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510(k) Data Aggregation
(22 days)
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/pickups, 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 general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. 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.
This special 510(k) is being submitted for a modification to the endoscopic instruments to incorporate monopolar electrosurgical capability on an endoscopic curved scissor instrument. This modification affects the instrument only and there are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci® Surgical System.
The endoscopic instruments are used with the da Vinci® Surgical System which consists of two integrated sub-systems as follows:
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and 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. 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) and 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 provider positioned adjacent to the PSC.
Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, 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 viewer located in 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 text is a 510(k) summary for a modification to the Intuitive Surgical® da Vinci® Surgical System, specifically incorporating monopolar electrosurgical capability on a curved scissor instrument. This submission is for a medical device and, as such, the "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to predicate devices rather than the performance of an AI algorithm against specific metrics.
Therefore, many of the requested fields are not directly applicable to this type of regulatory submission. However, I can extract information related to the device's performance demonstration for its substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Basic functional characteristics operate as intended and are similar to predicate devices. | "Bench testing has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited." |
| Design output meets design input requirements. | "Results of the design control process confirm that the design output meets the design input requirements." |
| No changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the core da Vinci® Surgical System. | "There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci® Surgical System." |
| The modification (monopolar electrosurgical capability on curved scissors) does not introduce new questions of safety or effectiveness. | The submission concludes "Substantially Equivalent" without raising new safety/effectiveness concerns, implying successful demonstration. |
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 explicitly stated. The "bench testing" would involve a number of units of the modified instrument, but a specific quantity is not reported.
- Data Provenance: Not specified, but generally, bench testing for medical devices is conducted in a controlled lab environment. This is a prospective assessment of the device's capabilities.
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 in this context. Substantial equivalence for this type of device modification typically relies on engineering and functional testing, not expert interpretation of outputs like with AI or imaging diagnostics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of data where there might be disagreement, often in clinical or AI performance studies. This submission focuses on engineering and bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was conducted. This device is a surgical instrument system, not an AI diagnostic or assistance tool in the conventional sense that would involve "human readers" and "AI assistance" for diagnostic improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical system that is operated by a human, not a standalone algorithm. The "bench testing" could be considered a form of standalone performance measurement for the instrument's functional characteristics, but not in the context of an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For this type of submission, the "ground truth" for the device's performance is adherence to established engineering specifications, functional requirements, and safety standards, as demonstrated through design analysis and bench testing. It's not a clinical or diagnostic "ground truth" derived from patient data or expert consensus.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth established for it.
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(28 days)
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/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, blunt and sharp dissection, approximation, ligation. cutting. electrocautery and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. 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.
Intuitive Surgical® Harmonic Curved Shears Instruments are designed to be used in conjunction with the da Vinci® Surgical System and with the Ethicon Endo-Surgery UltraCision® Harmonic Scalpel® Hand Piece (HP054) and UltraCision® Harmonic Scalpel® Generator Model 300 (GEN04), and is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. This instrument is not intended for use on cartilage, bone or hard objects, or for contraceptive tubal occlusion.
This special 510(k) is being submitted for a modification of Intuitive Surgical® Ultrasonic Shears. The subject device is similar to the Ultrasonic Shears instrument cleared by FDA in 2001 (K011281) and UltraCision® Harmonic Scalpel® LCS & CS Curved Shears instrument cleared by FDA in 2001 for Ethicon Endo-Surgery, Inc. (K993054). The Harmonic Curved Shears Instruments are to be used with the Intuitive Surgical® Endoscopic Instrument Control System, known as the da Vinci® Surgical System.
The da Vinci® Surgical System consists of two integrated sub-systems as follows:
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and 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. 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) and 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 provider positioned adjacent to the PSC.
Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, 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 viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
This submission is an abbreviated 510(k) for a modified device. The review of this document indicates that the acceptance criteria are not explicitly defined in terms of specific performance metrics or thresholds. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through design analysis, comparison, and bench testing, confirming that the basic functional characteristics are the same and that the design output meets the design input requirements.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in terms of shape, function, activation, and use. | The device is essentially identical in terms of shape, function, activation, and use to the predicate Class II endoscopic instrument. The primary difference is the use with the da Vinci Surgical System. |
| Basic functional characteristics are met and substantially equivalent to predicate devices. | Bench testing confirms that basic functional characteristics are substantially equivalent to the predicate devices. |
| Design output meets design input requirements. | Design analysis and comparison, as well as bench testing confirm that design output meets the design input requirements. |
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 does not specify a "test set" in the context of clinical data or patient data. The performance evaluation is based on "design analysis and comparison" and "bench testing." Therefore, information on sample size and data provenance for a clinical test set is not applicable or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable as the performance evaluation is based on engineering design and bench testing, not on expert-adjudicated clinical ground truth from a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable, as there is no mention of a human-adjudicated test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not an AI/CAD device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not an AI/CAD device. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this engineering-focused submission is established through comparison with predicate devices and verification against design input requirements via bench testing and design analysis, rather than clinical outcomes or expert consensus on clinical data.
8. The sample size for the training set:
This information is not applicable as this is not an AI/CAD device that relies on a training set of data.
9. How the ground truth for the training set was established:
This information is not applicable as this is not an AI/CAD device that relies on a training set of data with established ground truth.
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