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The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

The DEFENDO™ Disposable Suction Valve is a disposable device that attaches to the suction cylinder of an endoscope. When the valve is depressed, the suction function on the endoscope is activated, allowing for the suctioning of fluid through the stem of the valve where it flows into the Suction Pump Canister.

Here's a breakdown of the acceptance criteria and the study details for the DEFENDO™ Disposable Suction Valve, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Connection to Endoscope: 10 tests for BMI 100305, 10 tests for Olympus MH-443 (predicate).
• Priming Time: 10 tests for BMI 100305, 8 tests for Olympus MH-443 (predicate).
• Material Quantity Removed: 8 devices of BMI-215 (DEFENDO™) and 8 devices of Olympus MH-443 (predicate), each subjected to 10 suction tests. This totals 80 tests for each device type.
• Spring Force & Displacement: 10 tests for BMI 100305, 8 tests for Olympus MH-443 (predicate).
• Sharp Edges: 10 tests for BMI 100305, 8 tests for Olympus MH-443 (predicate).

Data Provenance: The study appears to be a prospective bench testing study conducted by Byrne Medical, Inc. The document does not specify the country of origin for the data generation, though Byrne Medical Inc. is based in Conroe, TX, USA. The predicate device, Olympus® MH-443, is manufactured by Olympus® Optical Co. Ltd. Tokyo, Japan.

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

• Number of Experts: For the "Spring Force & Displacement" test, it's mentioned that the differences were not perceivable in "blind tests by the tester or other selected parties (3 additional people)". This suggests 4 individuals participated in evaluating the tactile perception of force.
• Qualifications of Experts: The qualifications of these individuals are not specified in the provided document. For the "Sharp Edges" test, a "tester's hand" is mentioned, implying at least one individual performed the test, again with no specific qualification mentioned.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus). The evaluation criteria for most tests (e.g., connection, priming time, material quantity, sharp edges) relied on quantitative measurements or direct observation against the predicate device. For the "Spring Force & Displacement" test, a "blind test" by multiple individuals was mentioned, suggesting a qualitative comparison, but without a formal consensus or adjudication process detailed.

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

No, an MRMC comparative effectiveness study was not done. This study is a bench testing evaluation of a physical medical device (a suction valve), not an AI-powered diagnostic or imaging tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable here.

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

This is not applicable as the device is a physical medical device (a disposable suction valve) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for these tests was established by:

• Quantitative Benchmarking: Direct measurements and comparisons against a legally marketed predicate device (Olympus® MH-443 Suction Valve).
• Physical Observation/Assessment: Direct observation of ease of connection, absence of sharp edges, and tactile perception (for spring force).
• The "truth" was based on whether the performance characteristics of the new device were "comparable" or "substantially equivalent" to the predicate, as defined by the acceptance criteria.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical device and does not involve machine learning algorithms that require a training set.

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

This is not applicable for the same reason as above (no training set for a physical device).

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The DEFENDO™ Disposable Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The Byrne Medical DEFENDO™ Disposable Air/Water Valve is substantially equivalent to the Olympus® MH-438 Air/Water Valve.

The submitted document, K107409, describes the Byrne Medical DEFENDO™ Disposable Air/Water Valve and compares it to a predicate device, the Olympus® MH-438 Air/Water Valve (K001241). The primary goal of the submission appears to be to demonstrate substantial equivalence to the predicate device, rather than to prove the device meets specific acceptance criteria through a clinical study. The performance data presented focuses on comparative bench testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a clinical study. Instead, it aims to demonstrate substantial equivalence to a predicate device, which implies that its performance should be comparable to the predicate. The performance reported is from comparative testing against the predicate device for water flow.

Study Proving Acceptance Criteria:

The study proving the implied acceptance criteria is a comparative performance (bench) test.

• Study Type: Comparative Bench Testing (Water Flow Test)
• Objective: To compare the water flow rates of the Byrne Medical DEFENDO™ Disposable Air/Water Valve with the Olympus® MH-438 Air/Water Valve.

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

• Sample Size (Test Set):
  • Overall Water Flow Test: 10 Byrne Medical 100304 Air/Water valves and 10 Olympus MH-438 Air/Water valves. Measurements were taken over a time period of 0 to 40 seconds, yielding an 'n' of 188 for correlation analysis.
  • 0-7 Second Interval Water Flow Test: Although the same number of valves were likely used, the analysis focused on a shorter time period, resulting in an 'n' of 36 for correlation analysis.
• Data Provenance: The data is generated from bench testing (in-vitro performance testing) and not from human subjects. Therefore, concerns like country of origin for patient data or retrospective/prospective status are not applicable.

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

• Not Applicable. This study is a bench test comparing physical device performance (water flow) under controlled conditions. It does not involve human interpretation or subjective assessment that would require expert consensus for a "ground truth" as typically defined in diagnostic studies. The "ground truth" here is the measured performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a bench test measuring physical parameters, there is no need for an adjudication method by experts. The measurements are objective and quantitative.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study was not conducted. This is a bench test of physical device performance, not a study involving human readers interpreting clinical cases.

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

• No. This device is a physical medical instrument (an air/water valve), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Bench Test Measurement/Predicate Performance: The "ground truth" in this context is the measured performance of the legally marketed predicate device (Olympus® MH-438 Air/Water Valve). The Byrne Medical device's performance is compared directly against these objective measurements.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning algorithm. Hence, 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 machine learning algorithm, this question is not relevant.

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The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

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This document does not contain the detailed information necessary to complete the request regarding acceptance criteria and a study proving a device meets them. The provided text is a 510(k) clearance letter and summary for the "Endo SmartCap™," which primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results or acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or details about the ground truth establishment for a test set.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Results from a standalone algorithm performance study.
• Sample size for a training set or ground truth establishment for a training set.

The document primarily states the intended use of the device and its regulatory classification. It lists predicate devices but does not delve into their performance or comparison in detail.

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The ERBELIFT Hand Pump in conjunction with an ERBELIFT Flexible Probe is indicated for the induction of sterile normal saline into the submucosa to lift polyps or other mucosal lesions using direct visualization through a flexible endoscope.

The ERBELIFT™ Hand Pump and Flexible Probe are used for the delivery of pressurized sterile normal saline to the submucosa to lift polyps or other mucosal lesions. A control syringe is filled with sterile normal saline. The filled syringe is attached to the Flexible Probe via a hub with a standard luer lock and loaded into the Hand Pump. The Flexible Probe is primed with the saline and then the distal end of the Probe is placed down the working channel of the endoscope. Under direct visualization, the Probe's tip is placed against the target tissue without puncturing the mucosa. Then, the trigger of the Hand Pump is squeezed to produce the pressurized saline from the control syringe and through the Probe into the bed of the polyp or lesion to achieve a desired tissue lift.

The Hand Pump is made of nylon and stainless steel. It is 8-3/4" (22 cm) long, 6" (15 cm) wide, and having a thickness of 2-1/2" (6 cm). The Pump per squeeze of the handle delivers approximately 0.75 ml of normal saline. The Flexible Probe is made of Polyetheretherketone (PEEK) and nylon (Note: Medical grade inks and reducer are used to imprint logos on the device.). It has a 1.3 mm Outer Diameter and length of 260 cm. The distal tip is tapered to approximately 0.005" and delivers a jet stream of 120 um. The Hand Pump with the Flexible Probe can generate pressures in the approximate range of 145 to 650 psi which correlates to flow rates of 17 to 38 ml/minute.

The Hand Pump is reusable with the Flexible Probe being provided as sterile and single use.

The provided 510(k) summary for the Byrne Medical Incorporated ERBELIFT™ Hand Pump and Flexible Probe does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance with quantitative metrics. The document focuses on demonstrating substantial equivalence to predicate devices through similarities in intended use, materials, and form, and briefly mentions functional bench and animal lab testing. However, it does not provide specific acceptance criteria or performance metrics from these tests.

Therefore, the following sections will indicate where the information is not available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document states that "Functional bench and animal lab testing has demonstrated that the ERBELIFT Hand Pump and Flexible Probe lifts the submucosa safely and effectively," but it does not provide specific acceptance criteria or quantitative performance results for these tests. Therefore, this table cannot be fully completed from the given text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided document. The document mentions "Functional bench and animal lab testing" but does not give details on the number of samples, animals, or tests conducted.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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)

• This information is not available in the provided 510(k) summary. The document mentions "Functional bench and animal lab testing" but does not detail how ground truth or performance assessment was established, nor does it refer to human expert involvement in establishing ground truth for the device's functional performance.

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

• This information is not available in the provided 510(k) summary. Given that the testing mentioned is "functional bench and animal lab testing" for a medical device's physical performance, an adjudication method for human interpretation is unlikely to be applicable or described here.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The ERBELIFT™ Hand Pump and Flexible Probe is a physical medical device for injecting saline, not an AI-powered diagnostic or interpretive tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.

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

• No, standalone algorithm performance testing is not applicable as this device is a physical medical instrument, not a software algorithm. The device's operation involves a human user (endoscopist) directly.

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

• The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For this physical device, the "truth" would be objective measurements and observations from the "Functional bench and animal lab testing." This would likely involve:
  • Bench Testing: Direct physical measurements (e.g., pressure, flow rate, volume delivered, jet stream characteristics) and visual inspection of fluid delivery.
  • Animal Lab Testing: Direct visualization of submucosal lift, potentially histological analysis of tissue for damage, and observation of overall safety and effectiveness in an in-vivo model.
• The document implies that the "truth" for safety and effectiveness was derived from these direct experimental observations rather than expert consensus on interpretation of data.

8. The sample size for the training set

• Not applicable / Not available. The ERBELIFT™ Hand Pump and Flexible Probe is a physical medical device, not a machine learning model, so there is no "training set" in the context of data used for algorithm development. The development process would have involved design, prototyping, and testing, but not training data for an algorithm.

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

• Not applicable / Not available. As explained in item 8, there is no "training set" for this physical medical device.

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The DEFENDO™ Disposable Biopsy Valve is indicated for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

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Here's an analysis of the provided text regarding the DEFENDO Biopsy Valve, focusing on the requested information:

This document is a 510(k) clearance letter for a medical device (DEFENDO™ Biopsy Valve). It primarily focuses on the regulatory determination of substantial equivalence to a predicate device, rather than a detailed report of a clinical study with specific acceptance criteria and performance metrics for a novel algorithm or AI device.

Therefore, I cannot provide a complete answer to all your questions as the information is not present in the provided text. The document describes a device (biopsy valve), not a diagnostic algorithm or AI. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices. This typically means the manufacturer performed a series of tests to demonstrate that their device functions similarly and is as safe and effective as existing, legally marketed devices. However, the details of these tests, specific acceptance criteria, or a "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm are not described.

Let's address what can be extracted from the document:

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

This information is not provided in the document. The FDA letter is a regulatory clearance, not a detailed technical report of performance metrics. For a device like a biopsy valve, acceptance criteria would likely relate to biocompatibility, fluid sealing, ease of use, durability, and compatibility with specific endoscopes, but these specifics are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. As this is a physical medical device, "test set" would likely refer to the number of devices tested or the number of simulated procedures performed, but no such details are given.

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)

This information is not provided. This concept of "ground truth" and expert review is typically relevant for diagnostic algorithms or AI that interpret medical images or data. For a biopsy valve, the "ground truth" would be established through engineering specifications and functional testing, not expert consensus on medical findings.

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

This information is not provided. Adjudication methods are relevant for studies where multiple readers interpret data, which is not described here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as described in this document. This type of study is specific to AI or diagnostic imaging interpretation. The device being reviewed is a physical biopsy valve, not an AI system.

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

No, this is not applicable. The DEFENDO™ Biopsy Valve is a physical accessory used during an endoscopy procedure, not a standalone algorithm.

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

This information is not explicitly stated in the document. For a physical device like a biopsy valve, "ground truth" would generally be established through engineering specifications, material safety standards, and functional performance benchmarks (e.g., ability to maintain insufflation, resist leakage, allow instrument passage).

8. The sample size for the training set

This information is not provided. This concept is relevant for machine learning models, which is not what the DEFENDO™ Biopsy Valve is.

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

This information is not provided. This concept is relevant for machine learning models, which is not what the DEFENDO™ Biopsy Valve is.

In summary:

The provided document is an FDA 510(k) clearance letter for a physical medical device (biopsy valve). It confirms the device's substantial equivalence to existing devices but does not contain the detailed technical or clinical study data typically found in reports for AI or diagnostic algorithms, including specific acceptance criteria, performance metrics, ground truth establishment, or study designs like MRMC or standalone performance evaluations. For such a device, the "study" demonstrating its safety and effectiveness would involve engineering tests (e.g., mechanical durability, fluid integrity), biocompatibility testing, and functional assessments, which are not outlined in this regulatory letter.

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