(62 days)
The ultrasound system provides imaging information, used to guide the biopsy needle through the accessory to the anatomical site where the sample of physiological material is recovered for further analysis.
The Biopsy accessory attachment and handle, function with the ESAOTE Ultrasound Transducer previously cleared via K953819, connected with the AU4 Ultrasound system cleared via K944485/S3. The biopsy accessories consist of a metal and plastic bracket and needle guides that attach to the ultrasound transducer. The AU4 system software provides for the guidance of the biopsy needle through the biopsy accessory needle guide.
The provided document is a 510(k) summary for the "Biopsy Accessory attachment and handle" by Biosound Esaote, dated April 27, 1997. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.
Based on the content, there is NO information about acceptance criteria or a study proving the device meets specific performance criteria as typically defined for AI/ML-based medical devices. This submission predates the widespread use of such devices and the regulatory framework for them.
The document discusses:
- Device Description: A metal and plastic bracket and needle guides that attach to an ultrasound transducer.
- Intended Use: To guide a biopsy needle to an anatomical site for sample recovery, using imaging information from an ultrasound system.
- Materials and Biocompatibility: Polyurethane resin and stainless steel. Biocompatibility tests (cytotoxicity, sensitisation, irritation) were performed on the polyurethane resin according to ISO 10993.
- Sterilization: Cold sterilization with CIDEX solution.
- Substantial Equivalence Comparison: Compares features like materials, needle guide angle, sterilization method, removability, and compatibility with biopsy needles to predicate devices.
Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text. The document's purpose is to demonstrate substantial equivalence for a physical medical accessory, not to report on the performance of a software algorithm or AI.
If this were a typical AI/ML medical device submission, the requested information would look like this (but again, it's not present in the provided text):
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| N/A | N/A | N/A |
| (e.g., Sensitivity) | (e.g., ≥ 90%) | (e.g., 92.5%) |
| (e.g., Specificity) | (e.g., ≥ 85%) | (e.g., 88.1%) |
| (e.g., Accuracy) | (e.g., ≥ 88%) | (e.g., 90.3%) |
2. Sample size used for the test set and data provenance
- Test Set Size: Not provided.
- Data Provenance: Not provided (not relevant for this type of device submission).
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Number of Experts: Not provided.
- Qualifications: Not provided.
4. Adjudication method for the test set
- Adjudication Method: Not provided.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study
- MRMC Study: No, an MRMC study was not conducted or reported. This type of study is typically for evaluating human performance with and without AI assistance for interpretation tasks, which is not applicable to a physical biopsy accessory.
- Effect Size: Not applicable.
6. Standalone (algorithm only) performance study
- Standalone Study: No, a standalone performance study for an algorithm was not conducted or reported. The device is a physical accessory, not a software algorithm.
7. Type of ground truth used
- Ground Truth Type: Not applicable/Not provided. The "ground truth" mentioned in the document relates to biocompatibility testing against ISO 10993 standards and substantial equivalence to predicate devices, not clinical performance for diagnostic accuracy.
8. Sample size for the training set
- Training Set Size: Not applicable/Not provided, as this is not a machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as this is not a machine learning device.
§ 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.