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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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