performance, training/test set data, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this type of regulatory submission. This is a traditional medical device, not an AI/ML enabled device.

Based on the provided information, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

There isn't a table of specific performance acceptance criteria in the sense of accuracy, sensitivity, or specificity metrics typical for AI/ML devices. Instead, the "acceptance criteria" are implied by the non-clinical testing performed to establish substantial equivalence. The "reported device performance" are the results of these non-clinical tests demonstrating the device's physical and functional properties are comparable to the predicate.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" like in an AI study. The tests listed are non-clinical (e.g., mechanical, material, engineering tests) performed on samples of the device itself.
• Data Provenance: The tests are ex-vivo (meaning, performed outside of a living organism, likely in a lab setting using tissue phantoms or excised animal tissue for the "Simulated Use Soft Tissue Sampling"). The document does not specify a country of origin for the data beyond being conducted by Remington Medical, Inc. for their 510(k) submission. It is by definition "prospective" testing of manufactured devices for regulatory submission.

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

• Not applicable. Ground truth in the context of clinical or AI studies (e.g., disease presence) is not relevant here. The "ground truth" for these engineering tests would be the established specifications and performance of the predicate device, against which the subject device's non-clinical performance is compared. This is a comparison of physical device characteristics.

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

• Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations of medical data (e.g., radiologist reads), which is not part of this 510(k) submission's non-clinical 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:

• No. An MRMC study was not done, as this is for a traditional biopsy needle, not an AI-enabled device.

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

• No. This is not an algorithm, but a physical medical device.

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

• Not applicable in the AI/clinical sense. The "ground truth" for the non-clinical tests is based on engineering specifications, material properties, and the established performance characteristics of the predicate device. For the "Simulated Use Soft Tissue Sampling," the ground truth would be the ability to successfully obtain a biopsy sample comparable to that obtained by the predicate.

8. The sample size for the training set:

• 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:

• Not applicable. There is no "training set" or "ground truth" for it in the context of an AI/ML device.

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Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.

The Tuohy Epidural Needle is a device used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.

Tuohy Epidural Needles consist of a plastic cannula hub, containing a stainless steel bushing, affixed to a stainless steel cannula with medical grade adhesive and a stainless steel stylet affixed to a plastic stylet hub with medical grade adhesive. The cannula hub has the option of a permanent, fixed wing or a removable wing depending on user preference. The needle assembly is protected with a polypropylene sheath.

Tuohy Epidural Needles are provided as a sterile, single use, disposable devices. The Tuohy Epidural Needles will be available in a variety of lengths and gauges. They may be packaged individually or included in regional anesthesia trays (kits).

This FDA 510(k) premarket notification for the Remington Medical Inc. Tuohy Epidural Needle does not describe a study involving an AI/CADe device or its performance criteria, as it is for a physical medical device (an epidural needle).

Therefore, I cannot provide information on acceptance criteria and study details related to AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, or ground truth types in the context of an AI device.

The provided document details the substantial equivalence of a physical medical device (Tuohy Epidural Needle) to predicate devices. It focuses on the physical and functional characteristics of the needle.

However, I can extract the acceptance criteria and reported device performance for the physical device as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):

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

• Sample Size: The document does not specify the exact sample size for each performance test. It broadly states "Tests were performed on the Remington Medical Inc. Tuohy Epidural Needles."
• Data Provenance: The tests are described as "non-clinical testing" conducted to internal functional specifications and relevant ISO standards. No information on country of origin of data (likely internal company testing) or whether it was retrospective or prospective is given, as it refers to engineering and laboratory testing, not human subject data.

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

• Not applicable. This device is a physical epidural needle, not an AI/CADe system requiring expert-established ground truth from images or other medical data. The "ground truth" for this device's performance is objective measurement against engineering specifications and relevant ISO standards.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is mentioned as it is not a clinical study involving subjective interpretation. Performance is measured against objective standards.

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 not an AI 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 not an AI device.

7. The type of ground truth used:

• For the physical properties and performance (e.g., bond strength, flow, biocompatibility): The "ground truth" is established by international standards (ISO 7864, ISO 6009, ISO 10993-1) and internal functional specifications. These are objective, measurable criteria. For catheter placement, visual inspection under magnification was used to confirm no negative impact.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

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

• Not applicable. As this is not an AI device, there is no training set or ground truth in that context.

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The Remington Medical CentreFire 22 Biopsy Instrument is used to obtain multiple core samples from the prostate. It is not intended for bone.

The Remington Medical (RMI) CentreFire 22 Biopsy Instrument is a semi-automatic, reusable, spring-loaded mechanical device that is designed to be used with Remington Medical NAC Biopsy Needles to obtain core biopsy samples from the prostate.

1. Table of acceptance criteria and reported device performance:

The document describes non-clinical performance studies for the Remington Medical CentreFire 22 Biopsy Instrument, focusing on its substantial equivalence to a predicate device, the Medical Device Technologies, Inc. Ultra (K962969). The acceptance criteria for the subject device are implicitly met if its performance is equivalent to the predicate device and meets established requirements for consistent performance and reprocessing.

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

The document does not specify the exact sample sizes used for the non-clinical performance studies (Needle Excursion and Biopsy Sampling) or the reprocessing validations.
The data provenance is from internal non-clinical testing performed by Remington Medical, Inc. (prospective, as it was performed for this 510(k) submission). The geographical origin of the data is not explicitly stated, but it would be assumed to be conducted in the USA where Remington Medical Inc. is based.

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

Not applicable. The study involved non-clinical performance testing and reuse/reprocessing validations, not human-read interpretations requiring expert consensus for ground truth.

4. Adjudication method for the test set:

Not applicable. The study involved non-clinical performance testing and reuse/reprocessing validations, not human-read interpretations requiring adjudication.

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. The document explicitly states: "No clinical testing was required." The evaluation was based on non-clinical performance studies demonstrating equivalence to a predicate device.

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

Not applicable. This is a medical device (biopsy instrument), not an AI algorithm. The performance testing was for the physical instrument.

7. The type of ground truth used:

For the non-clinical performance studies (Needle Excursion and Biopsy Sampling), the ground truth was established through measurement and observation of physical characteristics and outcomes based on predefined test protocols and acceptance criteria. This would involve objective metrics such as actual penetration depth, visual assessment of sample quality and consistency, etc.

For the reuse/reprocessing validations, the ground truth was established by testing the efficacy of cleaning and sterilization protocols to ensure the instrument consistently met accepted standards for reprocessing (e.g., absence of biological residues, sterility assurance levels).

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a medical device, not an AI algorithm.

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The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.

The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources. It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal. A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are: Left Ventricle Tip to Right Ventricle Coil, Left Ventricle Ring to Right Ventricle Coil, Left Ventricle Ring to Left Ventricle Tip, Left Ventricle Tip to Left Ventricle Ring, Right Ventricle Tip to Right Ventricle Coil.

The provided text is a 510(k) summary for the Remington Medical Inc. Model 6149 Pacing Vector Selector Patient Adapter Cable. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement, as these are typically part of a detailed study report or testing documentation, not a 510(k) summary.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.

I can only extract the following relevant information from the provided text:

• Device Name: Guidant Model 6149 Pacing Vector Selector Patient Adapter Cable
• Device Description: A manually operated 3-channel Patient Adapter Cable designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It has no active circuits or power sources. It features a 2-pole, 5-position switch to select between five pacing vector options.
• Intended Use: Used during chronic implantation of a pacing or defibrillation lead system for PSA measurements, providing the capability to switch RV and LV tip and ring signals to five possible electrode combinations.
• Technological Characteristics Summary: The Model 6149 is an accessory to the ERA 300, and its addition is considered minor, raising no safety or effectiveness concerns.

To answer your specific questions, information not present in the provided text includes:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sizes used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. The device is a passive adapter cable, not an AI or imaging device that would typically undergo such a study.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done: Not present. The device is an adapter, not an algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence rather than a detailed performance study report. It indicates the device is a simple, manually operated adapter cable with no active components, making many of your questions about AI study methodologies (like training sets, ground truth establishment, and expert adjudication) not applicable to this particular device.

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The Remington CenterFire is Intended for use in obtaining biopsies from soft tissue such as liver, kidney, prostate, breast, spleen and various soft tissue turnors. It is not intended for use in the bone.

Remington CentreFire Biopsy Instrument

The provided text is a 510(k) clearance letter from the FDA for the Remington CentreFire Biopsy Instrument. It does not contain information about the acceptance criteria for a device's performance, nor does it describe any study that proves a device meets such criteria. Instead, it states that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the provided text. The document is a regulatory approval letter, not a technical report detailing performance studies.

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Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.

Drainage Bag

The provided document is a 510(k) clearance letter from the FDA for a Drainage Bag (K990428). This type of document is a regulatory approval and does not contain information about device acceptance criteria, performance studies, or AI performance metrics as requested in the prompt.

Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on:

1. Confirming that the device is substantially equivalent to legally marketed predicate devices.
2. Outlining the regulatory requirements for marketing the device.
3. Stating the intended use of the device.

There is no data presented in this document about clinical studies, test sets, ground truth, or AI performance.

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Needle Guides shall be single use only and are to be used by a mammographic x-ray specialist in a healthcare setting to aid in needle placement.

Needle Guide

This document is a 510(k) clearance letter from the FDA for a Needle Guide manufactured by Remington Medical, Inc. It explicitly states that the device is "substantially equivalent" to predicate devices, meaning it does not require a new study to prove its safety and effectiveness.

Therefore, the input does not provide information about:

• Acceptance criteria and reported device performance: Since it's a 510(k) clearance based on substantial equivalence, there are no specific performance acceptance criteria or study results presented in this document.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, type of ground truth for test or training sets, or how ground truth was established. These are all elements of a de novo or PMA submission, not a 510(k) based on substantial equivalence.

The document essentially states that because a similar device is already on the market and the new device is substantially equivalent, it does not need to go through the rigorous testing and reporting described in your request.

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