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Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

The Standard Staple-Line Reinforcement (SSLR23) is an implantable device designed to be used with Standard Bariatrics' TITAN SGS23R device (K210278) during laparoscopic surgery to position, clamp, staple, and resect long planes of soft flat tissue and organs, such as the stomach. The SSLR23 device consists of 2 (two) sheets of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material, configured to be used only with TITAN SGS23R and which provides a continuous sheet of Staple-Line Reinforcement for the entire length of the staple-line, up to 23cm in length. The device contains an applicator to aid in the installation of the SSLR23 on the TITAN SGS23R jaws. The SSLR23 device is single-use and supplied sterile.

The provided document is a 510(k) summary for a medical device called "Standard Staple-Line Reinforcement (SSLR23)". It describes the device, its intended use, comparison to a predicate device, and a summary of performance testing. However, it does not include information about acceptance criteria and reported device performance in a table format, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested.

The document states: "Pre-determined performance specifications were evaluated, tested and verification/validation activities were completed to demonstrate that the subject device... met the defined criteria. Testing on the subject device included reliability, staple-form, burst pressure, hemostasis, as well as applicable biocompatibility per applicable parts of ISO 10993-1, Biological evaluation of medical devices. Sterilization and packaging validation activities were also completed to support this submission."

It also explicitly says: "No clinical studies were required to support this 510(k) submission."

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a detailed study with specific acceptance criteria and performance metrics for a standalone device or comparative effectiveness.

Here's a breakdown of why I cannot fulfill each requested point:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. While it mentions "pre-determined performance specifications were evaluated" and "met the defined criteria", it does not list these criteria or the specific performance results in detail.
2. Sample sized used for the test set and the data provenance: This is not specified. The document mentions "testing on the subject device" but gives no details about sample sizes or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-driven ground truth establishment for a test set is mentioned. The testing appears to be primarily engineering/laboratory-based.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no adjudication process involving human review of test set results is described.
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. The device is a "Staple-Line Reinforcement" which is a physical surgical mesh, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states that "No clinical studies were required to support this 510(k) submission," implying that the testing was primarily non-clinical (e.g., bench testing, biocompatibility). It doesn't detail standalone performance in a clinical context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, as the testing described ("reliability, staple-form, burst pressure, hemostasis, as well as applicable biocompatibility, sterilization and packaging validation activities") would likely rely on physical measurements and standardized test methods rather than clinical ground truth sources like pathology or outcomes data.
8. The sample size for the training set: Not applicable. The device is a physical medical device, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The Standard Tapered Bougie, 38Fr (STB38) is indicated for use in conjunction with the Titan SGS® Stapler in vertical sleeve gastrectomy pouch creation for the application, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Tapered Bougie, 38Fr (STB38) is a non-sterile, single patient use device. The device comprises a tube with a rounded tip featuring drainage holes, and a tapered balloon at the distal end. The proximal end of the Standard Tapered Bougie, 38Fr (STB38) includes a standard Luer lock valve for balloon inflation/deflation using the 60mL/CC syringe (provided) and a 7.5mm inner diameter straight tube for connection to operating room suction, Standard Bougie Hand Pump (SBHP) or tapered tip syringe.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "Standard Tapered Bougie, 38Fr (STB38)". It outlines the device's characteristics, intended use, and comparison to a predicate device.

However, this document does NOT contain information about acceptance criteria for an AI/ML-based device, nor does it describe a study involving human readers, ground truth establishment by experts, or any MRMC (Multi-Reader Multi-Case) studies.

The "Performance Data" section (VII) lists various engineering and bench tests performed on the physical device (e.g., Dimensional Verification, Drainage Flow Rate Verification, Tensile Strength Verification, Biocompatibility Testing). These are typical performance tests for physical medical devices and do not relate to the performance of an AI/ML algorithm or its impact on human reader performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria for an AI/ML device based on the provided text, as the text describes a physical device, not an AI/ML system.

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The STANDARD BOUGIE SB38 is indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Bougie (SB38) is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide. The Standard Bougie Hand Pump (SBHP) is an accessory to the current Standard Bougie (SB38). The SBHP is provided to enable insufflation of the stomach to enable controlled rearrangement of the gastric folds/rugae of the stomach or to perform leak testing during gastric and bariatric procedures.

This document is a 510(k) premarket notification for a medical device called the "Standard Bougie, 38 Fr. and Hand Pump" (K212728). The purpose of the submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of quantitative benchmarks for a novel diagnostic or treatment device. Instead, the submission for this Class II surgical accessory focuses on demonstrating substantial equivalence to a predicate device by comparing their technological characteristics and performing verification and validation activities.

The "acceptance criteria" are implicitly met if the device demonstrates equivalent performance and safety to the predicate device and introduces no new safety concerns. The "reported device performance" is demonstrated through nonclinical testing to ensure the added hand pump accessory does not negatively impact the device's original functions (suction, drainage, irrigation, insufflation, sizing) and maintains its safety profile.

Here's a summary derived from the "Overview of Substantial Equivalence" table and the "Performance Data" section:

• Transit and 1 year Accelerated Aging
• Performance Testing post Transit and 1 year Accelerated Aging
• Pressure Decay Testing
• Insufflation Testing
• Reliability Testing |
  | Safety and Effectiveness (As safe and effective as predicate) | The nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device. The addition of the Standard Bougie Hand Pump does not raise any new types of questions. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes nonclinical performance data (bench testing) for the accessory component (Standard Bougie Hand Pump) and confirms the existing data for the main device (Standard Bougie SB38) remains applicable.

• Sample Size for Test Set: Not explicitly stated in terms of patient numbers, as this is a nonclinical study. The "test set" refers to the devices or accessories subjected to the specified engineering tests (Transit and 1 yr Accelerated Aging, Performance Testing, Pressure Decay, Insufflation, Reliability Testing). The number of units tested per test is not detailed.
• Data Provenance: This is a submission for a medical device by Standard Bariatrics, Inc. located in Cincinnati, OH. The data would originate from internal company testing and validation activities. The document does not specify if any of the testing was conducted outside the U.S.
• Retrospective or Prospective: Not applicable as this is nonclinical (bench) testing of a medical device accessory, not a clinical study involving patients or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes nonclinical (bench) testing of a surgical accessory, not a diagnostic device that requires expert interpretation for establishing ground truth (e.g., radiologist for imaging, pathologist for tissue samples). The "ground truth" here is defined by engineering specifications, risk assessments, and established testing methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving human readers interpreting data where consensus is needed to establish ground truth. The tests described are objective engineering tests.

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

This is not applicable. A multi-reader multi-case (MRMC) comparative effectiveness study is relevant for diagnostic devices, particularly those involving Artificial Intelligence (AI) assistance for human interpretation. The Standard Bougie and Hand Pump is a surgical accessory, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This question refers to the performance of an AI algorithm independent of human input. The device is a physical surgical tool with a mechanical accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device, in the context of its nonclinical performance evaluation, is based on:

• Engineering specifications and design requirements: The device's ability to meet its functional requirements (e.g., insufflation pressure, reliability, transit resistance, aging effects) as defined by its design.
• Risk assessment: The demonstration that the device (especially the new accessory) does not introduce unacceptable risks.
• Comparison to predicate device: The fundamental "ground truth" for a 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device, meaning it performs as safely and effectively.

8. The sample size for the training set

This is not applicable. A "training set" refers to data used to train machine learning models. This document describes the regulatory submission for a physical medical device, not an AI/ML product.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above (not an AI/ML product).

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The STANDARD BOUGIE™ SB38 is indicated for use in conjunction with the Titan SGS ™ stapler in vertical sleve gastrectorny pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Bougie SB38 is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

The provided text describes the regulatory clearance of the "Standard Bougie, SB38" device and outlines its characteristics and comparison to a predicate device, along with a list of performance tests conducted. However, it does not provide detailed acceptance criteria or the specific results of those performance tests. The document states that "Standard Bougie SB38 performance testing has been submitted in this 510(k)", and then lists the types of tests. It concludes that "The conclusion drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device." but does not present the data itself.

Therefore, for aspects requiring specific numerical data, sample sizes, expert qualifications, or details of a study (like an MRMC study or standalone performance), the information is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document only lists the types of performance tests conducted. It doesn't specify the acceptance criteria for each test or the quantitative results achieved by the device against those criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided text. The document lists performance tests but does not specify the sample sizes used for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable/available. The performance tests mentioned (Drainage Flow Rate Verification, Balloon Strength Verification, Balloon Size Verification, Balloon Firmness Verification, Tensile Strength Verification, Reliability Testing) appear to be engineering/mechanical tests rather than studies involving expert assessment of medical outcomes or images. Therefore, the concept of "ground truth established by experts" as typically seen in AI/diagnostic device studies does not apply here.

4. Adjudication Method for the Test Set

Not applicable/available. As the tests are engineering/mechanical in nature, an adjudication method (like 2+1, 3+1) is not typically used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text does not mention an MRMC comparative effectiveness study. The device is a "bougie," which is a physical medical instrument used as a sizing guide and for other functions during surgery, not a diagnostic imaging or AI device that would typically undergo an MRMC study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant.

7. Type of Ground Truth Used

Not explicitly stated, but implied as engineering/physical measurements. For the listed performance tests (e.g., strength, size, flow rate), the ground truth would be based on precise physical measurements and engineering specifications, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a physical device, this question is not relevant.

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The Titan SGS linear cutter is intended for longitudinal transection of gastric tissue for sleeve gastrectomy pouch creation.

The Titan SGS with implantable staples (Titan Stapler) is a single patient use, sterile instrument used for cutting and stapling gastric tissue for sleeve gastrectomy pouch creation. The Titan Stapler is supplied preloaded with staples, fires once and cannot be reloaded. The Titan Stapler is comprised of three main sections: Stapler, Cable, and Power Supply Unit. The stapler end effector is 230 mm long and contains 342 staples that are organized in 6 staggered rows, 3 on each side of the cut line. The staples range in closed staple height from 2.2 mm to 1.2 mm. Staples are formed into a traditional 'B' shape: similar to existing devices. As with other powered staylers, the Titan Stapler opens and closes through a simple mechanical linkage housed in the shaft and effector of the device. The device of the single-use Titan Stapler and a reusable power source which is supplied separately. There are no accessories supplied with the instrument. The Titan Stapler Power Source is designed to supply energy to the Titan Stapler and has a unique receptable port specific to the Titan Stapler.

The provided text describes the 510(k) premarket notification for the Titan SGS linear cutter. However, it does not contain the specific acceptance criteria and detailed study information requested in your prompt regarding device performance metrics like accuracy, sensitivity, or specificity.

The document focuses on demonstrating substantial equivalence to a predicate device (Echelon Flex Powered Plus) rather than proving the device meets specific performance criteria against a predefined ground truth in the way one might for an AI/ML diagnostic device.

Here's a breakdown of what is available and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document in the format of specific acceptance criteria (e.g., minimum accuracy of X%, sensitivity of Y%). The document states:

• "Pre-determined performance specifications were tested, and validation activities were conducted to demonstrate that the Titan Stapler met the defined criteria."
• "The Titan Stapler met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use."

However, the specific quantitative acceptance criteria and the corresponding reported performance values (e.g., specific measurements of staple line integrity, leak rates, etc.) are not detailed. It mentions "hemostasis as compared to the predicate device" in animal studies, but no numerical data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Clinical Study: "A comparative clinical study including 36 subjects at one site was conducted between the Titan Stapler and the predicate device, the Echelon Flex Powered Plus GST System on excised human stomach." This implies a prospective study using ex vivo human stomach tissue. The country of origin is not specified but given the FDA context, it's likely the US.
• IDE Study: "The study enrolled 62 subjects at three sites." This was a prospective study (IDE G200085). Country of origin is not specified, but again, likely the US.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The assessment of "comparable performance" in the clinical studies would have involved expert evaluation (e.g., surgeons assessing the staple line), but the number and qualifications of these experts are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

There is no mention of an MRMC study or AI assistance. This device is a surgical stapler, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as it's a physical medical device (surgical stapler), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "clinical study (36 subjects) on excised human stomach," the ground truth would likely involve direct visual and physical assessment by surgical experts regarding the quality of the stapled tissue (e.g., staple formation, integrity, transection line).

For the "IDE G200085 study (62 subjects)" which demonstrated "reasonable assurance of safety and effectiveness," the ground truth would typically involve a combination of:

• Clinical outcomes data: monitoring for adverse events (e.g., leaks, bleeding, stricture formation) specific to the stapler performance.
• Intraoperative and postoperative assessments: by surgeons and medical staff.

8. The sample size for the training set

This is not an AI/ML device, so there is no "training set" in the context of an algorithm. The development of the device would involve engineering design, bench testing prototypes, and animal studies before human studies.

9. How the ground truth for the training set was established

Not applicable as it's not an AI/ML device.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a surgical stapler, focusing on demonstrating substantial equivalence to a predicate device. It does not provide the kind of detailed performance metrics, acceptance criteria, and AI/ML specific study information you requested, as those types of studies and criteria are typically associated with diagnostic AI/ML products.

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The Standard Trocar is a sterile, single-use device consisting of an obturator, a cannula, a 5mm adapter and introducer sheath. This system is indicated for use in general and abdominal minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

The Standard Trocar is a single-patient-use disposable trocar manufactured from biocompatible medical plastics. The device is comprised of a trocar cannula, obturator, 5 mm adaptor, and introducer sheath. The Standard Trocar is a sterile, single patient use surgical instrument intended to establish a port of entry for 19mm outer diameter instruments to be used during minimally invasive procedures. The 5 mm adaptor provides the means for the trocar to also be used with 5 mm diameter instruments. The trocar is compatible with commercially available laparoscopic instruments. In addition, as Standard Bariatrics develops additional laparoscopic instruments, the Standard Trocar will accommodate those devices. The Standard Trocar is sterilized using gamma irradiation and provided to the user in a Tyvek tray with peel lid.

The provided text describes the 510(k) premarket notification for the "Standard Trocar" and compares it to a predicate device, the "Applied Medical Modular Trocar." This document is a regulatory submission to the FDA, not a study report on an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI-powered device.

The document discusses performance testing for a medical device (trocar) in terms of its physical and mechanical properties, biocompatibility, and usability, demonstrating substantial equivalence to a predicate device. It does not involve any AI components, ground truth, expert consensus for AI model evaluation, or MRMC studies.

Therefore, I cannot extract the requested information from the provided text as it is not relevant to AI/ML device evaluation.

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The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide.

The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

The provided text is a 510(k) summary for the Standard Bougie device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

The "Performance Data" section (VII) lists several types of verification and testing, such as "Drainage Flow Rate Verification," "Balloon Strength Verification," and "Device Usability." These tests are likely related to the physical and functional performance of the bougie itself, not to an AI system's diagnostic accuracy or a human-AI team's effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them from the provided text. The document describes a medical device (a bougie) used in bariatric surgery, not an AI or imaging diagnostic device.

To answer your request, I would need a different document that details the development, validation, and performance studies of an AI-powered medical device.

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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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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.

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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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

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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