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The intended use of the HS Catheter is for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes. The intended use of the SHG Catheter is for the delivery of saline into the female reproductive tract for examination of the uterus and fallopian tubes.

The HS Catheter devices consist of a plastic tube, the distal end of which has an inflatable cuff. A sheath is over the tube to provide a stiffener and guide. When the cuff is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the cuff with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. The HS catheters will be available in 5F and 7F sizes.

The SHG Catheter devices consist of a plastic tube with a blunt tip and one or more side holes at the distal tip. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. A sponge stop is provided to press on the external os of the cervix to reduce the back leakage of injected fluids. This devices is intended for use with saline solution, only. I n addition to the individual catheters, convenience kits will be offered that provide the physician with items helpful to the completion of the procedure.

The provided text is a 510(k) summary for a medical device (HS and SHG Catheters) and does not describe a study involving acceptance criteria in the typical sense of a performance study for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert involvement are not applicable in this context, as they pertain to clinical or performance studies that were not provided or performed for this specific 510(k) submission.

Here's the breakdown based on the information available:

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

• Not Applicable. The 510(k) summary does not report on specific performance metrics or acceptance criteria for a new clinical study. The basis for clearance is substantial equivalence to legally marketed predicate devices, not meeting specific performance thresholds in a new study.

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

• Not Applicable. No test set or associated data provenance is mentioned as no new clinical study was provided.

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. No ground truth establishment for a test set is mentioned.

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

• Not Applicable. No test set or adjudication method is mentioned.

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 a medical catheter, not an AI/ML device. No MRMC study was performed.

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

• Not Applicable. This is a medical catheter, not an AI/ML device. No standalone algorithm performance was assessed.

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

• Not Applicable. No new clinical data requiring ground truth was presented. The substantial equivalence argument relies on comparing the device's technological characteristics, intended use, and operating principles to those of predicate devices.

8. The sample size for the training set

• Not Applicable. This is a medical catheter, not an AI/ML device. No training set was used.

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

• Not Applicable. This is a medical catheter, not an AI/ML device. No training set or ground truth for it was established.

Summary of Device and Regulatory Pathway based on the Input:

• Device Name: H/S Catheter Set (Proprietary Name: HS and SHG Catheters)
• Applicant: Catheter Research, Inc. (CRI)
• Intended Use: For the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes.
• Regulatory Pathway: 510(k) Pre-market Notification, claiming substantial equivalence to predicate devices (K020292, K020951 & K020951, K022503).
• Key Basis for Clearance: The device has "the same technological characteristics as the predicate devices. The intended use and operating principles are identical. The H/S Catheter Set incorporates similar product design, materials packaging and sterilization as the predicate products."
• Clinical/Non-Clinical Testing: "None provided." This indicates that the substantial equivalence argument was made without new performance data, relying instead on comparison to existing legally marketed devices.

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The H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.

The H/S Catheter Set can be used for conducting either Hysterosalpingography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and fallopian tubes using ultrasound sonography). All components are provided sterile for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the H/S Catheter Set:

The provided document (K020951) is a 510(k) Pre-market Notification for a medical device. These types of submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria as might be seen for novel devices or PMAs.

Based on the information provided, there are no explicit, quantifiable acceptance criteria or detailed study results for device performance as requested in the prompt. The submission primarily relies on demonstrating that the H/S Catheter Set is "substantially equivalent" to a predicate device.

Here's an attempt to answer the questions based on the available information:

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

   Acceptance Criteria	Reported Device Performance
   (Not explicitly stated in the document as quantifiable performance metrics for efficacy or safety)	"Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the H/S Data Catheter Set performs safely and effectively."
   Substantial Equivalence to predicate device (Modified Hysterosalpingography Set K953034)	"The H/S Catheter Set has the same technological characteristics as the predicate device. The intended use, operating principle are identical. The H/S Catheter Set incorporates the same product design and is packaged and sterilized using the same materials and processes."

"The H/S Catheter Set is substantially equivalent to the predicate Modified Hysterosalpingography Set." |

**Note:** The document states "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described." However, **these specific performance requirements are not described or quantified in the provided text.** The "performance requirements" likely refer to bench testing for material compatibility, strength, sterility, etc., to ensure it functions similarly to the predicate, rather than clinical efficacy metrics.

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 specified. The document mentions "Pre-clinical testing," which typically refers to lab-based or bench testing, not patient data in the context of device performance.
*   **Data Provenance:** Not specified. Given it's pre-clinical testing, it would likely be internal lab data, not patient data from a specific country.
*   **Retrospective or Prospective:** Not applicable as it refers to pre-clinical testing, not patient studies.

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. The document does not describe a clinical study requiring expert-established ground truth. The "ground truth" for pre-clinical testing would be engineering specifications and test standards.

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

Not applicable. No clinical adjudication is mentioned.

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

No. This device is a catheter set, not an AI or imaging interpretation device. Therefore, an MRMC study is not relevant or mentioned.

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

Not applicable. This device is a catheter set, not a standalone algorithm.

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

For the "pre-clinical testing" mentioned, the ground truth would likely be based on engineering specifications, material standards, and functional requirements applicable to the device's design and intended use, demonstrating equivalence to the predicate. No clinical outcomes data or expert consensus on clinical findings is discussed.

8. The sample size for the training set

Not applicable. This device is a catheter set, and the submission does not mention machine learning or AI requiring a training set.

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

Not applicable. This device is a catheter set, not an AI/ML device.

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The Modified Hysterosalpingography Set is to be used for the injection of contrast material in the examination of the uterus and fallopian tubes.

The Modified Hysterosalpingography Set consists of three parts: a double-lumen, balloon bearing catheter; a semirigid placement sheath, and a syringe to inflate the balloon.

The double-lumen catheter will be available in two diameters, 5F and 7F, and is composed of a radiopaque flexible plastic tube 30cm. long. The distal end will have either a side port or end port. The balloon which is composed of a synthetic elastomer of a natural, clear polyurethane material is mounted 5 to 8 mm proximal to the The proximal end of the catheter is composed distal end. of a fitting leading to a bifurcation; one extension is for balloon inflation, the other for contrast injection.

The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and an outside diameter The length sufficient to provide semi-rigid flexibility. The distal end is flanged to provide a smooth is 20cm. non-traumatic surface to the tissues.

The syringe is either a 3cc or 6cc size for the 5F or 7F catheter, respectively. The 3cc syringe has a vent at the 1.5cc graduation providing that volume for inflation of The recommended volume for the 7F balloon the 5F balloon. is 4.0cc.

This 510(k) summary describes a medical device, the Modified Hysterosalpingography Set, and asserts its substantial equivalence to a predicate device. The performance data provided focuses on non-clinical tests to support this claim, rather than a study with acceptance criteria related to a specific clinical diagnostic accuracy or efficacy target typically seen with AI/ML or imaging devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a hysterography set) and the 510(k) summary (focused on substantial equivalence, not clinical diagnostic performance), the acceptance criteria are not for diagnostic accuracy but rather for functional and material equivalence.

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

• Test Set Sample Size: The document does not specify a numerical "sample size" in the context of typical clinical studies for diagnostic devices. The tests described are component-level functional and material tests. For "Inflation comparisons," "Over-inflation," and "Fatigue test," the sample size would typically refer to the number of balloons/devices tested. This number is not explicitly stated in the provided text.
• Data Provenance: The tests are non-clinical (laboratory/benchtop) tests. There is no mention of country of origin, nor is it a retrospective or prospective clinical study. The biocompatibility claim refers to a historical record of safe use of the catheter tubing material, implying retrospective data of clinical use from an unspecified geographical location.

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

• Number of Experts & Qualifications: Not applicable for the described non-clinical tests. These tests are objective measurements (e.g., diameter, volume, cycle count) and material property evaluations, not subject to expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests are objective measurements, not involving subjective interpretation or adjudication by multiple readers/experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (catheter set) used for diagnosis (injection of contrast material), not a diagnostic algorithm or imaging interpretation system that would typically undergo such a study.

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

• Standalone Performance: Not applicable. This device is a physical medical instrument, not an algorithm, and therefore doesn't have "standalone algorithm performance."

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

• Objective Measurements: For inflation characteristics and over-inflation resistance.
• Mechanical Testing Results: For fatigue life.
• Material Equivalence and Historical Device Safety Data: For biocompatibility, referencing the predicate device's material and its long history of clinical use.

8. The Sample Size for the Training Set

• Training Set Sample Size: 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

• Training Set Ground Truth Establishment: Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth.

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