(57 days)
iDrive™ Powered Handle: The iDrive™ Powered Handle, when used with the iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
iDrive™ RALC: The iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
Surgical stapler with Powered Handle, delivering implantable titanium staples. The iDrive™ Powered Handle with the iDrive™ Right Angle Linear Cutter delivers 2 rows of surgical staples on each side of the cutting blade, initiated by buttons on the powered handle.
The provided document is a 510(k) summary for a surgical stapler system (iDrive™ System), which describes the device, its intended use, and performance data from in-vitro and in-vivo testing. However, it does not contain specific acceptance criteria values or detailed study results in numerical format that would directly enable me to fill out a table of acceptance criteria and reported performance with numerical values.
The document lists various performance tests conducted, but it doesn't provide the quantitative acceptance criteria for each test or the specific quantitative results achieved by the device against those criteria. For example, it lists "Staple line pull-apart strength test" but doesn't state what the minimum acceptable pull-apart strength was or what the device's measured pull-apart strength was.
Therefore, I cannot generate the table requested in point 1 or provide detailed answers to points 2, 3, 4, 5, 6, 7, 8, and 9 as they pertain to specific quantitative study outcomes and methodologies that are not present in this summary.
Based on the information provided in the 510(k) summary, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
Information Not Available in Document: The document lists various performance tests but does not provide specific numerical acceptance criteria or the quantitative results achieved by the device for these tests. Therefore, a table with these details cannot be generated from the provided text.
| Acceptance Criteria (e.g., Min. Pull-Apart Strength) | Reported Device Performance (e.g., Measured Pull-Apart Strength) |
|---|---|
| Not specified in document | Not specified in document |
| e.g., Staple formation: >95% acceptable formation | e.g., Staple formation: X% acceptable formation |
| e.g., Burst strength: Minimum X mmHg without leak | e.g., Burst strength: Y mmHg without leak |
| ...and so on for listed tests | ...and so on for listed tests |
2. Sample Size Used for the Test Set and Data Provenance
Information Not Available in Document: The document mentions "In-vitro and in-vivo testing" but does not specify the sample sizes used for any of the tests listed (e.g., number of staple lines tested, number of animals in in-vivo studies, etc.). The provenance of the data (e.g., country of origin) is also not stated beyond being internal Covidien testing. The document is a regulatory submission, implying the studies were conducted by the manufacturer. Whether the studies were retrospective or prospective is not explicitly mentioned, but performance testing is typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Information Not Available in Document: The document does not describe the use of human "experts" to establish ground truth in the context of these performance tests. These are engineering and biological performance tests, not diagnostic image interpretation.
4. Adjudication Method for the Test Set
Information Not Available in Document: Adjudication methods (like 2+1, 3+1) are relevant to situations where subjective interpretation or consensus among multiple human reviewers is required (e.g., clinical trials with expert readers assessing outcomes). This is not applicable to the engineering and biological performance tests described in the 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Information Not Available in Document: An MRMC comparative effectiveness study, typically comparing human readers with and without AI assistance, is not mentioned. The device is a surgical stapler, not an AI or imaging diagnostic device where such studies are common.
6. Standalone (Algorithm Only) Performance Study
Information Not Available in Document: This question is relevant to AI algorithms. The device is a physical surgical stapler system, not an algorithm, so a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
For the performance tests listed:
- Staple line pull-apart strength test: Actual measured mechanical strength.
- Staple formation test: Visual and/or microscopic assessment against defined criteria for properly formed staples.
- Staple line burst strength test: Pressure required to cause a leak in a stapled tissue sample.
- Hemostasis (free bleed time) evaluation: Time to cessation of bleeding after stapling in in-vivo models.
- Air leak test: Presence or absence of air leakage.
- Tissue trauma evaluation: Histopathological assessment of tissue damage in in-vivo models.
- Knife Cutting Performance test: Assessment of cut quality, completeness, and effort.
- Product security on Tissue test while clamping and firing: Observational and/or force-based assessment of device stability and tissue retention.
- Autoclave Reliability test: Functional performance after sterilization cycles.
- Egress of material test: Gravimetric or qualitative assessment of material release.
- Fire and clamp Shaft peak stall output torque measurement: Mechanical force measurements.
- Battery and Battery charger tests: Electrical and functional performance of power components.
The "ground truth" for these tests would be the objective physical or biological measurements and observations against pre-defined engineering and biological specifications.
8. Sample Size for the Training Set
Not Applicable / Information Not Available in Document: This question refers to machine learning algorithms. The iDrive™ System is a mechanical device, not an AI system that requires a "training set" in the machine learning context. All tests described are performance and safety evaluations, not data used for model training.
9. How the Ground Truth for the Training Set was Established
Not Applicable / Information Not Available in Document: As explained in point 8, there is no "training set" for this type of device.
§ 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.