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510(k) Data Aggregation
(16 days)
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
The Contura MLB Applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four lumens symmetrically offset from the central lumen. The balloon is inflated to a 4.5 - 6 cm spherical shape by a controlled volume injection of a saline/contrast solution.
This document is a 510(k) summary for the Contura MLB Source Applicator for Brachytherapy, which is a medical device. This is NOT a study describing device performance against acceptance criteria in the typical sense of a clinical or statistical study with acceptance criteria often seen for AI/ML devices.
Instead, the document details preclinical studies demonstrating the device's intended performance under simulated use conditions and its dosimetry equivalence to predicate devices. The "acceptance criteria" here are generally implied as meeting the functional requirements for a remote-controlled radionuclide source applicator and demonstrating similar radiation dose distribution to already cleared devices.
Here's an attempt to structure the information based on your request, understanding that this is a device submission and not a typical performance study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance under Simulated Use Conditions: | Performed as intended under simulated use conditions. |
| * Ability to connect to commercially available HDR afterloaders. | (Implied: Yes, designed for this, and preclinical studies confirmed.) |
| * Ability to pass radiation source delivery wire through lumens. | (Implied: Yes, 5 lumens provided for this purpose, and preclinical studies confirmed.) |
| * Ability to inflate balloon to 4.5 - 6 cm spherical shape. | (Implied: Yes, by controlled volume injection of saline/contrast solution.) |
| Dosimetry Equivalence to Predicate Devices: | Demonstrated that the Contura MLB Applicator could deliver an equivalent radiation dose to predicate devices. |
| * Radiation dose distribution patterns. | (Implied: Similar patterns to K071229 and K030558.) |
| * Target tissue coverage. | (Implied: Adequate for the indicated use, similar to predicate.) |
| Safety: | (Implied: Safe for its intended use, based on preclinical studies and comparison to predicates.) |
| * Biocompatibility of materials. | (Not explicitly stated here, but generally part of device evaluation.) |
| * Mechanical integrity. | (Not explicitly stated, but part of preclinical studies.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of human subjects or data sets for an AI/ML device. The "test set" would refer to the physical device prototypes or simulations. The document does not specify the number of devices or simulated scenarios tested in the preclinical studies.
- Data Provenance: Not applicable. The "study" refers to internal preclinical testing conducted by SenoRx, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable as this is not a diagnostic AI/ML device relying on expert-established ground truth from images or clinical data. The "ground truth" here would be established by engineering and dosimetry measurements and comparisons. Experts involved would be engineering, physics, and potentially clinical personnel involved in designing and testing the device. Their number and qualifications are not specified in this summary.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of adjudication for "test sets" in the context of human expert disagreement on classifications. Adjudication methods are typically relevant for human-interpretable data where ground truth is ambiguous or requires consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical instrument, not a diagnostic AI/ML algorithm that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is not an AI/ML algorithm. The "standalone" performance refers to the device's functional and dosimetric performance on its own, which was evaluated through preclinical studies.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation was primarily based on engineering measurements, physical properties, simulated use conditions, and dosimetric calculations/measurements. This would involve:
- Functional tests: Verifying inflation mechanics, lumen patency, compatibility with afterloaders.
- Material properties: Ensuring biocompatibility and structural integrity.
- Dosimetry: Measuring or calculating radiation dose distribution and comparing it to known predicate devices and established radiation physics principles.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that uses a "training set." The development of the device would involve engineering design, prototyping, and testing, which isn't analogous to training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" for this device.
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