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The product is used for intraoperative monitoring and testing during surgical procedures
· to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation

The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations:

• · Measurement:
• o Auditory evoked potentials (AEP)
• o Electroencephalography (EEG)
• o Electrocorticography (ECoG)
• o Electromyography (EMG)
• o Somatosensory evoked potentials (SSEP)
• o Motor evoked potentials (MEP)
• o Train of Four (TOF)
• · Stimulation:
• o Transcranial electrical stimulation (TES)
• o Direct cortical and subcortical stimulation (DCS)
• o Direct nerve stimulation (DNS)
• o Transcutaneous intraoperative nerve stimulation (TINS)
• o Direct muscle stimulation (DMS)

The ISIS Headboxes and the ISIS Neurostimulator constitute multimodal intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.

The ISIS IOM Systems support the following measurement modalities:

• -Auditory Evoked Potentials
• -Transcranial and cortical Motor Evoked Potentials
• Somatosensory Evoked Potentials -
• Free-running and triggered Electromyography -
• Electroencephalography -
• Train of Four -

The provided document is a 510(k) summary for the ISIS Headboxes and ISIS Neurostimulator, which are intraoperative neuromonitoring systems. It focuses on demonstrating substantial equivalence to a predicate device (K212166) rather than establishing novel acceptance criteria and proving performance against them in a clinical study.

The document states that no additional clinical testing was performed for the subject devices. Instead, the submission relies on bench testing against established standards and internal requirements to demonstrate safety, effectiveness, and performance that is "as well as or better than" the predicate device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a de novo AI/ML device (which often involves clinical performance metrics like sensitivity, specificity, etc.) are not directly applicable or available in this document.

Here's an attempt to extract the relevant information based on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to a predicate device through bench testing rather than a de novo AI/ML device with pre-defined performance metrics, the acceptance criteria are primarily related to adherence to international standards and internal requirements for electrical safety, EMC, and software validation.

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

• Sample Size: Not applicable in the traditional sense of a clinical test set with patient data. The testing was primarily bench and software validation. The "sample size" would refer to the number of units tested, which is not specified, but implied to be sufficient for type testing.
• Data Provenance: The data refers to the results of internal bench tests and software validation activities, conducted by the manufacturer (inomed Medizintechnik GmbH) in Germany. It is entirely retrospective in the sense that it's performed on a developed product to meet predefined standards.

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

• This information is not provided because no clinical test set with expert-established ground truth was used. The ground truth for functional verification would be the expected output or behavior according to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable as there was no clinical test set requiring expert 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 comparative effectiveness study was done. The device is a neuromonitoring system, not an AI-assisted diagnostic or interpretive tool that would inherently involve "human readers" in that sense. The submission explicitly states: "No additional clinical testing was performed".

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

• The document implies that the "software validation" and "bench testing" constitutes a standalone performance evaluation of the device's functional integrity as an algorithm/system. The software (NeuroExplorer) and hardware components were tested to ensure they meet their predetermined specifications and comply with relevant standards independently of human interpretation of clinical outcomes. However, this is not an "AI algorithm only" type of standalone performance, but rather functional performance of medical device software/hardware.

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

• For the bench and software testing, the "ground truth" would be established by the engineering specifications, international performance standards (e.g., IEC 60601 series), and documented functional requirements of the device. This is a technical (rather than clinical/biological) ground truth.

8. The sample size for the training set

• This device is not described as an AI/ML device that requires a "training set" in the context of machine learning model development. Therefore, this question is not applicable. The software development follows a traditional software lifecycle process, not a machine learning training paradigm.

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

• Not applicable, as there is no mention of an AI/ML training set.

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ISIS Headbox 5042xx products:

The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues.

The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).

The products are not intended for monitoring life-sustaining functions.

ISIS Neurostimulator 504180:

The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:

• Transcranial electrical stimulation (TES)
• Direct cortical stimulation (DCS)
• Direct nerve stimulation (DNS)
• Transcutaneous electrical nerve stimulation (TNS)
• Direct muscle stimulation (DMS)

The ISIS Headboxes and the ISIS Neurostimulator constitute multimodality intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.

The ISIS IOM Systems support the following measurement modalities:

• Auditory Evoked Potentials
• Transcranial and cortical Motor Evoked Potentials
• Somatosensory Evoked Potentials
• Freerunning and triggered Electromyography
• Electroencephalography
• Train of Four

The provided text describes a 510(k) summary for the Inomed Medizintechnik GmbH's "ISIS Headboxes and ISIS Neurostimulator" (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (Cadwell Industries Inc./Cascade Intraoperative Monitor K162199).

Crucially, this document does not contain acceptance criteria or a study proving device performance in the way a clinical study for a new diagnostic or AI-driven imaging device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering performance testing (bench testing, electrical safety, EMC, software validation) and a comparison of technical specifications and intended uses.

Therefore, I cannot populate all sections of your requested table and provide information on aspects like sample size for test sets, ground truth establishment, expert adjudication, or MRMC studies, as these types of studies were explicitly not performed for this 510(k) submission. The document states: "No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator... Therefore, this section does not apply."

Here's the information that can be extracted relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission relying on engineering performance and comparison to a predicate, the "acceptance criteria" are primarily adherence to relevant electrical safety and electromagnetic compatibility (EMC) standards, and meeting predetermined specifications during bench testing and software validation. The "reported device performance" is the successful compliance with these standards and specifications.

• Adherence to FDA guidance: "The content of premarket submissions for software contained in medical devices, May 11, 2005"
• Adherence to FDA guidance: "Off-the-shelf software use in medical devices, Sep 27, 2019"
• Adherence to FDA guidance: "General principles of software validation: Final guidance for industry and FDA staff, Jan 02, 2002"
• Adherence to FDA guidance: "Content of premarket submissions for management of cybersecurity in medical devices. Oct 02, 2014"
• Adherence to IEC 62304:2006, Medical device software - Software life cycle processes | "Test results demonstrate that the inomed NeuroExplorer Software complies with its predetermined specifications, the applicable guidance documents, and standards." | The software ("NeuroExplorer") is categorized as a "MODERATE level of concern software." |
  | Electrical Safety | - Compliance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint).
• Compliance with IEC 80601-2-26:2019 (electroencephalographs).
• Compliance with IEC 60601-2-40:2016 (electromyographs and evoked response equipment). | "Test results demonstrate that the products comply with the applicable standards." | The document compares specific technical aspects like A/D resolution, hardware bandpass, sampling frequency, notch filter, CMRR, and amplifier noise to the predicate device, indicating equivalent or compliant performance with relevant standards. |
  | Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2:2014. | "Test results demonstrate that the products comply with the applicable standards." | |
  | Bench/Performance Testing | - Fulfillment of requirements formulated at multiple levels: electrical medical systems, system carrier, amplifier (Headboxes) and stimulator (Neurostimulator) modules, operating software (NeuroExplorer) incl. firmware, and accessories.
• Assessment of human factors influence on safety. | "The products successfully underwent the bench testing to confirm the fulfillment of the requirements at these levels as part of the verification and validation process."
  "The testing of the influence of human factors on the devices demonstrates that the products are safe to use and that no further improvement of the user interface design relating to safety is necessary." | This testing is internal to the manufacturer's verification and validation process. The specific quantitative "requirements" are not detailed in this public summary but are typically part of internal design specifications. |
  | Biocompatibility | N/A | N/A | The devices do not have patient contact materials, therefore testing was not applicable. |

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

This information is not applicable and not provided in the document. As stated, "No additional clinical testing was performed for the ISIS Headboxes and ISIS Neurostimulator... Therefore, this section does not apply." The testing described are engineering verification and validation tests, not clinical studies with patients or data sets in the typical sense for AI/diagnostic devices.

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

This information is not applicable. The performance testing was based on engineering standards and internal requirements, not expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) 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

No MRMC comparative effectiveness study was done. This device is an intraoperative neuromonitoring system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.

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

This information is not applicable. This device is an intraoperative neuromonitoring system, not primarily an algorithm performing a standalone diagnostic task. Its function is to measure and display electrophysiological signals and provide stimulation.

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

The ground truth or reference for device performance was established through engineering standards, technical specifications, and internal functional requirements. For example, electrical outputs meet specified ranges, and input signals are recorded with specified fidelity according to IEC standards. This is not clinical ground truth (e.g., pathology report, expert diagnosis).

8. The Sample Size for the Training Set

This information is not applicable. The document does not describe the use of an AI algorithm that requires a training set in the context of a machine learning model for diagnosis or interpretation. The software validation refers to standard software development practices, not AI model training.

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

This information is not applicable, as there was no mention of a training set for an AI algorithm.

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The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.

The Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is a single-use, sterile tracheal tube made of a polyvinyl chloride tube body, cuff inflation line and a compatible pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. The Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is sold in Murphy eye style. Each tube has a dorsal lumen with an opening above the cuff and a male suction connector port attached to the tube, which is close to the machine end of the tube. Access to the suction lumen is accomplished via a connection of the suction accessory pack (P/N 5-23000) directly to the male suction connector.

The provided document is a 510(k) Pre-market Notification for the Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port. This document describes the device and its substantial equivalence to a predicate device, rather than an AI/ML powered device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically relevant for AI/ML device evaluations, is not present in this document.

The document primarily focuses on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K091761) by comparing their characteristics and conducting non-clinical performance testing.

Here's an analysis of the information that is available in the document, framed as closely as possible to your request, but highlighting the difference in context:

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

The document does not provide a table of acceptance criteria with numerical performance targets and reported results in the way it would for an AI/ML algorithm's accuracy, sensitivity, or specificity. Instead, it describes "bench testing" to verify performance is "substantially equivalent" to the predicate. The "Principle of Test" column serves as the qualitative "acceptance criteria" for these non-clinical tests.

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

The document refers to "bench testing" but does not specify sample sizes for these tests. For a physical device, this would typically involve a certain number of units manufactured for testing. The provenance of material or components isn't explicitly stated beyond the manufacturer, Teleflex Medical, Inc. The document does not describe the use of "data" in the context of an AI/ML algorithm.

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

Not applicable to this type of device submission. Ground truth, in the context of AI/ML, involves human expert annotations or definitive outcomes, which are not relevant for the bench testing described here. The tests rely on established ISO standards and methods.

4. Adjudication method for the test set

Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, which is not relevant for the objective bench tests 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 is not an AI/ML device that assists human readers.

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

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

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria of the referenced ISO standards (e.g., ISO 10993-5 for cytotoxicity). This is not "expert consensus, pathology, or outcomes data" in the AI/ML sense, but rather adherence to validated scientific and engineering testing protocols.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. This is not an AI/ML device.

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The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.

The ISIS Tube is a single-use, sterile tracheal tube made of polyvinyl chloride tube body, cuff inflation line and a compatible pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. ISIS Tube will be sold in Murphy eye style. Each tube has a dorsal lumen with an opening above the cuff and a male suction connector port attached to the tube which is close to the machine end of the tube. Access to the suction lumen is accomplished via a connection of the suction accessory pack (P/N 5-23000) directly to the male suction connector.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Teleflex ISIS HVT Tracheal Tube:

Summary of Acceptance Criteria and Device Performance:

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining explicit performance acceptance criteria with numerical targets. The "Summary of Testing" section indicates that the device meets relevant international standards and that its suction/aspiration capability is equivalent to predicate devices.

Study Information:

Based on the provided text, the study conducted is primarily bench testing for equivalence and conformance to international standards.

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

   • The document does not specify the sample size for the test set used during the bench testing or compliance checks.
   • The data provenance is not specified beyond "Bench testing determined...". It's likely in-house testing conducted by Teleflex Medical, Inc.

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):

   • This information is not provided as the study described is bench testing against standards and predicate devices, not studies involving human (e.g., clinical) interpretation or ground truth establishment by experts in that context.

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

   • This information is not provided as the documentation describes bench testing for technical specifications and comparative performance, not a study requiring adjudication of human-derived data or expert consensus.

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, an MRMC comparative effectiveness study was not done. This document describes a medical device (tracheal tube), not an AI-powered diagnostic system where human reader performance would be a relevant metric.

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

   • No, a standalone algorithm performance evaluation was not done. This device is a physical medical device, not an algorithm.

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

   • The "ground truth" for the bench testing appears to be objective measurements and specifications defined by the referenced ISO standards and the measured performance of predicate devices. For example, the suction/aspiration capability was compared directly to that of other legally marketed devices.

7. The sample size for the training set:

   • This information is not applicable as the document describes the evaluation of a physical medical device, not an AI model that requires a training set.

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

   • This information is not applicable as the document describes the evaluation of a physical medical device, not an AI model.

In summary, the provided submission is an Abbreviated 510(k) for a medical device (tracheal tube). The "study" described is primarily bench testing and conformance to recognized standards, aiming to demonstrate substantial equivalence to existing predicate devices. It does not involve AI, human reader studies, or the methodologies typically associated with software-as-a-medical-device (SaMD) evaluations.

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The Isis System is intended for cryogenic destruction of tissue during surgical procedures. The Isis System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

The Isis System has the following specific indications:

• Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
• Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention)
• Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
• Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
• General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
• ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)
• Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions)
• Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Cryosurgical unit with argon-cooled probes

The provided text is a 510(k) summary for the Galil Medical Ltd. Isis™ System, a cryosurgical unit. It primarily focuses on the device's classification, predicate devices, and indications for use.

Crucially, this document does not contain information regarding:

• Acceptance criteria for device performance.
• Studies proving the device meets acceptance criteria.
• Device performance results.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone performance studies.
• Type of ground truth used.
• How ground truth was established.

The document is a regulatory approval summary, confirming the device's substantial equivalence to predicate devices for marketing purposes. It does not delve into the detailed technical performance or validation studies typically required for the information requested.

Therefore, I cannot provide the requested table and study details based on the provided input.

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The ISIS iQ UNO Handheld Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

The ISIS iQ UNO Handheld Electronic Breast Pump is a safe and effective powered breast pump used for expressing and collecting breast milk from the breasts of a lactating woman. The diaphragm within the pump is activated by a 6V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 6V DC power supply, hand controller, Avent ISIS standard manual breast pump parts, and feeding bottles. The hand controller is designed to replicate the handle of the Avent standard manual ISIS Breast Pump, and is used to control the frequency and level of vacuum. A sealed AC/DC transformer or a battery pack powers the ISIS iQ UNO Breast Pump.

The ISIS iQ UNO Handheld Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. After a comfortable manual pumping cycle has been established, the user engages the automatic pumping mode by depressing the control button on the hand controller. In the automatic mode, the pumping cycle is stored and controlled by the microprocessor. The user can switch between the automatic mode and manual mode at any time by repeatedly depressing the control button.

All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

The provided text describes the ISIS iQ UNO Handheld Electronic Breast Pump and its 510(k) submission, not a study involving a device that meets acceptance criteria with reported performance metrics like sensitivity or specificity. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, rather than a performance study.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, number of experts, adjudication methods, MRMC study, standalone performance, ground truth types for test and training sets) cannot be fulfilled from the provided text, as they pertain to performance studies that were not conducted for this device.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with electrical, mechanical, environmental, food-contact, and biocompatibility standards, rather than defining and meeting specific performance acceptance criteria like accuracy, sensitivity, or specificity.

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

No test set for performance was used as no clinical studies were performed (as stated in Section 8.9).

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

Not applicable as no clinical studies were performed and therefore no ground truth establishment was needed for device performance evaluation.

4. Adjudication Method for the Test Set

Not applicable as no clinical studies were performed.

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

No MRMC study was done. The document explicitly states, "No clinical studies were performed."

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was done. The device is a physical breast pump, not an algorithm. The document explicitly states, "No clinical studies were performed."

7. Type of Ground Truth Used

Not applicable as no clinical studies were performed.

8. Sample Size for the Training Set

Not applicable as no clinical studies were performed and this is a physical device, not an AI/ML algorithm.

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

Not applicable as no clinical studies were performed.

Summary of Non-Clinical Performance Data (as provided in Section 8.8):

While not framed as "acceptance criteria" for a performance study, the device met the following standards, which serve as its non-clinical acceptance criteria for regulatory clearance:

The study that "proves the device meets the acceptance criteria" in this context is the non-clinical testing that demonstrated compliance with these listed electrical, mechanical, environmental, and material standards. This testing was conducted by the manufacturer, Avent America, Inc., and the results were submitted as part of their 510(k) premarket notification (K052047). The FDA reviewed these non-clinical performance data and the technological characteristics, concluding that the device is safe and effective and substantially equivalent to predicate devices, thus allowing it to be marketed. No specific details about the methodology or sample sizes for this non-clinical testing are provided in the summary.

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The ISIS iQ DUO Twin Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

The ISIS iQ DUO Twin Electronic Breast Pump is a safe and effective powered breast pump for expressing and collecting breast milk from the breasts of a lactating woman. The pumping can be performed on one breast or two breasts simultaneously, from independent diaphragms. The diaphragms within the pump are activated by a 12V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 12V DC power supply, twin tubing with data cable, hand controller, Avent ISIS standard manual breast pump parts, and feeding bottles. The hand controller is designed to replicate the handle of the Avent standard manual ISIS Breast Pump, and is used to control the frequency and level of vacuum. A sealed AC/DC transformer powers the ISIS iQ DUO Breast Pump.

The ISIS iQ DUO Twin Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the strokelcycle of the control handle lever. After a comfortable manual pumping cycle has been established, the user engages the automatic pumping mode by depressing the control button on the hand controller. In the automatic mode, the pumping cycle is stored and controlled by the microprocessor. The user can switch between the automatic mode and manual mode at any time by repeatedly depressing the control button.

All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

The provided text describes the ISIS iQ DUO Twin Electronic Breast Pump and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This type of regulatory submission often relies on non-clinical performance data and limited clinical data to show safety and effectiveness, rather than extensive comparative effectiveness studies typical for novel medical devices or AI-powered diagnostics.

Given the nature of this submission, direct acceptance criteria in a quantitative, prescriptive manner (e.g., "sensitivity must be >90%") are not explicitly stated for individual device performance metrics in the way one might expect for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the demonstration of conformance to applicable safety and performance standards and the overall conclusion of substantial equivalence to a pre-existing legally marketed device (the Medela Pump in Style Advanced Breast Pump).

Here's an analysis based on the provided text, structured to address your specific points where information is available:

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

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

• Sample Size: 72 study subjects. This was split into:
  • 48 study subjects (24 English-speaking and 24 Spanish-speaking) for the Human Factors/Labeling Study.
  • 24 study subjects for the Home Use Study.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, as they involve actively recruiting and observing subjects using the device.

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

This information is not provided in the text. Given that the studies assess usability and safe/effective use for a breast pump, "ground truth" in the traditional sense of a diagnostic outcome is less applicable. The "ground truth" here is more about user experience, comprehension, and the device's ability to perform its function without adverse events, which would have been assessed by study personnel rather than clinical experts establishing a medical "ground truth."

4. Adjudication method for the test set

This information is not provided in the text. For human factors and home use studies, adjudication methods (like 2+1 review) are not typically used in the same way they would be for diagnostic accuracy studies. Assessment would likely be based on reported user feedback, observation, and analysis of safety events.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The ISIS iQ DUO Twin Electronic Breast Pump is a mechanical medical device, not an AI diagnostic, therefore, this type of study is not applicable and was not performed.

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

Not Applicable. The device is a mechanical breast pump. There is no "algorithm only" performance to evaluate in the context of an AI device. Its performance relies on its mechanical and electrical function, as well as user interaction. The "microprocessor" controls the pumping cycle based on user input, not autonomously interpreting medical data.

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

The concept of "ground truth" as typically defined for diagnostic devices (e.g., pathology for cancer detection) is not directly applicable here. For this breast pump, the "truth" or primary endpoints assessed in the studies relate to:

• User Safety and Effectiveness: Whether users could safely and effectively operate the device and express milk. This would be observed and reported.
• Usability/Human Factors: The clarity and appropriateness of the User Guide and the device's physical design. This would be assessed through user feedback and observation.
• Conformance to Standards: Verification that the device meets defined electrical, mechanical, and biocompatibility standards.

8. The sample size for the training set

Not Applicable. This is a hardware medical device, not an AI model that requires a training set.

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

Not Applicable. As there is no AI model or training set, the concept of establishing ground truth for it is irrelevant in this context.

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The ISIS MER System / Elekta MER System is intended to be used during neurosurgery to record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.

During neurosurgical interventions the ISIS MER System / Elekta MER System is used for optimal extra cellular recording and deep brain stimulation. The system operates the integrated neurostimulator that delivers impulses similar to the effect of an implanted electrode. Recording and stimulation of up to five channels are possible simultaneously. A sixth channel may be used for EMG recording for optimal patient surveillance.

The provided text is a 510(k) summary for the Inomed GmbH ISIS MER System / Elekta MER System. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on comparing the new device's technological characteristics, safety, and effectiveness to its predicate.

Based on the provided text, there is no information available regarding acceptance criteria, a specific study proving the device meets those criteria, or details regarding the methodologies listed in your request (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details, etc.).

Here's why and what information is present:

• Type of Submission: This is a Traditional 510(k). The primary goal of a 510(k) is to establish substantial equivalence to a predicate device, not necessarily to set new performance acceptance criteria or conduct extensive clinical effectiveness studies in the same way a PMA (Premarket Approval) would require.
• Focus of the Document: The document explicitly states: "The functionality for the ISIS MER System / Elekta MER System are equivalent to its predicate devices... in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison charts provided in this 510k submission." This indicates a focus on comparing technical specifications and intended use rather than presenting novel performance studies against defined acceptance criteria.
• Information Absent:
  • No table of acceptance criteria or reported device performance for newly established metrics.
  • No mention of a dedicated "study" to prove specific performance targets.
  • No details on sample sizes for test sets or training sets.
  • No information about data provenance, expert panels, adjudication methods, or ground truth establishment.
  • No discussion of MRMC studies or standalone AI algorithm performance, as this device (depth electrode recording system) is not an AI-driven diagnostic tool in the sense of image analysis.

Conclusion:

The provided 510(k) summary does not contain the information required to answer your questions about acceptance criteria and a specific study proving the device meets those criteria. The submission aims to demonstrate substantial equivalence to predicate devices (Axon Guideline System 3000A and Dantec / Medtronic Keypoint / Leadpoint system) based on similar technological characteristics, safety, and effectiveness, rather than establishing new performance benchmarks with detailed study results. The device itself is a depth electrode system for neurosurgery, not an AI-based diagnostic tool, which typically would involve the extensive validation studies you are asking about.

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