Search Results

The 840 Series Ventilator is intended to provide continuous ventilation to patients requiring respiratory support. The 840 Ventilator System with Expanded NeoMode Option is intended for patients with an Ideal Body Weight (IBW) as low as 0.3 kg.

The 840 Series Ventilator with Expanded NeoMode Option is intended for use in hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The PB 840 Ventilator consists of a Breath Delivery Unit (BDU, a Graphical User Interface (GUI) and a number of optional accessories, including a Compressor, a Back-Up Power Source (BPS), and three cart options. Depending on the patient ideal body weight (IBW), the appropriate patient circuit is attached to the PB 840 Ventilator System and patient. When the system is operational and connected to the appropriate utilities, the ventilator system delivers sensitive, precise breaths to critically ill patients

The Puritan Bennett (PB) 840 Ventilator System is a dual-microprocessor-based, touch screen controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult patients (with expanded NeoMode Option) or infant to adult patients (with no Option) who require either invasive ventilation or non-invasive ventilation.

The PB 840 Ventilator System includes software that is intended for patients with Ideal Body Weight (IBW) as low as 0.3 kg and provides the user with tidal volume to 2 mL. The ventilator determines values for operational variables and allowable settings based on breathing types and IBW. The software controls prevent inadvertent mismatching of patient size and breathing circuit type.

This document describes the Puritan Bennett™ 840 Series Ventilator System, a continuous ventilator. The submission is a 510(k) premarket notification for a modified version of an already cleared device, the Puritan Bennett™ 840 Ventilator System with Expanded NeoMode Option (K092847).

Based on the provided text, the device in question is a continuous ventilator, which falls under the regulation 21 CFR 868.5895. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove effectiveness against a specific set of clinical acceptance criteria in a standalone study. The modifications are software enhancements (communication, reduction of idle flow for neonates, update to alarm defaults for CPAP, removal of redundant code, update apnea interval) and hardware enhancements (new BD and GUI PCBAs due to obsolescence, new Pole Cart and new Compressor Cart, optional four-hour 803 Backup Power Source (BPS), new O2 Sensor Manufacturer, Fuse Upgrade on the 9.4" GUI Backlight Inverter PCBA).

Here's an analysis based on your requested information:

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

The document does not explicitly state "acceptance criteria" in the typical sense of a clinical study with performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" can be inferred from the regulatory requirements for demonstrating substantial equivalence for a medical device modification. The performance data focuses on demonstrating that the modified device continues to meet safety and performance specifications after changes.

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

The document does not mention "test sets" in the context of clinical data. The studies mentioned are primarily engineering-based (software V&V, electrical safety, EMC, usability). Therefore, concepts like sample size for a test set, country of origin, or retrospective/prospective data provenance are not applicable in this context. The "test set" would primarily refer to the device itself undergoing various non-clinical engineering tests.

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 is not applicable. The evaluations described are engineering verification and validation activities, not clinical studies requiring expert ground truth establishment for diagnostic or prognostic purposes. The "ground truth" for these tests would be the established engineering standards, specifications, and regulatory guidelines.

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

This is not applicable. As stated, the document describes non-clinical engineering tests, not studies that involve human interpretation requiring adjudication.

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 MRMC study was done, and the device is a ventilator, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.

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

A "standalone" performance study in the context of an algorithm or AI is not applicable here. The device is a ventilator, and its performance is evaluated through engineering tests, not as a standalone algorithm. The software verification and validation are "standalone" in the sense that they test the software's performance against its requirements, but not in the context of an AI algorithm's standalone clinical performance.

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

The "ground truth" for the tests mentioned would be based on:

• Software Verification and Validation: Software design specifications, functional requirements, and established coding standards.
• Electrical Safety and EMC: International standards (IEC 60601-1, IEC 60601-1-2) and national differences.
• Usability Testing: User requirements, design specifications for the carts, and observed user performance against intended use scenarios.

8. The sample size for the training set

This is not applicable. The Puritan Bennett™ 840 Series Ventilator System is a traditional medical device, not an AI/Machine Learning system that requires a "training set" in the computational sense.

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

This is not applicable, as there is no "training set."

Ask a specific question about this device

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 ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing or fusing.). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired or with compatible resectoscopes for endoscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

The indications for use include general (including urologic, thoracic, plastic, and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectorny, etc. The devices can be used on vessels (arteries, veins. pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments.

The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The ForceTriad™ Electrosurgical Generator is a full-featured electrosurgical generator with monopolar, bipolar, and LigaSure™ vessel sealing output modes. TThe generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.

The generator is used with a selection of electrosurgical instruments designed for use with the ForceTriad and the LigaSure Vessel Sealing generator. All of the LigaSure instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.

No changes are being made to the design, operation, or intended use of any of the current system except the software modifications to create the Bipolar Resection modes and to allow the ForceTriad to output system data to a computer. The subject of this 510(k) notification is in regards to the addition of specific definitions for "cut" and "coagulating" and the addition to the indications statement of a bipolar resection function for use with resectoscopes "for endoscopically controlled removal of tissue using 0.9% NaCl solution (saline) as the irrigation medium" and the hardware and software associated with the activation of this feature.

Here's an analysis of the provided text regarding the ForceTriad™ Electrosurgical Generator, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) premarket notification, which concerns substantial equivalence to predicate devices, rather than a detailed report of a new device's efficacy studies in the same way one might find for novel drug or medical device. Therefore, the information regarding specific acceptance criteria and detailed study outcomes for meeting those criteria is presented at a high level.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes (i.e., number of pork models or live porcine models) used for the bench and live animal testing. It also doesn't specify the country of origin for the data or whether the studies were retrospective or prospective, though animal model testing is inherently prospective.

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

This information is not provided in the document. The document refers to "bench testing" and "live porcine model" studies, but it doesn't detail how the "ground truth" or "acceptable results" were determined, nor does it mention the involvement or qualifications of experts in assessing the outcomes of these tests. For electrosurgical devices, ground truth might relate to tissue effects, seal integrity, or lack of collateral damage, which would traditionally be assessed by veterinary pathologists or surgeons.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of bench and animal testing for an electrosurgical device, it's less likely to involve the same type of "adjudication" seen in image-based diagnostic studies. Performance would likely be assessed against predefined engineering specifications (e.g., power output, tissue cut/coagulation characteristics).

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

• No MRMC study was done. The document explicitly states: "This premarket notification report does not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means there was no human reader study comparing effectiveness with and without AI assistance (as AI is not the primary focus here, rather software updates for device functionality).

6. Standalone (Algorithm Only) Performance Study

• No standalone algorithm performance study in the typical sense was performed or reported. This submission focuses on software updates to an existing electrosurgical generator to enable a bipolar resection feature. The "algorithm" here refers to the closed-loop control and Instant Response™ technology within the electrosurgical generator, which is designed to adjust output based on tissue impedance. The testing confirmed the device's functionality with these software updates, not an independent algorithm's diagnostic or predictive performance.

7. Type of Ground Truth Used

Based on the description of "bench testing using a pork model (to simulate prostate) and live porcine model using kidney (for hemostasis)," the ground truth for these tests would likely involve direct observation and measurement of tissue effects. This could include:

• Pathology/Histology: Microscopic examination of treated tissue to assess cut quality, depth of coagulation, cell viability, and collateral damage.
• Physiological Measurements: For hemostasis, this might involve quantitative measures of blood loss or time to achieve cessation of bleeding.
• Engineering Specifications: Measurement of power output, impedance feedback, and response times against predefined technical specifications.

The document states "Results were acceptable," implying that these assessments met predetermined performance standards.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI algorithm development. The software updates relate to activating a specific electrosurgical mode and recognizing accessories, not to a learning algorithm requiring a distinct training phase. The "software validation" and "testing" refer to verification and validation of the software's functionality and safety, not training an AI model.

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

As there is no mention of a "training set" for an AI algorithm, this question is not applicable to the provided document. The ground truth for the testing that was performed (bench and live animal) would have been established as described in point 7.

Ask a specific question about this device

The Versaport™ Bladeless Low Profile trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

The Versaport™ Bladeless low profile housing design is available in 2mm-3mm to 5mm in various lengths with radiolucent fixation sleeve. The 2mm-3mm to 5mm Versaport™ seal system accommodates 2mm-3mm to 5mm instrumentation respectively. There is a luer lock with cap for insufflation and rapid desufflation (in place of a stopcock).

This looks like a 510(k) summary for a medical device called the "Versaport™ Bladeless Low Profile Trocar." It's important to note that this document is a summary and likely doesn't contain all the detailed performance study information typically found in a full submission to the FDA. Based on the provided text, I can extract the following information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, it makes a general statement about substantial equivalence to a predicate device.

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

The document states "In-vitro and in-vivo tests were performed," but it does not specify the sample sizes used for these tests. The provenance of the data is not mentioned (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. For a physical medical device like a trocar, ground truth would typically be established through direct observation of performance in controlled environments (in-vitro) and/or in animal or human studies (in-vivo), rather than expert review of data like in an AI/diagnostic device.

4. Adjudication Method for the Test Set

This information is not provided. This concept is usually more relevant for diagnostic devices where multiple experts might independently assess results and then adjudicate disagreements.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes a surgical instrument, not a diagnostic tool that relies on human interpretation of outputs.

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

No. This device is a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable; the device is intended to be used by a human surgeon.

7. The Type of Ground Truth Used

For a physical device like this, the "ground truth" for performance would be based on:

• Direct observation of physical properties and function (e.g., ability to create and maintain a port of entry, seal integrity, instrument insertion/withdrawal, insufflation/desufflation).
• Comparison against the predicate device's established performance.
• Compliance with relevant standards (e.g., ISO Standard 10993-1 for materials).

The document states that in-vitro and in-vivo tests were performed to "verify that the performance of the Versaport™ Bladeless Low Profile trocar is substantially equivalent to the predicate device(s), and to validate that the Versaport™ Bladeless Low Profile trocar will perform as intended." This implies the ground truth was derived from the physical performance outcomes in these tests, evaluated against known performance characteristics of the predicate.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device that requires a training set.

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

This information is not applicable as this is not an AI/machine learning device that requires a training set.

Ask a specific question about this device

The SILS™ Port is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures. The SILS™ Port provides the ability to use three conventional laparoscopic trocars and an insufflation port through a single incision while providing the ability to maintain pneumoperitoneum.

Three laparoscopic trocars and an insufflation tube bound by a flexible port.

This document describes a 510(k) premarket notification for the Covidien SILS™ Port, a surgical trocar. The information provided is primarily for regulatory clearance and does not contain the detailed study results typically associated with establishing specific performance criteria for AI/ML devices. Therefore, I cannot fully complete all sections of your request based solely on the provided text.

Specifically, this submission is for a medical device (surgical port/trocar), not an AI/ML diagnostic or assistive device. The "performance data" section in the summary mentions "In-vitro and in-vivo testing has been performed in support of the intended use of this device," but it does not specify acceptance criteria, effect sizes, reader studies, ground truth, or sample sizes in the way one would for an AI/ML product.

However, I will extract and infer what I can from the provided text to address your points as best as possible.

Acceptance Criteria and Study for Covidien SILS™ Port (Surgical Trocar):

Based on the provided 510(k) summary, detailed acceptance criteria and a study design for AI/ML performance metrics are not applicable or provided, as this is a physical medical device (surgical port/trocar). The "acceptance" is primarily based on substantial equivalence to predicate devices and meeting safety and material biocompatibility standards.

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

Since this is a physical medical device and not an AI/ML algorithm, the concept of a "device performance" table as you might expect for an AI/ML product (e.g., sensitivity, specificity) is not present. Instead, performance relates to its functional use and safety. The document states:

For the remainder of your questions, the information is not present in the provided 510(k) summary as these questions are typically relevant to AI/ML device studies, not traditional medical device clearance.

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: This information is not typically part of a 510(k) summary for a physical medical device in the context of an AI/ML algorithm. The document mentions "in-vitro and in-vivo testing" but does not detail the sample sizes or provenance for these tests in this summary.

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: As this device is not an AI/ML algorithm requiring expert interpretation of outputs, this information is not relevant or included in the 510(k) summary.

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

• Not Applicable / Not Provided: This concept is not relevant to the clearance of this physical medical device.

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 type of study is specifically for AI/ML diagnostic or assistive devices and is not relevant to the SILS™ Port.

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

• Not Applicable / Not Provided: The SILS™ Port is a physical surgical tool, not an algorithm.

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

• Not Applicable / Not Provided (in the context of AI/ML): For a physical device, "ground truth" might relate to physical tests (e.g., material strength tests, leakage tests), but this is not specified in the summary nor is it the "ground truth" relevant to AI/ML performance.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no AI/ML algorithm to train for this device.

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

• Not Applicable / Not Provided: There is no AI/ML algorithm to train 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 Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.

The Valleylab Suction Coagulators are hand held electrosurgical devices used for the coagulation of tissue and aspiration of fluids during electrosurgical procedures. The devices are activated by a plastic button with a spring contact located in the handle of the device. The suction is activated by the surgeon placing a finger over the suction vent hole also in the handle.

The Suction Coagulators are a disposable, hand held device used in electrosurgical procedures. It provides control of both monopolar coagulation of tissue and suction of fluids in a single handle. The coagulation mode of operation is activated by a depressing a plastic button located on the top of the body. The activation of suction is activated by the surgeon's finger covering the suction port. Coagulation takes place at the uninsulated end of the suction tube. The Suction coagulator consists of four main elements:
-a metal, insulated, French sized tube
-a switching mechanism
-a two piece molded plastic body
-a cord with plug
The Suction Coagulator is supplied sterile and can be used with various electrosurgical generators.

The provided text describes a 510(k) summary for the Valleylab Suction Coagulators. It details the device, its intended use, and non-clinical as well as clinical testing.

Here's the analysis of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria with numerical thresholds. Instead, it states that:

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

• Sample Size for Test Set: Not applicable. No clinical testing was performed for this 510(k) submission to establish the safety and effectiveness of the new device itself. The submission relies on prior documented use of similar devices.
• Data Provenance: Not applicable for a test set specific to this device. The document mentions "published literature" documenting the use of similar Electrosurgical Suction Coagulators, implying retrospective evidence from various sources.

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

Not applicable. No new clinical test set was created for this submission. The effectiveness is based on existing published literature for similar devices.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set was created for this submission.

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 an electrosurgical instrument, not an AI-assisted diagnostic or interpretative tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This device is an electrosurgical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly define "ground truth" in the context of this device's performance. Instead, it relies on:

• Engineering Standards Compliance: IEC 60601-1 and IEC 60601-2-2 as benchmarks for electrical safety and performance.
• Published Literature: "Documented in the published literature" indicating "safe and effective use" of Electrosurgical Suction Coagulators in ENT procedures. This implies a reliance on clinical outcomes and expert observation from previously published studies on similar devices.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical instrument, not a machine learning model requiring a training set.

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

Not applicable. This device is an electrosurgical instrument, not a machine learning model.

Ask a specific question about this device

The SILS™ Clincher* single use articulating clincher has application in a variety . of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.

The SILS™ Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

The SILS™ Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.

The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery.

The SILS™ Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end.

The clincher, dissector, grasper, and shears contain opposing jaws to manipulate tissue, and the dissector, L-hook, and shears administer electrocautery. The end effector of each instrument articulates when the handle is deflected relative to the shaft and rotates when a rotation wheel is turned.

The provided text describes a 510(k) summary for several endoscopic hand instruments (SILS™ Clincher, Dissector, Grasper, L-Hook, and Shears). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance criteria in a clinical setting. Therefore, many of the requested details, particularly those related to AI algorithm performance studies, will not be present in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy thresholds). The acceptance criteria for a 510(k) submission like this revolve around demonstrating substantial equivalence to legally marketed predicate devices in terms of indications for use, technological characteristics, and safety and effectiveness.

The "performance data" mentioned refers to in-vitro and in-vivo testing to support the intended use and biological evaluation in accordance with ISO 10993-1:2003 for patient contact materials. However, specific quantitative results or how these results meet pre-defined acceptance criteria are not detailed in this summary.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) context):

Study Details (Based on available information in the document)

Since this is a 510(k) summary for conventional surgical instruments, there is no mention of an AI-powered device or associated studies. Therefore, many of the questions related to AI performance, ground truth, and expert evaluation are not applicable.

1. 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. The document refers to "in-vitro and in-vivo testing" but does not specify sample sizes, provenance, or whether the data was retrospective or prospective. This kind of detail is typically found in the full test reports, not a 510(k) summary.

2. 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. As this is not an AI device, there's no concept of establishing "ground truth" by experts in this context for diagnostic performance.

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

   • Not Applicable. This is relevant for diagnostic studies with human readers or AI.

4. 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. This document does not mention an MRMC study or AI assistance.

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

   • No. This is not an AI algorithm.

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

   • Not Applicable. For mechanical surgical instruments, "ground truth" would relate to successful mechanical operation, tissue manipulation, and safety, assessed through engineering tests, pre-clinical models (in-vitro/in-vivo), and potentially clinical observations, not derived from expert consensus on images or pathology.

7. The sample size for the training set:

   • Not Applicable. There is no AI model mentioned, thus no training set.

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

   • Not Applicable. There is no AI model mentioned, thus no training set ground truth.

Ask a specific question about this device

The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair

Absorbatack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with of 5, 10 or 20 tacks.

Here's an analysis of the provided text regarding the Absorbatack™ Absorbable Fixation Device. It appears this documentation describes a 510(k) submission for a medical device and not a study demonstrating the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the US. It does not contain information on a study with acceptance criteria and reported device performance in the context of, for example, diagnostic accuracy or treatment efficacy.

Therefore, many of the requested sections about study design, sample size, ground truth, and expert evaluation are not applicable in this context.

Analysis of Absorbatack™ Absorbable Fixation Device (K091900)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) pathway, the "acceptance criteria" are typically regulatory requirements for demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily achieved by showing identical technological characteristics, intended use, and materials, or by conducting performance testing to demonstrate equivalence if there are differences. This document explicitly states "Absorbatack™ Absorbable Fixation Device is identical to the predicate device" and "There has been no change to the Absorbatack ™ Absorbable Fixation Device." Therefore, no new performance data comparing it against specific quantitative acceptance criteria is presented for this particular submission.

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

• Sample Size: Not applicable. No test set (in the context of clinical or algorithm performance evaluation) is described.
• Data Provenance: Not applicable. The document relies on the identical nature of the device to its predicate, rather than new performance data from a specific test set.

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

• Number of Experts: Not applicable. Ground truth establishment is not relevant for this type of submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method

• Adjudication Method: Not applicable.

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

• MRMC Study: No. No such study is described or referenced.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Not applicable. This device is a physical surgical tack, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The ground for this submission is the established safety and effectiveness of the predicate device (K071920) through its prior clearance, and the assertion that the current device is identical.

8. Sample Size for the Training Set

• Sample Size: Not applicable. As this device is not an algorithm, there is no "training set."

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

• Ground Truth Establishment: Not applicable.

Summary of the Document's Content:

The provided documents detail a 510(k) premarket notification for the "Absorbatack™ Absorbable Fixation Device." The core of this submission is the claim that the device is substantially equivalent to a previously cleared predicate device (K071920), also named "Absorbatack™ Absorbable Fixation Device."

Key points from the submission:

• Identity to Predicate: The submitter explicitly states: "Absorbatack™ Absorbable Fixation Device is identical to the predicate device" and "There has been no change to the Absorbatack ™ Absorbable Fixation Device."
• Materials Evaluation: The materials were evaluated according to ISO 10993-1: 2003, "Biological Evaluation of medical devices - Part I Evaluation and Testing," and again, stated to be identical to the predicate device.
• Performance Data: The document states, "The modified labeling for the subject device is based on performance testing obtained for the predicate device." This indicates that no new performance testing for the subject device itself was conducted for this specific 510(k) submission; rather, it leveraged the existing data from the identical predicate.
• Intended Use: Fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures (e.g., hernia repair), which is consistent with the predicate.

In essence, this is a regulatory filing asserting that a device, which remains unchanged from a previously cleared version, is still substantially equivalent to that predicate. Therefore, it bypasses the need for new, extensive performance studies with specific acceptance criteria that would typically be seen for a novel device or a device with significant modifications.

Ask a specific question about this device