(15 days)
The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator.
The Contura Cavity Maintenance Catheter consists of a dual lumen silicone catheter with an inflatable balloon at its distal end. Two proximal ports are provided with Luer-type connectors for balloon inflation/deflation and for application of intracavitary vacuum. The Contura CMC is available in a spherical, 3.5-5.0 cm diameter balloon size.
The provided text describes the 510(k) summary for the SenoRx Contura Cavity Maintenance Catheter. It outlines the device's purpose, its equivalence to a predicate device, and the performance testing conducted. However, it does not contain the specific information requested about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, or details of a multi-reader multi-case study.
The document is a regulatory submission for device clearance, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to populate the table and answer the questions based only on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The overall implicit acceptance criterion is "substantial equivalence" to the predicate device and that the device "performed as intended." | Dimensional stability of the inflated balloon: Not explicitly detailed, but implied to be acceptable. |
| Burst volume testing: Not explicitly detailed, but implied to be acceptable. | |
| Balloon durability in an in vivo setting: Not explicitly detailed, but implied to be acceptable. | |
| Biocompatibility testing: Not explicitly detailed, but implied to be acceptable. | |
| Device performed "as intended." | |
| Device has "sub-set of the intended uses; same design; same patient contacting material; same operating principle; and same technological characteristics" as the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not provided (e.g., country of origin, retrospective/prospective). The testing appears to be preclinical (bench and in vivo), not human clinical data.
3. 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)
This information is not provided. The testing described is preclinical (dimensional stability, burst volume, durability, biocompatibility), which typically does not involve expert consensus for ground truth on clinical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As the testing appears to be preclinical and does not involve human interpretation of clinical data in a diagnostic context, an adjudication method for a test set is not applicable or described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described. This device is a physical medical device (catheter) and not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done or described. This device is a physical medical device (catheter) and not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the preclinical tests described (dimensional stability, burst volume, in vivo durability, biocompatibility), the "ground truth" would be established by objective measurements and laboratory standards for physical and material properties, as well as biological responses in an in vivo setting (likely animal models for some aspects of durability/biocompatibility) against predetermined specifications. It's not based on expert clinical consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.
8. The sample size for the training set
This information is not provided. This device is a physical medical device and would not typically have a "training set" in the context of an algorithm or AI.
9. How the ground truth for the training set was established
This information is not provided. As above, the concept of a "training set" and its "ground truth" is not applicable to the preclinical testing of this physical medical device.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.