(76 days)
The SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® have applications for general endoscopic surgery in gastrointestinal, and gynecological, general abdominal and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
This is a 510(k) premarket notification for a medical device (surgical stapler) and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a novel technology might.
Therefore, the requested information points regarding acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment, as they would apply to a clinical performance study for a diagnostic AI device, are not directly available or applicable in this regulatory document.
However, I can extract the relevant information regarding the type of study and the basis for acceptance, which is substantial equivalence.
Here's a breakdown based on the provided text:
Basis for Acceptance:
The device, "SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units (CMLC DLUs)," gained acceptance based on a demonstration of substantial equivalence to legally marketed predicate devices. This means the FDA determined that the new device is as safe and effective as a legally marketed device (predicate) when used for its intended purpose.
The "Study" Proving Substantial Equivalence:
The "study" in this context is the 510(k) Premarket Notification itself, which involved a comparison of the new device to predicate devices. The key elements of this comparison, as described in the document, are:
- Identical Technological Features (primarily): The CMLC DLUs are stated to have "identical technological features as the predicate devices (K020719)."
- Material Changes for Multi-Patient Use: The primary modification was a material change to allow for multiple cleaning and autoclave cycles, making the device reusable.
- Increased Anvil Clamp Force: The average anvil clamp force was increased from 50 lbs on the predicate to 100 lbs on the CMLC DLUs. This change would likely have been supported by engineering testing or calculations to ensure safe and effective operation within the design parameters.
- Identical Indications for Use: The Indications For Use statement for the CMLC DLUs is identical to two other predicate devices (K040398 and K032696).
Here's how the requested information maps to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance / Characteristics |
|---|---|
| Safety and Effectiveness (equivalent to predicate) | Substantially equivalent to predicate devices (K020719, K040398, K032696) in function and indications for use. |
| Technological Features (similar to predicate) | Identical technological features as predicate K020719. |
| Biocompatibility/Material Performance (for reusability) | Material changes to withstand multiple cleaning and autoclave cycles for multi-patient use. |
| Functional Performance (e.g., clamping force) (demonstrates safety and effectiveness) | Average anvil clamp force increased from 50 lbs (predicate) to 100 lbs (new device). |
| Intended Use (same as predicate) | Identical Indications For Use statement as predicate devices K040398 and K032696. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a separate test set in the clinical study sense. The "test" was the comparison to existing predicate devices. Any testing done regarding the material changes or increased clamp force would be internal engineering verification and validation, not typically detailed in 510(k) summaries in terms of human sample sizes or data provenance.
- Data Provenance: Not applicable in the context of a clinical study. The "data" are primarily the specifications, features, and intended use claims of the new device compared against the established predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This is not a study requiring expert readers to establish ground truth for a dataset. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate device, which is already legally marketed and accepted.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no "test set" requiring adjudication in the sense of a clinical trial or diagnostic performance study. The FDA reviews the provided information and makes the substantial equivalence determination.
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
- MRMC Study: No. This is not an AI device or a diagnostic device where human reader performance is a key metric. It's a surgical stapler.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This is a physical surgical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" is effectively the legal marketing status and established safety/effectiveness profile of the identified predicate devices. The new device is deemed "substantially equivalent" when compared against this established baseline.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.