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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

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.

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The Easy Loop is indicated for use in abdominal surgical procedures generally referred the Lady Loop is mare specifically referred to as loop ileostomy and loop colostomy, where a loop of bowel is pulled through an abdominal incision and retained colosiony, which a loop of bonet to pair in paints the exteriorized loop of bowel from retracting back into the abdominal cavity, is used in conjunction with commercially available ostomy appliances which collect the evacuated feces.

The Easy Loop is constructed of an eight inch long x 0.28" diameter PVC flexible tubing, to which is bonded at each end a 1.45" long generally arrowshaped slotted PVC coupling member whose shape allows easy passage through the mesentery for placement of the device while resisting unintended withdrawal , and whose shape and slots permit interlocking of the two ends of the device to form a closed loop around the exteriorized loop of bowel.

This document is a 510(k) premarket notification for a medical device called "Easy Loop" and does not contain information about explicit acceptance criteria or a detailed study proving its performance against such criteria. Instead, it claims substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission claims substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document states that the device "has been successfully employed by Board Certified Colon and Rectal Surgeons," but it does not specify what constitutes this "successful employment," the number of cases, or the nature of any "test set." The data provenance is also not specified beyond the implicit use in a clinical setting by surgeons. It's likely retrospective observation rather than a structured prospective study for the purpose of this 510(k).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document mentions that Board Certified Colon and Rectal Surgeons "found [the device] to be as safe and effective as the predicate device," but it doesn't detail how many surgeons were involved in this assessment or what specific "ground truth" they were establishing beyond a general assessment of safety and effectiveness.

4. Adjudication Method for the Test Set

This information is not provided. Given the lack of a structured "test set" and a formal evaluation method described, an adjudication method would not be applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done or at least not described in this document. The submission is based on a claim of substantial equivalence to a predicate device, not on a comparative study with human readers (surgeons in this context) and AI. This device is a physical medical instrument, not an AI/software device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The "Easy Loop" is a physical medical device (a colostomy rod), not an algorithm or software. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

The ground truth implicitly used for the claim of safety and effectiveness appears to be expert opinion/clinical experience of Board Certified Colon and Rectal Surgeons. They deemed the device "as safe and effective as the predicate device," indicating an observational, real-world assessment by qualified professionals. There's no mention of pathology, objective outcomes data, or a controlled study to establish a formal "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device.

Summary of Device Rationale and "Proof" of Meeting Acceptance Criteria (as per the document):

The submission argues for substantial equivalence by comparing the technological characteristics of the Easy Loop with a legally marketed predicate device (Loop Ostomy Rod by Convatec, 510(K) #K830945). The "proof" relies on:

• Clinical Experience/Expert Opinion: "This device has been successfully employed by Board Certified Colon and Rectal Surgeons and was found to be as safe and effective as the predicate device cited above."
• Tabulated Comparison of Technological Characteristics: The document states, "Please find a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution." (The table itself is not included in the provided text snippets but is referenced as being part of the original submission).

Essentially, the "acceptance criteria" were met by demonstrating that the Easy Loop is sufficiently similar in design, materials, and intended use to a previously approved device, and that clinical experience with it supports its equivalence in safety and effectiveness when compared to the predicate, according to Board Certified Colon and Rectal Surgeons. No specific quantitative performance metrics or formal study results are presented in these excerpts.

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