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The Qora AIM™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days.

The Qora Aeon™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days.

The Qora Arida™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device is intended to be until the collection pouch is filled or until it has been utilized for 72 hours, whichever comes first. The replacement with other same devices should not exceed 29 days.

The Qora AIM™, Qora Aeon™, and Qora Arida™ Stool Management Kits are non-sterile, single-use devices packaged in a product box. Each kit contains one hygienic device applicator that houses a soft indwelling fecal diverter. The Qora AIM™ and Qora Aeon™ kits contain an additional two odor-proof collection bags.

The primary component of the device is the fecal diverter. It consists of soft, pliable, and self-expanding indwelling diverter that remains apposed to the rectal wall and the transit sheath. The indwelling diverter is sufficiently compliant to collapse and expand with the adjacent anatomy during peristaltic contractions of the rectum. This pliancy within the rectum is designed to help reduce abrasion and subsequent clinical complicator is used to hygienically insert and deploy the indwelling diverter at the intended location inside the rectum.

The Qora Arida™ collection pouch is a thin, biocompatible conduit that facilitates the transfer and collection of fecal material from the indwelling diverter. The use of thin material is engineered to reduce the foreign body sensation and risk of anal sphinction. Furthermore, the Qora Arida™ kit offers a single port attached to the side of the collection pouch. The port is used to withdraw the device in a trauma-free way from the patient.

The Qora AIM™ and Qora Aeon™ kits utilize a transit sheath that is a thin, biocompatible conduit that facilitates the transfer fecal material from the indwelling diverter to the collection bag. The use of thin sheath is designed to reduce the foreign body sensation and risk of anal sphinction. The bag connection interface at the end of the transit sheath prevents accidental soiling of bed sheets, garments, etc. during the exchange of a collection bag or other regular maneuvers during patient handling. Furthermore, the Qora AlM™ and Qora Aeon™ kits offer three ports attached to the side of the transit sheath. One port is used to irrigate the indwelling diverter if needed. The second port is used to collect samples from within the transit sheath if desired. The third and final port is used to withdraw the device in a trauma-free way from the patient.

This document is a 510(k) premarket notification for the Qora AIM, Qora Aeon, and Qora Arida Stool Management Kits. It establishes substantial equivalence to a predicate device (Consure 120 SMS, K133465) rather than providing a study demonstrating performance against specific acceptance criteria. Therefore, the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, and training set information) cannot be fully extracted from this document as it describes a different type of regulatory submission.

However, based on the provided text, here is what can be inferred and what information is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with numerical performance targets and reported device performance against those targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device in terms of design, materials, and intended use. The performance data section describes general non-clinical testing.

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

The document describes non-clinical testing, but it does not specify sample sizes for any "test set" in the context of clinical performance or human subject data. The testing mentioned (structural, functional, biocompatibility) would typically involve laboratory or animal testing, not human test sets. Data provenance is not applicable in this context as it's not a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This document does not describe a study involving expert review or ground truth establishment for a test set, as it is not a clinical performance study.

4. Adjudication Method:

Not applicable, as no expert review or human subject test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done or reported in this document. This submission focuses on substantial equivalence based on technical characteristics and non-clinical testing, not on comparative clinical effectiveness with human readers or AI assistance.

6. Standalone (Algorithm Only) Performance:

No, a standalone performance study was not done or reported. These devices are physical medical products (Stool Management Kits), not AI algorithms or software with standalone performance.

7. Type of Ground Truth Used:

Not applicable. The performance data detailed within this document pertains to non-clinical testing (dimensional, functional, structural integrity, and biocompatibility), not clinical outcomes or expert consensus on a disease state. Therefore, "ground truth" in the context of clinical diagnostics or outcomes data is not relevant here.

8. Sample Size for the Training Set:

Not applicable. As described in point 6, these are physical medical devices, not AI algorithms requiring a training set.

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

Not applicable. This is not an AI algorithm, so there is no training set or ground truth establishment process for a training set.

Summary of what the document focuses on:

The document is a 510(k) submission seeking clearance for medical devices (Stool Management Kits). Its primary goal is to demonstrate substantial equivalence to an already legally marketed predicate device (Consure 120 SMS). This is achieved by comparing:

• Intended Use and Indications for Use: The new devices have largely the same indications for use as the predicate, with minor variations in usage duration for one model.
• Technological Characteristics: Detailed comparison of parameters like intended users, patient population, environment of use, condition of use, insertion method, diverter outer diameter, detachable collection bag, irrigation port, sampling port, retrieval method, closed waste bag volume, interface port, odor protection, and materials.
• Performance Data (Non-Clinical): Testing confirmed the new devices are substantially equivalent to the predicate in terms of structural and functional integrity. Biocompatibility testing (in accordance with ISO 10993) also confirmed safety.

The conclusion is that the line extensions do not raise any new issues of safety or effectiveness, thus proving substantial equivalence to the predicate device. This is a common path for medical device clearance and differs from the type of study that would involve clinical acceptance criteria, human reader studies, or AI algorithm performance mentioned in your prompt.

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Consure 120 SMS is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients.

The Consure 120 Stool Management System is a non-sterile device packaged in individual SteriClin (medical grade paper with peel-away PE lamination) pouches. Ten such individual pouches are packed in corrugated boxes for shipping. Each Consure 120 SMS pouch contains: -- I soft and hygienic applicator that houses a soft in-dwelling diverter and -- 3 collection bags. The primary component of the device is the fecal diverter. It consists of an indwelling, pliable, self-expanding lattice structure that remains apposed to the rectal wall and the transit sheath. The indwelling diverter is sufficiently compliant to collapse and expand with the adjacent anatomy during peristaltic contractions of the rectum. This pliancy within the rectum can reduce abrasion and subsequent clinical complications originating from the mucosal damage. The transit sheath is a thin, biocompatible conduit that facilitates the transfer fecal material from the indwelling diverter to the collection bag. The use of thin sheath reduces the foreign body sensation and risk of anal sphincter dysfunction. The applicator is used to hygienically insert and deploy the indwelling diverter at the intended location inside the rectum. Whereas the bag connection interface allows the prevention of accidental soiling of bed sheets, garments, etc. during exchange of collection bag or other regular maneuvers during patient handling.

The Consure 120 SMS™ device underwent several tests to confirm functional performance and structural integrity, as well as a comparative analysis against predicate devices.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document states that "100% receiving and in-process inspection" is performed, and the listed tests are conducted "on each lot prior to release." This suggests a continuous sampling or full inspection approach for manufacturing quality control, rather than a single large-scale test set.
The "Comparative analysis of Consure 120 SMS vs predicate devices" was performed "in-house." The document does not specify the sample size for this comparative analysis.
The data provenance is internal ("in-house") and appears to be from manufacturing and bench-top testing. There is no information regarding country of origin of data or whether it's retrospective or prospective in the context of clinical studies.

3. Number of Experts and Qualifications for Ground Truth

The provided document does not mention any ground truth established by experts for a test set. The testing described is primarily focused on engineering specifications, functional performance, and comparative bench-top analysis against predicate devices, not clinical performance or expert-adjudicated outcomes.

4. Adjudication Method for the Test Set

Not applicable, as no expert-adjudicated test set is described in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided text. The comparative analysis described is a bench-top comparison of device features and specifications, not a study involving human readers or clinical outcomes.

6. Standalone (Algorithm Only) Performance Study

Not applicable, as the Consure 120 SMS is a physical medical device (rectal catheter) and not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the device testing appears to be based on:

• Engineering Specifications: Defined dimensional and force thresholds for manufacturing and functional performance.
• Predicate Device Specifications: Published functional parameters and characteristics of the Bard® DigniShield™ Stool Management System, used for bench-top comparison.

8. Sample Size for the Training Set

Not applicable, as the Consure 120 SMS is a physical medical device and not an AI or algorithm that requires a training set.

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

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

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