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The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.

The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.

The provided text describes the 510(k) premarket notification for the "Irrigation Tubing with CO2 or Air" device, demonstrating its substantial equivalence to a predicate device. However, it does not contain detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in an AI/ML medical device submission.

The document pertains to an irrigation tubing device, which is a simple medical device, and not an AI/ML-driven device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC study, training set sample size, etc.) are not applicable to this type of submission.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document mentions "established internal acceptance criteria based on ISO 14971:2012" for risk analysis, and "design verification and validation" for performance. It also lists specific tests conducted. However, it does not provide a table detailing quantitative acceptance criteria (e.g., specific flow rates, leak tolerances) and the corresponding measured performance values.

Partial Information Available:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "benchtop testing" and "usability evaluation" but does not quantify the number of units or test iterations.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For the performance testing bench, it refers to internal testing by KeyMed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. This device is not an AI/ML device that requires expert-established ground truth for performance evaluation in the typical sense. Performance is assessed through engineering and physical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this is not an AI/ML device requiring human adjudication of performance.

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 device is not an AI/ML product.

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

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of clinical ground truth for an AI/ML device. For this physical device, "ground truth" would be established through engineering specifications, material properties, and physical measurements against defined standards.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML device and does not have a training set.

9. How the ground truth for the training set was established:

Not applicable. This device is not an AI/ML device.

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The OLYMPUS FLUSHING PUMP (OFP-2) and its accessories are intended for use during endoscopic procedures to wash blood, feces and other organic matter from the gastric and colonic mucosa site being visualized, diagnosed and to aid in the filling areas of the gastrointestinal tract with water in order to aid in examinations preformed with trans-endoscopic ultrasound probes.

The Olympus Endoscopic Flushing Pump (OFP-2) is a motorised pump designed to transfer water from a bottle, via a tube, to an endoscope.

The OFP-2 uses a peristalic pump head to move the water through the tube. The speed of rotation of the pump head is adjustable by the user, over nine steps, using flow control buttons on the front of the pump. The flow control buttons are connected to a digital controller that governs speed of rotation of the pump head. Nine LEDs on the front of the pump indicate the speed setting that has been selected.

The pump is operated by a footswitch or a button on the endoscope. It has an on/off button and a standby button.

The OFP includes a water container supplied non-sterile to be processed before use. Two water tubes of different lengths and an instrument channel adapter are supplied sterile. The Instrument Channel Adapter (MAJ-1606) and Instrument Channel Water Tube (MAJ-1607) are supplied sterile for single use only. to pump water through the instrument channel of the endoscope. The Auxilliary Channel Water Tube (MAJ-1608) is supplied sterile for single day only use.

The provided text is a 510(k) summary for the Olympus Endoscopic Flushing Pump (OFP-2). It details the device description, indications for use, and a summary of testing, primarily focusing on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance during a clinical study.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set information) are not explicitly present in the provided document.

However, I can extract the information that is available regarding the device's performance verification, validation, and general testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for the OFP-2's flushing performance (e.g., flow rate thresholds, cleaning efficacy metrics). Instead, it states that "The performance of the OFP-2 and its accessories was verified and validated" and demonstrates substantial equivalence to predicate devices. The study detailed is primarily a summary of testing focused on safety, biocompatibility, and sterilization, rather than a clinical performance study with specific acceptance criteria for clinical outcomes.

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

The document does not detail a specific "test set" in the context of clinical performance evaluation (e.g., number of patients, procedures, or images). The testing described relates to material and electrical safety.

• Sample Size: Not specified for biocompatibility (e.g., number of units tested, number of animals for in-vivo tests) or electrical safety (e.g., number of units tested).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests mentioned (biocompatibility, electrical safety, sterilization) are likely laboratory-based evaluations rather than clinical trials with patient data.

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

This information is not provided as the document does not describe a clinical study requiring expert assessment of a "test set" for ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the document does not describe a clinical study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance

This information is not applicable/provided. The OFP-2 is an endoscopic flushing pump, not an AI-powered diagnostic device. No MRMC study was mentioned, nor is AI relevant to its function as described.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/provided. The OFP-2 is a mechanical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the safety and performance verification that was done:

• Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and the results of specific laboratory tests (e.g., L929 MEM elution, Intracutaneous Injection, Kligman Maximization). The "ground truth" here is the pass/fail determination based on standard biological response.
• Electrical Safety: Ground truth is established by compliance with specified IEC, EN, UL, and CAN/CSA standards.
• Sterilization Effectiveness: Ground truth is established by validated steam sterilization protocols and durability testing of the water container over its expected life.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a mechanical pump, not a machine learning model, so there is no "training set."

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

This information is not applicable/provided as there is no training set for this device.

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For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the Olympus Suction Pump Model KV-5, confirming its substantial equivalence to a legally marketed predicate device.

It details:

• The device name and model.
• The regulation number and regulatory class.
• The date of the letter and previous correspondence dates.
• The contact information for the recipient.
• General information about FDA regulations and responsibilities.
• The intended use of the device: "For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not not intended for thoracic, domiciliary, field or transport use."

It does not provide:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes or data provenance for any test set.
3. Information on experts, ground truth establishment, or adjudication methods for a test set.
4. Details of any MRMC comparative effectiveness study or standalone algorithm performance.
5. Sample sizes or ground truth establishment methods for a training set.

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Ask a specific question about this device

Ask a specific question about this device