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510(k) Data Aggregation
The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical SureForm 45 Curved Tip and SureForm 45 Gray Reload are an addition to the existing SureForm 45 Stapling System (SureForm 45 and SureForm 45 Reloads - White, Blue, Green and Black) cleared January 18, 2019, K183224) and are designed for use exclusively with compatible Intuitive da Vinci Surgical Systems (Models IS4000 and IS4200). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use 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 SureForm 45 Curved Tip Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Gray Reload consists of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife.
The provided text describes the regulatory submission for the Intuitive Surgical SureForm 45 Curved Tip and SureForm 45 Gray Reload. However, it does not contain the detailed breakdown of acceptance criteria and device performance in a table, nor does it specify sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these typically apply to AI/software as a medical device (SaMD) clearances.
This document describes a conventional surgical stapling device, which is a hardware device cleared through a 510(k) premarket notification. The studies outlined are primarily bench and animal (in-vivo) testing for device functionality and safety, not AI/ML model validation.
Therefore, many of the requested fields are not applicable to the provided document. I will fill in the available information and explicitly state where information is not present or not applicable.
1. A table of acceptance criteria and the reported device performance
The document describes several animal validation studies (acute and chronic) where "acceptance criteria" were met. However, it does not detail the specific quantitative acceptance criteria or provide a table directly comparing them to reported device performance metrics. Instead, it offers qualitative statements about the outcomes of these studies.
| Study Name | Acceptance Criteria (Not explicitly quantified, but implied) | Reported Device Performance (Summary of Study Outcome) |
|---|---|---|
| Acute Testing: | ||
| Staple Line Performance | Acceptable rates for transection, tissue layer approximation, hemostasis, and staple formation. | The subject device met all acceptance criteria and exhibited acceptable pass rates in the areas of transection, tissue layer approximation, hemostasis, and staple formation. |
| Buttress Material Compatibility | Clinically acceptable tissue approximation, transection, hemostasis, and well-formed staples (even with buttress material). | Pass rates in the areas of transection, tissue layer approximation, hemostasis, and optimal staple formation were not adversely affected in a statistically significant manner when buttress material was used in accordance with the manufacturer's Instructions for Use. |
| Maximum Torque | Similar tissue effects (tissue approximation and hemostasis) compared to predicate; no more than three sub-optimal staples within each test fire. | The subject device met all acceptance criteria, exhibiting similar tissue effects (tissue approximation and hemostasis) when compared to the adjacent SureForm 60 staple lines. The subject device also met the staple formation acceptance criteria with no more than three sub-optimal staples within each test fire. |
| Design Validation | All acceptance criteria met (general statement). | The subject device met all acceptance criteria. |
| Burst Pressure (Jugular venous) | Non-inferiority to predicate device in burst pressure performance. | The staple lines from the subject device performed substantially equivalent to that of the predicate device. The subject device demonstrated non-inferiority to the predicate EndoWrist 30 Gray Reload. |
| Chronic Testing: | ||
| Lung Lobectomy | No leaks intra-operatively; survival through 28 days; no signs of bleeding or leakage at staple lines during terminal procedures; well-healed staple lines. | All staple lines passed assessment for leaks intra-operatively. All animals survived through the 28 day survival period. During the terminal procedures, there were no signs of bleeding or leakage at the staple lines. Staple lines were well-healed at the end of the survival period for both subject and predicate devices. |
| Nephrectomy | No leaks intra-operatively; survival through 28 days; no signs of bleeding at staple lines during terminal procedures; well-healed staple lines. | All staple lines passed assessment for leaks intra-operatively. All animals survived through the 28 day survival period. During the terminal procedure, there were no signs of bleeding at the staple lines, and staple lines were well-healed at the end of the survival period for both the subject and predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Acute Testing:
- Staple Line Performance: 1 Porcine animal
- Buttress Material Compatibility: 1 Porcine animal
- Maximum Torque: 1 Porcine animal
- Design Validation: 1 Porcine animal
- Burst Pressure: Porcine (Excised jugular venous tissue) - number of tissue samples not specified
- Chronic Testing:
- Lung Lobectomy: 8 Canine animals
- Nephrectomy: 8 Porcine animals
- Acute Testing:
- Data Provenance: Animal model (Porcine and Canine), prospective. The country of origin is not specified but generally refers to pre-clinical lab settings associated with the manufacturer (Intuitive Surgical, Inc. in Sunnyvale, California, USA).
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. This is a hardware device clearance, and the performance assessment described is based on direct observation of physical outcomes (e.g., staple line integrity, hemostasis, tissue healing) by qualified personnel in a pre-clinical setting, not on interpretation by human experts as with AI/software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The "ground truth" here is the direct physical outcome of the surgical procedure in animal models. No human expert consensus or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/SaMD product. The studies compare the subject device's performance to predicate devices and established performance criteria for surgical staplers, not human reader performance with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance studies is primarily based on:
- Direct observation of physical outcomes: E.g., visual assessment of staple line integrity, tissue approximation, hemostasis, gross pathology during survival periods and terminal procedures.
- Physiological measurements: E.g., burst pressure testing.
- Animal survival rates and health over a chronic period.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the context of an AI/ML model. The design and engineering process would involve iterative testing and refinement, but this is not analogous to an AI training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied for an AI/ML model.
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(59 days)
The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical SureForm 45 and SureForm 45 Reloads is a disposable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical Systems (Models IS4000 and IS4200). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use 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 SureForm 45 Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. As described in Table 1, the reloads are available in four configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).
The information provided describes the SureForm 45 and SureForm 45 Reloads surgical stapler system. The study focuses on demonstrating substantial equivalence to a predicate device, the SureForm 60, through various performance tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text describes the outcomes of the studies rather than explicit numerical acceptance criteria. However, the outcomes confirm that the device met these implicit criteria.
| Study Name | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Staple Line Performance | Acceptable transection, tissue layer approximation, hemostasis, and staple formation; no effect of wrist angle. | The subject device met all acceptance criteria and exhibited acceptable pass rates in the areas of transection, tissue layer approximation, hemostasis, and staple formation. Wrist angle also had no effect on the quality of staple formation. |
| Buttress Material Compatibility | Clinically acceptable tissue approximation, transection, hemostasis, and optimal staple formation when buttress material is used. | Pass rates in the areas of transection, tissue layer approximation, hemostasis, and optimal staple formation were not adversely affected in a statistically significant manner when buttress material was used in accordance with the manufacturer's Instructions for Use. |
| Maximum Torque | Similar tissue effects (approximation and hemostasis) compared to predicate; optimal staple formation (no more than three suboptimal staples per test fire). | The subject device met all acceptance criteria, exhibiting similar tissue effects (tissue approximation and hemostasis) when compared to the adjacent SureForm 60 staple lines. The subject device also met the staple formation acceptance criteria with no more than three sub-optimal staples within each test fire. |
| Design Validation | Meet all design input requirements and user needs/intended uses in a clinical laboratory setting. | The subject device met all acceptance criteria. |
| Burst Pressure | Substantial equivalence or non-inferiority to the predicate device. | The staple lines from the subject device performed substantially equivalent to that of the predicate device. The subject device demonstrated non-inferiority to the predicate SureForm 60 and SureForm 60 Reloads. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Sizes:
- Staple Line Performance: 4 Canine, 4 Porcine
- Buttress Material Compatibility: 4 Canine, 4 Porcine
- Maximum Torque: 2 Canine, 2 Porcine
- Design Validation: 3 Porcine
- Burst Pressure: Excised jugular venous and stomach tissue from Porcine (specific number of samples not quantified)
- Data Provenance: The studies were prospective acute in-vivo animal model studies using canine and porcine subjects. The country of origin is not specified but is implicitly assumed to be the location where Intuitive Surgical, Inc. conducts its preclinical research.
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)
The document does not provide details on the number or qualifications of experts used to establish ground truth for the animal studies. The evaluation appears to be based on direct observation of outcomes (e.g., transection, hemostasis, staple formation) and measurements (e.g., burst pressure) rather than subjective expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method as would be typical for studies involving human ratings or interpretations. The evaluations appear to be direct assessments of the surgical outcomes in the animal models.
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 comparative effectiveness study was performed or mentioned. The device is a surgical stapler system, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The SureForm 45 is a surgical stapler system, a mechanical device for use with a da Vinci Surgical System, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth was established through direct physiological and physical outcomes data observed in acute in-vivo animal models, including:
- Visual assessment of transection, tissue layer approximation, and hemostasis.
- Evaluation of staple formation (e.g., number of suboptimal staples).
- Quantitative measurements such as burst pressure.
8. The sample size for the training set
This question is not applicable. The SureForm 45 is a mechanical surgical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The "training" in this context refers to design and engineering work, not data-driven model learning.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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