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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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(124 days)
Standard Clamp
The Standard Clamp is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate 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 parallel in order to grasp tissue.
The provided text describes a 510(k) premarket notification for a medical device called the "Standard Clamp." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML algorithm.
Therefore, many of the requested details about acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/ML are not available in this document.
However, I can extract the information related to the device's pre-clinical evaluation which serves as a form of performance data for this physical medical device.
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantifiable acceptance criteria with corresponding performance metrics for the Standard Clamp. Instead, it describes a pre-clinical evaluation and its outcome.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Ability to clamp long planes of soft tissue without damage | "Testing demonstrated acceptable performance of the Standard Clamp." "No damage to surrounding tissues were caused by any of the clamps." |
| Histological tissue effects comparable to control/predicate devices | "The histology demonstrated similar types of tissue effects between the three clamps." |
| Conformance to device specifications | "The data demonstrate conformance to the device specifications." |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of animals or trials. The text mentions "a live anesthetized pig" (singular) and "the porcine stomach laparoscopically." It then refers to "histology samples... for each clamp," implying multiple clamping actions or multiple clamps tested on the same animal. The exact number of clamping instances or samples is not specified.
- Data Provenance: Prospective, in-vivo animal study. The location (country of origin) is not specified, but the submission is to the U.S. FDA.
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. The histological analysis would typically be performed by a veterinary pathologist, but their number and qualifications are not mentioned.
4. Adjudication method for the test set
Not applicable/not described. This was a direct observation and histological analysis, not a human reader study requiring 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
No, an MRMC study was not done. This device is a surgical instrument, not an AI/ML diagnostic tool, so this type of study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical instrument.
7. The type of ground truth used
The ground truth was established through:
- In-vivo observation of tissue effects during and after clamping.
- Histological analysis of resected stomach tissue after clamping.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(164 days)
Standard Clamp
The Standard Clamp is indicated for use in open procedures to grasp, clamp, and manipulate soft tissues.
The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.
The provided text does not describe acceptance criteria for a device, nor does it detail a study that proves a device meets specific acceptance criteria in the manner requested.
Instead, the document is a 510(k) Substantial Equivalence Determination letter from the FDA to Standard Bariatrics for their device, the "Standard Clamp." This letter affirms that the FDA has reviewed the company's premarket notification and determined the device is substantially equivalent to a legally marketed predicate device (the Doyen Atraumatic Bowel Clamp).
The "Performance Data" section of the document mentions some preclinical evaluations but does not provide the detailed information requested about acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.
Here's what can be extracted and what is missing, based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify quantitative acceptance criteria. It broadly states: "Testing demonstrates acceptable performance of the Standard Clamp, its ability to clamp the stomach, and non-traumatic tissue effect." This is a qualitative statement, not a set of measurable criteria with reported results against them.
2. Sample sized used for the test set and the data provenance
- Not Available. The document only mentions "in vivo" evaluation and "histological assessment." It does not specify the number of samples (e.g., animals, tissue samples), the country of origin, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Available. The document states a "histological assessment" was performed, implying a pathologist or similar expert would interpret the results, but it does not specify the number or qualifications of such experts.
4. Adjudication method for the test set
- Not Available. No information is provided regarding adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Not Available. No MRMC study is described. The comparison made is between the Standard Clamp's tissue effects and "other surgical devices including surgical staplers, soft tissue clamps, and graspers" and specifically the "Doyen clamp" in a histological assessment (tissue damage), not a human reader performance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a manual surgical instrument, not an AI algorithm. Therefore, "standalone" performance in the context of an AI algorithm is not relevant or described.
7. The type of ground truth used
- Histological assessment (Pathology). The document states: "Tissue effects from the Standard Clamp were compared... in a histological assessment." This implies that the ground truth for "tissue effect" was determined by pathological examination of tissue samples.
8. The sample size for the training set
- Not Applicable/Available. As this is a manual surgical instrument and not an AI/ML device, the concept of a "training set" is not relevant. No such data is provided for device development.
9. How the ground truth for the training set was established
- Not Applicable/Available. See #8.
In summary, the provided text confirms the FDA's marketing clearance based on substantial equivalence to a predicate device, and it briefly mentions preclinical testing related to tissue effects. However, it lacks the detailed methodology, acceptance criteria, and specific performance results typically found in a clinical study report for advanced medical devices, especially AI-driven ones.
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