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The Avail Sterile Water Filled Syringe is intended to be used to provide a sterile liquid for catheter inflation after insertion.

A sterile, water filled, single patient use syringe designed for catheter inflation only. Not for injection. The syringes are bulk packaged for sale to customers for inclusion in urological kits. The syringes are not marketed or sold as separate devices from urological kits. The intended use of the device is to provide a sterile liquid for Foley catheter inflation after insertion. The syringe cap is removed, the syringe luer tip connects directly to the catheter valve. The sterile water is expressed to inflate the catheter. The syringe is disconnected and discarded after use.

The provided submission, K112209, is for a Sterile, Water Filled Syringe (Pre-filled Catheter Inflation Syringe) by Avail Medical Products Inc. This device is not a software/AI device, but rather a medical device intended for catheter inflation. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, expert involvement, and AI-related metrics (like MRMC or standalone performance improvement) are not applicable to this type of submission.

Here's a breakdown of the relevant information from the document, acknowledging the limitations for a non-AI product:

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

Since this is a non-AI medical device, the "acceptance criteria" are related to its physical and functional characteristics, and substantial equivalence to a predicate device, rather than diagnostic performance metrics.

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

This information is not applicable as there was no "test set" in the context of an AI study. The "testing" referred to in the document is non-clinical performance and materials testing, not data-driven evaluation with a clinical test set.

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

This information is not applicable as there was no "test set" and no ground truth established by experts in the context of an AI algorithm's performance.

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

This information is not applicable as there was no "test set" 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:

No, an MRMC comparative effectiveness study was not done. This is a non-AI medical device; such a study is not relevant.

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

No, a standalone performance study in the context of an AI algorithm was not done. This is a non-AI medical device.

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

This information is not applicable as there was no "ground truth" in the context of evaluating an AI algorithm's performance. The "ground truth" for this device's functionality would be that it effectively and safely inflates catheters as intended, confirmed through engineering and biocompatibility testing.

8. The sample size for the training set:

This information is not applicable as there was no "training set" for an AI algorithm.

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

This information is not applicable as there was no "training set" for an AI algorithm.

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The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide sterile water for catheter inflation after insertion.

The Avail Sterile, Latex Free, Water Filled Syringe is a sterile, single patient use, disposable device that is substantially equivalent to the predicate device and other pre-filled syringes. The device is designed for catheter inflation only and is intended for single patient use as was the predicate device.

The provided text does not contain information about acceptance criteria, device performance, or a study proving that a device meets acceptance criteria. The documents are a 510(k) summary and an FDA clearance letter for a pre-filled catheter inflation syringe. They focus on establishing substantial equivalence to a predicate device and outlining regulatory information.

Therefore, I cannot populate the requested tables and information based on the provided text.

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The Steri-Lub Lubricating Gel is intended to be used in procedures requiring a sterile product (surgical and urological). The Lubrication Gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

The Steri-LubTM Lubrication Gel is a sterile, single patient use, disposable instrument that is substantially equivalent to the predicate device and other pre-filled syringes. All Steri-Lubrication Gel syringes are designed for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device only and are intended for single patient use.

This document is a 510(k) Pre-market Notification for a device modification, specifically for AVAIL MEDICAL PRODUCTS, INC.'s Steri-Lub™ Lubrication Gel. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study performing to acceptance criteria in the typical sense of a clinical trial or performance study for a diagnostic AI device.

Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.

This document describes a modification to an existing device (Steri-Lub™ Lubrication Gel) and seeks to demonstrate its "substantial equivalence" to its predicate device (Steri-Lub™ Lubrication Gel, K944060). The focus is on the similarity of materials and intended use, rather than a quantifiable performance metric for a and diagnostic or therapeutic AI device.

Here's a breakdown of what can be extracted and why other points are not applicable:

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

   • Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics because this is a substantial equivalence submission for a physical device modification, not a performance study for, for example, an AI diagnostic algorithm. The implicit acceptance criterion is "substantial equivalence" to the predicate device in terms of materials, intended use, and technological features.
   • Reported Device Performance: No specific quantitative performance data is provided as this is not a study assessing performance against a benchmark. The document states that the modified device and predicate device "contain similar materials of construction" and share the same "intended use."

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

   • Not Applicable. This document does not describe a performance study involving a "test set" of data or patients. It's a regulatory submission for a physical device.

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 a performance study for this type of device modification submission.

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

   • Not Applicable. No test set or adjudication process 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 lubrication gel, not an AI-assisted diagnostic tool.

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 (expert concensus, pathology, outcomes data, etc):

   • Not Applicable. No ground truth measurement is relevant for this device modification.

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not Applicable. No training set is used.

Summary based on the provided document:

This document is a 510(k) Summary for a device modification of a sterile lubrication gel. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (Steri-Lub™ Lubrication Gel, K944060). It is not a performance study for a diagnostic or therapeutic AI device, which typically involves the detailed performance metrics, sample sizes, and ground truth methodologies outlined in your request. The "proof" is the comparison of technological features (similar materials of construction) and identical intended use between the modified device and its predicate.

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The Medtronic MiniMed Paradigm Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

The Medtronic MiniMed Paradigm Sof-site infusion sets, models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir. The infusion sets attach to the medication reservoir by means of a proprietary connecter. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue of the user by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion. The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection. The adhesive patch is integral to the base and is used to secure the unit to the user.

The provided text is a 510(k) summary for the Medtronic MiniMed Paradigm Sof-site infusion sets. This document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical validation study for an AI/ML device would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) summary uses a comparison of technological features to demonstrate equivalence in safety and effectiveness, rather than a performance study against specific, quantified acceptance criteria for a new clinical function or AI algorithm.

Below is an attempt to address the prompts based on the available information, noting where the information is not present or relevant to this type of regulatory submission.

Acceptance Criteria and Device Performance

This 510(k) submission establishes substantial equivalence for the Medtronic MiniMed Paradigm Sof-site infusion sets by demonstrating that it is as safe and effective as its predicate devices, the Medtronic MiniMed Paradigm Quick-set and Sof-set Ultimate QR infusion sets. The "acceptance criteria" in this context are primarily qualitative and relate to the device sharing similar technological characteristics and materials of construction, and that any modifications (specifically to the distal connect mechanism) do not affect safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an algorithm or diagnostic device. The evaluation is based on comparison to predicate devices and an assessment of the impact of the design modification.
• Data Provenance: Not applicable. There is no mention of country of origin of data or whether it was retrospective or prospective, as no formal clinical data study is detailed for the new device's performance against specific metrics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of expert consensus on outcomes for a test set, is not described as part of this 510(k) submission. Regulatory review for 510(k) relies on regulatory experts at the FDA assessing the submission's claims of substantial equivalence based on engineering and design principles, existing predicate data, and non-clinical testing (if any were detailed, which it is not in this summary).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set or associated adjudication method is mentioned.

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

• MRMC Study: Not applicable. This is not an AI/ML or diagnostic imaging device that would typically undergo an MRMC study to compare human reader performance with and without AI assistance. The device is an infusion set.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Not applicable. This is a medical device (infusion set), not an algorithm or AI system, so the concept of "standalone performance" for an algorithm does not apply.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of expert consensus, pathology, or outcomes data for a performance study. For this 510(k), the "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate devices and the argument that the new device shares similar technological characteristics and materials, and that its modification does not compromise safety or effectiveness.

8. Sample Size for the Training Set

• Sample Size for 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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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The Medtronic MiniMed Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

The Medtronic MiniMed Sof-site infusion sets, models MMT-358S6. MMT-358M6. MMT-358L6. MMT-358S9. MMT-358M9. and MMT-358L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir. The infusion sets attach to the medication reservoir by means of a female Luer connector. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion. The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.

This document describes the Medtronic MiniMed Sof-site Infusion Sets and their 510(k) premarket notification (K030137). However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or a study detailing how the device met such criteria.

The document is a 510(k) summary and the FDA's clearance letter, which primarily focus on:

• Device Description and Intended Use: Explains what the device is and what it's used for (subcutaneous insulin infusion).
• Predicate Device Comparison: States that the modified device has similar materials and features to predicate devices, with the exception of the at-site connection mechanism, which is deemed not to affect safety or effectiveness.
• Substantial Equivalence: The FDA's determination that the new device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable to infusion sets in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and not applicable as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable in the way you're likely thinking (e.g., pathology for AI). Compliance with standards and in-vitro/in-vivo testing would typically be used for such products, but details are not provided.
8. The sample size for the training set: Not applicable and not mentioned.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

The document essentially states that the new device is considered safe and effective because it is substantially equivalent to existing, predicate devices, and a specific modification to the connection mechanism does not impact this equivalence. There is no detailed study methodology or performance data provided in this particular excerpt.

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