(423 days)
Coloplast Ostomy Rod is used for loop ostomy surgery. The ostomy rod is a device that is placed through a loop of the colon brought out through the abdominal wall to temporarily keep it from slipping back through the surgical opening during the loop (colostomy or ileostomy) ostomy procedure.
The Coloplast Ostomy Rod is a 90mm white HDPE rod with a fixed T at one end and a separate T piece that can be snaoped into the open end of the rod once it is in place. Holes in the ends of the T allow for suturing. The device is packaged in a laminated polvethylene and cas-permeable paper pouch. The product is sterilized by irradiation.
The provided text describes a 510(k) summary for the Coloplast Ostomy Rod, which is a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, and multi-reader multi-case studies for AI algorithms is not applicable to this document, as it describes a traditional medical device's regulatory submission, not an AI/ML-based device.
However, I can extract the relevant information that is present in the provided text.
Here's a breakdown of the information that can be extracted and why other parts are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength | Tested and monitored through ongoing testing. (Specific numerical criteria or results are not provided). |
| Flexural Strength | Tested. "Flexural strength and flexibility were compared with results for the Coloplast Ostomy Rod and the Conva-Tec Sure-Fit System giving similar results both well above the estimated effect from the colon." (Specific numerical criteria or results are not provided). |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization) | Tested according to ISO 10993-01 Biological Evaluation of Medical Devices. "All criteria for acceptance were met." (Specific criteria or results are not provided). |
| Leachable Profiles (Stability over time) | Tested for two lots (one at baseline, one near expiration). "There was no significant change associated with time." (Specific numerical criteria or test results are not provided). |
| Sterility | Labeled as sterile by irradiation. (Implies meeting sterility requirements, but no specific test results are detailed in this section). |
| Material Biocompatibility (HDPE) | "This is not the same material used for the ConvaTec Sure-Fit System, but is widely used in the medical industry and is shown to meet biocompatibility requirements." (Implies material acceptance based on general industry use and prior biocompatibility testing for the material itself, not necessarily for the final device in this context). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: The document describes non-clinical performance data (material properties, biocompatibility, leachables) rather than a clinical study or a test set for an AI/ML algorithm. Therefore, "test set" in the context of an AI/ML device is not relevant here. The tests mentioned (tensile, flexural, biocompatibility, leachables) are done on the device itself and likely involve a small number of samples (e.g., a few units from different lots) for engineering and biological safety testing. No country of origin for "data" is mentioned, as it's product testing, not 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)
- Not Applicable: There is no "ground truth" in the clinical sense mentioned in this document, as it's not a diagnostic device or an AI algorithm requiring expert consensus. The "ground truth" for the material and performance tests would be established by scientific and engineering standards for device functionality and safety, executed by qualified lab personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set or subjective assessment requiring adjudication is 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
- Not Applicable: This is not an AI/ML device, so no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: As mentioned, for this physical medical device, "ground truth" relates to objective engineering and biological safety standards (e.g., force measurements meeting a minimum threshold, biological assays showing no toxicity).
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI/ML device.
§ 876.4270 Colostomy rod.
(a)
Identification. A colostomy rod is a device used during the loop colostomy procedure. A loop of colon is surgically brought out through the abdominal wall and the stiff colostomy rod is placed through the loop temporarily to keep the colon from slipping back through the surgical opening.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.