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Thopaz+ is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. Thopaz+ is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. Thopaz+ is intended for use on patients in appropriate care settings.

The Medela® THOPAZ* suction pump is an innovative secretion aspirator intended to be used for thoracic drainage. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® THOPAZ* are: User friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ* suction pump ideally suited for thoracic drainage while mobilizing the patient.

The Medela® THOPAZ* suction pump is an AC/DC powered, maintenance-free aspirator which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.

The Medela® THOPAZ* suction pump has an electronic measuring and monitoring system for air and fluid being drained with optical and acoustic status display. The device is a dry system, which means that no fluids are necessary for operation. Important information about the course of therapy is displayed digitally and as graphics in the display. These data can be transferred to a PC upon completion of the therapy.

The Medela® THOPAZ* suction pump has a suction capacity of 5 liters per minute and a maximum vacuum up to -10 kPa (-75 mmHg). The pump is marked "low flow – low vacuum".

A variety of reusable and disposable accessories for pleural and mediastinal drainage are available.

This document describes a Special 510(k) submission for the Medela® THOPAZ+ Suction Pump, which is a modified version of the legally marketed Medela® THOPAZ (K130210). The submission focuses on demonstrating substantial equivalence to the predicate device and the safety and effectiveness of the modifications.

Based on the provided information, it's important to note that this is NOT a study demonstrating the performance of an AI/ML-based medical device against specific acceptance criteria for diagnostic or prognostic tasks. Instead, it's a 510(k) summary for a hardware medical device (a suction pump) that has undergone modifications. The acceptance criteria and performance data discussed relate to the functional and safety aspects of the device, rather than diagnostic accuracy.

Here's an analysis based on the provided text, addressing your points where applicable:

Acceptance Criteria and Device Performance

The document does not present a formal table of acceptance criteria and reported device performance in the way one would for a diagnostic algorithm (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the verification and validation activities conducted for the device modifications, ensuring that the device's fundamental performance characteristics (suction capacity, vacuum, and safety) remain equivalent to the predicate device and that the new features function as intended without compromising safety or effectiveness.

The core performance claims are:

• Suction capacity: 5 liters per minute
• Maximum vacuum: up to -10 kPa (-75 mmHg)
• Classification: "low flow – low vacuum"

These are described as having the "same performance characteristics as the unmodified legally marketed device Medela® THOPAZ."

The document highlights several modifications and their justifications, which implicitly serve as "performance improvements" or "safety enhancements" that were verified.

Here's an assessment of the other requested points, noting that many are not applicable or cannot be determined from this specific type of document (a 510(k) summary for a hardware device, not an AI study).

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 in the AI/ML context: This document is about a hardware medical device (a suction pump). There is no "test set" in the context of evaluating an algorithm's diagnostic or predictive performance.
   • For the device itself: The document refers to "Subsequent verification and validation activities for the applied changes" and "risk management" with "documented evidence" in the submission. These would involve testing of the physical device and its software (firmware) functions, likely under controlled laboratory conditions, to ensure functionality, safety, and performance (e.g., flow rates, vacuum stability, alarm functions, fluid level detection accuracy, user interface operation). The specific sample sizes for these engineering tests are not detailed in this summary. Data provenance is not mentioned.

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: There is no "ground truth" establishment by medical experts in the sense of labeling diagnostic images or clinical outcomes for an AI algorithm in this document. The "truth" for this device relates to its engineering specifications, safety standards, and functional performance. Experts involved would be engineers, human factors specialists, and potentially clinical users for usability studies, but their numbers and qualifications are not specified here.

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

   • Not Applicable: No adjudication method for a "test set" in the AI/ML context is mentioned or relevant here.

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:

   • Not Applicable: This is a hardware device (a suction pump), not an AI-assisted diagnostic tool. No MRMC study was performed.

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

   • Not Applicable: This is a hardware device. While it contains firmware (software running on the device), it's part of an electro-mechanical system. Its performance is always "human-in-the-loop" as it requires a clinician to operate it. There isn't an "algorithm only" performance in the sense of an AI model making independent decisions. The firmware controls pump functions and displays data to the user.

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

   • Not Applicable in the AI/ML diagnostic sense: The "ground truth" for this device's performance relates to engineering specifications, safety standards (e.g., ISO, IEC), and functional requirements met through verification and validation testing. For example, the "ground truth" for suction capacity would be a measured flow rate, for vacuum it would be a measured pressure, and for fluid level detection it would be the actual fluid volume present vs. what the sensor reports. This is based on objective physical measurements, not medical expert consensus for a diagnostic task.

7. The sample size for the training set:

   • Not Applicable: As this is a hardware device with firmware, there isn't a "training set" in the machine learning sense for an AI model. The firmware is developed through traditional software engineering methods, including coding, debugging, and testing, not by training on a dataset.

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

   • Not Applicable: No training set in the AI/ML sense exists for this device.

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The Medela® THOPAZ Suction Pump is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Medela® THOPAZ Suction Pump is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Medela® THOPAZ Suction Pump is intended for use on patients in appropriate care settings.

Powered Suction Pump

The provided text is a 510(k) summary for the Medela® THOPAZ Suction Pump. It asserts substantial equivalence to predicate devices but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with performance metrics.

Instead, it states:

• "The Medela® THOPAZ Suction Pump is equipped with the identical technology like other marketed devices. These technological features do not affect safety and effectiveness of the device or the application (pleural and mediastinal drainage)."
• "There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (pleural and mediastinal drainage)."
• "The Medela® THOPAZ suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices."

Therefore, I cannot populate the requested table or answer most of the questions because the document explicitly states the device is identical in technology and performance to predicate devices (K080212 and K043140) and does not present new performance data or studies to demonstrate meeting acceptance criteria.

The submission is based on the premise that since it's identical to already-cleared devices, new performance studies are not required.

Given the information provided, the following elements cannot be extracted:

• A table of acceptance criteria and the reported device performance: Not provided; the device is stated to be identical to predicates.
• Sample size used for the test set and the data provenance: Not applicable as no new performance study is detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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The Medela THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery).

Generally the Medela THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.

The Medela® THOPAZ pump is an innovative secretion aspirator intended to be used for thoracic drainage. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® THO-PAZ are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ ideally suited for thoracic drainage while mobilizing the patient.

The Medela® THOPAZ suction pump is an AC/DC powered, maintenance-free aspirator which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.

The Medela® THOPAZ suction pump has an electronic measuring and monitoring system with optical and acoustic status display. The device is a dry system, which means that no fluids are necessary for operation. Important information about the course of therapy is displayed digitally and as graphics in the display. These data can be transferred to a PC upon completion of the therapy.

The Medela® THOPAZ suction pump has a suction capacity of 5 liters per minute and a maximum vacuum up to -10 kPa (-75 mmHg). The pump is marked "low flow - low vacuum".

A variety of reusable and disposable accessories for thoracic drainage are available.

The provided text, K080212 for the Medela® THOPAZ Suction Pump, is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and supporting research in the way a clinical trial for a novel drug or a complex AI diagnostic system might.

Therefore, many of the requested sections about explicit acceptance criteria, detailed study designs, sample sizes, ground truth establishment, and multi-reader comparative studies are not directly applicable or inferable from this type of regulatory document.

Here's an attempt to address your request based on the available information:

Acceptance Criteria and Device Performance Study for Medela® THOPAZ Suction Pump (K080212)

1. Table of Acceptance Criteria and Reported Device Performance

Based on the 510(k) summary, the primary "acceptance criteria" for this device are its performance characteristics and intended use being substantially equivalent to its predicate devices. The reported device performance is presented in terms of its specifications and how they align with the predicate.

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

This is a 510(k) premarket notification, which primarily relies on comparison to predicate devices, not typically extensive clinical trials with "test sets" in the conventional sense of an AI or diagnostic study.

• Sample Size for Test Set: Not applicable or not described in this document. The submission focuses on demonstrating equivalence through comparison of design, specifications, and performance to predicate devices (Medela® Vario 8/18/ci Suction Pumps, K061205, and Medela® Dominant 35 c/i Suction Pump, K043544).
• Data Provenance: Not applicable in the context of a "test set" for a performance study. Any data supporting the device's technical specifications would typically come from internal engineering testing and validation based on design inputs, rather than external clinical data used for a diagnostic assessment.

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

Not applicable. This type of submission does not involve a "ground truth" established by experts for a test set in the way a diagnostic study would. The safety and effectiveness are established by demonstrating substantial equivalence to already cleared devices.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication by multiple experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

Not applicable. MRMC studies are typically performed for diagnostic imaging devices or AI systems where human reader performance is being evaluated with and without AI assistance. This document is for a powered suction pump.

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

Not applicable. This device is a physical medical pump, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a diagnostic "ground truth." The "ground truth" in this submission is the established safety and effectiveness of the predicate devices, against which the new device is compared. Its performance characteristics (suction capacity, vacuum) are objective measurements.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable for the same reason as above.

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