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The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• Laser Resection of the Prostrate (LRP)
• Laser Enucleation of the Prostate (LEP)
• Laser Ablation of the Prostate (LAP)
• Transurethral Incision of the Prostate (TUIP)
• Condylomas
• Urethral/ureteral structures
• Lesions of external genitalia
• Bladder neck incisions (BNI)
• Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

• Appendectomy
• Polyps
• Biopsy
• Gall Bladder calculi
• Biliary/Bile duct calculi
• Ulcers
• Gastric ulcers
• Duodenal ulcers
• Non Bleeding Ulcers
• Pancreatitis
• Haemorrhoids
• Cholecystectomy
• Benign and Malignant Neoplasm Gynecology
• Angiodysplasia
• Colorectal cancer
• Telangiectasias
• Telangiectasias of the Osler-Weber-Renu disease
• Vascular Malformation
• Gastritis
• Esophagitis
• Esophageal ulcers
• Varices
• Colitis
• Mallory-Weiss tear
• Gastric Erosions

Gynecology
Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

All variants of the laser family LEONARDO® Duster are laser systems with functions and ergonomics specially developed for medical applications. A touchscreen is used to set treatment parameters, such as Power in Continuous mode, Pulse energy (J) and Frequency (Hz) with Pulse width options in Pulse mode. User-friendly menu navigation and microprocessor-supported control ensure reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The Thulium doped fiber laser module produce a coherent laser radiation with the wavelength of 1940nm±3nm (aiming beam 525nm +/-10nm). An optical fiber delivers this energy to affected surfaces and organs. All fields of application are listed in the indications for use statement.

The subject model LEONARDO® Duster laser has a maximum laser output power of 60W. @ 1940nm The LEONARDO® Duster is available only as a single-wavelength device with 1940nm. All LEONARDO® Duster lasers can be operated in two basic modes, CONTINUOUS or PULSE MODE. Two application modes are available which defines the intended use of the device: Lithotripsy and Other. For safety reasons, the LEONARDO® Duster laser is equipped with a system for automatic recognition of the used optical fibers. Application fibers from CeramOptec are RFID encoded for communicating with the laser device. Reusable fiber probes are available in 6 different sizes. They are initially EO sterilized. Subsequent sterilization is via autoclave. Single patient use fiber probes come in 7 different sizes. They are initially EO sterilized.

This document is a 510(k) clearance letter for the Leonardo Duster laser system. It asserts substantial equivalence to a predicate device based on non-clinical testing. This type of clearance typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials for effectiveness if the indications for use and technological characteristics are sufficiently similar.

Therefore, the provided text does not describe a study involving acceptance criteria related to device performance in a clinical or AI-centric context, nor does it present acceptance criteria for an AI-powered device. It primarily focuses on the safety and effectiveness of a physical medical device (a laser surgical instrument) compared to a predicate device, which is a common pathway for 510(k) clearance.

The "acceptance criteria" presented here are inferred from the regulatory requirements for 510(k) clearance, namely, demonstrating substantial equivalence to a predicate device based on:

1. Identical Indications for Use.
2. Similar technological characteristics without raising new questions of safety or effectiveness.
3. Compliance with relevant performance standards and non-clinical testing (e.g., software validation, reprocessing validation, biocompatibility, sterilization, electrical safety, EMC, usability, laser safety).

Since this is not an AI/ML device or a comparative effectiveness study, many of the requested fields (e.g., sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, training set size) are not applicable.

Here's the breakdown based on the provided text's focus on a physical laser device clearance:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Determination)

Study Details Pertaining to the Leonardo Duster 510(k) Clearance

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

   • N/A. This 510(k) clearance is based on non-clinical (bench) testing and comparison to a predicate device, not a performance study on a test set of data (like for an AI/ML device). The "test set" in this context refers to physical devices and components being tested in a lab setting. These tests were conducted by "accredited testing laboratories," but the location is not specified beyond "Bonn, Nordrhein-Westfalen, Germany" for the manufacturer. No patient data is involved in this type of submission.

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):

   • N/A. No ground truth established by medical experts for a "test set" of patient data was carried out. The "ground truth" for a physical device like this is its adherence to engineering specifications and regulatory performance standards.

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

   • N/A. No adjudication of expert opinions on medical cases was performed as this is not a clinical or AI performance study.

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 study was not done. This is a physical laser surgical instrument, and the clearance is for the device itself, not an AI/ML component assisting human readers.

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

   • No. This is not an algorithm, but a physical medical device. Software validation was performed for the device's firmware, but this does not represent a "standalone algorithm" performance in the context of AI/ML.

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

   • N/A. As this is a physical device, the "ground truth" for its clearance is based on its adherence to engineering specifications, national and international consensus standards for medical devices (e.g., electrical safety, laser safety, biocompatibility, sterilization, usability), and its functional output parameters (e.g., laser power, wavelength, pulse characteristics). There's no clinical "ground truth" like pathology or outcomes data presented for this 510(k) summary, as "Clinical testing was not required to establish substantial equivalence."

7. The sample size for the training set:

   • N/A. No training set was used as this device is a physical laser surgical instrument, not an AI/ML algorithm.

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

   • N/A. No training set was used.

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The Leonardo Mini Blue 445nm Laser is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.

The laser family LEONARDO® Mini Blue is a laser system with functions and ergonomics specially developed for medical applications. A control panel is used to set treatment parameters, such as laser power. User-friendly menu navigation ensures a reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The fiber-coupled semiconductor laser diodes convert electrical energy to coherent laser radiation with the wavelength of 445 nm (aiming beam 635 nm). A beam transporting system delivers this energy to affected surfaces and organs. Depending on the model, the LEONARDO® Mini Blue laser has the following maximum laser output power: LEONARDO® Mini Blue: 10W@445nm. LEONARDO® Mini Blue is available as a single-wavelength device with 445 nm. All LEONARDO® Mini Blue laser can be operated in continuous mode. Additional special treatment modes for specific treatment procedures or in combination with corresponding application fibers are available, depending on the configuration of the unit. For safety reasons, the LEONARDO® Mini Blue laser is equipped with a system for automatic recognition of the optical fibers used. Application fibers from CeramOptec have coding for communicating with the laser device.

This document is a 510(k) Premarket Notification for the Leonardo Mini Blue 445nm Laser. It focuses on demonstrating substantial equivalence to a predicate device (A.R.C. Laser GmbH Device Wolf 445nm K192272) rather than presenting a study of diagnostic accuracy or a specific set of acceptance criteria for an AI/CADe device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/CADe device (specifically, clinical study design elements like sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable to this submission.

This submission is for a surgical laser, and its demonstration of substantial equivalence relies on:

• Comparison of Technical Characteristics: Showing that the Leonardo Mini Blue 445nm Laser has similar design, power, wavelength, and operational modes to the predicate device, with minor differences not affecting safety or effectiveness.
• Compliance with Recognized Standards: Demonstrating the device meets relevant electrical safety, EMC, usability, and laser safety standards (e.g., IEC 60601 series, IEC 60825-1, ISO 14971).
• Bench Testing: Stating that bench testing was performed and indicated the new device is as safe and effective as the predicate.
• Software Validation: The firmware was validated according to the FDA Guidance for software in medical devices.

Summary of what is present in the document related to "acceptance criteria" (non-AI/CADe context):

1. A table of acceptance criteria and the reported device performance:
   The document includes a "Substantial Equivalence Chart" (pages 4-5) which compares the characteristics of the Leonardo Mini Blue 445nm Laser (proposed device) to the A.R.C. Laser GmbH Device Wolf 445nm (predicate device). This serves as the "acceptance criteria" in the context of substantial equivalence for a medical device without an AI component.

   Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Proposed Device)	Compliance / Justification
   Indications for Use	Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.	Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.	SAME
   Display	Touch Screen	Touch Screen	SAME
   Mode	Diode Laser	Diode Laser	SAME
   Laser Power	0.5 W up to 10 W	Up to 10 W	SAME
   Laser Type	Diode Laser	Diode Laser	SAME
   Wavelength	445 nm	445 nm	SAME
   Aiming Beam	532 nm	635 nm	Both predicate and proposed device aiming beams are within the readily visible spectrum. No adverse safety or effectiveness impact.
   Aiming Beam Power	≤ 5 mW	Max. 4 Mw	Comparable. No adverse safety or effectiveness impact.
   Laser Class	4	4	SAME
   Operation Mode	Pulsed, Continuous Wave (CW)	Pulsed, Continuous Wave (CW)	SAME
   Pulse Length/Duration	≤ 4 Watt: 1 ms to 45 sec and CW

4 Watt: 1 ms to 60 ms | 10 Watt: 10 ms to 1 sec and CW. | Useful range for the indications. No adverse safety or effectiveness impact. |
| Pulse Frequency | ≤ 4 Watt: 0.01 Hz to 500 Hz and SP
4 Watt: 0.02 Hz to 6.6 Hz and SP | 10 Watt: 0.5Hz - 50Hz | Useful range for the indications. No adverse safety or effectiveness impact. |
| Cooling | Air | Internal Fan. | No adverse safety or effectiveness impact. |
| Main Power Supply | 100-240 V~, 47-63 Hz, 1.06-0.45 A | Mains operated OR Li-ion rechargeable battery. | No adverse safety or effectiveness impact. |
| Dimensions of System | H 10.06 cm, W 20.3 cm, 23.9 cm | H 6 cm, W 9 cm, L 21.5 cm. | SMALLER. No adverse safety or effectiveness impact. |
| Weight | 2.8 kg (6.17 pounds) | 0.960kg (without batteries) + 2x 0.045kg (battery weight) | LIGHTER WEIGHT. No adverse safety or effectiveness impact. |

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study for diagnostic accuracy on a test set. This is a comparison of technical specifications and compliance with standards.

3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for diagnostic performance is not established as no such study was conducted.

4. Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is not an AI/CADe device requiring such a study to demonstrate improved reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. This is not an AI/ML device trained on a dataset.

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

Instead, the document states:

• "The results of bench testing indicate that the new device is as safe and effective as the predicate device." (Page 5, Section 6)
• "Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Software validation documents were provided for a moderate level of concern." (Page 5, Section 7)
• Compliance with various recognized consensus standards (e.g., IEC 60601-1, IEC 60601-2-22, ISO 14971, IEC 62304) tested by an accredited laboratory (EZU) is cited as evidence of safety and effectiveness. (Pages 5-6, Section 7)
• "Clinical testing was not required to establish substantial equivalence." (Page 6, Section 8)

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The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The X-LEONARDO can be configured as a stand-alone diagnostic post-processing and reporting workstation.

The X-LEONARDO can be configured with a variety of syngo- or Windows -based software options which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques and OEM options

This Premarket Notification covers Siemens X-LEONARDO syngo-based multimodality workplace. syngo is a universal imaging platform based on Windows XP. The X-LEONARDO Workstation offers a comprehensive solution to view, optimize, and post-process diagnostic information and to aid the doctors in the evaluation of digital radiological examinations and patient information.

Due to special customer requirements based on the modality image type and the clinical focus, the X-LEONARDO Workstation can be configured with different combinations of clinical applications. syngo applications can be added to the X-LEONARDO multi-modality workplace either individually or as clinical focus packages.

The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The X-LEONARDO can be configured with a variety of syngo- or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available OEM applications.

The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The submission, K042995 for the Siemens X-LEONARDO Workstation, is a 510(k) Premarket Notification. For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a formal clinical study with performance metrics.

Instead, the submission focuses on:

• Device Description and Intended Use: Defining what the X-LEONARDO Workstation is and what it's used for (viewing, manipulation, communication, and storage of medical images and data).
• Technological Characteristics: Describing its software (syngo-based, Windows XP), DICOM compatibility, and how it's marketed (software-only or complete workstation).
• General Safety and Effectiveness Concerns: Mentioning risk management through risk analysis, software development, verification, and validation testing, and adherence to industry standards to minimize hazards.
• Substantial Equivalence: Explicitly stating that the X-LEONARDO Workstation is substantially equivalent to the LEONARDO Workstation (K040970) because it has the "same intended use and similar technical characteristics."

Therefore, I cannot populate the table or provide the requested study details as this information is not present in the given text. A 510(k) submission for a PACS workstation typically does not include detailed performance acceptance criteria or a comparative effectiveness study in the way an AI diagnostic device might. The "performance" is implicitly tied to its function as a viewing and processing workstation, and its substantial equivalence to a predicate device already on the market.

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The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The LEONARDO syngo Cardiology Workstation can be configured as a stand-alone diagnostic review and post-processing workstation with a variety of syngo or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

This premarket notification covers Siemens LEONARDO syngo Cardiology Workstation syngo is a universal imaging platform based on Windows XP. LEONARDO syngo Cardiology offers a comprehensive cardiology solution to view, optimize, post-process diagnostic information and aid the doctors in the evaluation of digital cardiological and radiological examinations and patient information.

Due to special customer requirements based on the modality image type and the clinical focus, the LEONARDO syngo Cardiology Workstation can be configured with different combinations of clinical applications. syngo applications can be added to the LEONARDO syngo Cardiology Workstation either individually or as clinical focus packages.

The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The LEONARDO syngo Cardiology Workstation can be configured with a variety of syngo- or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

The provided document (K042203 for Siemens LEONARDO syngo Cardiology) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific acceptance criteria for a new device.

Therefore, the information typically found in an acceptance criteria study (like detailed performance metrics, sample sizes for test/training sets, expert qualifications, and specific ground truth methodologies) is largely absent in this type of submission. The primary "study" is the comparison to the predicate device.

Let's address each point based on the available information:

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

Since this is a substantial equivalence submission, there are no explicit quantitative "acceptance criteria" presented in the document itself with corresponding "reported device performance" in the way a de novo or PMA submission would have for a novel device.

The acceptance criteria for a 510(k) is generally that the new device has the same intended use and similar technical characteristics to a legally marketed predicate device, and does not raise new questions of safety and effectiveness.

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

This information is not provided in the 510(k) summary. A 510(k) for a workstation like this typically relies on predicate device equivalence and internal verification/validation, rather than a clinical "test set" in the sense of patient data used for performance comparison.

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 information is not provided in the 510(k) summary.

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

This information is not provided in the 510(k) summary.

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

An MRMC study was not mentioned or performed as part of this 510(k) submission. This device is a workstation for viewing and post-processing, not an AI-powered diagnostic aid that would directly impact human reader performance through assistance.

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

This device is described as a "medical diagnostic workstation" with various "software options" and "commercially available post-processing techniques" intended to "assist the physician." It is not an algorithm performing a standalone diagnostic function without human involvement. Therefore, a standalone algorithm-only performance study as typically understood for AI-based devices was not applicable or performed.

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

The document does not detail specific "ground truth" establishment methods because it's focused on workstation functionality and equivalence rather than a diagnostic algorithm's accuracy against a clinical truth. Any internal verification and validation would be against functional specifications and existing image data, but not typically characterized as "ground truth" in this context.

8. The sample size for the training set

This workstation does not appear to employ machine learning or AI in a way that would require a "training set" in the context of deep learning models. It primarily provides tools for physicians. Therefore, a training set as understood for AI development was not applicable or mentioned.

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

As there's no mention of a training set for machine learning, this information is not applicable.

In summary:

This 510(k) pertains to a medical workstation that provides tools for viewing and post-processing cardiological and radiological examinations. Its clearance is based on substantial equivalence to an existing predicate device (LEONARDO K040970), meaning it has the same intended use and similar technological characteristics without raising new questions of safety and effectiveness. The document does not contain the detailed performance study information typically associated with novel diagnostic algorithms or AI-driven devices that would have specific acceptance criteria, test/training sets, or ground truth methodologies for performance evaluation.

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The LEONARDO is a medical diagnostic workstation for viewing, manipulation, and storage of medical images and data on exchange media. The LEONARDO can be configured as a satellite console, sharing a database with the main console of a CT, MR, or radiographic/fluoroscopic imaging system, as well as stand-alone diagnostic review and post-processing workstation. The LEONARDO can be configured with a variety of syngo- or Windows XP-based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

This premarket notification covers Siemens LEONARDO syngo-based multimodality workplace. syngo is a universal imaging platform based on Windows XP. Leonardo offers a comprehensive solution to view, optimize, post-process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information. Due to special customer requirements based on the modality image type and the clinical focus, the LEONARDO can be configured with different combinations of syngo-based applications, which can be added to the LEONARDO multimodality workplace individually or as clinical focus packages. The LEONARDO is a medical diagnostic workstation for viewing, manipulation, and storage of medical images and data on exchange media. The LEONARDO can be configured as a satellite console, sharing a database with the main console of a CT, MR, or radiographic/fluoroscopic imaging system, as well as stand-alone diagnostic review and post-processing workstation. The LEONARDO can be configured with a variety of syngo- or Windows XP-based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques. The LEONARDO will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete work station for the end-user (hardware and software package). It will be installed by Siemens service engineers. The LEONARDO supports DICOM formatted images and information. The workstation is based on the Windows XP operating system.

This 510(k) submission (K040970) for Siemens LEONARDO, a Picture Archiving and Communications System (PACS), is for a predicate device application. This means the device is being presented as "substantially equivalent" to an already legally marketed device (K010938, also a syngo Multimodality Workstation).

Therefore, this document does not contain specific acceptance criteria or a study demonstrating the device's technical performance against such criteria. Instead, the "proof" of meeting safety and effectiveness is based on its substantial equivalence to the predicate device.

Given this, I cannot provide the requested information in the format because the submission doesn't contain a performance study for the LEONARDO device itself. The key statements are:

• "The LEONARDO Workplace described in this premarket notification has the same intended use and similar technical characteristics as the device listed above."
• "In summary, Siemens is of the opinion that LEONARDO does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device."

To answer some of your points based on this type of submission:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission asserts substantial equivalence rather than reporting performance against specific acceptance criteria for the new device.
2. Sample size used for the test set and the data provenance: Not applicable. No new performance testing is detailed for the LEONARDO.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 device is a PACS workstation, not an AI-powered diagnostic tool.
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.
8. The sample size for the training set: Not applicable. The device is a workstation, not an algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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The BEAR® 1000 Ventilator is fully capable of ventilating the entire spectrum of patients requiring such support-from the Emergency Room to the ICU, from pediatric patients to adults.

The BEAR® 1000 Ventilator employs both microprocessor and microcontroller technology to vield a simple, compact design. This full-featured package has powerful performance capabilities-in terms of output capability, Sensitivity to patient demand and response time. They render the BEAR® 1000 Ventilator fully capable of ventilating the entire spectrum of patients requiring such support-from the Emergency Room to the ICU, from pediatric patients to adults.

The modifications to the Bear 1000 % Ventilator are minor, and primarily affect only the monitoring capabilities of the system, with the exception of the addition of one alarm. There is no impact to the control functions of the ventilator. These modifications are:

The addition of esophageal and tracheal pressure monitoring. All monitoring is the result of pressure data that is obtained through the esophageal and tracheal catheters and communicated to the Graphic Display via the RS-232 communication port.

The addition of one alarm -- Prolonged Esophageal Pressure.

The addition of one membrane key switch for filling the esophageal catheter balloon with air.

The addition of a bi-directional flow sensor at the patient wve using a presently approved and marketed technology to enhance the flow and volume monitoring capabilities. The bidirectional flow sensor measures inspiratory and expiratory flow that is used in calculating and displaying digital data and various waveforms/loops on the Graphic Display. The user has the option of using either the bi-directional flow sensor or the exhaled flow sensor.

The digital data calculated by and displayed on the Graphic Display has been enhanced to include 17 additional respiratory parameters which are categorically displayed on four user selected pages.

The provided text is a 510(k) summary for the BEAR 1000es Ventilator, which describes modifications to an existing device (BEAR 1000 Ventilator) by adding BICORE monitoring technology. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and validation study results in the manner typically seen for novel medical device clearances today.

Therefore, the requested information elements related to formal acceptance criteria, device performance tables, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not explicitly stated or detailed in this 510(k) summary.

Specifically, the document primarily discusses modifications to the device (new monitoring capabilities, an additional alarm, a key switch, and a bi-directional flow sensor), the electronic and pneumatic overview, and a comparison to predicate devices. It states that the modifications are "minor" and "primarily affect only the monitoring capabilities of the system, with the exception of the addition of one alarm."

However, it does describe the "Summary of Performance Testing" as follows:

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

• Acceptance Criteria (Implicit): The software was qualified by performing formal qualification procedures to verify the ventilator's performance "in accordance with the approved Design and Performance Specification." The Graphic Display qualification also involved a "complete verification of all features as specified in the Design and Performance Specification."
• Reported Device Performance: The document states that the software qualification resulted in "software Release 1.03." It also notes that "a FMEA was done for the Flow PCB and concluded that there are no risk associated with any potential failures of components on the PCB." No specific quantitative performance metrics (e.g., accuracy, precision) against defined acceptance ranges are provided in this summary.

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

• Not specified. The document mentions "a test ventilator" for software qualification but does not give a sample size, data provenance, or whether the testing was retrospective or prospective.

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

• Not applicable/Not specified. This type of expert assessment for ground truth is typically relevant for diagnostic imaging or AI algorithms for patient diagnosis, which is not the primary focus of this ventilator's approval. The "ground truth" for a ventilator's performance would likely be its adherence to engineering specifications and physiological parameters.

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

• Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a medical device (ventilator) with added monitoring capabilities, not a diagnostic imaging AI tool that would typically involve human "readers" and MRMC studies.

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

• The "software for the ventilator was qualified by performing formal qualification procedures on a test ventilator" and a "complete formal qualification was performed on the Graphic Display." This constitutes standalone testing of the device's software and hardware functions. However, no specific details on "algorithm only" performance are provided beyond general qualification.

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

• Ground Truth (Implicit): The "approved Design and Performance Specification" serves as the implicit ground truth against which the device's functional performance and new features were verified. For the FMEA, the "absence of risk associated with any potential failures" was the conclusion.

8. The sample size for the training set

• Not applicable. This document describes the qualification and testing of a hardware and software system for a ventilator, not a machine learning model that requires explicit training data. The "training" here would refer to the development and iterative testing of the software during the engineering process.

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

• Not applicable. (See point 8).

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