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The iStent infinite® Trabecular Micro-Bypass System Model iS3 an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.

The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The G2-W stents are manufactured from implant grade titanium (Ti6Al4V ELI per ASTM F136) and are coated with stearalkonium heparin. An area of reduced outside diameter, midway along the device, is designed to provide retention within the trabecular meshwork, while multiple outlet lateral lumens (4 outflow orifices) are designed to provide an exit route for aqueous from the anterior chamber. The stent has a single piece design, is 360 um in diameter, 360 um in height, and the central inlet and outlet lumen has a diameter of 80 um. The head of the stent has four side outlets that each have a diameter of 50 um.

Here's a breakdown of the acceptance criteria and study information for the iStent infinite Trabecular Micro-Bypass System, as presented in the provided FDA 510(k) summary, structured to answer your questions:

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

Please note that for the clinical effectiveness endpoints, explicit "acceptance criteria" are not stated as pass/fail thresholds in the provided text. Instead, the study reports the observed performance, and the FDA determined this performance supports substantial equivalence. For bench testing, direct pass/fail results against implicit or explicit criteria are mentioned.

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The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.

The da Vinci X/Xi (IS4200/IS4000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.

The provided document is a 510(k) premarket notification for da Vinci surgical instruments, focusing on the changes to their reprocessing instructions to include an optional automated cleaning and disinfection process. It doesn't contain a detailed study proving the device's clinical performance, but rather validation of its reprocessing efficacy. The focus is on ensuring the instruments remain safe and effective after being cleaned and disinfected by an automated washer-disinfector, similar to their prior manual cleaning method.

Here's an analysis of the acceptance criteria and the studies that address them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of instruments, number of cycles) for the Cleaning Validation, Thermal Disinfection Validation, or Reliability/Life Testing.

• Cleaning Validation: "all markers" implies multiple types of soil/contaminants were tested.
• Thermal Disinfection Validation: "the subject devices" implies a representative set of instruments.
• Reliability/Life Testing: "the subject devices within the scope of this submission" implies a representative set of instruments was tested through multiple reprocessing cycles.
• Human Factors Testing: "representative end users" were used for validation testing.

Data Provenance: The studies were conducted by Intuitive Surgical, Inc. as part of their 510(k) submission to the FDA. The nature of these tests (validation of reprocessing) implies they were prospective studies performed specifically to support this regulatory submission. There is no information about the country of origin of the data, but given it's an FDA submission, the tests would conform to U.S. regulatory standards.

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

The document does not explicitly state the number or qualifications of experts used to establish the "ground truth" for the test sets in the cleaning, disinfection, or reliability studies. These types of validation studies typically rely on established standards (e.g., AAMI, FDA guidance) for acceptance criteria rather than subjective expert consensus on "ground truth."

For Human Factors Testing:

• Experts involved: "Human Factors Engineers" participated in the design meetings.
• Ground Truth: For human factors, the "ground truth" is typically defined by the safe and effective execution of the reprocessing tasks by representative users, with risk analysis identifying potential use errors. The document states a "Usability Risk Analysis (URA)" was conducted and "validation test of representative Reprocessing Instructions was completed with representative end users," assessing "usability, effectiveness, and use safety." It does not specify how many experts defined the URA or evaluated the validation test outcomes.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for the test results. For cleaning, disinfection, and reliability tests, performance is usually objectively measured against predefined quantitative limits set by standards. For Human Factors, the validation testing would likely involve observation of user performance, identification of errors (critical and non-critical), and assessment against pre-defined safety and usability objectives. The report implies direct measurement and comparison to acceptance criteria.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question (da Vinci surgical instruments) and the submission's focus (reprocessing instructions) are not related to AI-assisted reading or診断 (diagnosis). This is a submission for medical devices that are physical surgical instruments and the validation of their cleaning and disinfection protocols.

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

Not Applicable. This is not an algorithmic or AI-based device, so the concept of standalone algorithm performance does not apply. The "device performance" here refers to the physical and functional integrity of the surgical instruments after undergoing a new reprocessing method (automated cleaning/disinfection) compared to how they performed after previous methods.

7. The Type of Ground Truth Used

• Cleaning Validation: Ground truth is established by quantitative measurement of residual soil/markers (e.g., protein, hemoglobin) against acceptance limits specified in recognized standards (AAMI TIR 30, AAMI TIR 12) and FDA guidance.
• Thermal Disinfection Validation: Ground truth is established by demonstrating the inactivation of microorganisms to a specified log reduction, as defined by FDA "Class II Special Controls Guidance Document."
• Reliability/Life Testing: Ground truth is established by verifying that the instruments maintain their functional and structural integrity after repeated reprocessing cycles, meeting specified performance criteria.
• Human Factors Testing: Ground truth is established by the successful, safe, and effective completion of reprocessing tasks by representative users, identifying and mitigating potential use errors through risk analysis and observed performance.

8. The Sample Size for the Training Set

Not Applicable. This submission is for physical surgical instruments and changes to their reprocessing instructions, not an AI/ML algorithm that requires a training set.

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

Not Applicable. See point 8.

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IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.

IS3 measurement system consists of: IS3 Instrument Hand-held instrument, Multi Peg Driver Driver to attach the ISQ peg to the implant, IS3 Charger 100-240 VAC to 5VDC charger for the instrument batteries, Multi Peg Measurement pin to attach to the implant. Different pins are available to fit different implant types.

The IS3 instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "Multi peg" is attached to the dental implant by a screw-connection, with the Multi Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the Multi Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. The measurement takes about 1 second.

The instrument consists of a microcontroller and circuits to send the magnetic pulses, to receive the measurement signal, and to present the measurement value. A circuit for battery-charging is also included. Two 2-digit LED displays, one on each side of the instrument, show the measurement value and also communicate possible error codes and software id number at start-up. One operating key is used to turn the instrument on and off. The electronics are contained in a plastic body, which is sealed except for the back of the instrument which has a charging connector. The plastic body is made from PC/ABS plastic except for the tip, which is made from PEEK. No part of the instrument is intended to contact the patient; however, there can be unintentional contact with the tip of the instrument. The instrument is battery-driven and contains re-chargeable NiMh-batteries. The batteries can be charged during use, but it should not be attached while measuring due to the risk of power line interference making it impossible to measure. For safety, a charger complying with IEC 60601-1 is used.The charger connector is of a type that does not allow other chargers to be connected, thereby eliminating the risk of the wrong charger being used.

The provided document for the HIOSSEN IS3 device (K180527) does not contain detailed acceptance criteria and a study that proves the device meets these criteria in the typical format of a clinical or performance study for AI/ML-enabled devices.

This FDA 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Tellos ISQ Buddy, K143445), not on providing performance metrics against specific, quantitative acceptance criteria for diagnostically or prognostically critical AI/ML-driven tasks. The IS3 device is described as measuring the resonance frequency of an implant pin to determine an "ISQ-value" for implant stability, which is a direct measurement based on a physical principle. It does not appear to involve AI/ML for image analysis, diagnosis, or prediction, which typically require detailed performance studies.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not applicable to the type of device and submission presented.

However, I can provide information based on the document's content regarding the device's technical performance and comparison to predicate devices, which serves as its "proof" of meeting requirements for substantial equivalence.

Here's a breakdown of the available information:

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

The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, AUC, or accuracy, as would be common for AI/ML-powered diagnostic devices. Instead, the "performance" is demonstrated by its functional equivalence and compliance with relevant standards, and it measures an ISQ value from 1-100.

2. Sample sized used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset for validating AI/ML performance. The "testing" mentioned refers to compliance with engineering standards (EMC, software validation, sterilization, biocompatibility, electrical safety) for the device itself, rather than testing its diagnostic accuracy on a clinical dataset. Thus, there is no sample size for a test set of clinical data from this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert-established ground truth for AI/ML performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. The IS3 is a direct measurement device, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone instrument for measuring ISQ value. Its performance is inherent in its design and compliance with technical standards, as outlined above. It's not an "algorithm only" in the sense of AI/ML, but a physical measurement system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the fundamental measurement principle, the "ground truth" is the physical resonance frequency of the attached pin, which the instrument is designed to accurately measure and convert to an ISQ value. Beyond this, the device's "performance" is assessed by its ability to meet engineering and safety standards, rather than by comparison to clinical ground truth for a diagnostic task.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.

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

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The Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model 1S3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The devices can be used with staple line or tissue buttressing material.

The Endowrist Stapler Instrument, when used with the compatible Stapler 45 Reloads, delivers multiple rows of staples and transects the tissue along the middle of the staple line. The Endowrist Stapler Instrument is a reusable device while the Stapler 45 reloads (available in various sizes) are single-use/disposable devices.

The EndoWrist Stapler 45 Instrument is intended for resection, transection, and/or creation of anastomoses in surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).

IS4000 EndoWrist Stapler 30 Instrument is intended for resection, transection, and/or creation of anastomoses in surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The Stapler 30 Instrument is a reusable, fully wristed articulating device offered in two configurations, a straight tip and a curved-tip.

EndoWrist Stapler Reusable Accessories consist of a Stapler Cable, Stapler Release Kit, Stapler Cannula, Blunt Obturator, Stapler Cannula Reducer, and Stapler Motor Pack (SMP).

EndoWrist Stapler 45 Accessories mainly consist of: Cannulae, which are essentially hollow tubes that provide a path for instruments to access the surgical site; Obturators, which provide a means of initially inserting the seal and cannula assemblies through the body wall by providing a fitted tip that extends beyond the cannula's most distal point; "Other" Accessories, include the SRK (Stapler Release Kit).

This FDA 510(k) summary (K170879) describes the reprocessing instructions for existing Intuitive Surgical EndoWrist Stapler instruments and accessories. It does not include detailed acceptance criteria or a study demonstrating device performance against specific acceptance criteria for the functionality of the staplers. Instead, the 510(k) focuses on validating the reprocessing instructions for these already cleared devices, ensuring they can be safely reprocessed for multiple uses without compromising their safety or effectiveness.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document as the document is not about the initial performance of a new device in terms of its clinical efficacy, but rather about the validation of its reprocessing procedures.

However, I can provide information relevant to the reprocessing validation that is present in the document.

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

Note: The document states "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements" for these tests. Specific quantitative acceptance limits or failure rates for the reprocessing validation are not 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)

• Sample Size: Not specified in this 510(k) summary for the reprocessing validation tests.
• Data Provenance: Not specified in this 510(k) summary. The context implies it would be internal testing by Intuitive Surgical, Inc.

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. The "ground truth" here relates to the effectiveness of reprocessing, established through laboratory testing and human factors studies, not clinical interpretation by medical experts.

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

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple reviewers. This document describes validation testing of reprocessing instructions.

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 document is not about AI assistance or clinical efficacy; it pertains to the validation of reprocessing instructions.

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

Not applicable. This document is not about an algorithm or AI.

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

For the reprocessing validation, the "ground truth" would be established by:

• Cleaning Validation: Objective measurements of residual soil/bioburden after reprocessing.
• Thermal Disinfection Validation: Objective measurements demonstrating inactivation or removal of microorganisms.
• Human Factors Validation: Observation and assessment of users' ability to correctly follow the reprocessing instructions.

8. The sample size for the training set

Not applicable. This document describes validation testing, not a machine learning model's training.

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

Not applicable. This document describes validation testing, not a machine learning model's training.

Study Information (from document):

The document states: "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of Cleaning Validations, Thermal Disinfection Validation and Human Factors Validation studies. Design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices."

This indicates that multiple studies were conducted to specifically validate the reprocessing instructions. The detailed methodology and results of these studies (e.g., specific protocols, microbial challenges, residual limits, human factors study design) are not provided in this summary but would have been submitted as part of the full 510(k) application. The conclusion is that these studies demonstrated substantial equivalence to the predicate device in terms of reprocessing effectiveness and safety.

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The Intuitive Surgical da Vinci Harmonic ACE™ Device is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Model IS 1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).

The Intuitive Surgical Harmonic ACE™ Device is used to deliver ultrasonic energy to enable transection and coagulation of tissue. The proximal end of the device is a re-usable instrument housing and attaches to the da Vinci Surgical System. The distal end is a disposable insert which consists of a shaft and grip assembly. The instrument housing and disposable insert are assembled together, attached to the da Vinci Surgical System and connected to Ethicon's Endo-Surgery Generator 300 (Model GEN04) using the Hand Piece (Model HP054). When the Harmonic ACE™ Device is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in two configurations: one for use with the da Vinci (IS1200); and the other for the da Vinci Surgical (122000/123000) Systems, respectively. The same disposable insert is used with all configurations of the instrument.

The provided text describes a 510(k) premarket notification for the Intuitive Surgical da Vinci Harmonic ACE™ Device. It states that "Performance tests (bench and animal lab tests) were conducted to demonstrate that the device is substantially equivalent to the predicate devices and that the design output meets the design input requirements."

However, this document does not provide specific acceptance criteria or detailed results of these performance tests. It states that the results "did not raise any new issues of safety or efficacy as compared to Intuitive Surgical's currently cleared Harmonic™ Curved Shears (K042855)," implying comparison to the predicate device's performance, but without detailing what those performance metrics or criteria were.

Therefore, many of the requested details cannot be extracted from this particular regulatory summary.

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

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

• Test Set Sample Size: Not specified. The document mentions "bench and animal lab tests" but does not give sample sizes for either.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. Animal lab tests would be prospective in nature, but no further details are given.

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

• This information is not provided in the document. For a surgical device, "ground truth" might involve assessments by veterinary surgeons (for animal studies) or engineers/pathologists, but no details are given.

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

• This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, 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 surgical instrument (Harmonic ACE™ Device) and not an AI/imaging diagnostic device that would involve human "readers" or AI assistance in interpretation. The studies performed were performance tests (bench and animal lab tests) for device function.

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

• Not applicable. This device is a surgical instrument and does not involve an algorithm working in "standalone" mode in the context of interpretation. Its performance is inherent to its mechanical and energy delivery capabilities.

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

• The document does not explicitly state the "type of ground truth." For bench tests, it would likely involve objective measurements against engineering specifications (e.g., thermal cameras for thermal spread, load cells for cutting force, pressure sensors for burst pressure). For animal tests, it might involve histological examination (pathology) of tissue effects or direct observation of surgical outcomes. However, this is inferred, not stated.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI that would require a "training set" in the traditional sense. The device's design is based on engineering principles and preclinical testing, not on learning from a dataset.

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

• Not applicable. As there is no "training set" for an AI algorithm, this question is not relevant to the described device.

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The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS3000) are intended to assist in the accurate control of Intuitive Surgiçal Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2. general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

This 510(k) is being submitted to request an expansion of the Indications for Use to include transoral otolaryngology surgical procedures. There are no changes in the design, technology, materials, manufacturing, performance, specifications, or method of use for the da Vinci Surgical Systems, EndoWrist Instruments and Accessories associated with this pre-market notification. The da Vinci Surgical Systems (Models IS1200, IS2000, IS3000) consists of two integrated sub-systems as follows: A Surgeon Console and a Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope within the operative field. The endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM); two hand-operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position with respect to the patient by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM), which is also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another individual positioned adjacent to the PSC.

Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical Systems, also known as Intuitive Surgical Insite® Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the surgeon located at the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.

The provided 510(k) summary (K090993) is for an expansion of the Indications for Use for the Intuitive Surgical da Vinci Surgical Systems to include transoral otolaryngology surgical procedures. Since this is an expansion of indication for an existing device, the study is focused on demonstrating substantial equivalence rather than meeting specific performance criteria.

Therefore, the structure for acceptance criteria and device performance table, and sections related to algorithm performance, training data, ground truth establishment, and MRMC studies are not directly applicable in the conventional sense for this submission. The 510(k) summary focuses on comparing the surgical tasks involved in the new indication to those already cleared for the device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this 510(k) is for an expansion of indications for an already cleared device (Intuitive Surgical da Vinci Surgical Systems), the acceptance criteria are not in the form of numerical performance metrics for an AI algorithm. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing treatment methods and the lack of new safety or effectiveness issues.

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

• Test Set Sample Size: Not explicitly stated as a numerical value within the 510(k) summary. It refers to a "multicenter retrospective clinical study" that included "transoral otolaryngology surgical patients." The exact number of patients or cases is not provided.
• Data Provenance:
  • Country of Origin: Not specified in the summary.
  • Retrospective or Prospective: Retrospective.

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

This submission does not involve an AI algorithm with a defined "ground truth" established by experts in the typical sense. The clinical study's "ground truth" would be derived from patient outcomes, surgical observations, and comparison to standard treatments.

• Number of Experts: Not applicable/not specified. The study involved a clinical assessment implicitly by the treating physicians and researchers.
• Qualifications of Experts: The study was conducted by "trained physicians in an operating room environment," as indicated in the Intended Use statement common to the da Vinci system.

4. Adjudication Method for the Test Set

Not applicable as this is a clinical outcomes study for an existing surgical device's indication expansion, not a diagnostic or AI performance study requiring expert adjudication of image annotations or classifications.

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

Not applicable. This is not a study measuring the effectiveness of human readers with or without AI assistance. It's a clinical study to support an expanded indication for a surgical robot.

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

Not applicable. The da Vinci Surgical System is a human-controlled robotic surgical system; it's not an autonomous algorithm. The study assesses the system's performance with a human surgeon.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the clinical outcomes and observations from the surgical procedures performed using the da Vinci system.

• Type of Ground Truth: Clinical outcomes (feasibility, efficacy, safety, functional assessment) from actual patient surgeries, compared to historical controls for alternative treatment methods (Open surgery, transoral surgery, and chemoradiation treatment).

8. Sample Size for the Training Set

Not applicable. The da Vinci Surgical System is a physical device, and this submission is for an expanded indication, not an AI algorithm that requires a training set in the machine learning sense. The device itself has been developed and refined over many years and multiple previous 510(k) clearances.

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

Not applicable for the reasons stated above.

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The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.

The Intuitive Surgical da Vinci Si Surgical System, model IS3000 (also known as the Endoscopic Instrument Control System) is a modification of the existing da Vinci S Surgical System, model IS2000. Essentially, the IS3000 is an updated and enhanced version of the existing IS2000 device. The new IS3000 provides a more intuitive user interface and improved ease-of-use. Overall, the model IS3000 is a computer-assisted device designed to facilitate complex surgery using a minimally invasive approach. The IS3000 consists of the following 3 main components: Surgeon Console (model SS3000), Patient Cart (model PS3000), and Vision System Cart (model VS3000).

The provided 510(k) summary for the Intuitive Surgical da Vinci Si Surgical System (Model IS3000) does not contain information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics in the way typically expected for AI/ML-based medical devices or diagnostic tools.

Instead, this submission is for an updated version of an existing surgical system, establishing substantial equivalence to a predicate device (da Vinci S Endoscopic Instrument Control System, Model IS2000). The focus is on demonstrating that the new model (IS3000) does not raise new safety or effectiveness issues and is substantially equivalent to legally marketed devices.

Therefore, many of the requested categories for AI/ML device evaluations are not applicable or not provided in this regulatory document.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• UL/IEC 60601-1:1988, Amendment A1: 1991-11, Amendment A2: 1995 (Medical Electrical Equipment - Part 1: General requirements for safety)
• IEC 60601-1-1:2000 (Medical Electrical Equipment - Part 1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems)
• IEC 60601-1-2:2001 (Medical Electrical Equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility - requirements and tests)
• IEC 60601-1-4:2000 (Medical Electrical Equipment - Part 1: General requirements for safety; Collateral standard: Programmable electrical medical systems)
• IEC 60601-2-2:1998 (Medical Electrical Equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment)
• IEC 60601-2-18:1996, Amendment A1: 2000 (Medical Electrical Equipment - Part 2: Particular requirements for the safety of endoscopic equipment) |
  | Functional Equivalence: Improvements in user interface and ease-of-use do not compromise the fundamental function or safety of the device and its components (Surgeon Console, Patient Cart, Vision System Cart, EndoWrist Instruments). | The IS3000 is described as "an updated and enhanced version of the existing IS2000 device" with "a more intuitive user interface and improved ease-of-use." The components serve the same fundamental purpose as the predicate. "There are no changes to the EndoWrist Instruments in this submission." |

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 mentions "Performance (bench) testing was conducted on the IS3000." However, it does not provide details on the sample size used for this testing, the specific test cases, or the provenance of any data (as it's a surgical system, not a data-driven diagnostic in the AI/ML sense). It's bench testing, implying laboratory-based functional assessments rather than patient data.

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. Ground truth, in the context of an AI/ML diagnostic's test set, is not a concept relevant to the type of bench testing described for this surgical system. The "truth" would be determined by engineering specifications and functional performance.

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

Not applicable. This is not a study requiring human adjudication of results or images.

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 surgical control system, not an AI-assisted diagnostic or image interpretation device.

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

Not applicable. The device is a surgical system designed for human-in-the-loop operation by a surgeon.

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

For this type of device, the "ground truth" for bench testing typically refers to engineering specifications, design requirements, and established performance parameters of the predicate device (IS2000). Compliance with these, and with technical standards, would form the basis of the "truth."

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI/ML algorithm that is "trained" on a dataset. The "training" for such a system would involve engineering design, development, and iterative testing.

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

Not applicable. As above, this is not an AI/ML algorithm with a traditional training set.

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DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.

DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.

The provided text is a 510(k) summary for the DDS diagnostic image review station. It does not contain any information regarding acceptance criteria or the results of a study proving the device meets said criteria.

The document primarily focuses on:

• Company Information and Contact: Impax Technology Inc., Paula Pfeifle.
• Submission Date: October 18, 1999.
• Device Name: DDS (with various trade names like DS3000, RS3000, etc.).
• Common Name: Diagnostic Review Station.
• Intended Use: To display and manipulate patient images and demographic information for diagnostic, review, and referral purposes, as a software package (with or without standard hardware), and as a standalone or connected system.
• Substantial Equivalence: Comparison to Radworks Medical Imagining Software with Quality Control Module.
• Technological Comparison: Both are software packages for standard PC hardware (Windows NT), DDS also supports Unix/Solaris. Both query, retrieve, transmit medical images, provide high-quality display, and allow digital processing, measurement, and annotation.
• Non-Clinical Performance and Test Data: Stated as following "standard procedures: test plans are developed, testing is carried out through a variety of automated and manual testing, and test results are recorded and reported." It also mentions "extensively tested by programmers, quality assurance specialists, and potential customers."
• Substantial Equivalence Conclusions: The intended use and technological characteristics are equivalent to the predicate device.
• FDA Clearance Letter: Confirms 510(k) clearance (K993532) on December 15, 1999, based on substantial equivalence for the stated indications for use.
• Indications for Use Statement: Reiterates the intended use of the DDS software.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document describes a regulatory submission for substantial equivalence based on technological comparison and non-clinical software testing, not a clinical performance study with specific acceptance criteria and results.

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