(97 days)
The Site~Rite" 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:
- Pediatric
- Peripheral Vessel
- 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, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures
Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
The Site-Rite® 8 Ultrasound System 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 Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a 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 throughout the insertion process.
The provided document is a 510(k) Summary for the Bard Access Systems, Inc. Site® 8 Ultrasound System with Pinpoint™ GT Technology. This document declares substantial equivalence to predicate devices and outlines the intended use, technological characteristics, and safety and performance testing. However, it does not describe specific quantitative acceptance criteria or a dedicated study proving device performance against those criteria in the way a clinical trial or algorithm validation study would.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared devices. It states that the device "met all pre-determined acceptance criteria" and refers to a series of safety and performance tests based on established medical device standards.
Therefore, I can extract information regarding the types of tests performed and the general statement of compliance, but cannot provide a table of precise acceptance criteria with corresponding performance metrics from the provided text. The document does not describe a study involving humans or experts to evaluate the AI component (Pinpoint™ GT Technology) in clinical performance terms.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
The document states: "The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the primary predicate device." It lists various standards that were used for "Verification and validation activities" to "demonstrate that the subject SiteRite® 8 Ultrasound System and subject SiteRite® 8 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements."
However, specific quantitative acceptance criteria (e.g., "accuracy > X%", "sensitivity > Y%") and measured performance values for the device are not provided in this summary. The "reported device performance" is qualitatively stated as meeting "predetermined performance requirements" and demonstrating "substantial equivalence".
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| General Performance | Met all pre-determined acceptance criteria and demonstrated substantial equivalence compared to primary predicate device. |
| Safety & Essential Performance | Met requirements of IEC 60601-1:2005, CORR. 1(2006), CORR 2(2007) |
| Electromagnetic Compatibility | Met requirements of IEC 60601-1-2:2007 |
| Ultrasonic Medical Diagnostic & Monitoring Equipment Safety | Met requirements of IEC 60601-2-37:2007 |
| Usability (Human Factors) | Met requirements of IEC 60601-1-6:2010 and IEC 62366:2007 |
| Software Life Cycle Processes | Met requirements of IEC 62304:2006 |
| Biological Evaluation (Biocompatibility) | Met requirements of ISO 10993-1:2009 |
| Acoustic Output Measurement | Met requirements of NEMA UD-2:2004 |
| Radio Frequency Devices (FCC) | Met requirements of Title 47 CFR FCC, Part 15 B, 15 C, and Part 18 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set with a sample size or data provenance. The verification and validation activities mentioned are typically engineering and bench-testing based, referring to compliance with standards rather than clinical data sets.
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. The type of testing described does not involve expert-established ground truth in the context of clinical accuracy or diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as there is no described test set that would require adjudication.
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 comparative effectiveness study involving human readers or AI assistance in the provided text. The "Pinpoint™ GT Technology" is described as providing "visual tools for passive magnetic tracking of a needle with respect to ultrasound image data," implying a guidance system rather than an AI performing diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the "Pinpoint™ GT Technology" as an algorithm is not detailed in terms of clinical accuracy or diagnostic performance in the provided text. The safety and performance tests listed are standard for medical electrical equipment and ultrasound systems, addressing general device functionality and electrical/biological safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the establishment of a "ground truth" in a clinical diagnostic sense. The verification and validation activities would rely on manufactured test environments and calibrated measurement tools to confirm compliance with technical specifications and standards. For the Pinpoint™ GT Technology's needle tracking, the "ground truth" would likely be the known physical position of the needle in a phantom or test setup.
8. The sample size for the training set
The document does not mention a training set, as it does not describe the development or validation of a machine learning algorithm in the context of a "training set." The Pinpoint™ GT Technology uses passive magnetic tracking, which is typically a sensor-based technology, not a machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
As no training set is mentioned, information on how its ground truth was established is also not provided.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.