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MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

MedGyn straight IUI, mini IUI, and curved, mini IUI catheters are used for intrauterine insemination for delivery of washed spermatozoa through the cervical os. The straight IUI is composed of a 21.4 cm length tube with subparts consisting of a polyethylene tube connecting with a polypropylene tube. The outer diameter of the polyethylene tube is 2.1 mm. That of the polypropylene tube is 2.75 cm. The tube is connected proximally to an ABS connector for attachment to a syringe. The mini IUI is exactly the same as the straight IUI except that the outer diameter of the inner polyethylene tube is 1.6 mm. The curved, mini IUI is exactly the same as the mini IUI except that it is slightly curved at its distal tip.

The provided text describes a 510(k) premarket notification for MedGyn IUI Catheters, asserting their substantial equivalence to a predicate device. The information primarily focuses on demonstrating that the new device does not raise different questions of safety and effectiveness, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of efficacy or performance metrics typical for AI/software devices.

The document discusses various performance tests conducted to support the safety and shelf life of the device, which are physical properties rather than AI model performance metrics.

Here is a breakdown of the requested information based on the provided text, acknowledging that many fields will be "N/A" due to the nature of this medical device (a catheter) as opposed to a software or AI device.

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified in terms of number of catheters or tests, but tests were "conducted on each version of the MedGyn IUI catheters." For biocompatibility tests, specific animal (rabbits, guinea pigs) and cell assays were used, but the exact number of samples or runs is not detailed.
• Data Provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by MedGyn Products, Inc. or their contracted labs. Not applicable to country of origin, retrospective or prospective in the context of clinical data for AI.

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

• Number of Experts: Not applicable. The ground truth for these physical and biological tests (e.g., cytotoxicity, endotoxin levels, sperm motility) is established through standardized laboratory assays and objective measurements, not expert human interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. The tests are objective laboratory assays with defined pass/fail criteria, 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

• MRMC Comparative Effectiveness Study: No. This is a physical medical device (catheter), not an AI/software 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

• Standalone Performance: No. This is not an algorithm or AI device.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for the performance tests mentioned (biocompatibility, sterility, sperm survival, stability) is based on objective laboratory measurements and standardized assay results (e.g., USP for endotoxin, ASTM F1980-07 for accelerated aging, microscopic evaluation for cytotoxicity).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

Summary based on the Provided Text:

The document describes the regulatory submission for IUI catheters, focusing on physical and biological safety testing to demonstrate substantial equivalence to a predicate device. It is not an AI or software-as-a-medical-device (SaMD) submission, so many of the requested criteria (like MRMC studies, AI performance metrics, training sets, and expert adjudication for nuanced interpretations) are not relevant to this document. The "studies" mentioned are laboratory tests designed to ensure device safety, biocompatibility, and functionality according to established medical device standards.

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MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctors' offices.

The MedGyn Digital Video Colposcope, models AL-106, AL-106SA and AL-106B (collectively, the "MedGyn Colposcope"), has the same application as traditional colposcopes. However, while traditional optical colposcopes use binocular eyepieces for magnification, the MedGyn Colposcope uses electronic imaging technology to assist doctors in reviewing, checking, analyzing, and diagnosing abnormalities or lesions of the vulva, vagina, cervix and external genitalia. It is designed to be used in hospitals, doctors' offices and clinics by qualified or trained personnel.

The MedGyn Colposcope is an active, non-contact examination device. It uses a HAD CCD color digital video camera with a digital magnification of up to 40x (or only 32x for model AL-106B), a field of view of 52° at 1x and 2° at 32X, and a green filtered light source. The camera is attached to a floor stand; model AL-106SA has a swing-arm floor stand. A cable coming from the bottom of the floor stand connects to the signal conversion box. The customer then uses the composite video cable or the s-video cable to connect a commercially available monitor to the conversion signal box.

Tissue is magnified and viewed on the doctor's own computer monitor (not included with device). Both the doctor and the patient can observe the monitor's screen, thus helping the doctor explain the abnormalities and the suggested treatments to the patient, and allowing patient to see the abnormalities for herself and better understand her medical situation.

The provided document is a 510(k) summary for the MedGyn Digital Video Colposcope, which outlines its substantial equivalence to a predicate device. This type of submission relies on non-clinical performance testing rather than clinical studies to demonstrate safety and effectiveness. Therefore, the device does not have "acceptance criteria" in the sense of a clinical trial's endpoint metrics, nor does it present a study that proves the device meets such criteria for diagnostic accuracy or clinical outcomes.

Instead, the document focuses on demonstrating that the MedGyn Colposcope meets relevant performance standards and technical specifications that are comparable to a legally marketed predicate device.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-clinical submission, "acceptance criteria" are tied to engineering specifications and compliance with voluntary performance standards. There are no diagnostic "performance" metrics (like sensitivity, specificity) derived from a clinical application in this document.

• IEC60601-1-1:2000 (Medical Electrical Equipment Safety - Collateral Standard: Medical Electrical Systems)
• IEC60601-1-2:2007 (Medical Electrical Equipment EMC)
• ISO 8600-3:1997 (Endoscopes - Field of View and Direction of View)
• ISO 8600-5:2005 (Endoscopes - Optical Resolution) |
  | On-Axis Resolution | (Implied: Sufficient for intended use, comparable to predicate, or within established industry benchmarks for colposcopes) | 11.31 line-pairs/mm |
  | On-Axis Angular Resolution | (Implied: Sufficient for intended use, comparable to predicate, or within established industry benchmarks for colposcopes) | 0.02534 degrees |
  | Geometrical Distortion | ≤ 3% (explicitly stated as acceptable) | - AL-106B = +1%
• AL-106 & AL-106SA = +2.49% |
  | Thermal Safety | (Implied: Minimal temperature rise, meeting safety standards) | From 200mm, temperature rise of only 0.20 Celsius after 30 minutes continuous working. |
  | Magnification | Up to 40x digital (AL-106, AL-106SA), up to 32x digital (AL-106B) and 1-36x optical (AL-106, AL-106SA), 1-18x optical (AL-106B) | AL-106, AL-106SA: Digital 1-40x, Optical 1-36x
  AL-106B: Digital 1-32x, Optical 1-18x |
  | Field of View (200mm WD) | (Implied: Sufficient for intended use, comparable to predicate) | At 1x >= 195mm (52°), At 32x >= 6.978mm (2°) |
  | Depth of View | (Implied: Sufficient for intended use, comparable to predicate) | 5mm~120mm |

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

• Sample Size: Not applicable in the context of clinical "test sets" for diagnostic accuracy. The testing mentioned in Section 7 ("Discussion of Non-Clinical Tests Performed") refers to engineering and bench testing of the device itself (e.g., resolution targets, distortion grids, temperature sensors) rather than patient data.
• Data Provenance: Not applicable. The "data" are measurements and compliance certificates from device testing, not patient data from a specific country or collected retrospectively/prospectively.

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

• Number of Experts: Not applicable. This submission does not involve a clinical test set requiring expert-established ground truth for diagnostic accuracy since it's a non-clinical performance evaluation focused on engineering specifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for the same reason as point 3.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with or without AI assistance, which is beyond the scope of a 510(k) summary relying on non-clinical testing to demonstrate substantial equivalence for a colposcope that is essentially an imaging tool, not a diagnostic AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No. This device is a colposcope, an imaging instrument used by a human clinician. It does not incorporate an independent algorithm for diagnosis that would typically warrant a standalone performance evaluation.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the clinical sense. The "ground truth" for the non-clinical tests involved objective physical measurements and compliance verification against established engineering standards (e.g., resolution charts, distortion grids, temperature probes).

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set" of data.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

In summary: The K122973 submission for the MedGyn Digital Video Colposcope is a demonstration of substantial equivalence based on non-clinical performance testing and compliance with voluntary international standards. It explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This means no clinical studies were conducted, and therefore, no "acceptance criteria" related to diagnostic accuracy or clinical outcomes were evaluated using patient data or expert ground truth. The acceptance criteria are engineering specifications and safety standards defined by regulatory bodies and consensus organizations.

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