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510(k) Data Aggregation
(22 days)
Disposable Standard Clamp
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.
The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The Standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures. The current Standard Clamp, Disposable has a jaw length of 25 cm. This Special 510(k) is being filed to add a new shorter jaw length (22 cm) to accommodate patients with smaller abdomens.
The Standard Clamp, Disposable is intended to be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. The Standard Clamp, Disposable is intended to be inserted into the peritoneal cavity through a 12mm trocar and used in up to six cycles of opening and closure to grasp, clamp and manipulate long, 1.2 to 4.5mm thick, planes of soft tissues such as the stomach. The Standard Clamp, Disposable is not intended for direct contact with the cardiovascular system, lymphatic system or cerebrospinal fluid. The Standard Clamp, Disposable can be used while a surgeon uses devices such as a stapler adjacent to tissue that is clamped with the Standard Clamp, Disposable, e.g., to help guide endoscopic staplers during resection of tissue such as in sleeve gastrectomy.
The provided text is a 510(k) summary for the Standard Clamp, Disposable surgical instrument. The document discusses the addition of a new, shorter jaw length (22 cm) to an existing device (Standard Clamp, Disposable 25 cm), and it asserts substantial equivalence to the predicate device.
However, the document does not contain the detailed type of study information requested in your prompt. Specifically, it does not include:
- A table of acceptance criteria and reported device performance (beyond a general statement that it "meets the same specifications").
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts or adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance data.
- Specific ground truth types for testing or training sets.
- Sample size for a training set.
- How ground truth for the training set was established.
Instead, the document states:
"Standard Clamp, Disposable performance bench testing was provided in K170379. Testing for the Standard Clamp, Disposable 22 cm is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Standard Clamp, Disposable 25 cm previously provided in K 170379. The data demonstrates that the Standard Clamp, Disposable 22 cm meets the same specifications for clamping and slip force as the Standard Clamp, Disposable 25 cm."
This indicates that bench testing was performed to compare the new device to the predicate device based on previously established specifications for "clamping and slip force." The specifics of these specifications, the acceptance criteria, and the detailed results are not present in this 510(k) summary but are referenced as being in another section (Section 018) and a previous submission (K170379).
Therefore, I cannot populate the table or answer the specific questions about clinical study details, expert involvement, or AI performance, as this information is not provided in the given text.
The document primarily focuses on demonstrating substantial equivalence based on:
- Identical Indications for Use.
- Similar Technological Characteristics (with the only difference being the jaw length).
- Bench Testing to ensure the new jaw length performs to the "same specifications for clamping and slip force" as the predicate.
- Validation of a packaging change.
This type of 510(k) submission, especially a "Special 510(k)" as mentioned for the jaw length change, often relies heavily on engineering bench tests rather than extensive clinical studies or expert-driven evaluations, particularly when the change is considered minor and does not significantly alter the device's fundamental technology or safety profile. The absence of details about clinical studies, expert reviews, or AI integration further supports the conclusion that this is not the type of device or submission that would typically include such data.
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(100 days)
Disposable Standard Clamp
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.
The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The Standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures.
This document describes a 510(k) premarket notification for the "Standard Clamp, Disposable". This application asserts substantial equivalence to a predicate device, K170379, also named "Standard Clamp, Disposable". The core argument for substantial equivalence relies on the subject device having identical technological characteristics to the predicate and the performance data for the predicate device still being applicable.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria in measurable terms (e.g., a specific percentage of reduction in staple cartridges, a maximum adverse event rate). Instead, it discusses the study's findings qualitatively.
| Acceptance Criteria (Explicitly stated in doc) | Reported Device Performance (from study) |
|---|---|
| Not explicitly stated as pass/fail criteria. The study aimed to evaluate the number of staple cartridges used and safety. | Safety: "no significant difference in post-operative adverse event rate (9.5% vs. 5.6%, p = NS)" between Standard Clamp and no clamp group. |
| Adverse Events (Standard Clamp group): No readmission or additional intervention required. One patient seen for syncope unrelated to procedure. | |
| Adverse Events (No Clamp group): One patient admitted for IV hydration due to persistent nausea/emesis. | |
| Serious Adverse Events (Both groups): "no occurrences of postoperative leak, bleeding, or stricture formation noted in either group." | |
| Effect on Staple Cartridges: The document states the study "evaluated the number of staple cartridges used" but does not report specific performance data or a comparison result regarding staple cartridge usage. It implicitly suggests the clamp's use is safe and guides staplers, but the direct outcome on cartridge quantity isn't quantified here. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 30 subjects
- Data Provenance: Prospective, single-center, randomized controlled study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting U.S. or internationally applicable clinical trial standards. The study was performed independently of Standard Bariatrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The study involves surgical procedures and post-operative follow-up, implying medical professionals were involved in assessing outcomes, but the specific number and qualifications of experts establishing ground truth (e.g., for adverse events) are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The study described is a clinical study comparing the use of the device (Standard Clamp) against a control (no clamp) in a surgical setting. It does not involve human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical surgical instrument, not an algorithm or AI system. Therefore, the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used
- The ground truth used was clinical outcomes data (e.g., post-operative adverse event rates, readmissions, interventions, specific complications like leak, bleeding, stricture formation). This would have been established through direct clinical observation, patient records, and follow-up examinations by medical professionals.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical surgical instrument, not an AI/ML algorithm that requires a training set. The performance testing relies on engineering bench tests and a clinical study.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
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(162 days)
Disposable Standard Clamp
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures.
The Standard Clamp, Disposable is a laparoscopic surgical instrument designed to grasp, clamp, and manipulate soft tissues. The following information details the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reliability Testing | 95% reliability at 90% confidence for performing 6 use cycles (opening and closure) and meeting requirements for trocar insertion, visual inspection, and functional performance for each cycle. | Testing completed without deviations. All samples met requirements for trocar insertion, visual inspection, and functional performance for each cycle. Zero failures were observed in simulated use cycles, demonstrating the ability to perform for its intended use, similar to the predicate device. |
| Tissue Compression | Clamping forces of the Standard Clamp, Disposable should be less than or equal to that of the reusable Standard Clamp (predicate device) when tested with excised porcine stomach. | Testing completed without deviations. Thirty (30) test runs demonstrated the Standard Clamp, Disposable compressed tissue with forces less than or equal to that of the Standard Clamp, Reusable. |
| Tissue Slippage | Tissue will not slip from the jaws when a working load (maximum load typically applied in surgical procedures) is applied, with 95% probability and 90% confidence, using excised porcine stomach. | Testing completed without deviations. Thirty (30) test runs demonstrated that tissue did not slip from the Standard Clamp, Disposable jaws when a working load was applied to the tissue, achieving 95% probability with 90% confidence. This demonstrates functionality substantially equivalent to the predicate device, reusable Standard Clamp. |
| Closure Strength | Closure mechanism must have a safety margin greater than or equivalent to 1.5, ensuring the worst-case stress on the closure system will not exceed the strength of the device closure system (jaws remain closed when placed in the closed position). | Testing completed without deviations. Ten (10) test runs demonstrated that the closure mechanism had a safety margin of 11.6, exceeding the required safety margin. This demonstrates that the closure system is functional for device use and substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Reliability Testing: The exact sample size for reliability testing is not explicitly stated, but the text mentions "All samples" and "zero failures" in "simulated use cycles."
- Tissue Compression: 30 test runs.
- Tissue Slippage: 30 test runs.
- Closure Strength: 10 test runs.
The data provenance is retrospective bench testing conducted by Standard Bariatrics. The type of data appears to be primarily laboratory measurements and observations from simulated use conditions. The country of origin of the data is not specified, but the submission is from Standard Bariatrics in Cincinnati, Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not mention the use of experts to establish ground truth for the bench tests. These tests appear to rely on objective mechanical measurements and observations against pre-defined performance metrics.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the testing involves objective measurements rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not provided." The study presented is bench testing comparing the proposed device to its predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical surgical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these bench tests is based on objective performance metrics and established engineering principles. For example, force measurements, tissue slippage observations, and safety margin calculations. For tissue compression and slippage, excised porcine stomach was used as a biological model.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical surgical instrument, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical surgical instrument, not an AI algorithm.
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