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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (breast, thyroid, testicles, prostate)

The device referenced in this Submission is a highly portable, software-controlled, diagnostic ultrasound system with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.

The provided text is a 510(k) Summary of Safety and Effectiveness for a diagnostic ultrasound system. It addresses an application to add a new clinical application ("Small Organ") to an existing device.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's compliance with various safety and performance standards for ultrasound systems and medical devices. However, it does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, resolution) for the imaging quality relevant to the new "Small Organ" application, nor does it provide a table of reported device performance against such criteria.

Instead, the acceptance criteria are implicitly that the device continues to meet the safety and effectiveness standards of its predicate device and applicable recognized consensus standards, with the new clinical application being demonstrated as substantially equivalent.

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

The document explicitly states: "No additional clinical testing is required, as the added indication for use is not a novel indication as shown by the predicate devices in Section 3."

This indicates there was no specific clinical test set used for this particular submission to evaluate the "Small Organ" application. The data provenance is effectively based on the previously cleared predicate device and the existing SonoSite system.

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

Since no new clinical test set was required and no clinical study was performed for this submission, there were no experts specifically engaged to establish ground truth for a test set related to the "Small Organ" application. The determination of substantial equivalence relies on existing regulatory clearances and technical specifications.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set was used for this submission.

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

Not applicable. This submission is for an ultrasound system, not an AI-assisted diagnostic tool.

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

Not applicable. This is for a diagnostic ultrasound system, not a standalone algorithm.

7. The Type of Ground Truth Used:

The ground truth for this submission is based on the established safety and effectiveness of the predicate device (Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224)) which already included "Small Organ" as a clinical application. The argument is that the SonoSite system, with its existing cleared technologies, is capable of performing this application equivalently. The document implies that the "anatomical site is amenable to current transducer and post-processing ultrasound technology available with the SonoSite Hand-Carried Ultrasound System (C1 Series) and predicate devices."

8. The Sample Size for the Training Set:

Not applicable. This submission does not involve a machine learning or AI model that requires a training set. The device is a traditional ultrasound system.

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

Not applicable.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, abdominal, intra-operative (abdominal organs, neurological, and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, transvaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN™ Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for biopsy guidance, imaging to assist in the placement of needles and catheters in vascular or other anatomical structures, and imaging guidance for peripheral nerve block procedures.

The devices referenced in this Submission are highly portable. software-controlled, diagnostic ultrasound systems with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.

The provided text is a 510(k) summary for SonoSite ultrasound systems. It describes the addition of a new clinical application ("intra-operative (neurological)") to existing ultrasound devices. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic algorithm.

Instead, the "Testing" section (Section 7 on page 3) states:

• "Each of the referenced SonoSite systems has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety, and has been found to conform to applicable medical device safety standards, as referenced in Section 4. Reports were previously included in the referenced predicate submissions."
• "No additional clinical testing is required, as the added indication for use is not a novel indication as shown by the predicate devices in Section 3."

This indicates that the acceptance criteria for this 510(k) submission are related to:

1. Compliance with general medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety). These were already met and documented in previous predicate submissions (K030949 and K014116), for which this document serves as an update adding a new indication for use.
2. Substantial equivalence to predicate devices that already have 'intra-operative (neurological)' as a clinical application. The argument is that since the new indication is not novel and the anatomical site is amenable to the systems' existing technology, no additional clinical testing is needed to prove effectiveness for this specific added use.

Therefore, the requested information components (table of acceptance criteria and performance, sample size, ground truth, adjudication, MRMC studies, standalone performance, training set size, etc.) are not available in this document because the submission relies on substantial equivalence and prior safety testing, rather than a new performance study proving diagnostic accuracy for the added indication.

Specifically, for the questions asked:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on regulatory compliance and substantial equivalence to predicate devices for the new indication, not a new performance study with specific metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No new clinical test set was used for the added indication. The submission relies on the fact that existing systems already meet safety standards, and the new indication is covered by predicate devices without requiring new clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth was created for this submission.
4. Adjudication method for the test set: Not applicable.
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 is for an ultrasound system, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new performance study in this submission.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm submission requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

The TERATECH Model 810C4, 81OL4, and 10LAP4 Probes are intended for use with the Model TERATECH2000, a portable ultrasoundimaging system.

The provided text is a 510(k) summary for TERATECH Model 810C4, 810L4, and 10LAP4 Probes. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

The document discusses:

• Device Name: TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes
• Predicate Devices: Philips LI9-5, Philips CT8-4, Philips LAP L9-5, and TERATECH 10V5 (along with their associated 510(k) clearances).
• Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific indications are tabulated for each probe model across various clinical applications and modes of operation (e.g., B-mode, M-mode, PWD, CWD, Color Doppler, Combined Modes, Other).
• Device Description: Technical specifications (Frequency, # Elements, Array type, Pitch, Elevation width, Geometric focus, Azimuth radius, Azimuth length) for each probe model.
• Basis for Substantial Equivalence: The subject devices are claimed to be "identical in mechanical design and materials to the respective Philips," and intended for the same clinical applications. The FDA's letter confirms substantial equivalence.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria and performance studies because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence, which does not typically include detailed performance study results against pre-defined acceptance criteria in the way a clinical trial or a more rigorous performance study might.

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