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The ultrasound system provides imaging information, used to guide the biopsy needle through the accessory to the anatomical site where the sample of physiological material is recovered for further analysis.

The Biopsy accessory attachment and handle, function with the ESAOTE Ultrasound Transducer previously cleared via K953819, connected with the AU4 Ultrasound system cleared via K944485/S3. The biopsy accessories consist of a metal and plastic bracket and needle guides that attach to the ultrasound transducer. The AU4 system software provides for the guidance of the biopsy needle through the biopsy accessory needle guide.

The provided document is a 510(k) summary for the "Biopsy Accessory attachment and handle" by Biosound Esaote, dated April 27, 1997. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.

Based on the content, there is NO information about acceptance criteria or a study proving the device meets specific performance criteria as typically defined for AI/ML-based medical devices. This submission predates the widespread use of such devices and the regulatory framework for them.

The document discusses:

• Device Description: A metal and plastic bracket and needle guides that attach to an ultrasound transducer.
• Intended Use: To guide a biopsy needle to an anatomical site for sample recovery, using imaging information from an ultrasound system.
• Materials and Biocompatibility: Polyurethane resin and stainless steel. Biocompatibility tests (cytotoxicity, sensitisation, irritation) were performed on the polyurethane resin according to ISO 10993.
• Sterilization: Cold sterilization with CIDEX solution.
• Substantial Equivalence Comparison: Compares features like materials, needle guide angle, sterilization method, removability, and compatibility with biopsy needles to predicate devices.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text. The document's purpose is to demonstrate substantial equivalence for a physical medical accessory, not to report on the performance of a software algorithm or AI.

If this were a typical AI/ML medical device submission, the requested information would look like this (but again, it's not present in the provided text):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Size: Not provided.
• Data Provenance: Not provided (not relevant for this type of device submission).

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

• Number of Experts: Not provided.
• Qualifications: Not provided.

4. Adjudication method for the test set

• Adjudication Method: Not provided.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study

• MRMC Study: No, an MRMC study was not conducted or reported. This type of study is typically for evaluating human performance with and without AI assistance for interpretation tasks, which is not applicable to a physical biopsy accessory.
• Effect Size: Not applicable.

6. Standalone (algorithm only) performance study

• Standalone Study: No, a standalone performance study for an algorithm was not conducted or reported. The device is a physical accessory, not a software algorithm.

7. Type of ground truth used

• Ground Truth Type: Not applicable/Not provided. The "ground truth" mentioned in the document relates to biocompatibility testing against ISO 10993 standards and substantial equivalence to predicate devices, not clinical performance for diagnostic accuracy.

8. Sample size for the training set

• Training Set Size: Not applicable/Not provided, as this is not a machine learning device.

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

• Ground Truth Establishment: Not applicable, as this is not a machine learning device.

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The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer.

Generally speaking, AccessPoint is a software product designed to provide the translation of different medical image formats into a form compatible to be displayed on a standard PC. Connection between sites including hospitals, out reach clinics, physician home and office are provided through the use of e-mail. The images and reports (patient studies) may be transported via e-mail in a secure manor (encryption of data) following standards used by the Internet and local LAN (Intranet), transport systems. A description of the various elements follow:
The AccessPoint™ software conforms to DICOM V3 service classes in the role of Service Class Reader.

Please note that the provided text is a "Safety and Effectiveness Summary" for a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as would be found in a full efficacy study. As such, some of the requested information (like specific acceptance criteria values, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC study details, and detailed ground truth methodology for training sets) is not explicitly stated or derivable from the provided document.

However, I can extract the available information and highlight what is missing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define a table of "acceptance criteria" with quantitative targets that the AccessPoint™ device must meet (e.g., a specific accuracy percentage, sensitivity, or specificity). Instead, it describes the device's functional capabilities and compares them to a predicate device to establish substantial equivalence.

The "performance" described is largely functional equivalence and compatibility rather than clinical performance metrics. The table provided in the document is a "Substantial Equivalence Table" comparing features.

Substantial Equivalence Table (from document)

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

• Sample Size for Test Set: Not explicitly mentioned in the document.
• Data Provenance: Not explicitly mentioned. The device is software designed to work with various existing imaging systems (Biosound/Esaote, Hewlett Packard, TomTec, MicroSonics, DICOM US, NM), implying it would be used with data potentially originating from different sources and countries where these systems are used. The document does not specify if a specific dataset (retrospective or prospective) was used for testing.

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

This information is not provided in the document. A "Safety and Effectiveness Summary" for a 510(k) usually focuses on technical equivalence and functional performance rather than clinical ground truth validation with experts.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, there is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study, nor an effect size for human readers improving with or without AI assistance. This type of study is not typically part of a 510(k) submission focused on image viewing and transport software. The device itself is described as "Medical Image Reading and Transport Software," not an AI diagnostic aid for interpretation.

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

• Standalone Performance: The document describes the software's standalone functionalities (e.g., its ability to translate image formats, display images, handle compression). It is inherently a "standalone" software product in that it performs its functions without direct human intervention in the processing of the image data, but its purpose is to present data to a human for interpretation. It is not an AI algorithm that makes diagnostic claims independently. The "performance" assessment is functional and comparative to existing predicate devices based on features.

7. The Type of Ground Truth Used

• Given the nature of the device (image translation and display software) and the context of a 510(k) summary focused on substantial equivalence to a predicate device, clinical "ground truth" (like pathology or outcome data) in the diagnostic sense is not applicable or mentioned. The "ground truth" for this device's performance would be whether it correctly translates and displays the various image formats as intended, and whether its features are comparable to the predicate device. This would likely be assessed through technical verification and validation, not clinical ground truth.

8. The Sample Size for the Training Set

• This information is not provided. The AccessPoint™ device is described as "Medical Image Reading and Transport Software" and is not an AI/ML model that is "trained" on a dataset in the conventional sense of machine learning for diagnostic inference. It is software that adheres to standards and handles various image formats.

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

• As explained in point 8, the concept of a "training set" and "ground truth" for a training set in the context of an AI/ML model does not directly apply to this type of medical image viewing and transport software as described in the document. The software is developed based on programming standards (e.g., DICOM V3, Windows operating systems, internet protocols) and compatibility with existing commercial ultrasound image formats. Its "correctness" is established through engineering and software validation against these specifications, not via a human-labeled training set for diagnostic purposes.

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The ARTOSCAN M is intended for diagnostic nuclear magnetic imaging of the knee, leg, ankle, foot, hand, wrist forearm and elbow. The device produces transverse, sagittal, coronal and oblique cross-sectional images displaying the internal structure of the anatomy being imaged.

ARTOSCAN M is an MRI system designed specifically to image the extremities: leg (thigh excluded), knee, ankle and foot, forearm, elbow, wrist and hand. A number of modifications have been designed to enhance the functioning of the ARTOSCAN system previously cleared under K931022. The modifications will collectively be referred to as the ARTOSCAN M. Once the modifications described herein are cleared, the ARTOSCAN M will be marketed in place of the original ARTOSCAN device. The difference in the name is very subtle and consists of adding an M after the ARTOSCAN name. Existing ARTOSCAN units (original configuration) can be upgraded to the ARTOSCAN M if the user so desires.

The provided text describes a medical device, the ARTOSCAN M, and its modifications from the original ARTOSCAN system. It details the device's features, intended use, and a comparison table with the predicate device (ARTOSCAN). However, it does NOT include specific acceptance criteria or a study proving the device meets said criteria.

The document is a "Safety and Effectiveness Summary" submitted for 510(k) clearance, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance.

Therefore, I cannot provide the requested information from the provided text. The document acts as a comparison between two device versions, highlighting improvements and equivalence, rather than a performance study with defined acceptance criteria and results.

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The Galileo Electroencephalograph with Evoked Potential option is indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system.

ACQ board: Analog input 32 channels, Analog output 32 channels, A/D conversion 12 bit, 10 micro sec/point, 4 converter, Accumulator 32 bit, Processor Motorola MC68000, Resident memory 1 MB, Trigger input TTL. Stimulators: a- General features: Working class I type of equipment B (acoustic and visual) I type of equipment CF (electrical), Safety requirements meets standard IEC 601-1-1 (CEI 62-5), Size 220 mm, 450 mm, 80 mm, Weight approx. 2 Kg, Power supply + 15V (0.7 A) -15V (0.7A) +5V (1A), Power absorption approx. 25 VA, Working conditions +5C/+35C; 30-75%RH, Atm pressure 700/1060 mBar, Storage and conveyance conditions -10/50C; 10-95% RH, Atm pressure 500/1060 mBar, Degree of protection against infiltration of liquids and solids IP20. b- Acoustic stimulator: Transducer Telephonics TDH39, Stimulation modes Tone, Click, Noise, Stimulation rate from 50 ms to 9980 ms (step 10 ms), Tone frequency 250,500,1000,1500,2000,2500,3000,4000,5000,7000 8000 Hz, Stimulus output Right monoaural, Left monoaural, Right monoaural + controlateral noise, Left monoaural + con- trolateral noise, binaural, Acoustic level 0,10,20,30,40,50,60,70,75,80,90 dB SL, Threshold adjustment -4,-2,0, +2, +4, +6 dB, Noise level relative to the stimulus's level -40,-30,-20,-10,0, + 10 dB, Polarity of the stimulus (in Click mode) Condensation, Rarefaction, Alternate, Duration tone mode: from 10 to 150 ms, with 10 ms steps click mode: from 50 to 960 us, 10 us steps. c- Visual stimulator: The stimulator generates two video images (pattern A and B), that are alternatively displayed on screen in response to a trigger command. Generally, each picture is composed of an arbitrary bit map of 512x256 pixels; in detail the current resident software, divides the image in 5 fields: 4 quadrants and a fixation area. Each field can contain one of the following textures: black white spatial frequency horizontal bars 1 spatial frequency horizontal bars 2 spatial frequency vertical bars 1 spatial frequency vertical bars 2 spatial frequency chequer board 1 spatial frequency chequer board 2 and the reverse of all of them. A composite video signal 1 Vpp is transmitted to the monitor with separate positive synchronisms and 8 contrast levels (2,5,10,20,30,50,75,100%) related to the maximum contrast level set on the . The line period is 64 us, the frame frequency 60 Hz. d- Electric stimulator: The electric stimulator is constant current type. Other features are: Amplitude from 0 to 50 mA, with two scales (0-5 and 0-50), Precision +/- 10% full range, Duration limited to 0.5 millisec (see Device Hazard Analysis), Isolation between the applied elements and the ground 1500 V AC (see Device Hazard Analysis), Patient's safety limited energy and stimulation frequency; protection against failure of the current sensor, Light indicators stimulus ON, overload, abnormal functioning.

Here's an analysis of the provided text, outlining the acceptance criteria and the study information as requested.

The provided document is a Safety and Effectiveness Summary for the Galileo Evoked Potential EEG Biosound Esaote. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

This type of submission to a regulatory body (like the FDA for a 510(k)) primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than conducting new performance studies against predefined acceptance criteria. The comparison table (807.92(a)(3)) highlights the technical similarities between the Galileo EP Option and its predicate devices (Esaote Phasis and Nicolet Viking II System).

Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable. This document does not describe a performance study with a test set.
• Data Provenance: Not applicable.

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

• Not applicable. This document does not describe a performance study using expert ground truth.

4. Adjudication method for the test set

• Not applicable. This document does not describe a performance study with a test set 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. This document does not mention an MRMC study. The device is an Evoked Potential Electroencephalograph, which is a diagnostic tool, not an AI-assisted interpretation system for human readers.

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

• Not applicable. This document does not describe a standalone algorithm performance study. The device itself is a standalone medical device.

7. The type of ground truth used

• Not applicable. This document does not describe a performance study that required establishing ground truth. The submission relies on demonstrating substantial equivalence to predicate devices, implying that the established clinical principles and diagnostic interpretations for those predicate devices would apply to this new device.

8. The sample size for the training set

• Not applicable. This document does not describe any machine learning or AI components that would require a training set.

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

• Not applicable. There is no training set described in the document.

In summary: The provided text is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices based on technical specifications and intended use. It does not include information about formal performance studies with acceptance criteria, test sets, or ground truth establishment. Such details would typically be found in more comprehensive testing protocols or clinical study reports, which are not part of this "Safety and Effectiveness Summary."

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The intended use is specific for each transducer: P12A - Vascular PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial

The subject devices are diagnostic ultrasound transducers described in the following tables.

The provided text is a summary for diagnostic ultrasound transducers and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It primarily focuses on:

• Submitter Information: Company details and contact person.
• Device Identification: Trade names, common names, and classification names.
• Predicate Devices: Listing of previously cleared devices considered substantially equivalent.
• Device Description: Technical specifications of the P10A, P12A, PT10A, and PA11-A transducers, including modes, frequencies, physical characteristics, and safety requirements.
• Intended Uses: Specific applications for each transducer (Vascular, Transcranial, Cardiac).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a 510(k) summary, which is typically a high-level overview for regulatory submission, rather than a detailed report of performance studies or acceptance criteria.

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The LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels

The LP13 is a diagnostic ultrasound transducer intended to be used in laparoscopic surgical procedures. The transducer is introduced into the abdomen through a trocar following the procedure described in the operator's manual. The distal tip of the device contains the transducer element and is movable. Movement of the transducer is controlled by the levers located on the handle of the device.

The provided text is a Safety and Effectiveness Summary for an ultrasound transducer, outlining its features and comparing it to a predicate device for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot fulfill the request.

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The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery. The transducer can be used to image abdominal anatomy during abdominal surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels.

The Esaote INT13 intraoperative transducer is designed and intended to be used in open (open as opposed to laparoscopic used with a trocar) abdominal surgical procedures. More specifically, the transducer is intended to be used to image abdominal anatomy during open surgical procedures.

This document describes a 510(k) premarket notification for a new diagnostic ultrasound transducer, the INT13 Intraoperative Transducer by Biosound, Inc. This submission focuses on establishing substantial equivalence to a predicate device, the Hitachi Intraoperative Ultrasound Transducer EUP - 033J (K884644), rather than presenting a study with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria and a study to prove the device meets them cannot be extracted from the provided text because such a study is not described.

The document primarily focuses on:

• Device Description: Specifications, materials, sterilization process.
• Intended Use: Diagnostic ultrasound intraoperative transducer for abdominal surgery, including Doppler mode for blood flow.
• Substantial Equivalence Comparison: A table comparing the INT13 to the predicate device (Hitachi EUP 088 J) based on intended use, technology, frequencies, operating modes, cable length, and safety standard.

In summary, the provided text does not contain information about acceptance criteria or a study demonstrating the device meets performance metrics. The core of this 510(k) submission is to argue for substantial equivalence to an existing device, which is a different regulatory pathway than proving specific performance against predefined acceptance criteria from a new clinical study.

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