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Fetzer Medical Gynecological Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.

This 510(k) covers 31 devices a total of 132 variants representing three general designs (vulsellum, tenaculum, and hysterectomy). These products are reusable manual surgical instruments to be used in gynecological procedures. They are scissor-like, self-retaining devices with ring handles and two blades and made of high-grade stainless steel or titanium. They are available in various sizes with different blade designs at the distal end (e.g., straight or curved). Some of these devices have an additional grasping claw at the distal end. The blades are heavily serrated or may have a profiled longitudinal groove to provide extra grip of the organ.

The subject devices vary in the jaw configurations and curvature to meet the surgeon's needs and preferences, based on individual, anatomical variations of the patients. The products are sold nonsterile and can be reused (cleaned and sterilized) according to the instructions for use.

This document does not describe "acceptance criteria" for a device in the context of clinical performance metrics (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating "substantial equivalence" of a new medical device to a predicate device for FDA clearance. The "performance criteria" described are engineering and biocompatibility tests rather than clinical study endpoints.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as it pertains to a 510(k) premarket notification for a manual surgical instrument, not an AI/software device that would typically have such performance criteria.

Here's the information that can be extracted or inferred:

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

• FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015)
• AAMI TIR12:2010. (Implicitly, the device's reprocessing instructions were validated and met these requirements). |
  | Boiling Water Test for Corrosion | No evidence of corrosion | Performed per ASTM F1089-10. (Implicitly, the device met the criteria and showed no unacceptable corrosion). |
  | Elasticity Test | Maintain functional elasticity | Performed per DIN 96198-3. (Implicitly, the device met the criteria for elasticity). |
  | Functional Equivalence | Perform as intended for its use | The device is demonstrated to have the "same intended use and fundamental technological characteristics" as the predicate device. Differences in material (titanium vs. stainless steel) or specific dimensions were deemed not to raise different questions of safety and effectiveness as titanium is widely used and both devices offer ranges of configurations. |

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified for any of the non-clinical tests. This typically refers to the number of devices or material samples tested.
• Data Provenance: The tests are described as "non-clinical performance testing" and involved laboratory studies, not patient data. Therefore, country of origin or retrospective/prospective is not applicable in the usual sense for clinical studies. The tests were performed in support of the device's substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device is a manual surgical instrument. "Ground truth" in the context of expert consensus is not relevant here; the ground truth is established by standardized material and performance testing.

4. Adjudication method for the test set

• Not applicable. This is for non-clinical, objective performance tests, not subjective interpretations 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

• Not applicable. This is not an AI or software device.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

• For Biocompatibility: The "ground truth" is adherence to ISO standards and established biocompatibility principles.
• For Cleaning & Sterilization Validation: The "ground truth" is the ability to render the device clean and sterile according to FDA guidance and AAMI standards.
• For Bench Performance Tests (Corrosion, Elasticity): The "ground truth" is the physical properties of the materials and device and its performance against established engineering standards (ASTM, DIN).

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not applicable.

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Integra® Gynecological Surgical Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.

Integra® Gynecological Surgical Forceps are designed to provide a secure grip on tissue during vaginal and abdominal hysterectomy procedures. These atraumatic instruments are designed to minimize laceration or perforation of the tissue even when required retraction is exerted. Due to differences in anatomy of the site and types of surgical procedures, a variety of configurations and models are offered to provide the surgeon with options to ensure clinical needs are met.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided 510(k) summary does not explicitly detail the specific quantitative acceptance criteria (e.g., "bacterial reduction of X logs," "no visible corrosion after Y cycles") for each test. It only states that the device "Passed," implying it met the criteria defined within those standards.

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

This document describes a pre-market notification for a medical device (Integra® Gynecological Forceps) which is a mechanical surgical instrument, not an AI or software-based device. Therefore, the concept of a "test set" in the context of data for AI algorithms is not applicable here.

The "test set" for this device comprises physical samples of the Integra® Gynecological Forceps that underwent various non-clinical performance and material validation tests (cleaning, sterilization, corrosion). The document does not specify the exact number of physical samples used for each test. All tests are prospective as they were conducted specifically for this 510(k) submission. The provenance of the data is from Integra York PA, Inc. (the manufacturer's internal testing or contracted labs).

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

Not applicable. This is not an AI or diagnostic device that requires expert ground truth labeling. The "ground truth" for a physical instrument is its functional performance, which is objectively measured against engineering and regulatory standards (e.g., "does it corrode?", "can it be sterilized?"). The experts involved would be engineers, microbiologists, and other technical specialists conducting and evaluating the tests, but not in the sense of establishing a "ground truth" for a classification task.

4. Adjudication Method for the Test Set

Not applicable. There is no subjective interpretation or classification that would require an adjudication method like 2+1 or 3+1. The tests yield objective "Pass" or "Fail" results against predefined criteria in the referenced standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a physical surgical instrument, not a diagnostic imaging or AI-assisted system. MRMC studies are used to evaluate the effectiveness of diagnostic devices on human performance.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective performance metrics and material compliance as defined by recognized industry and regulatory standards (AAMI, ASTM, ISO). For example:

• Cleaning: The ability to be thoroughly cleaned, likely measured by residual protein/bioburden levels after a cleaning cycle (criteria within AAMI TIR12 and TIR30).
• Sterilization: The ability to withstand sterilization processes without damage and achieve sterility (criteria within ANSI/AAMI ST79).
• Corrosion: Resistance to corrosion under specified conditions (criteria within ASTM F 1089-02 and ISO 13402).
• Biocompatibility: Conformance to established material standards (ASTM F899-11, ISO 7153-1) for surgical instruments made of stainless steel known to be safe in the body.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set for an AI/ML model.

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INSTRUMED gynaecological forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynaecological examination.

Instrumed gynaecological forceps are heavy forceps which have special designed jaws to hold securely without slipping during vaginal and abdominal hysterectorny procedures, yet do not lacerate the tissue to which it has been applied to even when it is necessary to exert traction.
The Instrumed gynaecological forceps are reusable surgical instruments.
To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:

• length and bending of the forceps and jaws .
• ring handles with a ratchet closure to adjust the amount of tension applied.
• jaw design, option of longitudinal grooves, teeth or cross serrations .
• the choice of jaw style depends on the surgeon's preference .
  The surgeon chooses the gynaecological forceps based on the anatomy of the site and the designs desired are based on the type of the surgical procedure.
  Instrumed gynaecological forceps are made of the ASTM F 899-07 standardized Stainless Steel.
  The instruments are offered in non-sterile condition.

This document is a 510(k) summary for a medical device called "Instrumed Forceps Gynaecological." It's a regulatory filing to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no acceptance criteria or dedicated study described that proves the device meets specific performance criteria in the way typically associated with advanced AI/Software as a Medical Device (SaMD) clearances or certain diagnostic devices.

Here's an analysis based on your requested information:

1. Table of acceptance criteria and the reported device performance

Explanation: This 510(k) is for a set of manual surgical instruments (gynecological forceps). For such devices, the "acceptance criteria" and "performance" are typically assessed through comparisons to predicate devices in areas like material composition, manufacturing processes, intended use, and general safety/effectiveness, rather than quantitative performance metrics like sensitivity/specificity for diagnostic AI. The document asserts comparability and successful completion of standard evaluations for surgical instruments like biocompatibility and sterilization.

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

• Sample Size: Not applicable. This document does not describe a clinical study with a "test set" of patient data in the context of device performance in a diagnostic or AI-driven sense. The "testing" mentioned is non-clinical and bench testing of the instruments themselves.
• Data Provenance: Not applicable.

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)

• Not applicable. There is no mention of a "test set" requiring ground truth established by experts. The device is a manual surgical instrument.

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

• Not applicable.

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 not an AI/SaMD product.

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

• Not applicable. This device is not an algorithm or SaMD.

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

• Not applicable in the context of diagnostic performance. For manual surgical instruments, "ground truth" relates to their physical properties, material conformity (e.g., ASTM F 899-07 standardized Stainless Steel), sterility, and ability to perform their mechanical function compared to similar devices. The document implies compliance with these standards through "non-clinical and bench testing."

8. The sample size for the training set

• Not applicable. This device is not an AI/Machine Learning model.

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

• Not applicable.

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