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510(k) Data Aggregation
(259 days)
The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.
The mcompass Biofeedback Anorectal Manometry System is a manometry system for the measurement of anorectal pressures. It provides visual feedback (biofeedback) of the muscle action allowing the patient to modulate the activity of the anorectal muscles, thereby reeducating the pelvic floor muscles. It is used in a clinical setting and consists of a non-sterile disposable catheter (2-channel or 5-channel), a previously cleared reusable RMD FOB (and related battery charger), and software that resides on a tablet PC and that collects, records and displays the pressure data. Air-charged balloons are used to measure contractile pressures of the anorectal canal and simulate a range of bowel fullness levels, in addition to measuring locational pressure at the distal tip of the catheter. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC
The provided text describes a 510(k) premarket notification for the mcompass Biofeedback Anorectal Manometry System (K143031). It focuses on demonstrating substantial equivalence to a predicate device (mcompass Anorectal Manometry System, K120088) rather than detailing specific acceptance criteria and a study to prove they are met in the same way one might for a novel AI device.
Therefore, the requested information, particularly regarding AI-specific criteria, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, is not present in this document. This document pertains to the regulatory clearance of a physical medical device.
However, I can extract the information that is present regarding performance data and validation:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence to an existing device, a direct "acceptance criteria" table with numerical performance targets similar to a novel AI algorithm's sensitivity/specificity is not explicitly stated. Instead, the "performance data" section focuses on demonstrating that the new device meets various safety and functional standards, and that its technological differences do not raise new questions of safety or effectiveness compared to the predicate.
| Category | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Complies with ISO 10993-5 (Cytotoxicity), ISO 10993-11 (Systemic Toxicity), ISO 10993-10 (Intracutaneous Injection Test, Sensitivity) for surface-contacting devices (<24 hours mucosal exposure). | Meets the specified ISO 10993 standards for Cytotoxicity (Elution Test & Neutral Red Uptake), Systemic Toxicity, Intracutaneous Injection Test (Irritation), and Kligman Maximization Test (Sensitivity). |
| Mechanical Testing | Meets standards for physical characteristics, system leak pressure, and burst pressure. | • Physical characteristics• System leak pressure• Burst pressure(All implicitly met as "Performance data" is listed and no deficiencies are noted.) |
| Electrical Safety and EMC | Complies with current standards for electrical safety and Electromagnetic Compatibility (EMC). | Meets current standards for electrical safety and EMC. |
| Software Verification and Validation | Complies with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). | Software verification and validation testing were conducted, and documentation was provided as recommended by the FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on device engineering, safety, and software validation rather than a clinical performance study with a test set of patient 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 in the document. As mentioned, the submission doesn't detail a clinical performance study with a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is not an AI-assisted diagnostic tool, but rather a system for anorectal manometry and biofeedback.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm performing a diagnostic task. It is a physical system with software for data collection, recording, and display. The software's performance was validated, but not as a "standalone algorithm" in the typical sense of AI product evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the software verification and validation, the "ground truth" would be defined by the software requirements and design specifications, with correctness verified through testing against expected outputs. For the device components, the ground truth is adherence to the specified engineering standards (e.g., ISO, electrical safety norms) and mechanical properties. There is no biological "ground truth" mentioned in the context of a clinical study in this document.
8. The sample size for the training set
This information is not provided in the document. This is not an AI device that would typically have a "training set" of patient data.
9. How the ground truth for the training set was established
This information is not provided in the document, as it is not applicable to this type of device submission.
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(78 days)
The mcompass Anorectal Manometry System is for use on patients requiring anorectal pressure studies.
The mcompass device is a manometry system for the measurement of anorectal pressures. It is used in a clinical setting and consists of a non-sterile disposable catheter, a reusable RMD FOB, and software that resides on a tablet PC that collects, records and displays data. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC. Pressures are measured via four small, air-charged, radial balloons evenly spaced around the distal circumference of the catheter and a fifth larger balloon, positioned near the distal tip. The four small balloons measure radial contractile pressures of the anorectal canal while the most distal balloon is used to simulate a range of bowel fullness levels, in addition to measuring locational pressure.
The Medspira mcompass™ Anorectal Manometry System did not report specific acceptance criteria or detailed study results in the provided document. The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting full clinical trial data with predefined acceptance criteria.
The information provided describes the device, its intended use, predicate devices, and the types of testing performed to ensure its functional and performance requirements.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
Specific quantitative acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) for the device's clinical performance are not explicitly stated in the provided document. The submission focuses on compliance with general functional, safety, and performance requirements through various standards.
Reported Device Performance:
The document states that "representative samples of the device underwent mechanical, electrical, and biocompatibility testing in accordance with the applicable industry standards." However, the quantitative results or specific performance metrics from these tests (e.g., exact pressure measurement accuracies, reliability figures) are not provided. The conclusion is simply that the device design "met its functional and performance requirements" and is "substantially equivalent" to predicate devices.
2. Sample Size for Test Set and Data Provenance
No information regarding a "test set" in the context of clinical performance or algorithm evaluation is provided. The functional and safety testing mentioned likely refers to laboratory-based engineering and safety tests rather than a clinical study test set for assessing diagnostic or prognostic performance. Therefore, sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable or not reported.
3. Number of Experts and Qualifications for Ground Truth
No information regarding a clinical study involving human experts to establish ground truth is provided. The device is a measurement system, and its "ground truth" would typically relate to the accuracy of its physical measurements against known standards, which is addressed by the functional and performance testing mentioned.
4. Adjudication Method
As no clinical study with human interpretation or expert-based ground truth is described, adjudication methods are not applicable or not reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This device is a measurement system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.
6. Standalone (Algorithm Only) Performance Study
The document does not describe an "algorithm only" performance study in the context of AI. The device includes software that "collects, records and displays data," implying a user interface for clinicians. The performance described relates to the accuracy of pressure measurements by the system as a whole.
7. Type of Ground Truth Used
For the functional and performance testing mentioned:
- Physical standards/calibrations: The "ground truth" for pressure measurements would be established through calibrated pressure sources and other physical reference standards used during the mechanical and electrical testing.
- Industry standards: Biocompatibility testing relies on established biological evaluation standards (ISO 10993 series).
8. Sample Size for Training Set
The document does not describe the use of machine learning algorithms requiring a "training set" in the context of AI. The software primarily handles data collection, recording, and display. Therefore, sample size for a training set is not applicable or not reported.
9. How Ground Truth for Training Set Was Established
As no training set for a machine learning algorithm is mentioned, this information is not applicable or not reported.
In summary: The provided document is a 510(k) summary for a medical device that measures anorectal pressures. It demonstrates substantial equivalence through compliance with safety and performance standards rather than presenting detailed clinical performance data with specific acceptance criteria, clinical study designs, or AI-specific evaluation metrics. The "study" referenced refers to laboratory-based functional, electrical, and biocompatibility testing against recognized industry standards.
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