(188 days)
The JustRight™ 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
The JustRight™ 5mm Stapler places two 25mm staggered rows of titanium staples while simultaneously dividing the tissue between the two staple rows. The unformed staple size is 2mm from staple backspan to staple leg tip. The system is provided with a stapler handle with one pre-loaded staple cartridge and reload cartridges are provided separately to allow for multiple staple line applications within one surgical procedure. The JustRight™ Stapler is compatible for introduction and use through a 5mm cannula sleeve and the stapler handle has a rotation knob to allow for 360° rotation of the staple cartridge.
The provided FDA 510(k) summary for the JustRight™ 5mm Stapler System (K132472) describes performance data from non-clinical testing rather than human clinical study data. Therefore, many of the typical questions for AI/diagnostic devices regarding acceptance criteria, sample sizes, expert ground truth, and comparative effectiveness studies are not fully applicable in the context of this device and documentation.
However, I can extract the information provided regarding the device's performance and the types of studies conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the successful completion and positive results of the listed non-clinical tests, demonstrating the device is "safe and effective and performs as intended" and "substantially equivalent to the predicate device." Specific numerical criteria are not detailed in this summary, but the types of performance evaluated are.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| In vitro Testing | |
| Device durability (multiple firings) | Evaluated successfully (implies meeting durability expectations). |
| Staple formation | Evaluated successfully (implies correct and consistent staple formation). |
| Device actuation and reload performance | Evaluated successfully (implies reliable operation and reloading). |
| In vivo Testing | |
| Tissue trauma evaluation | Evaluated successfully, including comparative testing to predicate (implies acceptable tissue trauma characteristics, comparable to predicate). |
| Knife cutting performance | Evaluated successfully (implies effective and clean cutting). |
| Device actuation and reload performance | Evaluated successfully (implies reliable operation and reloading in a live tissue environment). |
| Staple formation | Evaluated successfully (implies correct and consistent staple formation in a live tissue environment). |
| Staple line integrity | Evaluated successfully, including comparative burst testing to predicate, showing equivalence (implies the stapled line maintains structural integrity comparable to the predicate device, despite differences in staple count/line length). |
| Biocompatibility | |
| Biocompatibility in accordance with ISO 10993 | Testing conducted successfully. Tissue contact materials are biocompatible per ISO 10993. |
| Substantial Equivalence (Overall to Predicate device: Covidien Endo GIA™ 30mm 2.0 Size Stapler) | Demonstrated (implies that despite some differences in cartridge length, staple line length, number of staples/line, number of staple lines/cartridge, cannula size, shaft length, shaft diameter, cartridge articulation, and reload limits, the device performs equivalently to the predicate and does not raise new questions of safety or effectiveness). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided summary. The non-clinical studies involve in vitro and in vivo testing but do not detail the number of units tested or the number of animals (for in vivo).
- Data Provenance: The studies are non-clinical (in vitro and in vivo) and conducted by the manufacturer, JustRight Surgical LLC. The country of origin and whether it's retrospective or prospective are not applicable in the typical sense for clinical data, as this refers to lab and animal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical stapler, and the testing involves objective measurements of mechanical and biological performance (e.g., staple formation, burst strength, tissue trauma). Ground truth is established through standardized test methods and measurements, not expert consensus interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the "test set" here refers to non-clinical performance evaluations rather than image or diagnostic interpretations requiring expert adjudication.
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 a medical device (surgical stapler), not an AI/diagnostic software, and no human reader studies or MRMC studies were performed or are relevant to its premarket notification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for performance is based on objective measurements from specified test methods, engineering specifications, and established biocompatibility standards (e.g., ISO 10993). For in vivo testing, outcomes are measured directly (e.g., tissue trauma, staple line integrity/burst pressure).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is designed and validated through engineering principles and testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set or associated ground truth in the context of this 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.