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Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Other (Gynecological), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Fetal), Peripheral vessel, Musculo-skel (conventional), Musculo-skel (superficial).

The HD7 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The provided document is a 510(k) premarket notification for the Philips HD7 Diagnostic Ultrasound System and its associated transducers. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting performance metrics against specific acceptance criteria from a new clinical study. Therefore, much of the requested information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness (MRMC) studies is not present in this document.

The document focuses on establishing equivalence based on:

• Intended Use: Both the predicate and the HD7 are indicated for diagnostic ultrasonic imaging and fluid flow analysis.
• Technological Characteristics: They have the same gray-scale and Doppler capabilities, use similar technologies for imaging, Doppler functions, and signal processing.
• Acoustic Output: Both have acoustic output levels below Track 3 FDA limits.
• Manufacturing and Biosafety: Both are manufactured under equivalent quality systems, of materials with equivalent biosafety, and designed/manufactured to the same electrical and physical safety standards.

The tables provided in sections {5}-{17} are "Indications for Use Forms" which describe the clinical applications and modes of operation for which the device and each transducer are indicated. They categorize indications as:

• N: New indication
• P: Previously cleared by FDA (referring to previous 510(k) clearances for the predicate device).
• E: Added under Appendix E (also referring to indications previously cleared, but specifically in an appendix related to extensions/modifications).

These tables are not performance reports, but rather statements of intended use within the scope of existing clearances.

Based on the provided text, here's what can be extracted:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics. The "performance" assessment is qualitative, stating that the HD7 system and transducers function in a manner identical to other Philips ultrasound systems and transducers and are substantially equivalent to the predicate device (M2540/EnVisor ultrasound systems, cleared in K014191) in terms of safety and effectiveness.

• Identical intended use.
• Same gray-scale and Doppler capabilities.
• Essentially same technologies.
• Acoustic output below Track 3 FDA limits.
• Equivalent quality systems and biosafety materials.
• Designed and manufactured to same electrical and physical safety standards. |
  | Acoustic output levels below Track 3 FDA limits. | Acoustic output levels are below the Track 3 FDA limits. |

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. This 510(k) submission establishes substantial equivalence through comparison to a predicate device and engineering analysis, rather than new clinical performance data from a specific test set. No separate "test set" or data provenance information is mentioned.

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 document does not describe a clinical study requiring expert-established ground truth for a test set.

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

Not applicable. No test set or expert adjudication is described.

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 is not an AI-enabled device. No MRMC study or AI assistance is mentioned.

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 an algorithm, and its performance is inherently linked to human operation.

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

Not applicable. No new clinical performance study requiring a specific "ground truth" is reported in this summary. The basis for clearance is substantial equivalence to a predicate, which implies the predicate's established performance serves as the benchmark.

8. The sample size for the training set

Not applicable. No machine learning or AI component requiring a "training set" is described for this device.

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

Not applicable. See point 8.

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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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The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation.

The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.

The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.

The provided text describes a 510(k) premarket notification for the DICOMIT Dicom Image Manager - Addition of 3D Visualization Software Module. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document focuses on:

• Identifying the submitter and device.
• Classifying the device and its intended use.
• Comparing it to predicate devices to establish substantial equivalence.
• The FDA's decision to clear the device based on substantial equivalence.

Therefore, I cannot provide the requested table and details because the information is not present in the given text. The FDA clearance is based on substantial equivalence to existing devices, implying that detailed performance studies might not have been required for this specific 510(k) submission, as the fundamental technology and intended use were deemed similar to devices already on the market.

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