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The SIOS product is intended to optimize procedures in the operating room by providing consistent preoperative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities.

The SIOS product is limited to use with the following products:

• (1) Wolf Endocam 3CCD Endocam 5507,
• (2) Wolf Light Source Auto-CP 5131,
• (3) Wolf Insufflator Laparo CO2 Pacu 2332, and
• (4) Maquet OR Table ALPHAMAQUET 1150.

The Siemens Integrated Operating System (SIOS) is a system capable of networking select medical and non-medical equipment in the operating room (OR) and allowing trained medical personnel direct control of the equipment using remote control (i.e. voice command, touch screen console). The device combines a number of individual functional units through a standard interface to a centralized computer control station.

The provided text is a 510(k) summary for the Siemens Integrated Operating System (SIOS), which is an older document (dated December 15, 1999, with a corrected letter on July 27, 2015). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with acceptance criteria as would be expected for a novel AI/ML-driven device today.

Therefore, the document does not contain the detailed information required to populate a table of acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment methods, or information about expert adjudication, MRMC studies, or standalone performance. The SIOS is described as a system for controlling existing medical and non-medical equipment in an operating room and networking capabilities, not a diagnostic or AI-driven interpretative device that would typically undergo such performance evaluations.

Here’s a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) for the SIOS. Its purpose is to control other devices and handle data.

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

• Cannot be provided. The document does not describe any specific test set or data used for performance evaluation in the context of a clinical study or diagnostic accuracy assessment. The submission focuses on the functionality and safety of the control system 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)

• Cannot be provided. Since no specific test set requiring expert ground truth is mentioned, this information is not available.

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

• Cannot be provided. This information is not relevant or present in the document given the nature of the device and the 510(k) submission type.

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

• Cannot be provided. An MRMC study is not mentioned. The SIOS is an integrated operating system for control and data handling, not a device that assists human readers in interpreting medical images or data.

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

• Cannot be provided. The SIOS is a system for controlling other devices; it doesn't have an "algorithm-only" performance that would be evaluated in this context. Its function is to facilitate human operators' control of other equipment.

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

• Cannot be provided. No ground truth is established as the device is not making diagnostic or interpretative claims.

8. The sample size for the training set

• Cannot be provided. Training sets are typically associated with machine learning or AI models, which are not described for the SIOS in this document.

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

• Cannot be provided. As no training set is mentioned, this is not applicable.

Summary from the provided document:

The Siemens Integrated Operating System (SIOS) is a control and networking system for operating rooms. The 510(k) submission (K994231) demonstrates its substantial equivalence to predicate devices (HERMES™ Operating Room Control Center and Accessories by Computer Motion, and EndoALPHA™ Integrated Endosurgery System by Olympus). The "study" referenced in this context is the general comparison to these predicate devices, focusing on the technological characteristics and intended use rather than
quantitative performance metrics of a diagnostic or AI algorithm. The core functionality and safety were deemed equivalent by the FDA based on the comparison of features and intended use.

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The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

The endoscopic applications with TPS include use of the SES Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The endoscopic applications with TPS include use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

The provided text describes the Stryker HERMES-Ready™ Total Performance System, but it does not contain a study that proves the device meets specific acceptance criteria related to its performance characteristics.

Instead, the document primarily focuses on:

• Premarket Notification (510(k)) Summary: This outlines the device's intended use, its substantial equivalence to previously cleared devices, and general information required for FDA submission.
• Regulatory Classification: It details the device's classification and the regulatory controls it falls under.
• Voluntary Standards: It lists the voluntary standards (e.g., IEC 601-1, UL 2601-1) that the device will be designed and tested to. This indicates the intent to meet certain safety and performance benchmarks, but not the results of such testing or specific acceptance criteria.
• Indications for Use: This section describes the medical procedures and applications for which the device is intended.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document confirms the device's regulatory clearance based on substantial equivalence, but it does not elaborate on specific performance testing results or a study proving its acceptance criteria have been met.

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intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic vísualization

The Surgiflator-20 ECU described in this notification is a modified version of and substantially equivalent to the Surgiflator 20-PIM (K955791) which is manufactured by W.O.M. GmbH. The Surgiflator-20 ECU incorporates the same design features as the Surgiflator-20 PIM. The only difference is that the function adjustment feature of the Surgiflator-20 ECU has been modified. The modification consists of a serial interface to allow for surgeon selection of device settings utilizing the HERMES Operating Room Control Center (K980787).

The provided text is a 510(k) summary for the SURGIFLATOR-20 ECU, a laparoscopic insufflator. This document focuses on demonstrating substantial equivalence to a predicate device (Surgiflator 20-PIM) and does not contain the kind of detailed study data, acceptance criteria, or performance metrics typically found in clinical trial reports or academic papers for devices that rely on complex algorithms or diagnostic capabilities.

Instead, the submission leverages existing literature and the substantial equivalence pathway for a modified version of an already cleared device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available within this document.

Here's how the provided information relates to your request:

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

   • Not available. The document states the device "incorporates the same design features" as the predicate and the "only difference" is a modification to a function adjustment feature (serial interface for surgeon selection of device settings via the HERMES Operating Room Control Center). This suggests that the acceptance criteria for performance would implicitly be the same as the predicate, but these are not explicitly stated or quantified in this 510(k) summary. No specific performance data for the modified device is reported.

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

   • Not available. There is no mention of a dedicated test set or clinical study for the SURGIFLATOR-20 ECU in this document. The submission relies on existing literature and the equivalence to a previously cleared device.

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 available. No ground truth establishment is described as there's no test set or clinical study.

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

   • Not available. No test set or related adjudication process is described.

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

   • Not applicable. This device is a laparoscopic insufflator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

   • Not applicable. This is a hardware device; no standalone algorithm performance is relevant or described.

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

   • Not available. No ground truth is described. The safety and effectiveness are supported by referencing existing literature on laparoscopic techniques and the substantial equivalence to a predicate device.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a training set.

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

   • Not applicable. This device does not involve machine learning or a training set.

Summary of Device Rationale provided in the document:

The argument for safety and effectiveness is based on:

• Substantial Equivalence: The SURGIFLATOR-20 ECU is a modified version of the SURGIFLATOR 20-PIM (K955791), with the only difference being a modified function adjustment feature (serial interface to allow surgeon selection of device settings utilizing the HERMES Operating Room Control Center).
• Existing Literature: The submission references several books detailing the utility and safety of laparoscopic techniques and the use of high-flow insufflators. This literature serves as general background and support for the established safety and efficacy of the procedure and device type, rather than presenting specific study data for the new device. The provided references are:
  • "Operative Laparoscopy" by M.-A. Bruhat, 1992.
  • "Laparoscopy in gynecology, surgery and pediatrics" by H. Frongenheim, 1977.
  • "Minimal Invasive Surgery" by John G. Hunter and Jonathan M. Sackier, 1993.

In conclusion, this 510(k) summary uses the substantial equivalence pathway and reliance on established medical literature for the device type, rather than presenting a de novo study with specific acceptance criteria, performance metrics, or ground truth data for the modified device itself.

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