(28 days)
The sterile bag is intended to cover the motordrive/sled assembly during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.
The Permanent Sled Bag is a sterile, single-use device. It will be used with the iLab Ultrasound Imaging System. It is intended to cover the MDU5 PLUS motordrive/permanent sled assembly during intravascular ultrasound procedures and prevent transfer of mmicroorganisms, body fluids and particulate material to the patient and healthcare worker. The device consists of a long, narrow bag made of low density polyethylene and is e-beam sterilized. The bag is folded and packaged in a Tyvek®/Nylon or equivalent medical device packaging suitable for e-beam sterilization. The Permanent Sled Bag will not impede the 10cm travel of the sled. There is a faceplate that is attached to the Permanent Sled Bag that attaches to the MDU5PLUS motordrive. The Permanent Sled Bag is sufficiently clear as to not impede viewing of the MDU5PLUS display. The Permanent Sled Bag must not interfere with the installation of the MDU5PLUS/permanent sled assembly. The Permanent Sled Bag will be available as a standalone product or with IVUS catheters.
The provided document is a 510(k) Summary for the "Permanent Sled Bag," a sterile cover for an intravascular ultrasound motordrive/sled assembly. It does not describe a study involving software performance testing, AI, human readers, or medical image analysis. Instead, it focuses on non-clinical, bench/performance testing to establish substantial equivalence to a predicate device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device meets acceptance criteria are not applicable to this document.
However, I can extract the information relevant to the non-clinical testing performed for this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| End Seal Strength | Passed |
| Tabs/Stickers | Passed |
| Grip Points | Passed |
| Functional Efficiency | Passed |
| Display Viewing | Passed |
| MDU5PLUS Movement | Passed |
| Unit Compatibility | Passed |
| System Preparation with Sled | Passed |
| RoHS Compliance | Passed |
Note: The document states "All predetermined acceptance criteria were met during design verification as specified in the requirements of 21 CFR 820.30." For these bench tests, the criteria are implied to be "Pass" or "Fail" as indicated.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each bench test. The nature of these tests (e.g., "End Seal Strength," "Display Viewing") suggests samples of the manufactured device were tested, but the number is not quantified in this summary.
- Data Provenance: Not applicable in the context of clinical data. These are results from in-house bench/performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these engineering/performance tests is based on the specific design specifications and industry standards for mechanical and material properties, not expert clinical interpretation.
4. Adjudication method for the test set:
- Not applicable. The tests are "Pass/Fail" against pre-defined engineering and performance specifications.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a sterile bag, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical sterile cover, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for these tests is the device's conformance to its engineering specifications and functional requirements (e.g., maintaining sterility, not impeding movement, being sufficiently clear). These are objective measurements rather than a clinical ground truth.
8. The sample size for the training set:
- Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this 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.