(73 days)
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The new EV transducer has equivalent functionality to the existing transducer now being used. The new EV transducer has new patient contact materials.
This document is a 510(k) summary for a modification to an ultrasound system, specifically replacing patient contact materials in an EV transducer. It is not a study describing the acceptance criteria and performance of a device in the context of diagnostic accuracy or clinical effectiveness.
Therefore, I cannot provide the information requested in your prompt as it does not exist within the provided text. The document focuses on regulatory approval for a material change, not on diagnostic performance or AI-related evaluations.
Here's why the requested information cannot be extracted from the given text:
- No Acceptance Criteria for Diagnostic Performance: The document doesn't mention any performance metrics like sensitivity, specificity, accuracy, or AUC, nor does it define acceptance thresholds for such metrics. The "acceptance criteria" discussed are implicitly related to the safety and equivalence of the new patient contact materials, not clinical diagnostic performance.
- No Device Performance Data: There's no reported data on how well the device performs in detecting/diagnosing conditions. The focus is on the equivalence of the modified transducer to the predicate device in terms of functionality and scientific concepts, primarily driven by a change in patient contact materials.
- No Test Set/Data Provenance: There is no mention of a test set, its sample size, country of origin, or whether it's retrospective/prospective.
- No Expert Ground Truth or Adjudication: The concept of experts establishing ground truth or adjudication methods is absent, as the document isn't evaluating diagnostic accuracy.
- No MRMC Study: There's no mention of a multi-reader multi-case comparative effectiveness study, nor any discussion of AI assistance or human reader improvement.
- No Standalone Algorithm Performance: The device described is an ultrasound system and transducer, not an AI algorithm. Therefore, standalone algorithm performance is not applicable.
- No Ground Truth Type: Since there's no evaluation of diagnostic performance against a ground truth, the type of ground truth used is not mentioned.
- No Training Set: As it's not an AI model, there's no mention of a training set or how its ground truth was established.
In summary, the provided text is a regulatory submission for a minor modification (material change) to an existing medical device, not a performance study evaluating diagnostic efficacy.
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Attachment C
SD 800 SW Modification
K9 70034
510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
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- Submitter's Name / Contact Person: Paul Schrader Address: 3000 Minuteman Road, Andover Ma. 01810 Telephone Number: 508-659-2404 Date Summary was prepared: December 16,1996
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- Trade Name: SD 800 SonoDiagnost Ultrasound Imaging System Common Name : Ultrasound Imaging System Classification Pro Codes: 90 IYN & 90 IYQ
3) Identification of Predicate Device:
The predicate device for this submittal is the existing SD 800 and EV transducer which were reviewed by FDA on the SD 800 system that was submitted as part of K935923.
4) Description of the device or modification being submitted for premarket approval.
Functionality: The new EV transducer has equivalent functionality to the existing transducer now being used.
Scientific Concepts: same as existing EV transducer
Significant Characteristics of the Modification: The new EV transducer has new patient contact materials. It is this change that creates the need to file a 510(k) with the FDA.
The transducer is an existing transducer being sold and marketed by Echo ultrasound. Acoustic performance of the system / transducer combination will be handled as a 510(k) to file based on Appendix I of the February 1993 Ultrasound Guidance.
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Statement of Intended Use: No change from existing SD 800 platform reviewed during 510(k) 935923.
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Predicate Device Comparison: There are no significant differences in safety and efficacy between the 21370A and 21370B transducers. A detailed comparision of the transducers can be found in the 510(k) report.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.