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The SIB Catheter is intended for the delivery of diagnostic contrast media agents into the female reproductive tract for examination of the uterus

The SIB Catheter consists of a 5 F balloon catheter with a single lumen polyurethane shaft with an end hole. The balloon inflates upon infusion of contrast media into the uterus. Increasing the infusion rate will cause the balloon to grow thereby occluding the cervical canal. Cessation of saline injection will cause the balloon to collapse.

The provided text describes a 510(k) premarket notification for a medical device called the "SIB Catheter." The submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy or performance through a traditional clinical study with detailed acceptance criteria as one might find for a novel therapeutic device or diagnostic algorithm.

Therefore, many of the requested categories for a study proving device acceptance criteria cannot be directly answered from the provided text, as this type of information is not typically included in a 510(k) for a device like a catheter demonstrating substantial equivalence. The "acceptance criteria" here refer more to meeting design and manufacturing specifications.

Here's an analysis based on the provided text, highlighting what can and cannot be answered:

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

Based on the provided text, there isn't a specific table of acceptance criteria with reported performance metrics in the way one would evaluate an AI algorithm or a diagnostic test. The acceptance criteria for a device like the SIB Catheter in a 510(k) context primarily revolve around demonstrating:

• Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
• Performance Requirements: That the device meets its design and functional specifications (e.g., balloon inflation, material integrity, sterility).

The text states:

• "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the SIB Data Catheter performs safely and effectively."

This is a general statement of compliance, not a detailed breakdown of specific performance metrics or acceptance thresholds.

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

The text mentions "Pre-clinical testing" but does not specify the sample size, type of test set (e.g., in-vitro, animal, human), or data provenance. This is typical for a 510(k) focused on a relatively simple, non-novel device demonstrating substantial equivalence.

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 text does not describe a study involving expert-established ground truth for a diagnostic assessment. The "ground truth" for this catheter's performance would relate to its physical and functional specifications (e.g., balloon integrity, material biocompatibility, flow rates), which are typically verified through engineering and bench testing, not expert consensus on diagnostic images.

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

Not applicable. No expert-based adjudication in a diagnostic context is described.

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 catheter for contrast media delivery, not an AI algorithm or a diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm, but a physical medical device.

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

For a device like the SIB Catheter, the "ground truth" effectively comes from engineering specifications, material science testing, and manufacturing quality control. For instance:

• Balloon inflation capability: Verified against design specifications.
• Lumen patency: Verified against design specifications.
• Biocompatibility: Verified through standard testing (e.g., ISO 10993).
• Sterility: Verified through validation of sterilization processes.

The text does not go into this level of detail, simply stating that "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described."

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

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Procedure trays containing components intended for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes (i.e. Hysterosalpingography or Hysterosonography).

The H/S Procedure Tray, Elliptosphere Procedure Tray and Multi-Purpose Tray contain components that can be used for conducting either Hysterosalpinography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and falopian tubes using ultrasound sonography). All components are provided sterile for single use only.

The provided document describes a 510(k) premarket notification for "H/S Catheter Procedure Tray," "H/S Elliptosphere Procedure Tray," and "Multipurpose Procedure Tray." This submission is for medical devices, specifically procedure trays used for hysterosalpingography or hysterosonography.

Based on the content, this document does not contain the information required to answer your request. The request asks for details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, and MRMC studies, which are typically part of a comprehensive clinical validation report or performance study.

Here's why the provided text is insufficient:

• Type of Submission: This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo performance against specific acceptance criteria through a new study.
• Focus on Equivalence: The "Technological Characteristics" section explicitly states: "The expanded tray has the same technological characteristics as the predicate device. The intended use, operating principle, incorporate the same product designs incorporate the same materials and are packaged and sterilized using the same materials and processes." This indicates that the claim for acceptance is based on similarity to an already approved device, rather than new, independent performance testing against defined metrics.
• Lack of Study Details: There is no mention of a specific study, clinical trial, or performance data beyond the assertion of equivalence. All points in your request (sample sizes, experts, adjudication, MRMC, standalone performance, ground truth types and establishment) are absent because they are not typically required for a 510(k) pathway that relies solely on substantial equivalence without new clinical performance claims.
• Device Type: Procedure trays are collections of components. The performance claims for such devices usually relate to sterility, material compatibility, and the ability of the components to facilitate the intended procedure, not complex diagnostic accuracy metrics that would require algorithms or AI. The FDA letter even highlights that the drug components (povidone-iodine) are regulated separately.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The document serves its purpose for a 510(k) by establishing substantial equivalence to a predicate device (Ackrad H/S Procedure Tray K881680) rather than presenting new performance data.

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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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Injection of saline in the examination of the uterus using ultrasound techniques.

The Tampa Hysterosonography set will consist of two parts: a single lumen catheter and a semi-rigid introducing sheath. The catheter will be available in a 5-French diameter with a length of 33 cm. The distal end will have either a side port or end port. The proximal end will be fitted with a female luer-lock hub. The catheter will be banded with non-toxic ink 7 cm. from the distal tip. The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. It is 16 cm. long, and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.

This 510(k) summary describes a device focused on mechanical characteristics and equivalence, not algorithmic performance. Therefore, many of the requested categories related to AI/algorithm performance and clinical study design for such algorithms are not applicable.

Here's the information that can be extracted or deduced from the provided text:

Acceptance Criteria and Device Performance Study

Detailed Analysis of Requested Information:

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

   • See table above. The core acceptance criterion is "substantial equivalence" to predicate devices in terms of materials, construction, indications for use, safety, and effectiveness. The reported performance confirms these equivalences.

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

   • Test Set Sample Size: Not applicable. This is not an AI/algorithmic device requiring a dedicated test set with performance metrics like accuracy, sensitivity, specificity, etc. The "performance data" refers to the equivalence to predicate devices and their established clinical use.
   • Data Provenance: The "Clinical results" section refers to "Procedures for hysterosonography using the predicate IUI Set." This implies retrospective clinical experience with the predicate device(s). No specific country of origin is mentioned.

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 "ground truth" establishment in the context of an algorithmic test set described here. The "ground truth" for the predicate device's safety and effectiveness would have been established through its own clinical trials and usage, but details are not provided here beyond general mention.

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

   • Not applicable. No test set requiring adjudication is described.

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 physical medical instrument (catheter set) used for a procedure (hysterosonography), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant.

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

   • Not applicable. This is not an AI algorithm.

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

   • For the predicate device's safety and effectiveness, the "ground truth" would likely be derived from clinical outcomes data observed during hysterosonography procedures. However, the document only broadly states that clinical results "demonstrate the safety and effectiveness."

8. The sample size for the training set

   • Not applicable. There is no AI algorithm being trained.

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

   • Not applicable. There is no AI algorithm being trained.

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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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The Ackrad IUI Set is intended for use in cases where the recipient has had difficulty in achieving pregnancy in the customary way.

The Ackrad IUI Set consists of two parts: a calibrating probe and an introducing catheter, each of which is accompanied by a placement sheath to aid in insertion.

The calibrating probe is a clear flexible tube, closed and rounded at the distal tip. A movable stop is attached to assist in calibrating the depth of insertion. Five narrow bands, one cm apart, designate distances of 25, 26, 27, 28 and 29cm from the distal tip, with a wide band at 30cm from the tip. The proximal end is fitted with a two-cm length of large outside diameter tubing to serve as a handle. The diameter of the probe is 1.8 mm and the working length is 44.0 cm.

The introducing catheter is identical to the calibrating probe except that the distal end has an end port or side port within 3 mm of the tip, and the proximal end is fitted with a standard female luer-lock hub.

Both the probe and the catheter are composed of clear, naturally flexible polyurethane material. The movable stop is composed of clear polyvinyl chloride of a 55-60A durometer.

Both the calibration probe and the catheter have a placement sheath through which they pass as an aid in insertion. The sheath is composed of rigid polypropylene material, 20 cm long with an inside diameter of 3.4 mm and an outside diameter of 4.6 mm. The distal end is rounded to minimize trauma.

The ink used for the banding of the catheter and probe is No-tox no. M-1000, manufactured by the Colorcon Corp. of West Point, PA.

The device functions as a means of accurately injecting the sperm into the uterus of the receptor patient. The calibrating probe is first used to measure the proper depth for insertion. Then sperm is introduced into the uterus via the catheter and expelled at the proper depth. The placement sheath allows both the probe and the catheter to be advanced through the cervix of the patient easily and non-traumatically without buckling or inadvertently touching the vagina.

The provided text is a 510(k) summary for the Ackrad IUI Set for Intrauterine Insemination. It outlines the device description, intended use, technological characteristics, and performance data, primarily comparing it to predicate devices. However, it does not explicitly define "acceptance criteria" in a quantitative manner as would typically be seen in a modern medical device submission with clear performance metrics.

Based on the information provided, here's an interpretation of the "acceptance criteria" through the lens of predicate device equivalence and the "study" that supports it:

Interpretation of Acceptance Criteria and Device Performance:

The primary acceptance criteria for the Ackrad IUI Set appear to be demonstrating equivalence in design, materials, and function to previously cleared predicate devices, coupled with satisfactory performance in limited non-clinical and clinical tests to confirm safety and effectiveness for its intended use.

Here's a table based on the provided text, outlining implicit acceptance criteria derived from the comparisons to predicate devices and the reported test results. Since explicit numerical acceptance criteria are not stated, the "Reported Device Performance" column reflects the findings that implicitly demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

• Movable stop is "clear polyvinyl chloride of a 55-60A durometer."
• Placement sheath is "rigid polypropylene material."
• Marking ink (No-tox no. M-1000) and movable stop are FDA-approved materials and "do not contact body tissue during the procedure."
• Laboratory tests showed "Sperm motility as determined the next morning was not different from that of control sperm not incubated in the catheter" after overnight incubation at 37℃. |
  | Mechanical Integrity | Device components (e.g., proximal fittings) should withstand expected forces during handling and use. | - Pull tests on proximal fittings (5 samples) "all samples resisted a force of 1 kg." |
  | Marking Integrity | Graduations/bands should remain legible and intact during use. | - Wiping tests on banded area (10 samples) with warm water showed "No smearing or removal of the black markings was observed." |
  | Insertion Characteristics | Device should allow for easy, non-traumatic, and accurate insertion into the uterus. | - "The placement sheath allows both the probe and the catheter to be advanced through the cervix of the patient easily and non-traumatically without buckling or inadvertently touching the vagina."
• The device affords "flexibility and ease of insertion into the uterus." |
  | Functional Equivalence | Device should function similarly to predicate devices for intrauterine insemination, allowing for accurate depth calibration and sperm delivery. | - "The calibrating probe is first used to measure the proper depth for insertion."
• "Then sperm is introduced into the uterus via the catheter and expelled at the proper depth."
• "The intended use is the same as the Royal Women's Coaxial Catheter Set (i.e. intrauterine insemination)."
• The IUI probe and catheter are passed into the uterus "in exactly the same way" as the Ackrad H/S Catheter (for diagnostic use) which uses the same placement sheath. |
  | Clinical Safety & Effectiveness | Use in patients should be safe, without adverse effects or complications, and effective in achieving its intended purpose (intrauterine insemination). | - Clinical testing on 24-42 year old female patients (number not specified) at The Malden Hospital: "None of the patients experienced adverse affects and no complication occurred."
• Conclusion: "The Ackrad IUI set is a safe and effective device for achieving pregnancy following intrauterine insemination." |

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

• Non-clinical/Laboratory Tests:
  • Pull Tests: 5 samples.
  • Marking Integrity Tests: 10 samples.
  • Sperm Motility Tests: Undisclosed number of samples, referred to as "sperm were loaded into the catheter."
• Clinical Testing:
  • Sample Size: Undisclosed number of female patients, ranging in age from 24 to 42.
  • Data Provenance: Prospective, from "The Reproductive Endocrinology and Fertility Services department of The Malden Hospital (100 Hospital Road, Malden, MA 02148)," USA. Patients participated under informed consent.

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

The document does not detail the establishment of "ground truth" by experts in the context of a diagnostic or classification device. For this device (an IUI catheter set), clinical safety and effectiveness are assessed by medical professionals in a clinical setting; however, specific "expert" roles for establishing a ground truth as one might find for imaging or AI algorithm evaluation are not described. The clinical testing was performed at "The Reproductive Endocrinology and Fertility Services department" by medical personnel there.

4. Adjudication Method for the Test Set

Not applicable. The study is not an evaluation of diagnostic accuracy requiring adjudication of interpretations. The clinical testing assessed safety and general effectiveness in a real-world clinical application scenario.

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

No. An MRMC comparative effectiveness study, which typically evaluates the performance of human readers (with and without AI assistance) on a set of cases, was not mentioned or performed. This type of study is more relevant for diagnostic AI tools.

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

Not applicable. This is a medical device (catheter set), not an AI algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the clinical testing, the "ground truth" was essentially the clinical outcome data (no adverse effects or complications, and suitability for achieving pregnancy via IUI). For the non-clinical and laboratory tests, the ground truth was based on objective measurements (e.g., 1 kg force withstood, no smearing, sperm motility comparison to control). There was no "expert consensus," "pathology," or other typical diagnostic ground truth mentioned as this is not a diagnostic device.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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