Search Results

Manufacturer

Date Cleared

2025-04-24

(143 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K171701,K242318

Intended Use

da Vinci SP Surgical System, Model SP1098:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical da Vinci SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

da Vinci SP Instruments:
Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

Device Description

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "transanal local excision (TALE)" as a new representative, specific procedure in the Professional Instructions for Use.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary do not contain acceptance criteria or performance data for an AI-powered device. Instead, the document describes the clearance of the da Vinci SP Surgical System (SP1098), which is a robot-assisted surgical system, for an expanded indication: "transanal local excision (TALE)".

The performance data presented focuses on clinical performance and substantial equivalence of this surgical system for the new indication, not on the performance of a separate AI algorithm or its acceptance criteria.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set data) are not applicable or cannot be extracted from this document as they pertain to AI/ML device evaluations.

However, I can extract information related to the performance study conducted to support the new indication for the da Vinci SP Surgical System as described in the summary:

Study Proving Device Meets Acceptance Criteria (for the expanded indication)

The device in question, the da Vinci SP Surgical System (SP1098), is a robot-assisted surgical system. The 510(k) application (K243714) is for a labeling modification only, specifically to add "transanal local excision (TALE)" as a new representative, specific procedure. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the system, as modified by this labeling change, remains safe and effective for the new procedure, and is substantially equivalent to existing methods.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a labeling modification for a surgical system and not an AI/ML device with specific quantitative performance metrics like sensitivity/specificity, the "acceptance criteria" are implied by demonstrating substantial equivalence and satisfactory clinical performance through a combination of bench testing and literature review. The reported "performance" relates to clinical outcomes when using the da Vinci SP system for TALE compared to hand-held devices.

Implied Acceptance Criteria & Reported Device Performance for TALE Procedure:

Performance Metric Category	Implied Acceptance Criteria (Substantial Equivalence)	Reported Device Performance (da Vinci SP TALE)	Comparison to Predicate/Hand-held Devices
System Functionality/Access	Ability to provide robotic and laparoscopic instrument access to the rectum and securely installed during use.	Confirmed in cadaver bench testing. Evaluation of instrument motion, ability to reach targeted anatomy, and complete the procedure was confirmed.	Not directly compared, but the system's mechanical and functional performance was confirmed for the new application.
Insufflation Leakage	Insufflation leakage when used with compatible third-party port is within specification.	Verified in design verification testing.	Not directly compared, but met internal specifications.
Operative Time (minutes)	Comparable range to existing procedures.	32.1 – 198.8 minutes	Similar range (38 – 192 minutes) for hand-held devices.
Estimated Blood Loss (mL)	Low, comparable to existing procedures.	5 – 24.21 mL	Hand-held data: 5.00 – 143 mL. SP appears to be on the lower end or comparable.
Transfusion Rate (%)	Low/comparable to existing procedures.	0%	Hand-held data: 4.3% – 5.3%. SP appears to be lower.
Conversion to Open Surgery (%)	Low/comparable to existing procedures.	0%	Hand-held data: 0% – 5.13%. SP appears to be lower or comparable.
Negative Surgical Margin (%)	High, comparable to existing procedures.	100%	Hand-held data: 66% – 100%. SP appears comparable or better.
Intraoperative Complication Rate (%)	Low, comparable to existing procedures.	0%	Hand-held data: 0% – 1.8%. SP appears comparable.
30-day Postoperative Complication Rate (%)	Low, comparable to existing procedures.	11.8% – 15.4%	Hand-held data: 5% – 40%. SP appears within range.
Major (C-D grade ≥ III) Complication Rate (%)	Low/comparable to existing procedures.	NR (Not Reported)	Hand-held data: 0% – 11%. No direct comparison possible for SP for this metric from the provided data.
Average Length of Hospital Stay (days)	Short, comparable to existing procedures.	0 – 1 day	Hand-held data: 0.4 – 6.0 days. SP appears to be on the lower end.
Re-admission/Reoperation rate (%)	Low/comparable to existing procedures.	Re-admission: 11.8%; Re-operation: 0%	Hand-held data: Re-admission: 0% – 9.1%. SP re-admission rate is within range, re-operation rate appears lower.
Overall Mortality Rate (%)	Low/comparable to existing procedures.	0%	Hand-held data: 0% – 7.1%. SP appears comparable.
Recurrence Rate (%)	Low/comparable to existing procedures.	Local recurrence: 0%	Hand-held data: Local recurrence: 0% – 30%. SP appears lower or comparable.

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

Bench Performance Testing (Cadaver Study):
- Sample Size: Two complete TALE procedures were performed in one male cadaver.
- Data Provenance: Not explicitly stated, but implies a prospective experimental setting. Location (country of origin) not specified beyond "in a male cadaver."
Published Clinical Data Review:
- SP Transanal Local Excision (TALE):
  - Sample Size: 4 publications reviewed, covering a total of 81 patients (43 from two publications on full/partial-thickness resection, and 38 from two publications on partial-thickness resection only).
  - Data Provenance: Peer-reviewed literature published globally (implied by journal names like "Dis Colon Rectum," "ANZ J Surg," "Annals of surgery"). The studies themselves are prospective/retrospective clinical studies.
- Transanal Procedures with Hand-held Devices (TEM/TEO/TAMIS):
  - Sample Size: 42 publications reviewed, covering approximately 21,121 patients.
  - Data Provenance: Peer-reviewed literature published globally (various international journals listed). The studies themselves encompass Prospective, Retrospective, and Meta-analysis types.

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

Bench Performance Testing: The cadaver study was performed to "confirm the clinical performance" and "assess instrument motion... and ability to reach targeted anatomy and complete the procedure." This implies evaluation by trained personnel (likely surgeons experienced with the da Vinci system and TALE procedures), but the exact "number of experts" or their specific "qualifications" for establishing ground truth are not detailed in this summary. The design validation was to confirm clinical performance, implying expert judgment during the procedure.
Published Clinical Data: The "ground truth" for the clinical data came from the clinical outcomes reported in the original peer-reviewed studies themselves. These studies inherently involve practicing surgeons and pathologists establishing diagnoses, procedure success, and complications. The review process for the 510(k) would involve regulatory and clinical experts from the manufacturer analyzing and summarizing this previously established clinical data.

4. Adjudication method for the test set

Bench Performance Testing: No explicit adjudication method is described beyond the conduct of the procedures and confirmation of performance. It was a direct observation and assessment of the system's ability to perform the TALE procedure.
Published Clinical Data: For the literature review, a systematic search and screening were performed, and inclusion/exclusion criteria were applied to identify relevant publications. This implies a form of "adjudication" or selection process performed by the submitter's team to determine which studies were suitable for comparison, but not an independent adjudication of patient data for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No, an MRMC study was not conducted or referenced. MRMC studies are typically used to evaluate the impact of AI on human reader performance for diagnostic tasks (e.g., distinguishing cancerous from non-cancerous lesions). This 510(k) is for a robot-assisted surgical system, and the performance evaluation is based on the system's ability to facilitate a surgical procedure and its clinical outcomes, not on radiologists' diagnostic performance.

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

This question is not applicable. The da Vinci SP system is a surgical robot that is intended for human-in-the-loop performance (i.e., controlled by a trained physician). There is no "standalone" performance for such a device in the context of surgery. The "performance" is inherently a human-robot collaboration.

7. The type of ground truth used

Bench Performance Testing: "Ground truth" was established by the physical and functional performance of the da Vinci SP Surgical System in a cadaver model as assessed by the operators (surgeons/engineers) conducting the procedures (e.g., ability to access rectum, manipulate instruments, complete the procedure).
Published Clinical Data: "Ground truth" for clinical outcomes (e.g., operative time, complication rates, negative surgical margins) was derived from the data reported in the peer-reviewed clinical studies. This data would have been established by the clinicians, pathologists, and other medical professionals involved in the original studies based on patient diagnosis, surgical intervention, and follow-up. For example, tumor staging and lesion types were confirmed by pathology.

8. The sample size for the training set

This question is not applicable. The da Vinci SP Surgical System is a robotic system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development. The system's design and engineering principles are based on established robotics and surgical mechanics, verified and validated through a combination of engineering tests and clinical experience.

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

This question is not applicable, as there is no "training set" for an AI/ML algorithm for this device.

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K Number

K242318

Device Name

Manufacturer

Date Cleared

2024-11-26

(113 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K171632,K240502

Intended Use

da Vinci SP Surgical System, Model SP1098:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical da Vinci SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

da Vinci SP Instruments:

Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/ pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

Device Description

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "colorectal surgical procedures" to the indications, and to add "Low anterior resection / total mesorectal excision (LAR/TME), Colectomy (Right, Left, Transverse, Total, Hemi), Sigmoidectomy, and Abdominoperineal Resection (APR)" as new representative, specific procedures in the Professional Instructions for Use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a labeling modification to the da Vinci SP Surgical System. The modification adds "colorectal surgical procedures" to the indications for use. The document details the performance testing and clinical study conducted to support this change.

Here's a breakdown of the requested information:

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

For the Cadaver and Animal Performance Testing, the acceptance criteria was the successful completion of the specified surgical procedures, as rated by the participating surgeons. The study concluded that "Comparative animal and cadaver testing was conducted to demonstrate the equivalence of the SP1098 System to the multiport da Vinci Xi system, Model IS4000 for performing colorectal surgical procedures." The document states that surgeons completed questionnaires evaluating their ability to perform surgical tasks, implying successful performance.

For the Clinical Study, the acceptance criteria was demonstrating that the use of the da Vinci SP Surgical System in colorectal surgical procedures "does not raise different questions of safety or effectiveness" when compared to existing literature on multiport robotic-assisted colorectal surgery. This was assessed by comparing 95% confidence intervals (CI) of various clinical parameters from the SP study to those from published literature.

Table 1: Acceptance Criteria for Cadaver and Animal Testing (Excerpts)

Surgical Procedure	Procedure Completion Acceptance Criteria (Key highlights)
Low Anterior Resection / Total Mesorectal Excision	Sufficient colon mobilization to ensure tension-free anastomosis; Complete mesorectal dissection (e.g., intact mesorectal fascial envelope, circumferential resection, distal dissection to levator ani); Critical anatomy identified; Appropriate vessel ligation; Anastomosis complete and deemed surgically acceptable upon visual inspection; Acceptable leak test.
Right Hemicolectomy	Sufficient colon mobilization to ensure tension-free anastomosis; Critical anatomy identified; Appropriate vessel ligation; Anastomosis complete and deemed surgically acceptable upon visual inspection; Acceptable leak test.
Low Anterior Resection / Total Mesorectal Excision (Porcine)	Sufficient colon mobilization to ensure tension-free anastomosis; Anastomosis complete and deemed surgically acceptable upon visual inspection; Acceptable leak test; Hemostasis maintained.

Reported Device Performance (Clinical Study against Literature):

The conclusion for both LAR/TME and Right Colectomy studies states: "Comparison of the results from the da Vinci SP Surgical System to the published literature demonstrate that the 95% confidence intervals (CI) for all 12 clinical parameters in the SP study overlap the 95% CIs calculated from the published clinical literature on da Vinci Multiport systems for both LAR/TME and right colectomy. This comparison demonstrates that the da Vinci SP Surgical System is as safe and effective as the predicate device and does not raise different questions of safety or effectiveness."

Table 2: Clinical Study Performance (LAR/TME)

Clinical Study Parameter	K242318 (SP1098) Performance (Mean ± SE or Proportion)	da Vinci Multi-port Literature (Mean ± SE or Proportion)	Overlapping 95% CI (Yes/No)
Operative time	273.6 ± 14.84 min	282.3 ± 12.38 min	Yes
Length of stay	4.6 ± 0.69 days	7.7 ± 0.79 days	Yes
Estimated blood loss	75.2 ± 16.12 mL	63.0 ± 14.66 mL	Yes
Intra-operative adverse event	0%	5.8%	Yes
Major adverse event complication rate	10.3%	8.1%	Yes
Anastomotic complication rate	10.3%	6.4%	Yes
Transfusion rate	0%	2.3%	Yes
Conversion rate	0%	6.2%	Yes
Mortality rate	0%	0.6%	Yes
Readmission rate	14.3%	7.1%	Yes
Reoperation rate	0%	5.5%	Yes
Positive surgical margin	0%	Not reported in this table	N/A

Table 3: Clinical Study Performance (Right Colectomy)

Clinical Parameter	K242318 (SP1098) Performance (Mean ± SE or Proportion)	da Vinci Multi-port Literature (Mean ± SE or Proportion)	Overlapping 95% CI (Yes/No)
Operative time	208.2 ± 11.43 min	285.5 ± 26.92 min	Yes
Length of stay (days)	3.5 ± 0.38 days	5.1 ± 0.28 days	Yes
Estimated blood loss	37.0 ± 8.40 mL	98.7 ± 19.65 mL	Yes
Intra-operative adverse event rate	3.6%	2.8%	Yes
Major adverse event rate	0%	6.7%	Yes
Anastomotic complication rate	0%	4.2%	Yes
Transfusion rate	0%	7.3%	Yes
Conversion rate	0%	6.0%	Yes
Mortality rate	0%	0.6%	Yes
Readmission rate	0%	6.8%	Yes
Reoperation rate	0%	5.8%	Yes
Positive surgical margin	0%	Not reported in this table	N/A

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

Cadaver and Animal Performance Testing:
- Sample Size: Not explicitly stated as a number of distinct "test cases" in the traditional sense, but involved "three (3) independent practicing surgeons," each of whom performed "two (2) procedures in a cadaver model and one (1) procedure in a porcine model, for a total of 9 surgical procedures performed per system."
- Data Provenance: The location (country) of these studies is not specified in the document. The study was prospective in nature, as it involved actively conducting procedures for testing.
Clinical Study:
- Sample Size: 60 subjects (40 subjects in the United States and 20 subjects in South Korea).
  - LAR/TME cohort: 29 subjects (19 U.S., 10 South Korea)
  - Right Colectomy cohort: 28 subjects (18 U.S., 10 South Korea)
  - Other colorectal procedures: 3 subjects (Sigmoid Colectomy (N=2), Transverse Colectomy (N=1))
- Data Provenance: Prospective, multicenter, single-arm clinical study. Data originated from the United States and South Korea.

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)

Cadaver and Animal Performance Testing:
- Number of experts: Three (3) independent practicing surgeons.
- Qualifications of experts: Described as "independent practicing surgeons." Specific experience or years of practice are not detailed.
Clinical Study:
- The "ground truth" here is the clinical outcomes and parameters observed in the subjects undergoing the procedures. These were assessed by the participating clinical sites and reported. The ground truth for comparison was established via "systematic literature searches... conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods" of "recently published clinical literature between 2010 and March 2024 on multiport robotic systems." The clinicians performing the literature review would be the "experts" in this context, but their number and specific qualifications are not provided.

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

Cadaver and Animal Performance Testing: Not explicitly stated. The document mentions surgeons "completed questionnaires that evaluated their ability to perform surgical tasks." It's implied that the surgeons themselves assessed the criteria, but a formal adjudication method for discrepancies (if any) is not described.
Clinical Study: Not explicitly stated. Clinical outcomes data are collected and analyzed, but a specific independent adjudication committee or method for confirming every data point is not detailed in this summary. The comparison to literature would involve independent researchers analyzing published data.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of a surgical system ("da Vinci SP Surgical System") and its instruments, not an AI or imaging diagnostic tool that relies on human readers interpreting results with or without AI assistance. The "comparison" was between the SP Surgical System's outcomes and those reported in literature for multiport robotic systems, not human reader performance.

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

This question is not applicable as the device is a surgical system that inherently requires a human surgeon "in-the-loop" for its operation. It is not an algorithm-only device. The clinical study and cadaver/animal testing evaluated the system's performance when operated by surgeons.

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

Cadaver and Animal Performance Testing: Expert assessment of procedural completion and surgical outcomes by participating surgeons based on defined criteria (e.g., tension-free anastomosis, intact fascial envelope, acceptable leak test).
Clinical Study: Clinical outcomes data (e.g., operative time, blood loss, length of stay, adverse event rates, conversion rates, mortality rates, readmission rates, reoperation rates, positive surgical margin rates) collected prospectively from patients undergoing actual surgical procedures. This data serves as the ground truth for evaluating safety and effectiveness against an existing standard of care (represented by multiport robotic surgery literature).

8. The sample size for the training set

This information is not provided in the given document. The document describes premarket notification for a labeling modification for an existing surgical system (da Vinci SP). It is unlikely that a "training set" in the context of machine learning (where this term is most commonly used) would be applicable to this submission, as the device is a physical surgical system, not an AI or algorithm that requires a training set for model development. The focus is on verification and validation of the physical system for an expanded indication.

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

Since no training set for an AI/algorithm is mentioned or implied, this question is not applicable. The device is a surgical system.

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K Number

K240502

Device Name

Manufacturer

Intuitive Surgical Inc.

Date Cleared

2024-07-08

(138 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K153276,K231798

Intended Use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic and general thoracoscopic surgical procedures that are appropriate for a single port approach, and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups. needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic and general thoracoscopic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

Device Description

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "general thoracoscopic surgical procedures" to the indications, and to add "lobectomy, segmentectomy, wedge resection, segmentectomy, lymphadenectomy, thymectomy, and mediastinal mass resection" as new representative, specific procedures in the Professional Instructions for Use.

AI/ML Overview

This document is a 510(k) summary for the da Vinci SP Surgical System. It details the device's indications for use and presents performance data to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria (Performance Endpoints) and Reported Device Performance

The acceptance criteria for the clinical study were primarily based on safety and performance endpoints demonstrated by the incidence of adverse events and the rate of conversion to other surgical methods. While specific numerical acceptance thresholds are not explicitly stated as "acceptance criteria" in a table format, the study's success is defined by these metrics. The performance data presented indicates that the device met these implicit criteria by demonstrating favorable outcomes.

Clinical Study Parameter	Acceptance Criteria (Implicit from Study Design)	Study Data (K240502) - Thymectomy	Study Data (K240502) - Lobectomy
Device-related adverse event rate, %	Low incidence, comparable to predicate/literature	0%	0%
Conversion rate, % (to open, VATS, or multiport robotic)	Low incidence, demonstrating successful SP use	0%	0%
Intraoperative adverse event rate, %	Low incidence, comparable to predicate/literature	0%	0%
Subjects with major AE (Clavien-Dindo Grade III/IV/V), n (%)	Low incidence, comparable to predicate/literature	0 (0%)	3 (15.8%)
Subjects with minor AE (Clavien-Dindo Grade I/II), n (%)	Not exceeding expected rates/comparable	4 (30.8%)	6 (31.6%)
Operative time (minutes), mean ± SD	Within acceptable surgical ranges/comparable to literature	193.3 ± 56.51	229.6 ± 64.14
Estimated blood loss (mL), mean ± SD	Low, within acceptable surgical ranges/comparable to literature	11.9 ± 12.66	47.9 ± 47.41
Blood transfusion rate, %	Low/comparable to literature	0%	0%
Length of hospital stay (days), mean ± SD	Within acceptable clinical norms/comparable to literature	1.6 ± 0.51	3.8 ± 1.60
Rate of positive surgical margin, %	Low/comparable to literature (for malignant cases)	0% (N=7 malignant thymectomy)	0%
Readmission rate, %	Low/comparable to literature	0%	5.3% (1 subject)
Reoperation rate, %	Low/comparable to literature	0%	0%
Mortality rate, %	Low/comparable to literature	0%	0%

Note on "Acceptance Criteria": The document does not explicitly present a pre-defined table of numerical acceptance criteria. Instead, it describes the demonstration of safety and performance (low adverse event rates, zero conversions) and then performs a comparison to published literature for the predicate device, showing that the 95% confidence intervals overlap. This indicates that performance was considered acceptable if it was similar to that of the already-cleared multiport robotic systems.

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

Clinical Study Test Set (Prospective, Multicenter, Single-Arm):
- Total Subjects: 32 subjects
- Thymectomy Cohort: 13 subjects
- Lobectomy Cohort: 19 subjects
- Data Provenance: United States (6 institutions), prospective.
Pre-clinical Study Test Set (Cadaver and Animal Performance Testing):
- Subjects: 3 independent practicing surgeons
- Procedures: 18 surgical procedures total (5 procedures per surgeon in a cadaver model, 1 procedure per surgeon in a porcine model).
- Data Provenance: Not explicitly stated, but typically conducted in a controlled lab/testing environment.

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

Clinical Study: The ground truth for the clinical study was established by the clinical outcomes observed in patients undergoing surgery using the da Vinci SP Surgical System. This includes intra-operative observations and post-operative follow-up (30-day). The data was collected by the treating physicians and study staff at 6 institutions in the United States. The qualifications of these clinicians are not explicitly detailed, but they are implied to be "trained physicians" in an "operating room environment" as per the Indications for Use.
Pre-clinical Study: "Three (3) independent practicing surgeons participated" in this study. Their specific qualifications (e.g., years of experience, subspecialty) are not provided beyond "independent practicing surgeons." The "success criteria" for each procedure were "deemed surgically acceptable upon visual inspection" - implying these surgeons assessed the outcome as part of establishing the ground truth for this phase.

4. Adjudication Method for the Test Set

Clinical Study: Not explicitly stated. The study was a "single-arm" study. Adverse events were reported, and it's mentioned that none were "deemed to be device related." This suggests some level of medical review or adjudication, likely by the study investigators or a clinical events committee, but the specific process (e.g., 2+1, 3+1) is not detailed.
Pre-clinical Study: The surgeons performed the procedures and assessed completion/acceptability. No independent adjudication method is described beyond the surgeons performing the procedures and judging the outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC study was performed. The device is a surgical system, not an AI-assisted diagnostic or image interpretation tool for "human readers." Therefore, this section is not applicable. The comparison was between the da Vinci SP system and existing multiport robotic systems (literature comparison) or traditional open/VATS procedures in terms of surgical outcomes.

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

This is not applicable. The da Vinci SP Surgical System is a robotic surgical platform that requires human operation (surgeon-in-the-loop). It is not an algorithm performing a task autonomously.

7. The Type of Ground Truth Used

Clinical Study:
- Safety Ground Truth: Real-world clinical outcomes in patients (intra-operative and post-operative adverse events, complications, readmissions, reoperations, mortality).
- Performance Ground Truth: Successful completion of surgical procedures without conversion, operative metrics (time, blood loss), and critical clinical parameters like positive surgical margins.
Pre-clinical Study: Surgical outcomes in cadaver and porcine models assessed by surgeons based on defined procedure completion criteria (e.g., "complete dissection," "sufficient lymph node dissection," "hemostasis maintained," "critical anatomy identified").

8. The Sample Size for the Training Set

No specific "training set" for an AI model is mentioned as this device is a surgical system, not an AI/ML algorithm. The development and validation of such a complex system would involve extensive engineering, bench testing, pre-clinical trials (as described), and then clinical studies. The design and validation relied on established medical device development processes and prior knowledge from the predicate device (da Vinci Xi Surgical System).

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

Not applicable, as there is no mention of an AI/ML training set in the context of this device's submission. The "ground truth" for the device's design verification and validation would have been established through engineering specifications, biomechanical principles, surgical anatomical knowledge, and established clinical practices, leading to the performance criteria tested in the pre-clinical and clinical studies.

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K Number

K232773

Device Name

Manufacturer

Intuitive Surgical, Inc

Date Cleared

2024-06-04

(267 days)

Product Code

Regulation Number

Type

Panel

Da Vinci SP Surgical System (SP1098)

Reference & Predicate Devices

K231798

Intended Use

da Vinci SP Surgical System (SP1098):

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic surgical procedures that are appropriate for a single port approach, and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

EndoWrist SP Instruments:

Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups. needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach, and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

Device Description

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally-invasive approach. The system consists of three major subsystems: a Surgeon Console, a Vision Cart, and a Patient Cart.

At the Surgeon Console, the surgeon controls all movements and endoscope by using two hand controls and a set of foot pedals. The surgeon views the live endoscope image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the endoscope light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscope image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. It supports the positioning of the surgical port and manipulation of the surgical instruments and endoscope.

AI/ML Overview

The provided text is a 510(k) summary for the da Vinci SP Surgical System (SP1098). It details the device's indications for use, its description, and a comparison to a predicate device. However, it does not contain any information regarding specific acceptance criteria for device performance, nor does it describe a study (including sample sizes, ground truth establishment, or expert adjudication) that proves the device meets such criteria.

The document states: "Verification and validation testing, consisting of software testing, and clinical validation, on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified. The subject device met the same acceptance criteria as the predicate device, the test results demonstrate that the subject device is substantially equivalent to its predicate device."

While it mentions "clinical validation" and "acceptance criteria," it does not provide the details requested in your prompt. The focus of this 510(k) summary is on demonstrating substantial equivalence to a predicate device, primarily through technological comparison and by asserting that the new device met the same acceptance criteria as the predicate. It does not elaborate on what those criteria were or the specifics of the study that validated them.

Therefore, I cannot fulfill your request for the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based on the provided text. This document is a regulatory submission summary, not a detailed study report.

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K Number

K230033

Device Name

Manufacturer

Intuitive Surgical Inc.

Date Cleared

2023-04-05

(90 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K173906,K202571

Intended Use

da Vinci SP Surgical System, Model SP1098:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

Endo Wrist SP Instruments:

Intuitive Surgical Endo Wrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign turnors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

Device Description

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "simple prostatectomy" as a new representative, specific procedure in the Professional Instructions for Use. Simple prostatectomy is a "covered" procedure under radical prostatectomy as an "umbrella" procedure. This 510(k) also includes the addition of performance data (cadaver) for "transvesical prostatectomy" as validated approach for prostatectomy in the Performance Data section of the User Manual.

AI/ML Overview

The provided text is a 510(k) summary for the da Vinci SP Surgical System, Model SP1098. It primarily discusses a labeling modification to add "simple prostatectomy" as a representative procedure and the justification for this change. The document does not describe acceptance criteria for a device performance study in the typical sense of a new device validation with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence by comparing performance data from literature for different prostatectomy approaches.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Device Performance (as inferred from the provided text):

The "acceptance criteria" here are not explicitly stated numerical thresholds for performance. Instead, the inherent acceptance criterion is that the new procedure ("transvesical prostatectomy" for both simple and radical cases) performed with the da Vinci SP Surgical System demonstrates similar clinical outcomes to previously cleared prostatectomy approaches (extraperitoneal and transabdominal radical prostatectomy) performed with the same device. This demonstrates "substantial equivalence" and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	"Acceptance Criteria" (Implicit: Similar to cleared approaches)	Reported Device Performance for Transvesical Prostatectomy (TVP) using da Vinci SP System
Operative Time (Avg)	Ranges should be similar.	Simple (TVSP): 153 - 232.43 min
Radical (TVRP): 199 - 212 min	147 - 203.2 min	114 - 248.2 min
EBL (Avg)	Ranges should be similar.	Simple (TVSP): 100 - 227.13 mL
Radical (TVRP): 100 - 1359 mL	50 - 197.2 mL	50 - 200 mL
Conversion Rate	Ranges should be similar and ideally low or 0%.	Simple (TVSP): 0%
Radical (TVRP): 0%	0%	0%
Intraoperative Complication Rate	Ranges should be similar and ideally low.	Simple (TVSP): 0% - 2.4%
Radical (TVRP): 0%	0% - 2.0%	0% - 2.7%
30-Day Postoperative Complication Rate	Ranges should be similar and ideally low.	Simple (TVSP): 0% - 12.5%
Radical (TVRP): 5.0% - 12.8%	3.8% - 18.3%	0% - 15.2%
Major (C-D grade ≥ III) Complication Rate	Ranges should be similar and ideally low.	Simple (TVSP): 0% - 7.14%
Radical (TVRP): 0% - 2.6%	0% - 11.7%	0% - 6.5%
Length of Stay	Ranges should be similar.	Simple (TVSP):

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K Number

K211316

Device Name

Manufacturer

Date Cleared

2021-07-23

(84 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K202968

Intended Use

Da Vinci SP Surgical System, Model SP1098:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

EndoWrist SP Instruments:

Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups. needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.

Device Description

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is the surgical port and to manipulate the surgical instruments and is positioned at the operating room table and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, study details, or performance metrics for the da Vinci SP Surgical System (SP1098).

The document is a 510(k) premarket notification clearance letter from the FDA. It states that the device is "substantially equivalent" to a legally marketed predicate device (K202968, Da Vinci SP Surgical System). The clearance is based on a review of the device's indications for use and a comparison to the predicate device.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that:

Nonclinical testing was "limited to software verification and a human factors evaluation, analogous to the testing of Dual Console mode for the reference device."
Verification and validation testing "confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified, analogous to the reference device verification and validation testing for Dual Console mode."

This means the study described is primarily a software verification and validation and a human factors evaluation focused on the new "Dual Console" feature, rather than a clinical trial or performance study against specific acceptance criteria for the surgical system's overall function. The FDA's decision relies on the analogy to the predicate device's prior substantial equivalence determination.

Therefore, I cannot provide the requested table or detailed answers to questions 1-9 based on the provided text. The document does not describe:

Specific acceptance criteria for the device's clinical performance.
Reported device performance against such criteria.
Sample sizes for test sets (beyond general software V&V or human factors, which are not detailed).
Data provenance, expert qualifications, or adjudication methods for ground truth because a clinical performance study with such elements is not described.
Whether MRMC or standalone performance studies were done for clinical effectiveness.
Type of ground truth used for performance validation.
Training set sample size or how ground truth was established for a training set, as it seems the evaluation focused on incremental changes rather than a de novo AI performance assessment.

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K Number

K211595

Device Name

Manufacturer

Date Cleared

2021-06-23

(30 days)

Product Code

Regulation Number

Type

Special

Panel