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The Greatbatch Scientific MR Compatible Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Greatbatch Scientific MR Compatible Hysteroscopes are available in standard and autoclavable 2.0mm and 4.0mm outer diameters with 0° and 30° viewing angles.

The provided text describes the 510(k) summary and FDA clearance letter for the Greatbatch Scientific MR Compatible Hysteroscope. It states that the device was tested for MR compatibility. However, the document does not provide detailed information about the acceptance criteria or the specific study details for proving the device meets those criteria. The information below is limited to what can be extracted from 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)

The document does not specify the sample size or data provenance for the MR compatibility testing.

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. The testing was for MR compatibility, which typically involves physical measurements rather than expert interpretation of data.

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

Not applicable. This is not a study involving human interpretation of results.

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

Not applicable. This device is a medical instrument, not an AI software, and the testing was for MR compatibility, not for diagnostic accuracy that would involve human readers.

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

Not applicable. This is a medical instrument, not an AI algorithm. The testing was for the inherent MR compatibility of the device.

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

The ground truth for MR compatibility would be established by specific performance standards and physical measurements as defined by applicable medical device standards for MR safety (e.g., ASTM standards for MR compatibility). The document does not explicitly state the specific standards or measurements used.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The Greatbatch Scientific MR Compatible Laryngoscope is intended for use in endoscopic visualization and surgery on the trachea, pharynx and larynx in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

The Greatbatch Scientific MR Compatible Laryngoscope is available in standard and autoclavable 8.0mm, 70° angle.

The provided text describes the Greatbatch Scientific MR Compatible Laryngoscope and its MR safety testing.

Here's an analysis of the acceptance criteria and study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Implied Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for magnetic attraction, torque, or artifact. However, the FDA's clearance implies that the reported performance was deemed "acceptable" for MR compatibility. For RF heating, a 1.1°C rise is reported, which is generally considered a safe and acceptable level for medical devices in an MR environment. The "artifact same as the device ++" implies that the new device's artifact profile is comparable to, and thus acceptable relative to, the predicate device.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • The document describes a single device being tested for MR compatibility. It's not a study with a "test set" in the typical sense of evaluating diagnostic performance with multiple patient cases. Instead, it's a physical device testing to ensure safety and compatibility in an MR environment. Therefore, the "sample size" is 1 device.
• Data Provenance:
  • The testing was performed directly on the Greatbatch Scientific MR Compatible Laryngoscope.
  • The location of the testing is implied by the "GE Signa 64 MHz MR System," suggesting a controlled laboratory or clinical setting where such equipment is available. No specific country of origin for the data is mentioned, but the submitter is based in New York, USA.
  • The study is prospective in the sense that the new device was subjected to specific MR compatibility tests.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This submission is for device safety and compatibility testing, not for diagnostic performance evaluation or establishing a "ground truth" for clinical outcomes or interpretations. The "truth" in this context is the physical behavior of the device in an MR environment. The experts involved would be engineers and physicists conducting and interpreting the MR safety tests according to established standards.

4. Adjudication Method

• Not applicable. This study is not a clinical performance study requiring adjudication of expert interpretations. The results are objective measurements of physical properties.

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

• No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic performance of AI or imaging interpretation by human readers, which is not the purpose of this submission.

6. Standalone Performance (Algorithm Only without Human-in-the-loop)

• Yes, in spirit. The MR compatibility tests performed are akin to a "standalone" evaluation of the device's physical properties without human interaction influencing the measurements. The device itself (the laryngoscope) is the subject of the performance evaluation in the MR environment. There is no algorithm involved.

7. Type of Ground Truth Used

• The "ground truth" for this study is based on objective physical measurements and established MR safety standards/guidelines. For example, magnetic attraction is measured by string deflection and torque, artifact by visual inspection of images, and RF heating by temperature sensors. There isn't a "pathology" or "outcomes data" ground truth in this context.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set." The device is a physical instrument.

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

• Not applicable. As there is no training set involved, this question is not relevant.

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For use to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures in a MR or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field.

The Greatbatch Scientific MR Compatible Laparoscope and Operating Laparoscopes are available in standard and autoclavable 8.0mm, 10.0mm sizes, with 0°, 30° or 45° angles.

The acceptance criteria for the Greatbatch Scientific MR Compatible Laparoscope and Operating Laparoscope are focused on MR compatibility within a 1.5 Tesla static magnetic field. The study conducted to prove this compatibility involved testing an 8.0mm endoscope from Greatbatch Scientific in conjunction with a 1.5 Tesla GE Signa Magnet.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: The test set included "A Greatbatch Scientific MR Compatible 8.0mm endoscope". This suggests a sample size of one device (an 8.0mm endoscope) for the tests described.
• Data Provenance: The testing was conducted in a laboratory setting using a 1.5 Tesla GE Signa Magnet. The report does not specify the country of origin but implies a controlled, non-clinical environment. The study is prospective as it involves direct testing of the device for its compatibility.

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

This type of information is not applicable (N/A) to this study. The tests performed are objective physical measurements of the device's interaction with an MR environment (magnetic attraction, torque, artifact, and heating). The "ground truth" is established by direct measurement of physical properties, not by expert interpretation.

4. Adjudication method for the test set:

Not applicable (N/A). As mentioned above, the tests are objective physical measurements. There is no expert adjudication involved in determining magnetic attraction, torque, artifact intensity, or temperature rise. These are measured values against predefined criteria.

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. This study is not an MRMC comparative effectiveness study. It assesses the physical compatibility of a medical instrument with an MR environment, not the performance of an AI algorithm or its impact on human readers.

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

No. This study is not related to an algorithm's performance. It evaluates a physical device (a laparoscope).

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

The "ground truth" for this study is based on objective physical measurements and established MR safety standards/guidelines. The measured values for magnetic attraction, torque, artifact generation, and temperature rise are directly assessed against thresholds considered safe and acceptable for an MR-compatible device.

8. The sample size for the training set:

Not applicable (N/A). This study describes the testing of a physical medical device for MR compatibility. There is no "training set" as there is no machine learning or AI component involved.

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

Not applicable (N/A). As there is no training set.

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The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes and Accessories are intended for use by practioners to treat the small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal- mandibular joint of patients in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes are available in standard and autoclavable 1.7mm, 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the core acceptance criterion is related to MR compatibility.

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

The provided 510(k) summary does not specify the sample size used for the MR compatibility testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective). This information is typically found in the detailed test report, which is not included here.

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

This type of information is not applicable to a device like an arthroscope, which is evaluated for physical performance characteristics (like MR compatibility) rather than for diagnostic accuracy based on expert interpretation of images or other data. The "ground truth" for MR compatibility would be established through engineering tests and measurements, often against established standards.

4. Adjudication Method for the Test Set

This concept is not applicable to the type of performance data presented here. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., of medical images) where there might be disagreement among experts. For physical device testing, the results are usually objective measurements, not subject to adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers are involved in interpreting output. The Greatbatch Scientific MR Compatible Arthroscopes are physical medical devices, not AI software.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone study in the context of an algorithm or AI performance was not done. This device is a physical instrument, not an algorithm. The testing performed was related to the physical properties of the device itself (MR compatibility).

7. The Type of Ground Truth Used

The "ground truth" for this study was established through engineering and performance testing related to MR compatibility. This would involve objective measurements of electromagnetic interference, heating, and other physical interactions with an MRI environment, likely against predefined limits (e.g., as per ASTM standards for MR safety). It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This concept is not applicable. The device is a physical arthroscope, not an AI model requiring a training set.

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

This concept is not applicable as there is no training set for a physical medical device like this arthroscope.

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The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended to facilitate and aid in tracheal . - intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnet field.

The MR Fiber Optic Intubating Laryngoscope consists of a handle which is manufactured from brass and is chrome plated. The cell used to provide the light source energy is a proprietary "c" size cell.

The provided document describes the 510(k) premarket notification for the "MR Fiber Optic Intubating Laryngoscope Handle." This is a medical device submission, and the focus of the testing and acceptance criteria is on demonstrating the device's substantial equivalence to existing predicate devices, particularly its safety for use in an MRI environment.

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

1. Table of Acceptance Criteria and Reported Device Performance

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The Greatbatch Scientific MR Compatible Sinuscope is intended for use in sinus endoscopy surgery in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

The Greatbatch Scientific MR Compatible Sinuscope is available in standard and autoclavable 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.

Here's a breakdown of the acceptance criteria and study information for the Greatbatch Scientific MR Compatible Sinuscope, based on the provided documents:

Acceptance Criteria and Device Performance

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