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510(k) Data Aggregation
(188 days)
JUSTRIGHT SURGICAL, LLC
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.
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(175 days)
JUSTRIGHT SURGICAL, LLC
The JustRight Surgical™ Vessel Sealing System is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter wherever vessel ligation is required.
The JustRight Surgical™ Vessel Sealing System consists of the JustRight™ Generator and a JustRight™ Sealer. The JustRight™ Generator is designed to provide low power bipolar RF energy for vessel-sealing applications. The JustRight™ Generator is for use only with JustRight Sealer instruments. The Sealer is a hand held ring handle design with either a 10 cm or a 20 cm Shaft length that is compatible with a 3mm (ID) cannula. The JustRight™ Sealer attaches to the generator via a 10' cord.
The JustRight Surgical™ Vessel Sealing System demonstrated its performance through a series of bench and animal studies to support its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or specific numerical performance targets for the device. Instead, it relies on demonstrating equivalence to predicate devices through various tests.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Function & Durability | Not explicitly defined as quantitative criteria, but implicitly means meeting expected operational standards. | Bench testing of the JustRight Surgical™ Vessel Sealing System was performed to evaluate device function and durability. The document states that the testing was performed "to evaluate device function and durability," implying successful operation within expected parameters. Specific results or metrics are not provided. |
| Electrical Safety | Compliance with IEC 60601-1-1 | Testing was conducted and found to be in accordance with IEC 60601-1-1. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Testing was conducted and found to be in accordance with IEC 60601-1-2. |
| Biocompatibility | Compliance with ISO 10993 | Testing was conducted and found to be in accordance with ISO 10993. |
| Vessel Sealing Performance | Equivalence to predicate device (Valleylab Ligasure™ Vessel Sealing System) in ability to seal blood vessels and vascular bundles up to 5 mm. | Animal testing of the JustRight Surgical™ Vessel Sealing System was conducted, which "confirmed device performance to be equivalent to the predicate device." No specific quantitative metrics (e.g., burst pressure, thermal spread) are provided, but the equivalence implies meeting the performance standards of the predicate. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size for the animal testing. It only mentions "Animal testing."
- Data Provenance: The document does not specify the country of origin of the data. The studies were conducted by JustRight Surgical LLC. The information provided is retrospective, as it's part of a premarket notification submitted to the FDA after the tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies described are technical performance tests (bench and animal), not diagnostic or interpretative studies requiring expert ground truth in the typical sense (e.g., radiologists interpreting images). The "ground truth" for the animal study would be the physiological outcomes observed by the researchers/veterinarians involved.
4. Adjudication method for the test set:
This information is not provided. Given the nature of the bench and animal testing, a formal adjudication method as understood in clinical trials or diagnostic studies (e.g., 2+1, 3+1) is not typically applicable. The results would be objectively measured or observed by the testing personnel.
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, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (vessel sealing system), not an AI-powered diagnostic tool, and therefore human reader performance/improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a medical instrument that delivers energy for vessel sealing; it is not an algorithm or AI system. Therefore, a "standalone algorithm performance" assessment is not applicable. The performance evaluated was the direct function of the device itself.
7. The type of ground truth used:
- Bench Testing: The ground truth for bench testing (electrical safety, EMC, biocompatibility, function, durability) would be objective measurements against established engineering standards (IEC, ISO) and internal design specifications.
- Animal Testing: The "ground truth" for the animal testing would be the observed physiological outcomes and performance metrics (e.g., effectiveness of vessel sealing) measured directly in the animal models, compared against the performance of the predicate device. This is essentially outcomes data within a controlled animal study.
8. The sample size for the training set:
The device is a hardware system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
As there is no training set for an AI/ML algorithm, this question is not applicable.
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