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declipseSPECT Laparoscopy is an enhancement of the declipseSPECT system for minimal invasive surgery using a laparoscopic gamma probe. declipseSPECT Laparoscopy works in conjunction with a laparoscopic nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Laparoscopy is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.

declipseSPECT Laparoscopy is used intraoperatively or on pathological specimens. For any intraoperative usage the laparoscopic gamma probe needs to be covered by a protective sterile cover. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicians that are trained to use the system.

The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel. declipseSPECT Laparoscopy is compatible currently to following nuclear uptake detectors:

| Probe
Manufacturer | Probe Model | Probe Handle Model | Energy range of
gamma rays |
|-----------------------|-------------|--------------------|-------------------------------|
| Crystal Photonics: | SG04 | CXS-OP-SZL-45 | 60-245 keV |

Not Found

The provided documentation describes the declipseSPECT Laparoscopy device, but it lacks the specific details required to complete a comprehensive acceptance criteria and study report. The document is a 510(k) clearance letter from the FDA, indicating substantial equivalence to a predicate device, but it does not contain the detailed performance study results or acceptance criteria themselves.

Therefore, I cannot provide the requested information from the given text. The document states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not include the detailed performance metrics or the studies used to demonstrate that equivalence beyond a general statement of intent and indications for use.

To answer your request, a much more detailed technical document, such as a summary of safety and effectiveness, clinical study report, or design validation report, would be needed.

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declipseSPECT Viewer works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Viewer is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.

declipseSPECT Viewer may also be used intraoperatively or on pathological specimens if a protective cover is used to cover the nuclear uptake detector. dedipseSPECT Viewer may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist and physicians that are trained to use the system.

The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

Not Found

This document is a 510(k) clearance letter from the FDA for the "declipseSPECT Viewer" device. It does not contain the detailed information required to answer the prompt regarding acceptance criteria and performance studies.

The prompt asks for specific details about the study design (sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details), which are typically found in the summary of safety and effectiveness or in the full submission, not in the clearance letter itself.

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

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Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

CSS300 is an extension for nuclear uptake detectors designed to obtain 3D images from small organs and structures labeled using radionuclides emitting gamma rays by acquiring data while moving freely with the hand the said detectors. Examples of nuclear uptake detectors compatible with CSS300 are the nuclear uptake detectors by Crystal Photonics. CSS300 includes also analysis and display equipment, an optical camera, a cart and an ergonomic arm which allows positioning the required positioning sensor and camera in a suitable position while using the device.

This document focuses on the 510(k) summary for the "Confident Surgery Suite 300 (CSS300)" system and primarily discusses its intended use and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, detailed study designs, or performance metrics that would be typically found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot fully complete the table and answer all questions as the requested information is not present in the provided text.

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

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

This information is not present in the provided document. The document lists safety standards met (EN 60601-1, UL 60601-1, EN 60601-1-2:2007) and indicates CE Mark compliance, which are general regulatory requirements, not specific performance acceptance criteria for the imaging capabilities.

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

This information is not present in the provided document.

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 present in the provided document.

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

This information is not present in the provided document.

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

There is no mention of an MRMC study or AI in the context of improving human reader performance. The CSS300 is described as an "extension for nuclear uptake detectors designed to obtain 3D images" and "make their use more intuitive and thus enable better patient treatment," but it doesn't describe AI-assisted interpretation. Therefore, this information is not present.

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

The device is described as "working in conjunction with a nuclear uptake detector" and generating images for interpretation by "trained personnel." This implies a human-in-the-loop system. There is no mention of a standalone algorithm performance study. This information is not present.

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

This information is not present in the provided document.

8. The sample size for the training set

This information is not present in the provided document.

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

This information is not present in the provided document.

Summary of what is available from the document:

• Device Name: Confident Surgery Suite 300 (CSS300)
• Intended Use: Extends nuclear uptake detectors to generate 3D images of radionuclide distribution in the human body using tracking technologies and image reconstruction. Images are for documentation and reporting, and interpretation is by trained personnel.
• Regulatory Basis: 510(k) clearance based on substantial equivalence to predicate devices (Neoprobe Model 1500, SI-Handheld Gamma Finder, VectorVision2, Nexstim Eximia).
• Technology: Combines nuclear uptake detection with an infrared tracking system and image reconstruction.
• Safety Standards: Meets EN 60601-1, UL 60601-1, EN 60601-1-2:2007, and bears the CE mark.

To provide the requested details, a different type of document, such as a validation study report, clinical trial summary, or a more detailed section of the 510(k) submission focusing on performance characterization, would be required.

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The SI Handheld Gamma Finder is indicated to detect and quantify the gamma photons in the body intra-operatively or extra-operatively, when gamma emitting radiopharmaceuticals are administered into the human body.

The gamma-detector, energy discriminator, amplifier, controls and energy supply have been assembled into a single hand-held unit SI-Handheld Gamma Finder® (HGF), which is shielded by a biocompatible polymer. The probe's shape is conical; its shaft tapers off towards a tip that holds the collimator, the crystal and the PINdiode while a head of larger diameter houses the display, menu buttons, and other components. The device is held in one hand by the middle of the shaft. Outer diameters and weight are designed so as to allow single-handed use over periods of time longer than those of routine sentinel biopsies. The polymer casing of SI HGF is water resistant and thus allows extended cleansing with commercial surface disinfectants. The probe tip may even be immersed in disinfectants for several hours. This fulfills standard requirements of hospital hygiene. Disinfection of the probe is comparable to other, larger probes that are being used like Gamma Finder in conjunction with disposable sterile plastic covers. The HGF can be switched on or off by any key. Results are numerically shown in the liquid crystal display in counts per second (CPS), and updated every second. The HGF has only four keys. The currently measured value can be retained in the display for 5 seconds by pressing Key A. The HGF is packaged and transported in a small suitcase. The HGF can only be operated by a Sonnenschein Lithium Battery (SL2770/T), with a maximum charging current of 15 mA. It is not user replaceable. The display of the HGF will display an battery symbol, warning the user the battery life is approximately 20 hours from exhaustion. If the battery is exhausted, the display will show "LobAt". The only accessory is a Sterile Sleeve (No. SI-FOL-101) that accompanies each device, along with the User Manual.

Here's an analysis of the provided text regarding the "SI-Handheld Gamma Finder (HGF)" acceptance criteria and study, structured to answer your specific questions:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results for novel acceptance criteria. As such, some of your requested information (e.g., specific acceptance criteria for performance metrics, detailed sample sizes for training sets, MRMC study details) is not explicitly present in the document. Where information is not available, it will be noted.

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria for a novel device, as it is a 510(k) submission seeking substantial equivalence to a predicate device (Neoprobe Model 1500). The "study" mentioned refers to verification testing to ensure the HGF performs comparably and meets safety standards, rather than proving performance against specific acceptance metrics in a clinical trial.

Study Details

The document refers to "verification testing conducted by a university as to both system and technical evaluations" rather than a single, comprehensive "study" with a defined clinical endpoint.

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

   • Test Set Sample Size: Not explicitly stated. The verification testing seems to be internal technical and system evaluations, not a clinical trial with patient-specific "data provenance."
   • Data Provenance: The verification testing was conducted by "a university." The country of origin is not explicitly stated for the testing, but the company is based in Berlin, Germany. The nature of the testing (technical/system evaluation) suggests it involved devices and possibly radioactive sources, not patient data in the sense of retrospective or prospective clinical data.

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

   • Not applicable as the verification testing described is technical/system evaluation, not a clinical study requiring expert ground truth for diagnostic accuracy.

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

   • Not applicable. The reported testing is technical verification, not a clinical study requiring adjudication of expert interpretations.

4. If a multi-reader multicase (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 MRMC comparative effectiveness study was done. This device is a gamma detection probe, not an AI-assisted diagnostic tool.

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

   • Yes, the device itself is a standalone measurement instrument. Its performance is evaluated on its ability to detect and quantify gamma radiation, independently of human interpretation of a complex algorithm's output. The "verification testing" would assess this standalone performance.

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

   • For the technical verification testing, the "ground truth" would likely be established through calibrated radioactive sources of known energy and activity, and adherence to relevant electrical, biocompatibility, and sterilization standards. It is not expert consensus, pathology, or outcomes data related to patient diagnosis.

7. The sample size for the training set:

   • Not applicable. This device is a hardware instrument with firmware, not a machine learning model that requires a "training set" in the conventional AI sense.

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

   • Not applicable for the same reasons as above.

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For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical , laparoscopic or thoracoscopic surgical procedures.

The Modified GAMMA GUIDANCE SYSTEM is a portable battery powered system used for non-imaging procedures. It includes a hand-held sensor probes, a counting unit, and a cable interconnecting the two.

The provided text is a 510(k) summary for the "Modified GAMMA GUIDANCE SYSTEM." It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, this document does not contain the detailed acceptance criteria or a study proving the device meets those criteria.

Generally, a 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full performance study with acceptance criteria in the same way a PMA (Premarket Approval) would. The FDA letter confirms the substantial equivalence finding based on the information provided in the 510(k) submission, which would have included performance data, but that data is not detailed in the summary.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be stated based on the given document:

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

• Not provided in the text. The document states the device is substantially equivalent to a predicate device (GAMMA GUIDANCE SYSTEM, K961321), implying its performance is comparable. However, specific acceptance criteria or quantitative performance metrics for the "Modified GAMMA GUIDANCE SYSTEM" are not listed.

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

• Not provided in the text.

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 provided in the text.

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

• Not provided in the text.

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 gamma guidance system, a medical instrument for detecting and quantifying radiation, not an AI-assisted diagnostic imaging system that would involve human "readers" or an "AI vs. without AI assistance" comparison in the typical MRMC study context.

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

• Not applicable. This is a hardware device (probe, counting unit, cable), not an algorithm.

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

• Not provided in the text. (This would typically relate to the "predicate device" information, which is also not detailed enough here.)

8. The sample size for the training set:

• Not applicable/Not provided. This device is a physical instrument, not a machine learning model that undergoes "training."

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

• Not applicable/Not provided. This device is a physical instrument, not a machine learning model that relies on establishing ground truth for a "training set."

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The intended use of the device here in question, i.e. the Care Wise C-Trak Automatic Analyzer, remains unchanged from the intended use of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trak Automatic Analyzer is designed- as are all similar devices - to detect and quantify nuclear radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

The Care Wise C-Trak Automatic Analyzer consists of a battery-powered analyzer designed to operate a hand held probe, display the data from the detected radiation, and display and control the system's operating parameters.

Based on the provided text, the device in question, the "Care Wise C-Trak® Automatic Analyzer," is a portable radioisotope detector. The document describes its intended use and establishes its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with acceptance criteria for a new clinical performance claim. Therefore, much of the requested information cannot be found in the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be found in the provided text. The document asserts the device's function (to detect and quantify nuclear radiation) but does not define specific performance metrics or acceptance criteria for that function. It relies on the substantial equivalence to predicate devices, implying that if the predicate devices meet performance standards, this device, being equivalent, also meets them.

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

• Cannot be found in the provided text. There is no mention of a specific test set, patient data, sample size, or study design (retrospective/prospective).

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

• Cannot be found in the provided text. No ground truth establishment related to a test set is discussed.

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

• Cannot be found in the provided text. There is no mention of an adjudication process.

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

• Cannot be found in the provided text. This device is a radioisotope detector, not an AI-assisted diagnostic tool for image interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device type and is not mentioned.

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

• Cannot be found in the provided text. While the device "detects and quantifies nuclear radiation" automatically, the document doesn't provide performance data for this "standalone" functionality or describe a specific study for it. The focus is on substantial equivalence, implying its performance is comparable to existing devices.

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

• Cannot be found in the provided text. Since no specific study with a test set is outlined, the type of ground truth used is not mentioned.

8. The sample size for the training set

• Not applicable / Cannot be found in the provided text. This device is a physical instrument for radiation detection, not a machine learning or AI model that requires a training set in the typical sense.

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

• Not applicable / Cannot be found in the provided text. As this is not an AI/ML device requiring a training set, the establishment of ground truth for such a set is not relevant and not discussed.

Summary of available information related to "study" and "demonstration of effectiveness":

The primary "study" or justification for the device's effectiveness and safety, as described in this 510(k) summary, is its substantial equivalence to predicate devices.

• Predicate Devices:
  • NeoProbe 1000 and 1500 Analyzers (K971167)
  • Care Wise C-Trak® Biopsy System (K922117)
  • Care Wise OncoProbe II™ Analyzer (K896588)
  • Other products marketed before May 28, 1976 (Medical Device Amendments)
• Documentation for Substantial Equivalence:
  • Page 65A of Volume 17 of the Journal of Nuclear Medicine, January 1976 (enclosed as Attachment V).
  • NeoProbe promotional literature (enclosed as Attachment VI).
• Safety Aspects Mentioned:
  • Comprehensive shielding of high voltage sites.
  • Operation only from internal batteries (eliminates electrical current leakage risks).
  • Designed for safe operation in an operating room environment, provided flammable anesthetic gases are not used.

In essence, the document confirms the device's regulatory clearance based on its similarity to existing, approved devices, rather than presenting a new, dedicated performance study with defined acceptance criteria.

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The Neoprobe® Model 1500 Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

The Neoprobe® Model 1500 Portable Radioisotope Detector ("Model 1500") consists of (1) a microcomputer-based control unit: (2) a 12 mm collimated detector probe tip, a 12 mm non-collimated detector probe tip, and a 19 mm noncollimated probe tip, all of which are reusable, steam sterilizable and contain a cadmium zinc telluride crystal gamma ray detector; (3) a disposable sterile probe handle with an attached polypropylene cable; (4) a check source disk containing a known quantity of 1201; and (5) a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings.

Based on the information provided in the 510(k) summary (K971167) for the Neoprobe Model 1500 Portable Radioisotope Detector, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device is seeking substantial equivalence to predicate devices, particularly the Neoprobe Model 1000 GEN 1C. Therefore, the "acceptance criteria" are implicitly the functional performance characteristics of the predicate device, especially its 11mm EtO sterilizable detector probe, and the "reported device performance" are the measurements obtained for the new Model 1500's 12mm probes.

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

The summary describes laboratory studies to demonstrate functional equivalence.

• Sample Size: Not explicitly stated as a number of probes or trials. It refers to general testing of "the cleared 11 mm and the new 12 mm collimated and non-collimated probe tips." This implies testing of at least one of each type of probe.
• Data Provenance: The studies were laboratory studies conducted by Neoprobe Corporation. No specific country of origin for the data is mentioned, but it can be inferred to be from the company's location (Dublin, OH, USA). The studies are inherently prospective as they were specifically designed and executed for this 510(k) submission.

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 to the described study. The study focused on technical performance characteristics (counting efficiency, spatial resolution) of the device itself, rather than diagnostic accuracy requiring expert interpretation of clinical data. The "ground truth" for these measurements would be physical standards and known radioactive sources.

4. Adjudication Method for the Test Set

This is not applicable. There was no human interpretation or diagnostic decision-making involved in the laboratory performance tests that would require adjudication. The measurements were objective physical science tests.

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 comparative effectiveness study was not done. This device is a radioisotope detector, not an AI-powered diagnostic tool. The submission focuses on the hardware's functional equivalence.

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

Yes, in essence. The laboratory studies directly assessed the performance of the device's detector probes (counting efficiency, spatial resolution) independently of a human operator, making it a "standalone" performance evaluation of the hardware components. There is no "algorithm" in the sense of artificial intelligence.

7. The Type of Ground Truth Used

The ground truth used for these laboratory studies would be based on:

• Known Radioactive Sources: Standardized sources of 135I, 111In, and 99mTc with known activities and decay characteristics.
• Physical Measurement Standards: Accurate measurement tools for distance and physical arrangements to determine spatial resolution.
• Engineering Specifications: Comparison against expected physical and engineering principles for gamma ray detection.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device's submission. The device is a hardware instrument, not a machine learning model that requires training data.

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

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

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The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. The GEN 1C in indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes are administered.

The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector ("Model 1000") consists of a microcomputer-based control unit, a cadmium zinc telluride gamma ray detector probe, a cable used to connect the probe to the control unit, a check source containing a known quantity of 129 I, and a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings. The detector probe is available in two sizes: (1) a detector probe with a 19 mm external diameter and a detector diameter of 15 mm; and (2) a detector probe with an 11 mm external diameter and a detector diameter of 7 mm. Optional accessories include a detector probe collimator and a detector probe shield.

Here's a breakdown of the acceptance criteria and study information for the Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than defining new, specific acceptance criteria with numerical targets. The "acceptance criteria" here is implicitly "functional equivalence" to the previously cleared device.

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

• Sample Size (Test Set): Six randomly selected 11 mm GEN 1C probes were used for counting efficiency comparison. A "representative probe" was used for distance-function and spatial resolution measurements.
• Data Provenance: The studies were described as "laboratory studies." No information is given regarding the country of origin or whether the data was retrospective or prospective.

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

• Not applicable. This device is a radioisotope detector, and the performance assessment described is based on physical measurements of counting efficiency and spatial resolution using calibrated radioactive sources, not interpretation of data by human experts to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a radioisotope detector, and its performance is evaluated based on its physical detection capabilities, not its assistance to human readers in interpreting clinical cases.

6. Standalone Performance Study

• Yes, a standalone performance evaluation was conducted. The "laboratory studies" described measured the performance characteristics (counting efficiency, spatial resolution) of the device itself (the 11 mm GEN 1C probes) without human interaction for interpretation.

7. Type of Ground Truth Used

• The "ground truth" in this context refers to known physical properties and measurements. This includes:
  • Calibrated radioactive sources: Such as 129I, 111In, and 99mTc, with known activity and emission characteristics.
  • Geometric setups: Controlled distances and configurations for spatial resolution measurements.
  • Predicate device's performance: The Model 1000 GEN 1B probe's performance served as a benchmark for "functional equivalence."

8. Sample Size for the Training Set

• Not applicable. This device is a hardware radioisotope detector. There is no mention of a "training set" in the machine learning sense. The device's operation is based on established physical principles of radiation detection, not learned algorithms.

9. How Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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