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The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.

The T-Quest System consists of a small mobile scintillation camera, accessories such as optional phantoms, and an optional patient bed. This product includes a notebook computer, an acquisition board, and IM512P Data and Image processor software marketed by MEDX, Inc. under the trade name of NuQuest™ Software. This system is primarily used for the acquisition, processing, and analysis of planar images of the thyroid gland and other small organs.

This appears to be a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria in the typical sense of a de novo or PMA submission.

Therefore, many of the requested sections (2-9) about sample size, ground truth, expert adjudication, MRMC studies, and training sets are explicitly not applicable to this type of submission document as they are not typically required or included. The "study" mentioned here is primarily one of non-clinical device performance comparison and adherence to industry standards, not a clinical trial.

Here's the information extracted and interpreted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission details non-clinical performance and substantial equivalence based on technical specifications and phantom studies, not a clinical test set with patient data in the typical sense.
• The "test set" for performance was likely phantom images, though the specific number of phantom images or type of phantoms is not detailed.
• The data provenance mentioned relates to adherence to international safety and performance standards (UL, CAN/CSA, NEMA) and comparison to a legally marketed predicate device (Inter Medical Gamma Camera System Model CX 250 C Plus, K052473).

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

• Not Applicable. No ground truth established by external experts is described for a clinical test set. The assessment of "excellence" for phantom images (linearity, resolution, uniformity) would have been determined internally by MEDX, Inc. engineers or quality assurance personnel against the NEMA standard.

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

• Not Applicable. No clinical test set or adjudication method is described.

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

• Not Applicable. No MRMC study or AI component is mentioned. This device is a traditional gamma camera system.

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

• Not Applicable. This is a physical device (gamma camera) with associated software (NuQuest™). Its performance is inherently linked to its operation, not a standalone algorithm in the AI sense. The "standalone" performance here refers to the device's technical specifications and adherence to NEMA standards.

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

• For Performance Testing: The ground truth for performance testing (linearity, resolution, uniformity) was based on physical phantom measurements and adherence to NEMA NU 1-2001 industry standards.
• For Substantial Equivalence: The "ground truth" for demonstrating substantial equivalence was the technical specifications and proven performance of the predicate device (Inter Medical Gamma Camera System Model CX 250 C Plus, K052473).

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device requiring a training set in that context. The device and its software (NuQuest™ based on IM512P) have a history of prior FDA clearances (K945792, K961104), indicating established functionality rather than a recently trained algorithm.

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

• Not Applicable. See point 8.

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The AUTO SUTURE* ultrasonic hand instruments have application in abdominal, pediatric, gynecologic, thoracic, urologic and general open and endoscopic procedures for the transection, dissection and coagulation of tissue(s). The instrument is available with a hook probe, with a shear and with a ball probe.

The subject instruments consists of three endoscopic hand instruments which connected by an acoustic transducer to a generator. The hand instruments consist of an ultrasonic shear, ultrasonic hook probe and ultrasonic ball probe.

The provided text is a 510(k) Premarket Notification for a medical device and therefore does not contain the detailed study information typically found in a clinical trial report or a performance study to assess acceptance criteria. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against pre-defined acceptance criteria for a novel technology.

However, I can extract the information provided and note where details are missing based on your request.

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

Based on the provided 510(k) summary, explicit acceptance criteria and corresponding reported device performance against those criteria are not available. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Ethicon Ultracision ultrasonic hand instruments, K961104). The "device description" and "intended use" sections describe the device's function, but no quantitative performance metrics or acceptance thresholds are listed.

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 510(k) summary. The document does not describe any specific test set or data provenance from a performance study.

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 510(k) summary. Given that it's a 510(k) for an ultrasonic surgical instrument, the "ground truth" would likely relate to objective measurements of tissue transection, dissection, and coagulation capabilities, rather than expert interpretation of images. However, no such studies are detailed.

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

This information is not provided in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (an ultrasonic surgical instrument for transection, dissection, and coagulation of tissue). This type of study is typically used for diagnostic devices involving human interpretation of data, often with AI assistance, which is not the function of this surgical tool.

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

This concept is not applicable to the AUTO SUTURE* Ultrasonic Hand Instrument system. This is a physical surgical tool operated by a human, not an algorithm.

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

This information is not provided in the 510(k) summary. For a surgical instrument, "ground truth" related to its performance would likely involve objective measures of tissue effect (e.g., precise cutting, effective coagulation, minimal thermal spread), which would typically be assessed in preclinical (e.g., animal or benchtop) studies. However, the details of such studies are not included in this summary.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

In summary, the provided 510(k) Premarket Notification primarily serves to demonstrate substantial equivalence to a predicate device rather than detailing comprehensive performance studies with explicit acceptance criteria, sample sizes, expert involvement, or adjudication methods as requested. These types of detailed studies would likely have been performed during the development and verification/validation phases but are not included in this summary document.

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