(206 days)
The Navina Classic System is indicated for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management.
The Navina Classic System is intended to promote evacuation of the colon and rectum by instilling water into the lower part of the colon through a rectal catheter which incorporates an inflatable balloon.
The Navina Classic System is composed of a single use rectal catheter with an inflatable balloon, a water container, a control unit for manual control of instillation water flow and manual balloon inflation and deflation, and tubing with integral connectors for connection of the device components.
The Navina Classic System is intended to promote evacuation of the contents of the colon and rectum by instilling water into the lower part of the colon through the rectal catheter which incorporates an inflatable balloon.
The provided document is a 510(k) premarket notification for the Dentsply Sirona Navina Classic System. It focuses on demonstrating substantial equivalence to a predicate device (Peristeen Anal Irrigation System), rather than detailing original clinical performance studies with specific statistical acceptance criteria for a novel AI/device.
Therefore, many of the requested details, such as those related to AI model acceptance criteria, ground truth establishment for test sets, MRMC studies, and standalone algorithm performance, are not applicable or not available in this document because the device itself is a mechanical medical device, not an AI/ML product.
However, I can extract information related to the performance testing that was conducted:
Acceptance Criteria and Reported Device Performance
The document describes non-clinical performance testing against "requirements." While specific numerical acceptance criteria are not explicitly stated in a table format with corresponding reported values, the text indicates that the device met these requirements.
Note: The document states, "The performance of the Navina Classic System satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence." This implies that internal acceptance criteria were established and met for each test.
| Test Category | Specific Performance Tests | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Control Unit | - Control of air leakage | Meets specified leakage limits. | Satisfactorily met requirements. |
| - Complete deflation of balloon (air release) | Achieves complete balloon deflation. | Satisfactorily met requirements. | |
| - Control of maximum pump force | Stays within specified pump force range. | Satisfactorily met requirements. | |
| - Ability to instantly stop water flow | Stops water flow immediately upon control. | Satisfactorily met requirements. | |
| - Control of water flow rate | Maintains specified water flow rate. | Satisfactorily met requirements. | |
| Rectal Catheter | - Hydrophilic coating at insertion and withdrawal | Maintains lubricity for smooth insertion/withdrawal. | Satisfactorily met requirements. |
| - Flexibility | Meets specified flexibility standards. | Satisfactorily met requirements. | |
| - Even balloon inflation | Inflates uniformly without deformities. | Satisfactorily met requirements. | |
| - Balloon burst diameter | Bursts at or above specified diameter. | Satisfactorily met requirements. | |
| - Balloon burst volume | Bursts at or above specified volume. | Satisfactorily met requirements. | |
| - Rectal catheter flow rate | Achieves specified flow rate. | Satisfactorily met requirements. | |
| - Rectal catheter flow rate after catheter kink | Maintains acceptable flow rate after kinking. | Satisfactorily met requirements. | |
| Water Container | - Proper air pressure | Maintains specified air pressure. | Satisfactorily met requirements. |
| - Accuracy of the scale of the water container | Provides accurate volume measurement. | Satisfactorily met requirements. | |
| Connectors | - Control of air leakage | Meets specified leakage limits. | Satisfactorily met requirements. |
| - Tensile and torque resistance after simulated repeated use | Withstands specified tensile and torque forces after repeated use. | Satisfactorily met requirements. | |
| Navina Classic System | - System backflow verification testing | Prevents backflow as specified. | Satisfactorily met requirements. |
| Biocompatibility (ISO 10993) | - Cytotoxicity (ISO10993-5:2009) | Non-cytotoxic. | Non-cytotoxic. |
| - Irritation (ISO10993-10:2010) | Non-irritating. | Non-irritating. | |
| - Sensitization (ISO10993-10:2010) | Non-sensitizing. | Non-sensitizing. | |
| - Genotoxicity (ISO10993-3:2014) | Non-genotoxic. | Results demonstrate support for substantial equivalence. | |
| Leachable Compounds | - Verification of leachables after simulated repeated use | Meets safety limits for leachable compounds. | Results support substantial equivalence. |
Study Details
As the document is a 510(k) for a physical medical device, not an AI/ML product study, many of the requested fields are not applicable (N/A).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly quantified in terms of "samples" in a clinical or data sense for bench testing. It refers to the physical units tested to verify performance. The document does not specify the number of units or iterations for each non-clinical test.
- Data Provenance: N/A for bench testing. These are laboratory tests conducted on the device components.
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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):
- N/A. Ground truth in the context of AI/ML device performance (e.g., image annotation) is not relevant here. For a mechanical device, performance is evaluated against engineering specifications and industry standards. There is mention of "consensus expert review (Emmanuel et al)" for the contraindications and precautions, referencing a published paper by medical professionals, but this is for clinical context, not for establishing ground truth for a test set in the AI sense.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept applies to human review of data, typically in AI/ML performance studies.
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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. This is a mechanical device, not an AI-assisted diagnostic tool. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance data, the "ground truth" or reference for acceptance is against pre-defined engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and relevant regulatory requirements.
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The sample size for the training set:
- N/A. This device does not involve a "training set" in the machine learning context.
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How the ground truth for the training set was established:
- N/A. This device does not involve machine learning or a training set.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.