Search Results

The Extracorporeal Shock Wave Lithotripter, model: U200, is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Extracorporeal Shock Wave Lithotripter, U200, is intended to treat urinary tract stones using ESWL. The Extracorporeal Shock Wave Lithotripter generates high-energy shock waves using a shock wave generator that is focused to produce a highly concentrated stress area at the focal point. These pressure pulses are focused on a specific point in the body where the Urinary calculi are located using assisted movement and manual localization through B-ultrasound. The pressure generated by the shock wave causes the human urinary tract stones to produce physical effects to achieve the therapeutic purpose of crushing stones.

The Extracorporeal Shock Wave Lithotripter, U200, is composed of main unit, control console, patient table, electrical cabinet, power supply unit, and computer.

Control platform is integrated control of electric cabinet, main engine and treatment bed.

Electrical cabinet is used to provide power control of the whole machine, and shock wave source function control.

Main Unit contains the L-shape arm and the support matrix of the impact wave source, and realize the movement of L-shape arm up and down, rotation and oscillation of the impact wave source inside and outside.

Power box is power supply of the whole machine, power supply input voltage 120 V, 60 Hz, 3000VA.

Treatment bed is used for patient support and treatment position, and provides three-dimensional movement to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling.

Principle of operation:

The extracorporeal shock wave lithotripter generates pressure pulses using an electromagnetic shock wave generator, with water serving as the transmission medium. These high energy shock waves with peak acoustic pressure up to 35MPa are focused on a specific point using a lens. In addition, the lithotripter often incorporates an ultrasound-based assisted movement system which locates and aligns the shock wave focus with the urinary tract stone. The shock waves create a stress effect on the stone. After several hundred to around two thousand discharges, the stones are fragmented into smaller pieces which can be excreted from the body.

This document is a 510(k) clearance letter for an Extracorporeal Shock Wave Lithotripter (U200). It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the clinical study's primary effectiveness endpoint. Instead, the clinical study aims to demonstrate that the device has a "safety and effectiveness profile that is similar to the predicate device." The reported device performance is presented as successful outcomes in various subgroups. The key performance metrics are "effective rate" for stone fragmentation.

• FAS (Full Analysis Set): 79.2%
• PPS (Per-Protocol Set): 86.4% |
  | Localization Accuracy: Auxiliary positioning target error, number of auxiliary positioning operations, and total time of auxiliary positioning operations should demonstrate relative speed, accuracy, and convenience. | Localization Performance:
• Auxiliary positioning target error: within 3mm
• Number of auxiliary positioning operations: within 3 times
• Total time of auxiliary positioning operations: within 15min
  (Stated as "relatively fast, accurate, and convenient, and the system ergonomics performance is good.") |
  | Safety: Device should be safe with no device malfunctions reported in the clinical investigations. | Safety: "The incidence of device malfunction does not happen in these clinical investigations." "patients treated by the Extracorporeal Shock Wave Lithotripter (model: U200) are safe." |
  | Subgroup Effectiveness (Inferred, as results are presented): Demonstrate effectiveness across different stone sizes, locations, and densities. | Stone Size:
• Stones 5-10mm (FAS): 92.9% effective rate
• Stones 10-15mm (FAS): 60.0% effective rate
• Stones 5-10mm (PPS): 100% effective rate
• Stones 10-15mm (PPS): 66.7% effective rate |
  | | Stone Location:
• Kidney stones (FAS): 80.0% effective rate (Renal calyx: 75.0%, Renal pelvis: 100%)
• Ureteral stones (FAS): 78.6% effective rate (Upper ureteral: 70.0%, Middle ureteral: 100%, Lower ureteral: 100%)
• Kidney stones (PPS): 80.0% effective rate (Renal calyx: 75.0%, Renal pelvis: 100%)
• Ureteral stones (PPS): 91.7% effective rate (Upper ureteral: 87.5%, Middle ureteral: 100%, Lower ureteral: 100%) |
  | | Stone Density:
• Density 1000HU (FAS): 81.8% effective rate
• Density 1000HU (PPS): 81.8% effective rate |

Study Details from the Provided Text:

1. Sample Size Used for the Test Set and Data Provenance:

   • Clinical Test Set Sample Size: 25 subjects enrolled, 22 subjects completed the study. (4 subjects failed screening, 3 dropped out). The study used both a Full Analysis Set (FAS) and a Per-Protocol Set (PPS) for effectiveness calculation, implying some missing data handled by intent-to-treat (FAS) and per-protocol (PPS).
   • Data Provenance: The clinical investigation was a "multicenter, open-label clinical design." The specific countries of origin for the clinical data are not mentioned, but the manufacturer and correspondent are based in China. The retrospective or prospective nature is not explicitly stated, but "clinical investigations" with "subjects screened," "enrolled," and "followed for a period of follow-up" strongly suggest a prospective study design.

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

   • The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for stone fragmentation. The primary effectiveness endpoint, "effective rate," is defined based on the outcome of the ESWL treatment, likely assessed clinically (e.g., successful fragmentation and clearance/passage of stones). This assessment would typically be done by treating physicians (urologists) or through imaging (e.g., ultrasound, X-ray) reviewed by radiologists, but the document does not specify.

3. Adjudication Method for the Test Set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for assessing the "effective rate" or other clinical outcomes. It suggests that the clinical outcomes were observed and reported as part of the study.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

   • No. This device is an Extracorporeal Shock Wave Lithotripter, which is a physical medical device for breaking up stones, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

   • Not applicable in the AI sense. The device's primary function is a physical therapy. However, the document does mention "PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling." It also states "Software Verification and Validation was performed, and it was demonstrated that the software performs as intended." This implies a standalone software performance assessment, but not a standalone diagnostic algorithm performance assessment. The device's "localization/stone targeting system" appears to be an integral part of its operation, not a separate diagnostic algorithm.

6. The Type of Ground Truth Used:

   • For the clinical effectiveness endpoint ("effective rate"), the ground truth is based on clinical outcomes (successful stone fragmentation and presumed clearance) observed in patients after receiving ESWL treatment. This would typically be assessed by follow-up imaging and clinical evaluation.
   • For Localization Accuracy, the ground truth was likely established by physical measurements comparing the "target location" to the "shock wave focus."

7. The Sample Size for the Training Set:

   • The document does not mention a separate training set or its sample size for the clinical study. This is a medical device clearance, not an AI model development project where explicit training sets are typically discussed. If any software component used machine learning, details of its training would be relevant, but those are not provided. The clinical study described appears to be a validation/test set for the entire system's clinical performance.

8. How the Ground Truth for the Training Set Was Established:

   • Since no explicit training set for a machine learning model is mentioned, the method for establishing ground truth for a training set is not applicable based on the provided text.

Ask a specific question about this device

The Delta III Pro Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Pro Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.
The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table: .
• Control Desk/Image Storage (UIMS). .
  The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.
  The therapy and X-ray C-arm house the shock wave source ("EMSE") and the complete X- ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, a flat panel image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.
  The Delta III Pro's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.
  The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-rav control and image handling.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, accuracy against a ground truth).

Instead, the document is a 510(k) submission for a Delta III Pro Lithotripter, which is a medical device for fragmenting urinary tract stones. The submission focuses on demonstrating substantial equivalence to a predicate device (Dornier Delta III Lithotripter, K201074) based on minor modifications.

The "Performance Data" section describes compliance with electrical safety, electromagnetic compatibility, radiation protection, safety of lithotripsy equipment, safety and performance of x-ray equipment, and usability engineering standards (IEC standards), as well as software verification and validation. These are engineering and regulatory compliance criteria, not performance metrics like sensitivity or specificity for a diagnostic AI.

Here's a breakdown of why the requested information for acceptance criteria and related study details cannot be found in the provided text:

• This is not an AI/ML device in the context of diagnostic performance: The device is a lithotripter, which physically breaks down stones. Its performance is measured by its safety, efficacy in stone fragmentation, and compliance with various engineering standards, not by diagnostic accuracy.
• The "Performance Data" section refers to regulatory compliance and non-clinical testing: "Non-clinical functional testing successfully passed and met all design requirements" and compliance with IEC standards are mentioned. This refers to engineering verification and validation, not a clinical study comparing its diagnostic performance against a ground truth with human experts.
• No mention of human readers, AI assistance, or diagnostic metrics: The text does not discuss human interpretation of images/data, AI algorithms for analysis, or metrics like accuracy, sensitivity, specificity, AUC, etc.

Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I cannot create the table or answer the questions the way they are designed for an AI/ML diagnostic device.

However, I can extract the information that is present regarding "performance" in the context of this device and its submission:

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

The document does not explicitly state "acceptance criteria" for diagnostic performance, but it lists standards with which the device complies. The "reported device performance" is primarily stated as successful compliance with these standards and established design requirements.

2. Sample size used for the test set and the data provenance
This information is not provided because it's a non-clinical, engineering verification for a physical device, not an AI/ML diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" in the diagnostic sense is established for this type of device.

4. Adjudication method for the test set
Not applicable.

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-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the diagnostic sense. The "ground truth" for this device would be established engineering specifications, safety standards, and performance benchmarks for stone fragmentation, which are not detailed in this summary.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in that context.

9. How the ground truth for the training set was established
Not applicable.

Ask a specific question about this device

The Lite-Med LM-9300 Plus Lithotripter is indicated for fragmentation of kidney stones and renal pelvic stones and for upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL).

The Lite-Med LM-9300 Plus is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9300 Plus system consists of a shockwave generator, an operator interface (industrial PC with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, two more optional subsystems are necessary. The first is a C-arm X-ray fluoroscopy device and the second is an ultrasound imaging unit. Normally one of the imaging devices is sufficient. For most advanced ESWL designs such as LM-9300 Plus both X-ray and ultrasound are used for patient positioning and monitoring purposes.

Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.

The provided text describes a medical device, the Lite-Med LM-9300 Plus Lithotripter, and its clearance by the FDA based on substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance metrics, or any study involving AI or human readers.

The document specifically states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices." This indicates that no clinical performance study, multi-reader multi-case study, or standalone algorithm performance assessment was conducted or submitted for this device in the context of its 510(k) clearance. The clearance is based on the device's technical characteristics being similar to a previously cleared predicate device and compliance with relevant safety standards.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and technical equivalence, not clinical performance data or AI model evaluation.

Ask a specific question about this device

The STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2 is indicated for the use in the noninvasive fragmentation of calculi in the kidney, in upper, middle and lower ureter for all adults and children 3 years or over.

The MODULITH® Lithotripter SLX-F2 is an Extracorporeal Shock Wave Lithotripter Device. It generates shock waves that are focused onto the urinary calculi so that the stone fragments can be passed with the patient's urine.

The provided text is a 510(k) summary for the KARL STORZ Endoscopy-America, Inc. Modulith SLX-F2, an Extracorporeal Shock Wave Lithotripter. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria for an AI/algorithm-driven device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for AI, or multi-reader multi-case (MRMC) studies.

The provided text only discusses the following in relation to performance data:

• Non-Clinical Performance Data: "The MODULITH SLX-F2 follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, IEC 61849), Software Verification and Validation Testing (Guidance for the Content of Premarket Submissions for Software Contained in Medical Device Level of concern: Moderate). Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the MODULITH SLX-F2 has met all its design specification and is substantially equivalent to its predicate device."
• Clinical Performance Data: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. However, literature reviews on the effectiveness of the subject device or equivalent devices on pediatric population and an analysis of stone composition in patient between 1 to 18 years old to support the applicability of OUS data to US population was provided to establish substantial equivalence for use in pediatric populations."

In summary, the document does not provide the 9 specific pieces of information requested because it's a 510(k) summary for a physical medical device (lithotripter), not an AI/algorithm-driven device requiring performance metrics like sensitivity, specificity, or MRMC studies.

Ask a specific question about this device

The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk/Image Storage (UIMS).

This document is a 510(k) summary for the Delta III Lithotripter, detailing minor changes to an existing device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a human-in-the-loop performance evaluation. The information provided primarily consists of engineering and software validation.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria for clinical performance in the way one might expect for a new diagnostic or AI device. Instead, the "acceptance criteria" are implied by compliance with standards and functional validation tests, with the reported performance being "does not impact the performance" and "equal to or better than the predicate."

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

The document describes bench testing and standards compliance, not a clinical test set with patient data. Therefore, there is no mention of a "sample size for the test set" in the context of patient data, nor its provenance (country of origin, retrospective/prospective). The tests mentioned are engineering and software validation tests.

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

This type of information is not applicable to the submission described. The described tests are about technical performance, safety, and functionality, not about expert interpretation of medical images or patient outcomes. Ground truth in this context would refer to engineering specifications or validated functional requirements.

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

This is not applicable as the submission describes engineering and software validation, not a clinical study requiring adjudication of diagnoses or findings.

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 or is mentioned. The submission is for minor changes to an existing lithotripter, focusing on hardware component replacements and software updates, not AI integration for improved human reading.

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

This is not applicable. The device (Delta III Lithotripter) is a medical device for shock wave lithotripsy. While it includes image processing software (UIMS with AGFA MUSICA), the evaluation described is for the functional performance of these components within the overall system, not a standalone algorithm being evaluated for diagnostic accuracy without human involvement. The AGFA MUSICA software enhances X-Ray image processing, but it's part of the lithotripter system for visual guidance during procedures, not a diagnostic AI algorithm.

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

For the described tests, the "ground truth" would be established by:

• Engineering specifications and regulatory standards: For electrical safety, EMC, radiation protection, and usability.
• Predicate device performance: For the ultrasound image quality and camera image quality, the ground truth for comparison is the performance of the components being replaced.
• Functional requirements: For the UIMS software validation, the ground truth is that the software should perform its intended function (e.g., image processing, PACS connection) without negatively impacting other equipment functions.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific validation tests.

8. The sample size for the training set

Not applicable. This submission does not involve a machine learning or AI model that requires a training set in the conventional sense. The UIMS software update involves incorporating the AGFA MUSICA package, which is likely a pre-existing, validated image processing software, not a custom-trained model for this specific application.

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

Not applicable, as there is no mention of a training set.

Ask a specific question about this device

The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.

The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table;
• . Control Desk - Image Processing.

The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.

The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete Xray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.

The Delta III's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.

This document describes a 510(k) submission for the Delta III Lithotripter, which is a modification to a previously cleared device. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies to establish absolute performance against defined acceptance criteria for a novel device.

Therefore, the typical structure for reporting acceptance criteria and study details for a new device's performance may not be fully applicable here. However, I can extract the information provided regarding the changes and how their safety and effectiveness were addressed.

Here's an analysis based on the provided text, addressing the points you requested where relevant:

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

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., stone free rate, re-treatment rate) for the modified device, as this is a modification to a predicate device. The primary performance demonstration is focused on showing that the changes do not negatively impact safety or effectiveness.

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

The document describes tests for compliance with electrical, EMC, radiation, and usability standards, as well as software and hardware verification. These are typically engineering and bench tests, not clinical studies with human subjects in the traditional sense. Therefore, the concept of "sample size used for the test set" for patient data, country of origin, or retrospective/prospective does not apply to the provided performance data. The tests performed are on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The performance data provided is based on compliance with international standards and internal engineering verification, not on expert adjudication of clinical outcomes or images.

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

This section is not applicable, as the tests are for engineering compliance and verification, not for clinical outcomes 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

This section is not applicable. The device is a lithotripter, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.

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

This section is not applicable. The device is a physical medical device (lithotripter), not an algorithm.

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

For the verification tests mentioned (e.g., electrical safety, software functionality), the "ground truth" is defined by the requirements of the applicable international standards (e.g., IEC 60601 series) and the design specifications of the device. For example, for electrical safety, the ground truth is compliance with the specified voltage limits or isolation requirements in the standard. For software, it's meeting the intended function and not introducing errors.

8. The sample size for the training set

This section is not applicable. The document describes a physical medical device and its modifications, not a machine learning or AI model that requires a training set.

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

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III Lithotripter is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk Image Processing.

The provided document is a 510(k) summary for the Dornier Delta III Lithotripter, detailing its substantial equivalence to predicate devices. It mentions a retrospective confirmatory clinical study, but it does not provide specific acceptance criteria or the study's detailed results in a format that allows for a table of acceptance criteria vs. device performance.

Here's an analysis of the information available and what is not present in the document, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "A retrospective confirmatory clinical study was performed using the Delta III Lithotripter. As compared to the currently cleared Dornier Lithotripters, the overall treatment results were comparable for the subject device. The complication rate was extremely low."

However, specific numerical acceptance criteria (e.g., stone-free rate, fragmentation rate, complication rate thresholds) and precise reported device performance metrics against those criteria are not provided in this 510(k) summary. The summary only gives a qualitative statement of comparability and low complication rates.

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

The document does not specify the sample size for the retrospective confirmatory clinical study. It is stated to be a "retrospective confirmatory clinical study." The country of origin of the data is not specified.

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

This information is not provided in the document. The type of ground truth used (e.g., imaging, clinical outcomes) is also not detailed for the clinical study.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The clinical study described is a "retrospective confirmatory clinical study" to compare overall treatment results and complication rates, not specifically to evaluate human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device is an extracorporeal shock wave lithotripter, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable and not mentioned. The performance data section refers to compliance with standards for acoustic output, electrical safety, and electromagnetic compatibility for the hardware device itself.

7. Type of Ground Truth Used

For the retrospective clinical study, the document broadly refers to "overall treatment results" and "complication rate." It does not explicitly state the method by which ground truth for treatment success or stone fragmentation was established (e.g., follow-up imaging, clinical assessment, pathology).

8. Sample Size for the Training Set

The Delta III Lithotripter is a hardware device for lithotripsy, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, this concept is not applicable and not provided. The device development involved design and verification testing, and compliance with standards.

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

As above, the concept of a "training set" for an AI algorithm is not applicable to this device.

Ask a specific question about this device

The Gemini XXP-HP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Gemini XXP-HP is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology. The Gemini XXP-HP is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm for Shockwave Treatment, Patient Table, Control Desk User Interface. The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-arm. The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete X-ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones. The Gemini XXP-HP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling. The Gemini XXP-HP also includes a camera to view in real time the integrity of the patient to bellows coupling interface.

The provided text describes the 510(k) summary for the Dornier Gemini XXP-HP lithotripter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a new device type, especially one leveraging AI. Therefore, much of the requested information cannot be directly extracted as it pertains to a different type of device assessment (e.g., AI/ML device performance).

However, I can extract information related to the device's performance based on the clinical study mentioned, even if it's not framed as "acceptance criteria."

Here's the breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal acceptance criteria in a quantitative table format that would typically be seen for a new AI/ML device being evaluated for specific metrics (e.g., sensitivity, specificity, accuracy). Instead, the clinical study aimed to confirm usability, safety, and effectiveness of the modified lithotripter.

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

• Sample Size: Not explicitly stated in the provided text. The phrase "a confirmatory clinical study was performed" implies a patient cohort was involved, but the number of patients is not given.
• Data Provenance: Not explicitly stated. Clinical studies for such devices are typically multi-site and can involve different countries, but this information is absent. It's likely prospective since it's a "confirmatory clinical study."

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

This information is not applicable as the study described is a clinical study on a medical device, not a study evaluating an AI algorithm where ground truth for imaging or diagnostic tasks would be established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typical for expert review of AI outputs, not for the direct outcome of a lithotripsy procedure.

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

• Was it done? No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which doesn't apply to a lithotripter device that directly performs a physical intervention.
• Effect size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Was it done? No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context refers to the clinical outcomes and safety observations from the patients treated with the device. This would typically include:

• Stone fragmentation (assessed via follow-up imaging)
• Stone-free status
• Adverse events (e.g., hematoma, pain, other complications)

This is effectively a form of outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. This device is a physical medical device. It does not involve an AI algorithm with a training set.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Lite-Med LM-9300 ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL).

The Lite-Med LM-9000 ELMA is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9300 ELMA system consists of a shockwave generator, an operator interface (industrial computer with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, one or two more subsystems are necessary. The first is a C-arm X-ray fluoroscopy device and the second is an ultrasound imaging unit. Normally one of the imaging devices is sufficient. For most advanced ESWL designs such as LM-9300 ELMA both X-ray and ultrasound are used for patient positioning and monitoring purposes.

Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the LM-9300 ELMA Lithotripter:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format for a diagnostic device. Instead, it describes performance based on the clinical outcome of stone fragmentation. The key performance indicator is the "stone-free ratio."

Ask a specific question about this device

CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

ESWL, model CS-2012A-3, is an mobile electromagnetic lithotripter with a focal zone to treat patients, the shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an spherical concave electromagnetic coil, a membrane and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient.

It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shockwave is then focused to the focal point. The stones to be fragmented are positioned at this focal point by moving the motorized patient table in 3 axis. The localization is performed with a separate and commercially available mobile fluoroscopic x-ray unit and/or US equipment.

The device includes following parts:

1. ESWL device
   The ESWL device contains therapy head, main switch, control panel, target indicator and foot pedal. It also provides patient with treatment, controls functions of CS-2012A-3.
2. Therapy table
   Therapy table consists of table (For personal hygiene, the table should be covered by disposable medical nonwoven fabrics in treatment), table supporter and 3-dimension movement.

Patient is positioned on therapy table. Table cutout area allows positioning of therapy table near patient, table can be moved as required. Table motion is completely independent of ESWL device. It has its own 3 dimension movement, not to link CS-2012A-3.

The provided document describes the acceptance criteria and study data for the Extracorporeal Shock Wave Lithotripter, model CS-2012A-3.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are implicitly demonstrated through its compliance with various standards and the outcome of the clinical study, particularly the success rate. The specific "acceptance criteria" for the clinical study's success rate are not explicitly stated as a numerical threshold in isolation but are presented as the achieved performance which is deemed satisfactory for substantial equivalence.

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

• Sample Size (Clinical Test Set): 144 patients (105 male, 39 female).
• Data Provenance: The document states that "clinical investigations were performed at 2 sites." The country of origin is not explicitly stated for these clinical sites, but the manufacturer is Suzhou Xixin Medical Instruments Co., Ltd. from China, suggesting the studies likely took place in China. The studies were prospective in nature, described as "clinical investigations were performed... to support this application."

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

The document does not specify the "number of experts" or their "qualifications" involved in establishing the ground truth for the clinical test set. It mentions that the device is "intended for use by attending physician" and that "experiences of physicians have shown that patients treated by the CS-2012A-3 are safe and having high evaluations". This suggests that the clinical outcomes (e.g., stone fragmentation, removal) assessed by the attending physicians served as the ground truth, but the details of their roles in data adjudication are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "overall success rate" was measured, implying a clinical assessment of treatment efficacy by the medical professionals involved in the study.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The clinical study focused on the performance of the CS-2012A-3 device itself, not on comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

This device is an Extracorporeal Shock Wave Lithotripter, a physical medical device, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed.

7. Type of Ground Truth Used (Clinical Test Set)

The ground truth for the clinical test set was based on clinical outcomes. Specifically, the "overall success rate" of the treatment was measured, with success presumably defined by the fragmentation and/or removal of kidney and ureteral calculi. The document mentions "patients with stones were treated" and the evaluation of the "device function."

8. Sample Size for the Training Set

The document does not refer to a "training set" as this device is a physical medical instrument, not a machine learning or AI model that requires a data training set. The development and validation of the device would have involved engineering tests and potentially pre-clinical studies, but not a data training set in the context of AI.

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

As there is no "training set" in the context of an AI/machine learning device, the concept of establishing ground truth for a training set is not applicable to this device.

Ask a specific question about this device