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510(k) Data Aggregation
(160 days)
The Fecobionics Anorectal System is for use on patients requiring anorectal pressure studies and testing of defecatory function. The Fecobionics System must only be used by appropriately trained clinicians. The Fecobionics System enables evaluation of rectal volume and shape, rectoanal inhibitory reflex, anal diameter during defecatory push pressure, and anorectal angle changes. The Fecobionics device is only intended to be used in adult patients.
The Fecobionics Anorectal System (Fecobionics System) is a portable anorectal manometry device for use on patients requiring anorectal pressure studies and evaluation of defecatory function. The Fecobionics System consists of three main components: AR-100 Probe, DH-100 Data Hub, and Fecotracker App (installed on a provided PC-based laptop). The AR-100 Probe is a single-use, non-sterile disposable, battery-powered probe designed to be inserted manually into the rectum and wirelessly transmit data to the external Data Hub, which wirelessly sends the data to the PC with the Fecotracker App. The system provides clinicians with real-time manometric data and geometric mapping information in a single examination. The probe features a balloon designed to be filled with saline by means of a detachable fill tube and a Luer-Lock connection with a syringe. The inflation of the balloon allows the evaluation of sensation thresholds of the lower rectum and assesses and triggers Recto Anal Inhibitory Reflex (RAIR). To mimic the defecation process, the wireless probe is designed to be defecated as an untethered free distensible mass. In total, the Fecobionics System enables the evaluation of rectal sensitivity, rectal volume, and shape, recto anal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes. The AR-100 Probe is 10cm long, and its interior bendable core is 10mm in diameter. When inflated with the allowed maximum saline inflation volume (100 mL), the balloon reaches a diameter of up to 5cm.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for device performance beyond the successful completion of various tests. Instead, the acceptance criteria are largely implied by meeting the requirements of recognized standards and demonstrating "no difference," "comparable," or "high correlation" with the predicate device or expected results.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meets ISO 10993-1, -5, -10, -11, -23 standards (non-cytotoxic, non-sensitizer, non-irritant, non-pyrogenic). | "All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is non-cytotoxic, a non-sensitizer, a non-irritant, non-pyrogenic, is suitable for its intended use, and is substantially equivalent to the predicate device." |
| Electrical Safety: Meets IEC 60601-1 standard. | "All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is substantially equivalent to the predicate device." |
| Electromagnetic Compatibility (EMC): Meets IEC 60601-1-2 standard. | "All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is substantially equivalent to the predicate device." |
| Software Verification and Validation: Meets IEC 62304 standard. | "All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is substantially equivalent to the predicate device." |
| Functional Performance Accuracy: Verification in simulated use conditions (new and aged devices). | "No difference in results between aged and not aged samples. When applicable, the relevant performances and accuracy obtained are comparable with the predicate device. All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is suitable for its intended use and is substantially equivalent to the predicate device." |
| Mechanical and Performance Tests: Verification of physical specifications, strength, sealing, wireless transmission, battery life, cleaning. | "No difference in results between aged and not aged samples. When applicable, the relevant performances are comparable with the predicate device. All results met acceptance criteria and demonstrate the Fecobionics Anorectal System is suitable for its intended use and is substantially equivalent to the predicate device." |
| Clinical Study (Sensory Measurement): Outcomes related to sensory measurements comparable to the predicate. | "The outcomes on 10 patients met the criteria for success related to the sensory measurements as outlined in the protocol. A high correlation was found between the sensation levels and the volume data with the two technologies. No questions of safety were raised by the study. The results demonstrate the Fecobionics Anorectal System is suitable for its intended use and is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The only explicitly mentioned test set with a sample size is the clinical study:
- Sample Size: 10 patients
- Data Provenance: The document states it was a "nonsignificant risk (NSR), observational, randomized clinical study." This implies a prospective study design. The country of origin of the data is not specified.
For the other performance tests (Biocompatibility, Electrical Safety, EMC, Software V&V, Functional Performance, Mechanical and Performance), the sample sizes are not explicitly stated. The provenance for these is "Preclinical and clinical tests" and "verification bench testing," implying laboratory or engineering testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For the clinical study, it mentions "appropriately trained clinicians" are required to use the device, but it doesn't specify how many or their qualifications for establishing ground truth or evaluating the data. Given the comparative nature of the clinical study (comparing sensory measurements between the Fecobionics system and the predicate), it's likely the clinicians involved acted as evaluators, but their number and specific qualifications are not detailed.
4. Adjudication Method 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, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. The device described is a diagnostic tool (anorectal manometry system) for measuring physiological parameters, not an AI-assisted interpretation or diagnostic aid for human readers. It provides data for clinicians to interpret, but it doesn't mention an AI component that assists human reading.
- Therefore, there is no effect size related to human readers improving with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The document implies the device provides raw data and measurements to clinicians ("The Fecobionics System provides clinicians with real-time manometric data and geometric mapping information in a single examination"), rather than producing an automated diagnosis or interpretation. Thus, the concept of "standalone algorithm performance" as typically applied to AI diagnostics is not directly applicable here. The device itself is a measurement system.
- The "functional performance accuracy verification" and "mechanical and performance tests" can be considered standalone performance tests of the device's measurement capabilities. The clinical study, while involving patients and comparison, still focuses on the device's ability to accurately measure sensory parameters.
7. The Type of Ground Truth Used
For the clinical study:
- The ground truth for sensory measurements was established by comparison to the predicate device. The study looked for "high correlation... between the sensation levels and the volume data with the two technologies," implying the predicate device served as the reference for acceptable sensory measurement.
For the other performance tests:
- Engineering specifications and recognized standards served as the ground truth. For example, IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility, and internal design requirements for mechanical and functional performance.
8. The Sample Size for the Training Set
- The document does not mention a training set in the context of an AI/ML algorithm. This indicates the device is not based on a machine learning model that requires a distinct training phase. The functional and clinical testing described are for verification and validation of a hardware and software system.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a training set or AI/ML algorithm, this question is not applicable.
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(123 days)
RED is used to evaluate the neuromuscular function of the patient's ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.
RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The RED catheter consists of an open-cell foam ball encased inside of a balloon, coupled to a hollow catheter. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume of air it displaces when inflated in room air is 52ml. This passive expansion provides the same function as filling an empty balloon with water or air. When expanded, the volume of material inside the patient's rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate. This is measured by asking patients the questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually.
The acceptance criteria and study proving the device meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Device can safely be used to evaluate neuromuscular function of the patient's ability to expel its contents from the rectum in adults with functional constipation. | Clinical evidence from a prospective trial of 60 adults "clearly supports product safety and performance and the indications for use in that RED can safely be used to evaluate neuromuscular function of the patient's ability to expel its contents from the rectum in adults with functional constipation (defined by Rome IV criteria)." The specific quantitative measure for "safely" is not explicitly defined here but is inferred to be the absence of reported adverse events or complications during the study. The ability to evaluate neuromuscular function is indirectly supported by the fact that the device is analogous to traditional balloon expulsion tests. |
| Device can be safely and effectively used as a qualitative test for rectal hypersensitivity. | The study "demonstrates that RED can be safely and effectively used as a device for qualitative testing for rectal hypersensitivity, whereas 31.0% of patients experienced rectal hypersensitivity with RED distended when queried on the patient perception to defecate." Safety is again inferred from the absence of reported adverse events. Effectiveness for qualitative testing for rectal hypersensitivity is demonstrated by the ability to identify a significant percentage of patients (31.0%) exhibiting this condition as per patient perception to defecate when the RED device is distended. |
| RED offers benefits with respect to assessing hypersensitivity compared to primary predicate. | "RED offers benefits... Firstly, the equipment and complexities required to use the primary predicate greatly limits the access to hypersensitivity testing. As such, the large subpopulation of individuals who are hypersensitive to lower volumes, but are never tested due to testing complexities of the predicate, are likely to benefit greatly through referral to physical therapy. Further, as the sensitivity evaluation simply requires asking a question about urge to defecate for individuals who are already undergoing rectal expulsion testing, it provides that added benefit at no additional risk than rectal expulsion testing alone with RED would provide." This criterion is met by detailing the advantages of RED in terms of accessibility and ease of use, leading to increased detection of hypersensitivity. |
2. Sample size used for the test set and the data provenance:
- Sample Size: 60 adults
- Data Provenance: Prospective clinical trial. The country of origin is not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the clinical trial. However, it mentions that patients with functional constipation were "defined by Rome IV criteria," which are internationally recognized diagnostic criteria established by experts in gastroenterology. The evaluation for rectified hypersensitivity also involved "querying on the patient perception to defecate," suggesting reliance on patient self-report interpreted within clinical guidelines.
4. Adjudication method for the test set:
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" for functional constipation was based on Rome IV criteria, and rectal hypersensitivity was determined by patient perception to defecate when the RED device was distended. This suggests reliance on established diagnostic criteria and patient report rather than an expert adjudication process for image or data interpretation.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. The RED device is described as operating without electronics or software, and is not an AI-assisted device. The study focused on the device's standalone performance and its comparison to traditional methods in terms of accessibility and ease of use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done for the device in the context of its intended use. The RED device itself is a mechanical device, and its "standalone performance" refers to its ability to perform the balloon expulsion test and facilitate the qualitative assessment of rectal hypersensitivity as described, without additional electronic or software components. The clinical trial evaluated its performance in these applications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functional constipation: Expert consensus-based diagnostic criteria (Rome IV criteria).
- For rectal hypersensitivity: Primarily patient perception/self-report regarding the desire or urge-to-defecate at lower volumes of distension, interpreted qualitatively.
8. The sample size for the training set:
The provided text describes a clinical trial for performance evaluation, not a machine learning model, therefore, there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
As there is no machine learning model or training set, this question is not applicable.
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