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Use in laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.

The FastClamp Endoscopic Clamping System is a non sterile, reusable, laparoscopic clamp instrument. It comprises a table clamp to securely attach to the operating table accessory rail, and an instrument clamp to lock the instrument in place once the instrument has been positioned.

The FastClamp Endoscopic Clamping System underwent several non-clinical tests to demonstrate its performance and safety, as described below:

1. Acceptance Criteria and Device Performance

• 5mm and 10mm nominal test bars (between Ø4.2- Ø7.4 and Ø9.2- Ø11.4) are positioned in appropriate recess in the jaws and the locking mechanism can be deployed. | The pass results in TN100346 (Exhibit 6) show that the FastClamp Endoscopic Clamping system passes the input criteria, capable of accommodating a range of instruments between Ø4.2- Ø7.4 and Ø9.2- Ø11.4, and gripping them to withstand a load of 1kg. |
  | FastClamp Bed Frame Fixation Testing | |
  | - FastClamp Endoscopic clamping system is attached to the bed rail over drape; it does not move when a load of 10kg is applied to front, back and both sides. | The pass results in TN100346 (Exhibit 6) show that the FastClamp Endoscopic Clamping system passes the input criteria to withstand a load of 10kg applied to front, back and both sides. It provides an extremely strong and stable instrument platform once it has been correctly adjusted and locked into position. |
  | Recommended Loadings for FastClamp Endoscopic Clamping System | |
  | - The FastClamp Endoscopic Clamping System is capable of holding the liver retractor and supporting simulated liver weight of 4kg. | The pass results in TN100384 show that FastClamp Endoscopic Clamping system passes the input criteria: capable of holding a liver retractor in a static position during retraction of simulated liver weights up to 4kg which is double the weight of the average male adult liver. |
  | Packaging Drop Testing | |
  | - Pass in accordance with pass criteria ASTM D4169-1996. After 100% inspection of product after dropping from a height of 610mm, there should be no visible defects found in the product. | The pass results in TN100372 (Exhibit 7) show that the FastClamp Endoscopic Clamping System passes the input criteria where the packaging remained in one piece and the product was not damaged in any way. |
  | FastClamp Juustification of 2 Year Usable Lifespan | |
  | - The FastClamp Endoscopic Clamping System is capable of passing 200 full clean, wash and autoclave cycles, and still functions safely and correctly. | The pass results in TN100362 (Exhibit 10) show that FastClamp Endoscopic Clamping system passes the input criteria, capable of functioning safely after 200 full clean, wash and autoclave cycles. The cosmetic change in color is due to the temperature during autoclaving, and once the change has occurred, there is no evidence of deterioration in the properties of function of the plating. |
  | FastClamp Steam Sterilization Validation | The steam sterilization process used for FastClamp Endoscopic Clamping System has been validated in accordance with ISO 17665 (Sterilization of health care products – Moist heat). The results showed that the sterilization requirement has been satisfied in accordance with ISO17665. FastClamp Endoscopic Clamping System Instruction for Use (IFU) has been updated to reflect the sterilization parameters which are 135°C for 30 minutes using gravity displacement with 90 minutes minimum dry time. (Full report in TN100420) |
  | Materials Biocompatibility (Cytotoxicity) | The extract of the negative control (polypropylene filters) was non-cytotoxic to L929 cells. The extract of the positive control (rubber bands) was cytotoxic to L929 cells. The extract of the test material was non-cytotoxic. (Full report in TN 100359, Exhibit 9) |
  | Materials Biocompatibility (Extractivity Testing) | The gravimetric and visual results show that no significant levels of extractable material were found. This justified not conducting ISO 10993-10 skin irritation and skin sensitization tests, as only the extractant would be assessed if no measurable extractable material was present. (Full report in TN 100359, Exhibit 9) |

2. Sample Sized Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample sizes as individual quantities for each test within the "test set" framework typical for AI/software validation. Instead, it describes multiple bench tests, stress tests, and validation procedures.

• FastClamp Jaw capability testing, Bed frame fixation testing, Recommended loadings: The sample size for these tests is not explicitly quantified as a "test set" but rather described as testing the FastClamp Endoscopic Clamping system, implying testing on representative units.
• Packaging drop testing: The inspection was 100% of the product after dropping, implying that the tested units were fully inspected.
• 2 year usable lifespan: The test involved "200 full clean, wash and autoclave cycles" on the FastClamp Endoscopic Clamping system, indicating repeated cycling on one or more representative units.
• Materials Biocompatibility: These tests (Cytotoxicity and Extractivity) were performed on "the test material," implying samples of the materials used in the device.

The data provenance is not explicitly stated in terms of country of origin but is from internal non-clinical testing ("Bench Testing"). The tests are prospective in nature, as they are specifically designed to evaluate the physical and material properties of newly manufactured devices under controlled conditions.

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

This section is not applicable as the validation criteria are based on objective physical measurements and standardized test procedures (e.g., ability to hold weight, withstand cycles, ISO standards, ASTM standards), not subjective expert interpretation of output or images. Therefore, "ground truth" as it relates to expert consensus is not relevant here.

4. Adjudication Method for the Test Set:

Not applicable. The tests involve objective measurements against predefined input criteria, not interpretation or adjudication by multiple individuals.

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 device is a mechanical clamping system, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a mechanical clamping system, not an algorithm. The "standalone" performance here refers to the device's physical capabilities without human intervention (e.g., holding a load), which is precisely what the bench tests evaluate.

7. The Type of Ground Truth Used:

The "ground truth" used is based on:

• Objective Physical Measurements: Forces (1kg, 10kg, 4kg), dimensions (Ø4.2-Ø7.4, Ø9.2-Ø11.4), height (610mm drop).
• Standardized Test Protocols: ASTM D4169-1996 for packaging, ISO 17665 for sterilization, ISO 10993-1:2002 for biocompatibility.
• Functional Criteria: Ability to remain static, ability to deploy locking mechanism, absence of visible defects, safe and correct function after cycles, satisfaction of sterilization requirements, non-cytotoxicity, and no significant extractable material.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical product and does not involve machine learning or a training set in the conventional sense.

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 YelloPort port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.

The YelloPort port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.

The device comprises a trocar, available with a range of tips styles, and a base. The base forms the cannula and has a removable 'cap' which retains the valve and/or lip seal. The trocar and cannula elements of the device are fully reusable and can be sterilised in pressurised steam. Valves and seals are essential accessories used in conjunction with the cannula and are available in a range of formats depending on the specific market requirements.

YelloPort is ergonomically designed to be strong and durable yet lightweight and easy to handle. Medical grade polymers ensure the main elements are fully reusable and can be autoclaved in pressurised steam. Cannulae are available with a choice of internal diameters and a range of working lengths.

Trocars are made from the finest surgical steels, hand finished to give reliable and lasting performance. The patented shielded trocar is also fully reusable and can be taken apart for ease of cleaning and maintenance. The precision ground and polished cutting tubes can be replaced economically if they become blunt or damaged.

The combination of reusable cannulae and trocars together with single-use valves / seals makes YelloPort a highly cost effective solution.

The device is manufactured from materials that comply with the requirements of ISO 10993 in terms of biocompatibility.

The YelloPort valves and seals are sterilised using a validated method of gamma irradiation, thereby providing a sterility assurance level of 106.

The YelloPort cannulae bodies and trocars are provided non-sterile. Sterilisation instructions are provided in the instructions for use. The Surgical Innovations steam sterilisation and cleaning validation methods are based on the AAMI TIR No 12-1994, Designing, Testing and Labelling Reusable Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufactures and proves a sterility assurance level of 106. Sterilisation validation of the steam sterilisations is based on three sterilisation cycles at one half the exposure time. The use of Bacillus sterothermophilus spore strips or inoculum is the utilised indicator.

Here's an analysis of the provided text regarding the YelloPort Port Access System's acceptance criteria and study, structured to address your specific points:

Note: The provided document is a 510(k) Summary, which is a premarket notification for devices demonstrating substantial equivalence to a legally marketed predicate device. It primarily focuses on equivalence and safety/performance aspects for regulatory clearance, rather than a full-scale clinical or comparative effectiveness study. Therefore, some of your requested information (especially regarding AI, human readers, and detailed ground truth for training) will not be present as it's not relevant to this type of device or submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance data. Instead, it describes general performance aspects and states that the device was deemed "fit for purpose" based on various bench tests.

• Capable of ease of insertion into abdominal wall.
• Reliable if containing moving parts (for reusable components).
• Assessed through a range of bench tests (TN100097, TN100144, TN100199, TN100200).
• "Performs well." |
  | Sealing Performance (Pneumoperitoneum Maintenance) | - Must maintain pneumoperitoneum when instruments are inserted.
• Must maintain pneumoperitoneum when no instruments are inserted.
• Tested for both seal and valve performance at ranges from 0mmHg to 24mmHg.
• Assessed through a substantial amount of test work (TN100131, TN100155, TN100156).
• "Performs well." |
  | Biocompatibility | - Materials must comply with ISO 10993 requirements.
• Stated that materials do comply. |
  | Sterility & Sterilization | - Valves and Seals: Sterilised using validated gamma irradiation method, achieving a sterility assurance level (SAL) of 10⁻⁶.
• Cannulae Bodies and Trocars (Reusable): Provided non-sterile. Sterilization instructions provided. Steam sterilization and cleaning validated based on AAMI TIR No 12-1994, proving a SAL of 10⁻⁶. Validation based on three sterilization cycles at half exposure time using Bacillus stearothermophilus spore strips/inoculum. |
  | Reusability / Durability | - Full reusability of main elements (trocar, base, cannula) with autoclaving in pressurized steam.
• Patented shielded trocar fully reusable and can be taken apart for cleaning and maintenance. |

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

• Sample Size: Not explicitly stated as numerical counts for "test sets" but refers to "a range of bench tests" and "a substantial amount of test work." The specific number of devices tested for each identified Technical Note (TN) is not provided in this summary.
• Data Provenance: The tests were "bench tests" performed by Surgical Innovations Group plc. The country of origin of the data is implicitly the UK, where the company is based. The data is retrospective in the sense that it's generated as part of design verification and validation prior to market submission.

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

• The document states that "advice from industry experts and clinicians" was used in establishing the "methodical approach" for trocar performance testing.
• The number of experts is not specified.
• The qualifications of those experts are broadly described as "industry experts and clinicians," without further detail on their specific specializations (e.g., surgeon, biomedical engineer) or years of experience.
• No specific "ground truth" was established by experts in the context of clinical outcomes, but rather their advice guided the bench test methodology.

4. Adjudication Method for the Test Set

• Not applicable. This was bench testing, not a study involving human interpretation of data requiring adjudication. Performance was measured objectively against test protocols.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• This device is a surgical instrument (trocar/cannula system), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

• No, a standalone performance study in the context of an algorithm's performance was not done. This device is a manual medical instrument, not an algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance was established through objective measurements and observations during bench testing against predefined criteria and protocols (e.g., force required for insertion, leakage rate at different pressures, material properties as per ISO standards). It relied on engineering principles and validated sterilization methods.
• It does not involve expert consensus, pathology, or outcomes data in the way AI/diagnostic devices might.

8. Sample Size for the Training Set

• Not applicable. This device does not use an "AI algorithm" that requires a training set. The design and manufacturing process for the device were subject to design controls and risk assessments.

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

• Not applicable. As there is no AI algorithm, there is no "training set" or "ground truth for the training set" in this context. The manufacturing and design processes followed ISO 9001/ISO 13485, ISO 14971, and 21 CFR § 820.30 standards, with verification and validation activities conducted by Surgical Innovations.

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