(287 days)
The Endomag Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
The Endomag Magseed Pro Magnetic Marker is intended for use as a soft tissue marker. The marker is visible under ultrasound and radiographic imaging. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
The Magseed Pro Magnetic Marker is a sterile, single use device composed of a selfexpanding four-sided tetrahedral nitinol structure, with side lengths of 6.3 mm with a magnetic core. The device is not inherently magnetic. It is capable of being magnetized and located by Endomagnetics' Sentimag Gen 2 or Gen 3 devices. The Magseed Pro Magnetic Marker comes preloaded in a 17-gauge needle delivery system.
The Magseed Pro Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site intended for surgical removal. The Magseed Pro Magnetic Marker is subsequently localized by using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimage Systems, Sentimag Gen 3 K222832 or Sentimag Gen 2 K153044). The marker can be detected up to 45 mm from the Sentimage probe. The surgeon may use compression of the tissue with the probe to improve detection. The marker is located and surgically removed with the target tissue.
Additionally, Magseed Pro can be used in combination with Sentimag Gen 3 in Measure mode. When used in this modality, the distance between the location of Magseed Pro and the tip of the Sentimag Gen 3 probe can be measured. This distance is graphically displayed on the LCD screen of Sentimag Gen 3 in this mode.
Based on the provided text, the device in question is the "Magseed Pro Magnetic Marker System." The document describes its acceptance criteria and the study conducted to prove it meets them.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Efficacy: Successful placement and retrieval of the Magseed Pro marker with the target region excised in the specimen for breast/soft tissue lesions (primary endpoint). | All Magseed Pro markers were successfully retrieved with the target region excised in the specimen. (Implied from the absence of contrary reporting and the positive conclusion of substantial equivalence). |
| Safety: Rate of device-related Adverse Events (AE's or SAE's). | No device-related adverse events were observed in any of the patients. |
| Safety: Presence of unexpected histological tissue responses. | No unexpected tissue reactions were observed in any of the patients. |
Note: While the document lists "Dimensional verification," "Robustness testing," "Insertion, deployment and withdrawal force testing," "MRI Compatibility," "Biocompatibility testing per ISO 10993-1," and "Corrosion testing" as performance tests, it does not explicitly state numerical acceptance criteria or detailed results for these. However, the overall conclusion of substantial equivalence implies they met their internal acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 60 patients.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical performance testing" conducted in patients, implying prospective data collection during the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical test set. The ground truth appears to be based on direct clinical observation (successful retrieval) and pathological examination (target region excised, absence of unexpected tissue responses).
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to be derived directly from the outcomes of the surgical procedures and subsequent pathological assessments.
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 involving human readers assisting with or without AI was not conducted. This device is a physical marker and delivery system, not an AI-powered diagnostic tool. The clinical study focused on its physical performance (placement, retrieval, safety).
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical marker, not an algorithm or software. Its performance is evaluated in conjunction with human use (placement, surgical removal) and detection systems (Sentimag Gen 2/3).
7. The Type of Ground Truth Used
The ground truth used was:
- Clinical Efficacy: Successful physical retrieval of the marker and excision of the target tissue during surgery.
- Pathology: Histological examination of excised tissue to confirm target region removal and assess for unexpected tissue responses.
- Outcomes Data: Observation of device-related adverse events.
8. The Sample Size for the Training Set
The document does not mention a training set, as this is a physical device and not a machine learning model. The clinical study involved 60 patients for performance and safety evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for a machine learning model.
§ 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.