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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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Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.

Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use.

There are several types of dilators made from stainless steel or aluminum:

• Cooley Coronary Dilators
• Cooley Vessel Dilators
• Garrett Vascular Dilators
• Hiebert Vascular Dilators
• DeBakey Vascular Dilators
• Sarns-Style Dilators
• Myocardial Dilators

These dilators are available in a range of different length and diameters.

The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end.

Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts.

The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.

The provided document is a 510(k) premarket notification for a medical device: Fetzer Medical Vessel Dilators. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness from scratch through extensive clinical trials for new medical technologies like AI/ML devices. As such, the information you're asking for, particularly regarding acceptance criteria, study design for proving performance, and expert-driven ground truth establishment (which is typical for AI/ML diagnostic devices), is not present in this document.

The document focuses on non-clinical performance testing (reprocessing, sterilization, biocompatibility, mechanical tests) to demonstrate that the Fetzer Medical Vessel Dilators are as safe and effective as existing, legally marketed predicate devices.

Here's a breakdown of why your specific questions cannot be answered by this document and what is provided:

Why the document does not contain the requested information (related to AI/ML device performance studies):

• Device Type: The Fetzer Medical Vessel Dilators are manual surgical instruments, specifically vessel dilators. They are not an AI/ML diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device. This involves comparing indications for use, technological characteristics (design, materials, performance), and demonstrating that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) or conducting large-scale clinical studies with human readers, ground truth consensus, or advanced statistical analyses like MRMC studies, which are common for AI/ML-driven diagnostic devices.
• Performance Data Scope: The "performance data" mentioned in this document refers to physical testing of the device (e.g., cleanability, sterilizability, mechanical strength), not diagnostic accuracy or clinical outcomes in patients.

What the document does provide regarding "Testing":

The document details performance testing conducted to show the device's characteristics are similar to the predicate devices and that it meets relevant standards for a surgical instrument.

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

• Acceptance Criteria (Implicit): For this type of device, the "acceptance criteria" are broad and relate to meeting industry standards and demonstrating comparable performance to the predicate device in specific functional aspects.

  • Automatic Reprocessing Validation according to ANSI/AAMI ST81: The implicit acceptance criterion is that "contamination...could be removed...by the given cleaning and disinfection instructions."
  • Sterilization testing: The implicit acceptance criterion is that "the device will be adequately sterilized under the validated sterilization parameters" to achieve a SAL (Sterility Assurance Level) of 10^-6.
  • Biocompatibility testing (ISO 10993-5): The implicit acceptance criterion is that materials are "non cytotoxic for the indicated contact duration."
  • Mechanical tests: The implicit acceptance criterion is that devices "were able to withstand the required pulling force without deformation or failure."

• Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Sets: The document refers to "worst case devices" for reprocessing validation and "test specimens" for sterilization testing. The exact number of units or biological samples tested is not specified.
• Data Provenance: This is not applicable in the context of clinical patient data. The tests are laboratory-based. No country of origin for clinical data is mentioned as no clinical studies were performed. The tests are retrospective in the sense they were done before submission.

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

• Not applicable. The "ground truth" for these tests relates to measurable physical/biological parameters (e.g., residual protein levels, bacterial reduction, material cytotoxicity, mechanical force applied), not expert interpretation of medical images or patient outcomes.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus building among experts for subjective interpretations, which is not relevant for the objective laboratory tests performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This type of study is for evaluating observer performance, typically in diagnostic imaging. It was not conducted for this surgical instrument.

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

• Not applicable. This relates to AI/ML algorithm performance. The device is a manual surgical tool.

7. The type of ground truth used:

• Laboratory-based measurements against established standards:
  • Reprocessing: Measured contamination levels (red blood cells, residual protein, organisms, total organic carbon) against AAMI TIR 30 guidelines.
  • Sterilization: Reduction of bioindicators/challenge suspension to achieve SAL 10^-6.
  • Biocompatibility: Cytotoxicity results per ISO 10993-5.
  • Mechanical: Resistance to pulling forces.

8. The sample size for the training set:

• Not applicable. This is typically for machine learning models. No training set for an algorithm was used.

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

• Not applicable. See point 8.

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Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.

Fetzer Medical Self-retaining Retractors are reusable manual instruments made from stainless steel, aluminum or titanium. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use. Devices are available with the following features: frame type retractors, Ring handle retractors, MIS Port retractor.

The document describes the submission for a medical device called "Fetzer Medical Self-Retaining Retractors" for 510(k) clearance. The device is a self-retaining retractor for neurosurgery.

Here's an analysis of the acceptance criteria and the study used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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