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The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

• Pediatric
• Peripheral Vessel and Vascular Access
• Small Organ (breast, thyroid, parathyroid, testicles)
• Musculo-skeletal (conventional and superficial)
• Cardiac (adult and pediatric)

Typical examinations performed using the Site~Rite® 8 Ultrasound System include:
Vascular: Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian)
Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access
Interventional: Guidance for biopsy and drainage
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures

Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.

The subject Site-Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled).

The Site~Rite® 8 Ultrasound System has two optional needle guidance technologies available depending on the selected probe.

Both available needle guidance technologies are designed to track and display the location and trajectory of a needle under ultrasound guidance. The technologies consist of software installed on an ultrasound system and sensors incorporated into the ultrasound probes. The sensors detect a passive magnetic field emitted from the needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process.

Cue™ Needle Tracking System requires the use of a Site-Rite® 8 Ultrasound System with the Cue™ Needle Tracking System software module, Cue™ 20mm Linear Probe, the Cue™ Needle Tracking System Activator and a Cue™ compatible needle. The Cue™ 20mm Linear Probe contains sensors for tracking Cue™ compatible needles (following magnetization by the Cue™ Needle Tracking System Activator). The tracked needle's current position, trajectory, and Intersection Window are displayed over the ultrasound image.

Pinpoint™ GT Needle Technology requires the use of a Site~Rite® 8 Ultrasound System with the Pinpoint™ GT Needle Technology software module, 20mm Pinpoint™ GT Linear Probe and a Pinpoint™ GT Safety Introducer Needle. The 20mm Pinpoint™ GT Linear Probe contains sensors for tracking Pinpoint™ GT Safety Introducer Needles, which contain a permanent magnet within the safety canister of the needle. The tracked needle's current position, trajectory, and point of intersection with the ultrasound plane are displayed over the ultrasound image.

The subject device, SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is bringing forward and amending the currently cleared SiteRite® 8 Ultrasound System with Pinpoint™ GT Needle Technology's functionality (K152554). The subject Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology differs from its predicate device (K152554) primarily because it incorporates an additional needle guidance technology (Cue™ Needle Tracking System) that is similar to the one present in the reference device (K140254). Cue™ Needle Tracking System tracks a qualified needle that has been magnetized using the Cue™ Needle Tracking System Activator. All other previously cleared features of the predicate device are being brought forward.

Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology includes the following components:

• Site~Rite® 8 Ultrasound System Console
• Cue™ 20mm Linear Probe
• 20mm Pinpoint™ GT Probe
• 32mm Linear Probe
• Cue™ Needle Tracking System Activator

Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is compatible with the following accessories:

• Cue™ Activator mounting arm
• Pinpoint™ GT Needle Guide Kits
• Site~Rite® Needle Guide Kits
• Site~Rite® Probe Cover Kits
• MER Roll Stand
• Optional printers* with mounting hardware
• Kickstand mounting accessory
• Probe holder accessory
• Site~Rite® Keyboard
• USB storage device* (flash/pen drive) with no external power connection
• Silex® Wireless Bridge*

The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to demonstrate that the device meets those criteria for the "Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology".

The document focuses on establishing substantial equivalence to a predicate device (K152554) and a reference device (K140254) by comparing intended use, indications for use, and technological characteristics. While it lists various nonclinical tests and references guidance documents and standards, it does not provide specific performance metrics or thresholds for acceptance criteria, nor does it detail the results of these tests in a quantifiable manner to show how the device met them.

Here's a breakdown of what can be extracted and what is missing:

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

The document lists "Design Requirements and Corresponding Nonclinical Tests" but does not explicitly state acceptance criteria in terms of numerical thresholds or performance targets. It also does not present numerical or descriptive results of how the device performed against these unstated criteria.

• Design Requirements (from the document):

  • User needs
  • Physical characteristics
  • Electrical, electronic, and radiation characteristics
  • Thermal characteristics
  • Mechanical characteristics
  • Operating environment
  • Labeling characteristics
  • Equipment and device interfaces and mounting
  • Minimum requirements for computing platform
  • Usability requirements
  • Operating requirements
  • Software requirements
  • Dimensional Characteristics
  • Chemical characteristics
  • Biological and biocompatibility characteristics
  • Packaging characteristics

• Corresponding Nonclinical Tests (from the document):

  • Site-Rite® 8 Ultrasound System Software Verification
  • Cue™ Needle Tracking System Accuracy
  • Site-Rite® 8 Ultrasound System Image Verification
  • SiteRite® 8 vs. SiteRite® 6 Image Comparison
  • Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report
  • Site-Rite® 8 Ultrasound System Electrical Safety and EMC - IEC 60601-1 Edition 3.1
  • Site~Rite® 8 Operational Temperature and Humidity Testing
  • Site-Rite® 8 Mechanical Testing
  • Site~Rite® 8 Response Time Verification
  • Cue™ VAD Library Information Verification
  • Admin Tool Verification
  • Site-Rite® 8 Shared Requirements Verification
  • Site-Rite® 8 Verification and Validation Rationale
  • Site~Rite® 8 Cleaning Solution Compatibility Verification
  • Site~Rite® 8 Biocompatibility Assessment
  • Cue™ Activator Ship Test Verification
  • Ultrasound Probe Ship Test Verification

Reported Device Performance: The document states:
"Testing verifying the performance requirements of the subject device software when connected to a Cue™ 20mm Linear Probe was conducted and is included in this Abbreviated premarket notification, the results of which support substantial equivalence."
However, the actual results of these tests are not provided in this excerpt. We know that "Cue™ Needle Tracking System Accuracy" was tested, among others, suggesting a focus on the accuracy of needle tracking, but no specific accuracy values or acceptance thresholds are given.

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

• Sample Size: This information is not provided in the document.
• Data Provenance: This information is not provided in the document. The studies listed are generally non-clinical in nature (e.g., software verification, electrical safety, mechanical testing).

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

This information is not provided. Given that the studies listed are non-clinical, the concept of "experts establishing ground truth for a test set" in a clinical context isn't directly applicable here. If "expert" refers to engineers or technicians verifying software or hardware performance, their number and qualifications are not mentioned.

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

This information is not provided.

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

• The document explicitly states: "No human clinical data was provided to support substantial equivalence."
• Therefore, an MRMC study was not performed and no effect size can be reported. The device is not described as having "AI assistance" for human readers in the traditional sense, but rather "visual needle tracking to assist with ultrasound guided vascular access."

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

• The non-clinical tests listed include "Cue™ Needle Tracking System Accuracy" and "Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report". These sound like standalone performance tests of the system's needle tracking capabilities. However, the details of these tests (e.g., what metrics were measured, the test setup, the results) are not provided.

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

• For the non-clinical performance tests mentioned (e.g., accuracy of needle tracking), the "ground truth" would likely be established through precise mechanical or optical measurements in a controlled laboratory setting. However, the specific methodology for establishing this ground truth is not described in the provided text.

8. The sample size for the training set

This information is not provided. The document does not describe any machine learning or AI components that would typically require a "training set." The needle tracking technologies (Cue™ and Pinpoint™ GT) are based on detecting magnetic fields from needles, which is a physics-based approach rather than a data-driven machine learning approach requiring a training set.

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

This information is not applicable/provided for the reasons stated in point 8.

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TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid. testes), neonatal and adult cephalic. trans-esoph. (Cardiac), trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.

TE7/TE5 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, LVO, Color M, Smart 3D, TDI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).. This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

This document describes the Shenzhen Mindray Bio-medical Electronics Co., LTD TE7/TE5 Diagnostic Ultrasound System (K180912) and its substantial equivalence to predicate devices. The information provided heavily references previously cleared devices and standards, indicating that no new clinical study was conducted for this specific submission to establish de novo acceptance criteria or device performance.

Therefore, the requested information elements related to a new study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type for test/training sets, training set sample size, how training ground truth was established) are not applicable as they relate to newly conducted efficacy or performance studies. The submission relies on demonstrating equivalence to existing, cleared devices and compliance with recognized standards.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since no new performance study with specific criteria and results is outlined for this submission, the "acceptance criteria" are implied by compliance with safety standards and substantial equivalence to predicate devices. Device performance is considered equivalent to the predicate devices.

Study Proving Device Meets Acceptance Criteria:

The device meets its implied acceptance criteria by demonstrating substantial equivalence to existing legally marketed predicate devices and by compliance with recognized national and international safety and performance standards. The submission explicitly states: "Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards." (Page 31)

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. No new clinical performance or efficacy studies were conducted for this 510(k) submission. The submission relies on non-clinical tests and equivalence to predicate devices.

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 new clinical performance or efficacy studies were conducted for this 510(k) submission that would require establishing ground truth from experts for a test set.

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

Not applicable. No new clinical performance or efficacy studies requiring adjudication were conducted for this 510(k) submission.

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 submission concerns a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study was performed as confirmed by the statement "Clinical Studies: Not applicable. The subject of this submission, TE7/TE5 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." (Page 32).

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

Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm, and no such performance study was conducted for this submission.

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

Not applicable. No specific ground truth establishment for a new performance study is mentioned in this 510(k) submission. The device's safety and effectiveness are established through compliance with existing standards and comparison to predicate devices, which would have had their performance and safety established previously.

8. The sample size for the training set

Not applicable. No new machine learning or AI algorithm development requiring a training set is described in this 510(k) submission.

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

Not applicable. As no new training set is indicated, this question is not relevant to the provided documentation.

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The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

The Navi e/ Navi s/Navi X Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, and the combined mode. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. The Navi e/ Navi x/Navi X Diagnostic Ultrasound System consists of the main unit named Navi series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley, ECG module and batteries. Three models for the main units are included in this submission, that is Navi s, Navi e and Navi X. Eight different models of probes are available for the Navi series.

The provided text describes the Navi e/Navi s/Navi X Diagnostic Ultrasound System and its substantial equivalence to predicate devices, but it does not contain detailed acceptance criteria or a specific study proving the device meets those criteria, especially not in the context of AI/ML performance.

Instead, the document outlines various non-clinical tests conducted to ensure the device's safety and performance in a general sense, largely by comparing it to predicate ultrasound systems.

Here's an analysis of what information is available and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance metrics for the device. It generally states that "all of the tested parameters met the predefined acceptance criteria" for performance testing, but the criteria themselves are not enumerated.

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

• Test Set Sample Size: Not applicable as no specific test set (e.g., imaging dataset for AI/ML evaluation) is mentioned. The performance testing refers to general ultrasound system performance.
• Data Provenance: Not applicable.

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

Not applicable, as no ground truth establishment for a test set (in the context of AI/ML or specific clinical performance evaluation) is mentioned.

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

Not applicable, as no clinical test set with ground truth requiring adjudication is mentioned.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable, as there's no mention of AI assistance for human readers or a study evaluating it.

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

No, a standalone algorithm performance study was not done. The document does not describe any specific AI/ML algorithms that would require such a study. The software verification and validation are for the overall system software, deemed "moderate" level of concern.

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

Not applicable. The document discusses regulatory compliance, biocompatibility, electrical safety, and general performance of the ultrasound system, not the performance of an AI/ML component against a clinical ground truth.

8. The sample size for the training set:

Not applicable, as no AI/ML training set is mentioned or described.

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

Not applicable, as no AI/ML training set or its ground truth establishment is mentioned.

Summary of what the document does include regarding performance:

The document primarily focuses on demonstrating substantial equivalence to predicate ultrasound devices through:

• Biocompatibility testing: According to ISO 10993-1, ISO 10993-5, and ISO 10993-10, for cytotoxicity, sensitization, and skin irritation of probes and glue.
• Electrical safety and electromagnetic compatibility (EMC) testing: Compliance with IEC 60601-1:2012 and IEC 60601-1-2:2007.
• Performance testing: According to IEC 60601-2-37:2007 for ultrasonic medical diagnostic and monitoring equipment. It also mentions evaluation of "clinic measurement accuracy and system sensitivity" where "all of the tested parameters met the predefined acceptance criteria."
• Acoustic output measurement and real-time display: Compliance with NEMA UD 2:2004 and NEMA UD 3:2004.
• Software Verification and Validation Testing: Conducted per FDA guidance for "moderate" level of concern software.

Conclusion:

This submission for the Navi e/Navi s/Navi X Diagnostic Ultrasound System is for a conventional ultrasound imaging system. It does not describe any AI/ML components or their performance characteristics. Therefore, the specific information requested about AI acceptance criteria, clinical study designs (MRMC, standalone), ground truth, and training data is not present in the provided text. The "performance testing" mentioned refers to the general technical and functional performance of the ultrasound system itself, not the diagnostic performance of an AI algorithm.

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