(210 days)
Using SCOUT Bx Delivery System, the SCOUT Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT System) the SCOUT Reflector is located and surgically removed with the target tissue. The SCOUT System is intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
The SCOUT Bx Delivery System (including the SCOUT Reflector) is a sterile, single use device composed of a SCOUT Reflector preloaded in a delivery system. The SCOUT Reflector, when used in conjunction with the SCOUT Handpiece and SCOUT Console, can be used as a guide for the surgeon to follow in the excision of tissue. The SCOUT Reflector is visible using ultrasound and radiography. The SCOUT® Console, SCOUT Handpiece and SCOUT Reflector are components of the SCOUT Surgical Guidance System. The SCOUT Bx Delivery System is intended to be used with compatible Hologic® Biopsy Devices (Eviva® 0913-20, Eviva 1213-20, BREV09 (20mm aperture) and ATEC® ILS 0914-20).
The provided text is a 510(k) summary for the SCOUT Bx Delivery System. It outlines the device description, indications for use, comparison to a predicate device, and the performance testing conducted. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study that proves the device meets the criteria in the context of an AI/ML medical device performance study.
The relevant sections are focused on bench testing and biocompatibility for a physical medical device (implantable marker delivery system), not on software performance, diagnostic accuracy, or human reader effectiveness with AI assistance.
Therefore, many of the requested items, such as expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training/test set details, are not applicable or present in this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document mentions various bench tests and biocompatibility tests. While it states "Performance Testing-Bench" and lists categories like "Compatibility with legally marketed 3rd party Biopsy Device," "Deployment Accuracy," "Cannula Effective Length & OD," etc., it does not provide the specific quantitative acceptance criteria or the reported performance values for these tests. It only lists that these tests were conducted as part of the substantial equivalence determination.
2. Sample sizes used for the test set and the data provenance:
- Sample sizes: Not specified for any of the performance tests.
- Data provenance: Not applicable in the context of clinical data for AI testing, as this document describes bench and biocompatibility testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for AI/ML diagnostic devices (e.g., expert interpretation of images) is not relevant to the described physical device testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert-based adjudication is mentioned.
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. The document explicitly states: "No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device." This confirms that no clinical studies involving human readers or AI assistance were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical device, ground truth would be based on engineering specifications and physical measurement standards (e.g., ISO, ASTM standards listed). Not expert consensus or pathology in the diagnostic sense.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
In summary:
The provided text documents the 510(k) clearance for a physical medical device (SCOUT Bx Delivery System) and outlines the bench and biocompatibility testing performed to demonstrate substantial equivalence to a predicate device. It does not contain any information related to AI/ML device performance studies, diagnostic accuracy, or human reader interaction with AI, which are the typical contexts for the requested acceptance criteria and study details.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.