(68 days)
The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging.
The USHIFU Stepper is a mechanical device which is manually controlled in the horizontal and vertical directions. It is designed to allow for finite adjustments in these planes. It is composed of light-weight materials, is pre-assembled and easily attached to a surgical table.
Here's an analysis of the provided information, addressing your questions about acceptance criteria and the study:
The provided document is a 510(k) summary for a medical device called the "USHIFU Stepper." Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, design, and materials, rather than presenting performance data from a specific study against acceptance criteria.
Therefore, I cannot populate the table or answer most of your questions based on the provided text.
Here's what I can infer and what is missing:
Acceptance Criteria and Study Information (Not Present in Document)
| Acceptance Criteria Category | Acceptance Criteria Value | Reported Device Performance | Comments / Missing Information |
|---|---|---|---|
| Performance Metrics | Not specified | Not reported | The document does not define any quantitative or qualitative performance metrics (e.g., stability, precision, ease of use beyond simple operation). |
| Clinical Endpoints | Not specified | Not reported | No clinical endpoints are mentioned, as the device is a mechanical support, not one with diagnostic or therapeutic output. |
| Safety Endpoints | Not specified | Not reported | General safety is implied by substantial equivalence, but specific safety criteria or test results are not provided. |
| Usability/Usability Test | Not specified | Not reported | No usability criteria or testing is detailed. |
Study Details (Information Not Present in Document)
1. Sample sized used for the test set and the data provenance:
Not available. The document does not describe any specific test set or clinical study.
2. 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 available. No study or ground truth establishment is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not available. No study or adjudication method is described.
4. 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/Not available.
- The device is a mechanical support for an ultrasonic probe, not an AI device.
- Therefore, an MRMC study comparing human readers with/without AI assistance would not be relevant to this device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable/Not available.
- The device is a mechanical support, not an algorithm.
- No standalone performance testing of an algorithm is described.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not available. No study or ground truth establishment is described.
7. The sample size for the training set:
Not available. The device is a mechanical device, not an AI model, so the concept of a "training set" is not applicable in this context.
8. How the ground truth for the training set was established:
Not applicable/Not available. The device is a mechanical device, not an AI model, so the concept of establishing ground truth for a training set is not applicable.
Summary of the USHIFU Stepper 510(k)
The K080870 submission for the USHIFU Stepper is a Traditional 510(k), which aims to demonstrate substantial equivalence to a previously legally marketed device (the predicate device: K843573, Super Scan/Biopsy Guide, CIVCO).
The core argument for substantial equivalence is based on:
- Intended Use: Both devices are for supporting and stabilizing an ultrasonic probe during prostate imaging.
- Design: Both are mechanical devices allowing for adjustments. The USHIFU Stepper is described as manually controlled in horizontal and vertical directions, allowing for finite adjustments.
- Composition/Materials: Both are composed of light-weight materials, pre-assembled, and easily attached to a surgical table (implied for the predicate as well, given the equivalence claim).
The FDA's review concluded that the device is substantially equivalent, allowing it to be marketed. This type of submission generally does not require new clinical studies or detailed performance testing against acceptance criteria if substantial equivalence can be demonstrated through comparison to a predicate device with similar technological characteristics and intended use. The 510(k) process often relies on existing data or widely accepted engineering principles to demonstrate safety and effectiveness for devices that are similar to those already on the market.
§ 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.