Search Results

The Nortech Flo-Assistant™ Product is indicated to provide a squeezing mechanism to a tubing set, providing increased capacity fluid irrigation for arthroscopic procedures.

The Flo-Assistant™ is designed to be used with the Nortech® 7-510-33 Flo-Assistant™ tubing set for increased fluid capacity. The device is comprised of a main unit, cable and foot pedal assembly.

I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the Flo-Assistant™ device, primarily focusing on its description, intended use, and assertion of substantial equivalence to predicate devices. It does not include details about clinical trials, performance specifications, or study methodologies.

Ask a specific question about this device

The NORTECH IntraMyst Humidification System is indicated for use as a means of supplying humidity within the intra-abdominal cavity during diagnostic and/or operative laparoscopic procedures.

Nortech's IntraMyst Humidification System incorporates front panel controls that are similar to Northgate's current Insufflators. The system is designed to provide continuous or on demand humidification to the laparoscopic environment. This may reduce the incidence of postoperative pain, diminish the likelihood of adhesion formation and reduce laparoscope lens fogging. The controller will contain the appropriate pneumatics for supplying and controlling the gas to the catheter at 100 PSI and 5 LPM. In addition, the controller will have displays for indicating abdominal pressure, overpressure, gas supply low, mist active, active pressure sense and amount of fluid dispensed.

The Nortech IntraMyst Humidification System is a Class II device designed to provide continuous or on-demand humidification to the laparoscopic environment. The provided SSS document acts as a 510(k) premarket notification, which is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence, rather than specific performance metrics from a dedicated clinical study for this device.

Here's an analysis based on the provided document:

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

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

The document does not describe a clinical "test set" in the traditional sense for evaluating device performance against pre-defined criteria. This is a 510(k) submission focused on substantial equivalence, which primarily relies on direct comparison to predicate devices, engineering testing (to meet standards), and possibly bench testing. Therefore:

• Sample Size for Test Set: Not applicable in the context of a clinical performance study. The evaluation likely involved engineering tests and potentially bench tests, but no specific human clinical test set is described.
• Data Provenance: Not applicable in the context of a clinical performance study. The information provided is about the device's design, materials, intended use, and its assertion of substantial equivalence to predicate devices, rather than clinical data from a new study.

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

Not applicable. As this is a 510(k) submission focusing on substantial equivalence, there is no mention of a human-in-the-loop clinical test set requiring expert consensus for ground truth.

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

Not applicable. No clinical test set requiring adjudication is described.

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 a laparoscopic insufflator and humidification system, not an AI-based diagnostic or assistive technology for human readers.

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

Not applicable. This is a medical device, not an algorithm. Its performance would be evaluated through engineering specifications, bench testing, and compliance with standards, not as a standalone algorithm.

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

Not applicable. For a 510(k) submission of this type of device, "ground truth" isn't typically established in the sense of clinical outcomes or expert labels. Instead, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective, and the new device demonstrates equivalence to them through design, materials, and intended use. Performance is implicitly demonstrated by meeting recognized safety and performance standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed using a training set.

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

Not applicable. This device is not an AI/ML product developed using a training set.

Ask a specific question about this device

The NORTECH 40LPM ABDOMINAL INSUFFLATOR®, 72-00203-0 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.

The Abdominal CO, Gas Insufflator (catalog # 72-00203-0) incorporates front panel controls similar to our current Omniflator® model #7640, although it utilizes membrane switches. The Abdominal Insufflator has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank.

This document is a 510(k) premarket notification for a laparoscopic insufflator. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.

The document does not contain acceptance criteria for device performance or a study demonstrating that these criteria are met. This type of information is typically found in design verification and validation reports, which are part of the technical documentation submitted to the FDA but are not usually included in the public-facing 510(k) summary or cover letters.

Therefore, I cannot provide the requested information based solely on the provided text. The prompt asks for information that is not available in these specific parts of the 510(k) submission.

To answer your questions, I would need access to the actual performance and testing data, which are not present in the provided excerpt. The document only states that the device is substantially equivalent, implying that its performance is comparable to existing predicate devices, but it does not quantify this performance or detail specific tests.

Ask a specific question about this device

Ask a specific question about this device

THE HYDROTOWER® ARTHROSCOPIC ADMINISTRATION TUBING SET IS USED TO MOVE FLUID FROM THE TOWER BAG TO THE PATIENT.

The Hydrotower® Arthroscopic Administration Tubing Set is designed to be used with the Nortech® Hydrotower® System. The device is comprised of pvc tubing, check valve, a pressure relief valve, and numerous polymer fittings.

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Hydrotower® Arthroscopic Administration Tubing Set, which primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table or answer the questions related to the study design, sample sizes, expert qualifications, or comparative effectiveness.

Ask a specific question about this device

Ask a specific question about this device

THE NORTECH HYDROTOWER FLUID MANAGEMENT SYSTEMS SHALL BE USED FOR SUPPLYING FLUID FOR GENERAL ENDOSCOPIC PROCEDURES.

The Hydrotower ® Fluid Management System incorporates a peristaltic pump, motor, controller, power supply, and associated tubing and a sensor. The product allows continuous flow to an Endoscopic instrument by the constant refilling of a fluid "reservoir" bag. The control of flow rates and source pressures remains in the physician's control by the conventional method of raising or lowering the "reservoir" bag.

This document is a 510(k) premarket notification for the Hydrotower® Fluid Management System. It states that the device is substantially equivalent to legally marketed predicate devices and is intended for supplying fluid for general endoscopic procedures.

However, the provided text does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or any aspects of a clinical study or performance evaluation.

Therefore, I cannot provide a description of the acceptance criteria and the study that proves the device meets them based on the given input. The document is primarily an FDA clearance letter and a summary of safety and effectiveness, not a detailed performance study report.

Ask a specific question about this device

THE NORTECH GAS WARMER II IS INDICATED FOR WARMING GAS (95-1059F/35-40.5°C) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.

The CO, Gas Warmer II Unit is designed to be used in conjunction with an insufflator to provide continuous non-adjustable heating of gas to a laparoscopic instrument. The CO2 Gas Warmer II Unit is comprised of a control unit and reusable heat exchanger and power cords.

The provided text describes a medical device, the Northgate Technologies Inc. CO2 Gas Warmer II, and its regulatory clearance based on substantial equivalence. It does not contain information about acceptance criteria or a study demonstrating device performance against specific criteria in the way typically seen for AI/ML-driven devices or those requiring extensive clinical studies to prove effectiveness.

The clearance is based on substantial equivalence to predicate devices. This means that instead of conducting new performance studies to meet new acceptance criteria, the manufacturer demonstrated that their device is as safe and effective as a device already legally marketed.

Therefore, most of the requested information about acceptance criteria and performance studies is not applicable to this type of regulatory submission in the way the questions are framed for AI/ML or efficacy-proving studies.

Here's a breakdown based on the provided text:

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

• Acceptance Criteria: The implicit acceptance criterion for this device, based on the provided document, is that it warms gas to a range of 95-105°F / 35-40.5°C. This is stated as the "Indications For Use" and is the essential function described. There are no other performance metrics or specific thresholds (e.g., accuracy, sensitivity, specificity, or response time) explicitly mentioned as acceptance criteria for regulatory clearance.
• Reported Device Performance: The document does not provide a specific performance study or test results demonstrating that the CO2 Gas Warmer II achieves this temperature range. The substantial equivalence argument implies that it does achieve this, or would be expected to, based on the design, materials, and intended use being similar to already-cleared devices.

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. The provided document is a 510(k) clearance letter and a summary of safety and effectiveness, which relies on substantial equivalence. It does not describe a clinical or performance study with a 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. There was no test set or ground truth established for this type of submission.

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

• Not applicable. There was no test set.

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 insufflator accessory, not an AI-driven diagnostic or assistive tool for human readers.

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

• Not applicable. This device is hardware for warming gas, not an algorithm.

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

• Not applicable. No ground truth in the context of diagnostic performance was established or required for this 510(k) submission. For warming devices, "ground truth" would typically refer to measured temperature in design validation, but this specific data is not in the provided documents.

8. The sample size for the training set

• Not applicable. As a hardware device cleared through substantial equivalence, there is no "training set" in the machine learning sense.

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

• Not applicable. See point 8.

Ask a specific question about this device

The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs'® Intracorporeal Electro-Mechanical Lithotriptor probes for the fragmentation of urinary calculi.

The Intracorporeal Electro-Mechanical Lithotriptor (EML) generator incorporates front panel controls that include a lighted main "Power Switch." An "Energy Switch" and "Rate Switch".

The provided text describes a 510(k) summary for the Nortech® Electro-Mechanical Lithotriptor (EML). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with acceptance criteria for a novel device performance claim. Therefore, the information requested in your prompt (acceptance criteria, specific study design, sample size, expert ground truth, MRMC study, standalone performance, training set details) is not extensively provided in these documents, as it's not typically required for a 510(k) submission that relies on bench testing for substantial equivalence.

However, based on the text, I can extract the following information relevant to device performance and the "study" that proves it meets criteria for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, the document doesn't define "acceptance criteria" in the way one might for a clinical trial's primary endpoint (e.g., "sensitivity > 90%"). Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to a predicate device. The performance is assessed through bench testing to show similar functionality and effectiveness in fragmenting calculi.

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

• Test Set Sample Size: The document does not specify a numerical sample size for "bench testing." It mentions a comparison of "the two (2) systems" (Nortech EML and EMS Swiss Lithoclast). This implies a qualitative and quantitative comparison of their performance on a set of calculi, but no specific count of stones or test runs is provided.
• Data Provenance: The data is from bench testing conducted by the manufacturer, Northgate Technologies Inc. The country of origin for the data is not explicitly stated but would presumably be the United States, where Northgate is located (Elgin, IL). The data is prospective in the sense that it was generated specifically for this submission to compare the two devices.

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

The document does not indicate the involvement of experts to establish a "ground truth" for the bench tests in the sense of clinical interpretation. The "ground truth" for the bench testing would be the objective physical fragmentation of calculi, which can be measured and observed without expert clinical interpretation. The assessment of "similarity in the way the calculi was fragmented" would likely be based on objective observations and physical measurements rather than expert clinical consensus.

4. Adjudication method for the test set

Not applicable. There is no mention of a human-based adjudication process for the bench testing results described. The comparison was likely based on objective measurements and observations of stone fragmentation.

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 medical device (lithotriptor) for physical stone fragmentation, not an AI or imaging diagnostic device that involves "human readers" or "AI assistance."

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

Not applicable. This device is an electro-mechanical lithotriptor, not an algorithm. Its operation inherently involves a human operator (physician) positioning the probe and activating it. The "standalone performance" referred to in the document is the EML unit's ability to fragment stones in bench tests, independent of a live patient, but still operated by a human.

7. The type of ground truth used

The "ground truth" for the bench testing was the objective physical fragmentation of urinary calculi. This would involve direct observation, measurement of fragment size, and potentially energy required for fragmentation. There is no mention of pathology, expert consensus (in the clinical interpretation sense), or outcomes data for this specific bench study.

8. The sample size for the training set

Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

Not applicable. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment process.

Ask a specific question about this device

THE NORTECH OMNIFLATOR® 7640 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.

The Omniflator® Model 7640 CO, Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6630/6600. The 7640 has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO, from a central supply or E-Cylinder tank.

The provided text is a 510(k) summary for the Nortech Omniflator® 7640 Laparoscopic Insufflator. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about:

• Specific acceptance criteria for device performance (numerical thresholds for accuracy, precision, etc.).
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number/qualifications of experts or ground truth establishment methods.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.

The document is a regulatory submission demonstrating substantial equivalence to existing devices, which is a different type of evaluation than a study proving performance against specific acceptance criteria. The substantial equivalence relies on the device being similar in design, materials, and intended use to previously cleared devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text.

Ask a specific question about this device