Search Results

The Argyle™ Polyurethane Umbilical Vessel Catheter is intended for short-term vascular access via umbilical vessels in neonatal patients.

The Argyle™ Polyurethane Umbilical Vessel Catheter is a single-lumen catheter made of a polyurethane catheter tube which is insert molded to a polypropylene hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion. Encapsulated within the catheter walls are three barium sulfate strips spaced 120° apart, which run the length of the catheter. Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 25 cm from the tip. Catheter placement must be confirmed by x-ray. The Argyle Polyurethane Umbilical Vessel Catheter will continue to be available in three sizes: 2.5 Fr.; 3.5 Fr.; and 5 Fr. Each device will continue to be packaged in a Tyvek pouch; 10 pouches are packaged in a carton. The Argyle Polyurethane Umbilical Vessel Catheter does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging is not made of natural rubber latex.

The provided document is a 510(k) summary for a medical device called the Argyle™ Polyurethane Umbilical Vessel Catheter. It describes the device, its intended use, and states that it has undergone non-clinical performance testing to demonstrate substantial equivalence to a predicate device.

Crucially, this document notes that no clinical testing was performed for the determination of substantial equivalence (Section 8. Clinical Data).

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets those criteria from this document. The device's approval was based on non-clinical performance data (laboratory testing) demonstrating that the modified device continues to meet product specifications and is substantially equivalent to an existing device.

The document states:

• "Laboratory testing was completed to support substantial equivalence between the modified device and the current device. The modified device was evaluated to show compliance to the standards requirements as well as performance characteristics related to the modification of the device. The results of the testing show that the modified device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence." (Section 7. Non-Clinical Performance Data)
• "No clinical testing was performed for the determination of substantial equivalence." (Section 8. Clinical Data)

Without clinical data, the concept of "acceptance criteria" and "device performance" in the context of clinical studies, human readers, ground truth established by experts, etc., as requested in your prompt, does not apply to this specific submission. The non-clinical performance data would involve engineering tests (e.g., material strength, fluid flow, biocompatibility) against predetermined specifications, but these are not equivalent to the clinical study parameters you've asked for.

Ask a specific question about this device

DOBBHOFF™ Dual Port Feeding Tubes, with and without Flow-Through Stylet, are for the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

The DOBBHOFF nasogastric enteral feeding tubes are small bore enteral access catheters. These feeding tubes include an external proximal access port for connection to enteral feeding sets and to oral tip, enteral syringes. The tubing is constructed with a radiopaque material and with a hydrophilic coating to assist with insertion of the tube and, if a stylet was in place during tube insertion, to assist with removal of the stylet. The stylet is made of specially designed metal wire which may be optionally utilized to assist with tube placement. The tubes are each equipped with external markings in units of centimeters to assist in measuring the amount of tube inserted into the alimentary tract.

The provided text is a 510(k) summary for the DOBBHOFF™ Dual Port Feeding Tubes. It describes the device, its intended use, and its comparison to legally marketed predicate devices. Critically, it states:

"No clinical evaluations were performed or relied upon for a determination of substantial equivalence."

This means that the information needed to answer the user's request, which focuses on acceptance criteria and a study proving the device meets those criteria, is not present in the provided text. The device's clearance was based on nonclinical testing (EN1615:2000 for performance and ISO 10993-1:2009 for biocompatibility) and a demonstration of substantial equivalence to predicate devices, not on a clinical study with acceptance criteria for device performance.

Ask a specific question about this device

The Covidien Acute and Chronic Catheter Repair Kit is intended to repair the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien. Do not use this kit to repair a catheter if the damaged portion of the extension tubing is more than 0.5 cm away from the distal end of the luer adapter. Specific hemodialysis catheters that can be repaired using this kit include: Palindrome ™ Chronic Care Catheters, Palindrome TM Emerald™ Chronic Care Catheters, Palindrome ™ Ruby™ Chronic Care Catheters, Palindrome™ Sapphire™ Chronic Care Catheters, MAHURKAR™* Maxid™ Chronic Care Catheters, MAHURKAR™* 8 Fr. (2.67mm) Single Lumen Acute Care Catheters, MAHURKAR™* 8 Fr. (2.67mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 10 Fr. (3.33mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 11.5 Fr. (3.83mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 13.5 Fr. (4.50mm) High Flow Dual Lumen Acute Care Catheters, MAHURKAR™* 12 Fr. (4.00mm) Triple Lumen Acute Care Catheters. (Note: do not use this kit to repair the infusion lumen.)

The Covidien™ Acute and Chronic Catheter Repair Kit is intended to be used for the repair of a broken luer adapter, clamp, or extension tubing (only the most proximal 0.5-cm of tubing) of an existing catheter. When one of these components is damaged the implanted catheter will be clamped off using the existing clamp and a slide clamp that will be provided as apart of the catheter repair kit. Then the damaged extension tube will be cut off and the existing clamp will be removed while the slide clamp will provide the stasis of the catheter. After removing the existing clamp a threaded repair collar will be placed over the remaining extension tube. The barbed connector will then be inserted barb end first into the extension tube. Once in place the repair collar will be threaded onto the new repaired back end to secure the placement

Here's an analysis of the acceptance criteria and study information based on the provided text, using the requested format:

Acceptance Criteria and Device Performance Study for Covidien™ Acute and Chronic Catheter Repair Kit

The provided documentation details the performance testing conducted for the Covidien™ Acute and Chronic Catheter Repair Kit.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing was performed to "evaluate the performance" in these areas. Specific numerical acceptance thresholds and quantitative results are not provided in the extracted text.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Testing was performed to evaluate the performance."

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

This information is not applicable and not provided. The study conducted was a technical performance evaluation of a physical repair kit, not an assessment requiring expert interpretation of data or images to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided, as the study does not involve expert interpretation or subjective assessments that would require adjudication.

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

No MRMC comparative effectiveness study was mentioned. The study described is a technical performance evaluation of the repair kit itself, not a study involving human readers or AI assistance.

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

This information is not applicable. The device is a physical catheter repair kit, not an algorithm or AI system. The performance evaluation is inherently a "standalone" assessment of the physical repair's integrity and function.

7. Type of Ground Truth Used

The "ground truth" for this study was established through objective engineering and physical testing against established industry and regulatory standards (FDA and ISO guidance for Tensile Strength, Dynamic Flow, Leak, and Burst). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for this type of device performance evaluation. The "ground truth" refers to whether the repaired catheter meets predefined physical and functional specifications.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical repair kit, 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, as there is no training set for this device.

Ask a specific question about this device

The Palindrome P Hemodialysis Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion.

The Palindrome P Catheter Repair Kit is indicated to repair the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s) of the Palindrome P Hemodialysis Catheter

The Palindrome Reverse Tunneled Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion.

The Palindrome reverse-tunneled catheter repair kit is intended for the repair of the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s). A repair can only be made if the tubing length between the hub snap connector and the exit sit is a minimum of 5.5 cm

The Palindrome P Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The Catheter will be supplied with a detached connector assembly allowing for the catheter tip to be positioned in the vein and tunneled retrograde to the exit site. The hub and back end of the catheter is then assembled with a snap lock connector with compression ring.

A Palindrome™ Reverse Tunneled catheter repair kit will be offered to replace damaged extensions and / or extension adaptors.

The provided text describes the 510(k) Premarket Notification for the PalindromeTM P Hemodialysis Catheter. It outlines the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does NOT contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's a breakdown of why and what information is missing:

• Acceptance Criteria and Reported Device Performance: While the document states "Testing was performed to compare the proposed Palindrome™ P Reverse Tunneled Catheter to predicate device. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed predicate devices," it does not provide a table of specific acceptance criteria (e.g., flow rates, material biocompatibility thresholds, tensile strength limits) or the quantitative results from these tests. It only makes a general claim of substantial equivalence.

• Sample Size and Data Provenance for Test Set: This information is completely absent. The document mentions "testing was performed" but provides no details on the number of catheters tested, the source of any data (e.g., in-vitro, in-vivo, animal studies, human clinical data), or whether this data was retrospective or prospective.

• Number and Qualifications of Experts for Ground Truth: Since no specific clinical or image-based studies are detailed, there is no mention of experts, their qualifications, or their role in establishing ground truth. This type of information would typically be relevant for diagnostic devices that rely on expert interpretation.

• Adjudication Method: Similar to the above, without specific clinical or diagnostic study details, an adjudication method is not mentioned.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This document pertains to a medical device (hemodialysis catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not applicable or mentioned. There's no AI component in this device.

• Standalone (Algorithm Only) Performance: As this is a physical medical device and not an algorithm, the concept of "standalone performance" for an algorithm is not applicable.

• Type of Ground Truth Used: The document implies that the "ground truth" for substantial equivalence would be the performance characteristics of the predicate devices. However, the specific metrics and how they were established for either the predicate or the new device are not detailed.

• Sample Size for Training Set: Since this is a physical device and not an AI model, there is no concept of a "training set" in the machine learning sense.

• How Ground Truth for Training Set was Established: Not applicable for the same reason as above.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence through a general statement of "verification/validation" against predicate devices. It does not offer the granular detail concerning acceptance criteria, study methodologies, expert involvement, or data characteristics that your questions are looking for, particularly those questions relevant to AI/ML or diagnostic devices.

To answer your questions accurately, a much more detailed technical report or study protocol usually submitted to the FDA (beyond the public 510(k) summary) would be required. This summary is intended to provide an overview to justify commercialization based on equivalence, not to fully detail all underlying testing.

Ask a specific question about this device

The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.

The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.

The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.

The proposed Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. The proposed catheter also contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.

The provided document describes a Special 510(k) submission for a device modification: the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™). The modification involves adding a silver impregnated sleeve to an existing device (Kendall's 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating - Palindrome™ Emerald™).

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved by a peripheral or poundine patient theter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications.

The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications.

The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is a dual lumen polyurethane tube that bifurcates into two 5.0 Fr polyurethane tubes (pigtails), the proximal ends of the tubes ending in insert molded hubs. One pigtail is longer than the other. The primary longer lumen will be clear. The shorter secondary lumen will be tinted a lavender color to distinguish it from the primary lumen.

The provided text describes a medical device, the Kendall Argyle® 1.9 Fr Dual Lumen Neonatal/Pediatric Peripherally Inserted Central Catheter, and its 510(k) submission to the FDA. It does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or information on reader studies, training sets, or ground truth establishment.

The document primarily focuses on:

• Device Identification: Proprietary name, common name, classification, and predicate devices.
• Description: Physical characteristics of the catheter.
• Intended Use: For venous catheterization or long-term IV administration in neonates/pediatric patients, with details on placement and types of fluids/medications administered.
• Technological Characteristics: Stating equivalence to predicate devices in materials, function, indications for use, and design.
• Nonclinical Testing: Biocompatibility testing performed according to ISO-10993, confirming material biocompatibility.
• FDA Communication: The 510(k) clearance letter confirming substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the given text. This information would typically be found in a more detailed clinical study report or performance evaluation document, which is not part of this 510(k) summary.

Ask a specific question about this device

The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing.

The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.

Here's a breakdown of the acceptance criteria and the study information for the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™):

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming substantial equivalence to a predicate device (Kendall Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip, K043272). The primary modification is the addition of a silver-impregnated sleeve. Therefore, the acceptance criteria and performance are focused on demonstrating that this modification is safe and effective, and that the new device remains substantially equivalent.

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

• Sample Size:
  • In-vitro studies: Not explicitly stated how many samples were used for each microorganism or how many repeated challenges were performed.
  • In-vivo studies: Not explicitly stated how many rabbits were used in the infection model.
• Data Provenance: The studies were prospective bench and animal testing conducted specifically for this device submission. The clinical isolates used for in-vitro and in-vivo testing indicate a connection to real-world pathogen strains, but the testing itself was performed in a controlled laboratory/animal environment. There is no mention of human clinical data from any country in this summary.

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

Falls outside the scope of this document. This submission details bench and animal testing. There are no human "readers" or "experts" establishing ground truth in the context of diagnostic interpretation, as this is a medical device for placement within the body, not a diagnostic imaging or AI product. The ground truth for the microbial studies would be objective laboratory measurements (e.g., colony-forming unit counts).

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human interpretation of data where adjudication would be necessary.

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-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.

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

Not applicable. This is not an algorithm, but a physical medical device with a modified component. The "standalone" performance here refers to the device's inherent physical and antimicrobial properties, which were tested in a controlled environment without human intervention during the measurement phase.

7. The Type of Ground Truth Used

• Biocompatibility, Silver Amount, Silver Elution: Objective laboratory measurements against established standards and limits.
• Microbial Colonization Reduction (In-vitro & In-vivo): Quantitative microbiological methods (e.g., colony-forming unit counts) that directly measure the reduction in microbial load. This is an objective, empirical ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

The proposed device is an extension to the Kendall Monoject PreFill™ ADVANCED™ Flush Syringe line is to include one or more PreFill syringe configurations equivalent to those already marketed by Tyco Healthcare with the syringe delivered to the customer in a package that will maintain the sterility of the syringe exterior surface.

The provided text is a 510(k) summary for a medical device: "Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery." This document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.

However, the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria in the context of an algorithm or AI performance. The document is for a physical medical device (pre-filled syringes) and a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, primarily through nonclinical testing (like biocompatibility) and comparison of technological characteristics.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (for an algorithm).
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth used, or training set details.

The nonclinical testing mentioned in the document is:

Nonclinical Testing:

• Biocompatibility testing against ISO Standard 10993, Part 1 and FDA modified matrix (G95-1).

This testing is relevant to the safety and compatibility of the physical syringe and its contents with the human body, not to the performance of any AI or algorithmic component.

Ask a specific question about this device

The device is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication.

The GiEntriport with Universal Single Lumen Adaptor is a multiport Device Description. The GiEnthport with Offirstal Surges or to a single lumen feeding tube.

The provided text contains information about a 510(k) Premarket Notification for the GiEntriport Single Lumen Adaptor. However, it does not describe a study involving acceptance criteria, reported device performance, sample sizes for test/training sets, expert involvement, or comparative effectiveness studies of AI. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a performance study with detailed metrics.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

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

• Cannot be provided. The document states that "Engineering evaluation, and testing were conducted to demonstrate that the design of the proposed device was equivalent to the predicate devices, and/or met the requirements for gastric decompression and delivery of fluids as such devices, as defined in EN1615:2000." This indicates that some testing was done to meet standards (EN1615:2000) and demonstrate equivalence, but the specific acceptance criteria and detailed reported performance metrics are not provided in this 510(k) summary.

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

• Cannot be provided. The document mentions "Engineering evaluation, and testing" but does not detail sample sizes, types of tests performed, or data provenance.

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. This device is a medical tube/adaptor, not a diagnostic imaging AI system. The concept of "ground truth" established by experts for a test set, as typically applied to AI/Machine Learning in diagnostics, does not apply here. The "ground truth" for this device would relate to its physical performance and safety characteristics.

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

• Not applicable. See point 3.

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 system. No MRMC studies or AI assistance are mentioned or relevant to this type of device.

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

• Not applicable. This is a physical medical device.

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

• Cannot be directly answered in the AI/ML context. For this device, the "truth" would be its adherence to established engineering standards (EN1615:2000) for safety and performance, and functional equivalence to predicate devices for its intended use (gastric decompression, fluid/nutritional delivery).

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

• Not applicable. See point 8.

Ask a specific question about this device

The Kendall SCD™ System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Kendall SCD™ and SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh) are pneumatic compression devices for applying pressure to a patient's leg for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

The SCD™ System is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of DVT and PE. The SCD" System consists of a controller, a pair of tubing sets, and a pair of single-patientuse disposable sleeves. The SCD™ product line has been a standard in the mechanical DVT and PE prevention industry.

The provided document is a 510(k) premarket notification for Kendall SCD™ Sleeves and Kendall SCD Express™ Sleeves. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, detailed study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.

Ask a specific question about this device