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The Stryker Cassette Pump is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. This device provides sterile irrigant solution, serves as a conduit for suction, and functions as a cannula for accessory instrumentation, including electrosurgical devices.

The Stryker Cassette Pump is a modification of the currently marketed Stryker Strykeflow Suction Irrigator in that the batteries are rechargeable and relocated with the motor to a re-usable pump console. The single use tube set is equivalent to the Stryker Strykeflow Suction Irrigator.

The provided text is a 510(k) summary for the Stryker Cassette Pump, demonstrating its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance results. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.

However, I can provide what is stated and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing: Specific quantitative acceptance criteria (e.g., maximum flow rate, minimum suction pressure, battery life, seal integrity) and the exact measured performance values for the Stryker Cassette Pump are not detailed. The document only states that "Laboratory and performance testing demonstrate that the characteristics of the Stryker Cassette Pump are equivalent in Safety and Effectiveness to the referenced predicate devices."

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

Missing: The document does not specify any sample sizes for a "test set" in the context of device performance. The entire submission is about demonstrating substantial equivalence, not a standalone clinical or experimental study with a defined test set. Data provenance (country of origin, retrospective/prospective) is not applicable here as it's a device submission, not a study involving patient data.

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

Missing: As there is no "test set" and ground truth in the context of an AI/human performance study, this information is not applicable. The assessment here is based on engineering and performance testing against established standards and predicate devices.

4. Adjudication Method for the Test Set:

Missing: Not applicable for this type of device submission.

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

Missing: No MRMC study was done or mentioned. This is a medical device approval document, not related to AI comparative effectiveness.

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

Missing: This is not applicable as the device is a physical pump, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the established safety and performance characteristics of the predicate devices and the compliance with recognized voluntary standards.

• Established Predicate Device Performance: The functional specifications, safety profiles, and clinical indications of the Strykeflow Suction Irrigator (K954726) and Davol® X-Stream" Laparoscopic Irrigation System (K003790) serve as benchmarks.
• Voluntary Safety and Performance Standards: The device's adherence to standards such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60529, ISO 10993, and ANSI/AAMIHF-18 2003 forms the basis of its "ground truth" for safety and general performance.

8. The Sample Size for the Training Set:

Missing: Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."

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

Missing: Not applicable.

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Circon Corporation's Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.

The Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is comprised of a Tsunami™ Battery-Powered Pump that may be attached to a source of irrigation tubing connected to a Surgiflex WAVE suction-irrigation handpiece, and a length of suction tubing connected between the handpiece and a vacuum source (usually a suction canister that is connected to a wall suction outlet). Irrigation solution is introduced to the surgical site and fluids, debris and smoke are evacuated from the site via a disposable suction-irrigation probe. All components of the system are supplied sterile, disposable in a sealed plastic tray for single patient use.

This 510(k) summary (K992126) for the Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System does not contain specific acceptance criteria or the details of a study proving the device meets acceptance criteria in the way typically expected for performance claims of AI/ML-enabled devices.

This document is for a traditional medical device (a battery-powered irrigation pump) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing numerical performance metrics against predefined acceptance criteria for a new clinical function or AI algorithm.

Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluations, which is not applicable here.

Here's an explanation based on the provided text, highlighting why certain information is absent and what is available:

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

• Not Applicable/Not Provided: This document does not present acceptance criteria in a quantitative, measurable format (e.g., sensitivity, specificity, accuracy thresholds) for a specific clinical outcome or an algorithm's performance. The "performance" assessment here is focused on demonstrating that the device functions similarly to legally marketed predicate devices for its intended use, without raising new questions of safety or effectiveness. The comparison is primarily around design, operating principles, materials, sterility, and method of delivery/evacuation.

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/Not Provided: There is no "test set" in the context of an AI/ML device evaluation. This device is a hardware component. Any testing conducted would likely involve engineering verification and validation (e.g., flow rate, pressure, battery life, material compatibility, sterility) rather than a clinical study with a patient data test set.

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/Not Provided: Since there's no test set requiring ground truth labeling (e.g., image annotation, diagnosis), there's no mention of experts for ground truth establishment.

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

• Not Applicable/Not Provided: No test set, no ground truth adjudication method.

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/Not Provided: This is not an AI-assisted device, so an MRMC study is irrelevant.

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

• Not Applicable/Not Provided: This is a hardware device; there is no standalone algorithm.

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

• Not Applicable/Not Provided: No ground truth in the AI/ML sense is mentioned. Any "ground truth" equivalent for this device would be established through engineering specifications, standards, and possibly bench testing against known values (e.g., measuring actual fluid flow against specified flow rates).

8. The sample size for the training set

• Not Applicable/Not Provided: There is no AI/ML model, hence no training set.

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

• Not Applicable/Not Provided: No training set, no ground truth for it.

Summary of what is described in the document relevant to device acceptance (though not in the requested AI/ML format):

The primary "acceptance criteria" and "study" for this device are framed around substantial equivalence to predicate devices already on the market.

• Intended Use: The device is intended to "provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage." This intended use is compared directly to predicate devices.
• Technological Characteristics Comparison: The document states that "Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is substantially equivalent to Cabot's Surgiflex® Suction-Irrigation Probes, Davol's Hydro-Surgi Laparoscopic Irrigator and Stryker's Laparoscopic Suction Irrigator."
  • Basis for Substantial Equivalence: "All of these devices employ substantially equivalent design considerations and operating principles, and their materials of construction are safe for the intended uses. All of these devices are supplied sterile for single-use only, and none actively delivers any form of electrical energy to the patient."
  • Conclusion: "Any differences between the various devices do not raise new questions regarding safety or effectiveness."

In essence, the "study" is a comparison with predicate devices, showing that the new device shares fundamental technological characteristics and intended use with already cleared devices, and any differences do not negatively impact safety or effectiveness. This comparison is the method for demonstrating that the device meets the (implied) regulatory acceptance criteria for market clearance via the 510(k) pathway.

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The suction devices, when attached to an external source of vacuum, are used for aspiration, removal, or sampling of body fluids during surgical procedures.

These devices are rigid, hollow tips or tubes, that when attached to an external source of vacuum are used for aspiration, removal, or sampling of body fluids during surgical procedures. Some suction devices are fitted with Fiber Optic bundles.

The provided text is a 510(k) premarket notification letter from the FDA to Walter Lorenz Surgical, Incorporated, regarding "Suction Instrumentation." It is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain any information regarding specific acceptance criteria, performance metrics, or details of a study (clinical or otherwise) that would prove the device meets such criteria.

Therefore, I cannot fulfill your request for the tables and information outlined because the source material does not provide it. The document confirms the device's regulatory classification, intended use, and substantial equivalence to existing devices but does not delve into empirical performance data or study methodologies.

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These suction handles are used in conjunction with a vacuum-powered, single patient, body fluid suction apparatus. The handles provide a means to aspirate, remove or sample body fluids from a surgical wound or body orifice via vacuum.

The Medi-Vac Flexi-Clear™ Suction Handles are made of polyvinyl chloride in a variety of sizes and are offered sterile.

This is a 510(k) premarket notification for a medical device (Medi-Vac Flexi-Clear™ Suction Handles), not an AI/ML software device. Therefore, the requested information about acceptance criteria, study design, and performance metrics for AI/ML models (e.g., sample size for test sets, expert ground truth, MRMC studies) is not applicable to the provided text.

The document discusses the substantial equivalence of the Medi-Vac Flexi-Clear™ Suction Handles to a predicate device (Argyle® Yankauer Suction Tube) based on characteristics like intended use, size, configuration, materials, and physical properties.

The "Summary of Testing" table outlines the results of biocompatibility tests conducted on the device.

Here's the information that is extractable from the provided text, structured to align with your request where possible, but noting the inapplicability of AI/ML-specific fields:

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

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is summarized under "Summary of Testing" in the provided document. These are standard biocompatibility tests.

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 for these biocompatibility tests. For medical device biocompatibility, samples of the device material are typically used for in vitro or in vivo testing according to ISO 10993 standards. The exact number of samples or biological replicates is not detailed in this summary.
• Data Provenance: Not specified. Biocompatibility testing is generally performed in certified laboratories.

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. For biocompatibility testing, ground truth is established by standardized laboratory assays and protocols, interpreted by trained laboratory personnel and toxicologists, not by a panel of clinical experts in the same way an AI model's output would be adjudicated.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are for expert consensus in diagnostic imaging or similar fields. Biocompatibility test results are typically objective measurements or observations against established criteria.

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 a physical medical device, not an AI/ML diagnostic or assistive software.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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

For biocompatibility testing, the "ground truth" is based on standardized biological responses and endpoints measured according to recognized test methods (e.g., ISO 10993 series). This includes observing cellular responses (cytotoxicity), tissue reactions (intracutaneous reactivity, sensitization), and blood interactions (hemocompatibility), with results interpreted against predefined pass/fail criteria.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which to define a training set. This is a physical medical device.

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

Not applicable. There is no AI/ML model for which to define a training set and its ground truth.

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The Kendall Curity Thoracentesis Tray is intended to be used to drain fluid from the pleural cavity.

The proposed Kendall Curity Thoracentesis Tray is a sterile, single use procedural tray containing the components required to perform a thoracentesis. This submission covers proposed changes to the aspirating needle and thoracentesis catheter. An ergonomically designed polycarbonate hub will be insert molded onto the needle cannula and a polyurethane hub insert molded onto the catheter shaft. In addition, the catheter shaft material will change from Teflon® to polyurethane. There will be no changes to the current dimensions or performance specifications.

In addition, a new product code will incorporate Kendall's thoracentesis catheter-over-needle with an automatic valve that acts to occlude the proximal end of the catheter lumen. The valve is an integral part of the catheter. Once the needle is withdrawn from the valve, a spring mechanism occludes the catheter lumen.

This document describes a 510(k) submission for the Kendall Curity Thoracentesis Tray. It is a pre-amendment device, therefore much of the information you have requested about acceptance criteria and study design is not applicable or not provided. Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the functional or biocompatibility tests.
• Data Provenance: Not specified, but implied to be from internal Kendall Healthcare Products Company testing. The document is silent on country of origin or whether it's retrospective/prospective.

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

• Not Applicable. This device is a medical instrument (thoracentesis tray), not an AI/diagnostic tool. "Ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant for this type of submission. The performance is assessed through material and functional testing against specified engineering parameters.

4. Adjudication Method

• Not Applicable. See point 3.

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

• No. This is not a diagnostic device or imaging modality that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

• Engineering Specifications/Standards: The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards (like ISO-10993 for biocompatibility), and functional requirements (e.g., no leakage, sufficient pull-off force for the hub).

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

Summary of Device and Evidence:

The Kendall Curity Thoracentesis Tray is seeking 510(k) clearance based on substantial equivalence to existing predicate devices. The submission focuses on changes to the aspirating needle and thoracentesis catheter (material change and hub design) and the incorporation of a new automatic valve. The evidence provided is primarily from nonclinical testing:

• Biocompatibility testing to ISO-10993 standards confirmed no toxic diffusible substances.
• Functional/Mechanical testing was performed for hub pull-off force, potential for leakage, and siphoning capability of the automatic valve.

The document explicitly states that there will be "no changes to the current dimensions or performance specifications" for the existing components, implying that the new or modified components also meet the established performance levels of the predicate devices. The 510(k) pathway relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and performance.

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It is intended for uses in any procedure in which the control of suction force is desired.

The Stryker Suction Regulator (SSR) controls the rate of suction from any product that requires suction control. It consists of an inlet tube with a suction adapter at the end, an outlet tube with a suction adapter at the end, and a handpiece. The handpiece controls suction by varying the amount of ambient air entering the tube set. As more air is let into the tube set, suction force at the inlet tube is reduced. As less air is let into the tube set, suction force is increased.

The provided text is a summary of safety and efficacy for a medical device (Stryker Suction Regulator) and does not contain information about acceptance criteria or a study proving that the device meets those criteria. Therefore, I cannot extract the requested information.

The document focuses on:

• Device Classification and Name: Listing various classifications and the proprietary name of the device.
• Device Description: Explaining how the suction regulator works.
• Material and Sterilization Standards: Mentioning biocompatibility testing (ISO 10993) and sterilization validation (AAMI ST 27, AAMI ST 32).
• Substantial Equivalence Claim: Stating that the device is equivalent to the "Arthrex Suction Regulator" and does not raise new issues.

There's no mention of specific performance metrics, acceptance thresholds, or a study that evaluates the device against such criteria.

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The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Y ankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).

The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs

This is a 510(k) summary for a Suction Connecting Tubing device. It describes the device, its intended use, and identifies a predicate device. However, this document does NOT contain information regarding acceptance criteria, performance studies, or any of the detailed data points you've requested about AI/algorithm performance.

The provided text focuses on the regulatory aspects of introducing a physical medical device (suction tubing), not on the validation of an AI or algorithmic medical device. Therefore, I cannot generate the requested table and information based on this input.

To answer your request, I would need a 510(k) summary (or similar regulatory submission document) for a device that involves an algorithm, AI, or software component whose performance is being evaluated and compared to acceptance criteria.

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