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ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macroand micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si). ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE docs not set in-situ following implantation. ALTAPORE is available in 1.5ml, 2.5ml, 5ml, 10ml, and 20ml configurations.

AI,TAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary. the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bony healing in a critical defect model as confirmed with radiographic, histolopatholgical, histomorphometric, and mechanical analyses. ALTAPORE undcrgocs ccll-mediated remodeling and is replaced by natural bone.

Here's an analysis of the acceptance criteria and study information for the ALTAPORE device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for ALTAPORE primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantifiable acceptance criteria that are then met by performance metrics. The "acceptance criteria" here are implied by the comparison to predicate devices and the general safety and effectiveness requirements for bone void fillers.

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

• Test Set Sample Size: Not explicitly stated as a numerical count of subjects or defects. The text refers to "in vivo animal studies" and "critical size defect implantation in-vivo animal studies" but does not provide specific numbers for the animals or defects studied.
• Data Provenance: The studies mentioned ("in vivo animal studies") suggest prospective animal studies. The country of origin for the data is not specified in the provided text.

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

• The concept of human "experts" establishing ground truth for evaluating the device's performance in a diagnostic or interpretive context (e.g., radiologists interpreting images affected by AI) is not applicable to this device. ALTAPORE is a bone void filler, and its performance is assessed through objective biological and material properties, as well as animal studies. Evaluation methods mentioned include radiographic, histopathological, histomorphometric, and mechanical analyses, which typically involve trained professionals interpreting results, but not in the context of defining "ground truth" for a labeling or classification task.

4. Adjudication Method for the Test Set

• Not applicable in the context of this device's evaluation. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert opinions during diagnostic AI evaluations. This device's evaluation relies on objective measurements and scientific analysis in animal models.

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 type of study is relevant for diagnostic AI tools where human readers are involved in interpreting medical images or data. ALTAPORE is a medical device (bone void filler), and its performance is not assessed through human reader interpretation of AI output.

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

• Not applicable. This device is not an algorithm or AI system. It is a physical bone void filler. The "standalone" performance here refers to the device's inherent properties and biological interactions as assessed in in vitro and in vivo (animal) studies, without human intervention in its function. The studies evaluate the material itself.

7. The Type of Ground Truth Used

• The "ground truth" for evaluating ALTAPORE's performance in animal studies was established through a combination of objective scientific analyses:
  • Radiographic analysis: Imaging confirming bone formation.
  • Histopathological analysis: Microscopic examination of tissue to assess new bone growth and remodeling.
  • Histomorphometric analysis: Quantitative microscopic analysis of tissue structures.
  • Mechanical analysis: Testing the strength and integrity of the repaired bone.
  • In vitro studies: Demonstrating apatite layer formation in simulated body fluid.

8. The Sample Size for the Training Set

• Not applicable. The concept of a "training set" is relevant for machine learning algorithms. ALTAPORE is a physical medical device, not an AI or algorithm that requires training data.

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

• Not applicable. As mentioned above, there is no "training set" for this device.

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The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors.

The proposed devices, which are the subject of this Special 510(k) Premarket Notification. consist of a power injectable extension set without the One-Link Needle-free IV connector, extension set codes with the One-Link Needle-free IV connector bonded to the rest of the set, standard bore power injectable extension sets, and a power injectable extension set with a one piece male Luer. They are single use disposable devices intended for use with a vascular access device for the withdrawal of fluids and/or the continuous or intermittent administration of fluids.

The provided document describes a Special 510(k) Premarket Notification for updated configurations of the Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K120443) by adding new set configurations, rather than introducing a completely new device or technology. Therefore, the "study" described focuses on non-clinical performance testing to ensure the new configurations maintain the safety and effectiveness of the predicate device.

Here's a breakdown of the requested information based on the provided text, recognizing that some points are not fully applicable or explicitly detailed for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results meet their acceptance criteria," but does not explicitly list the specific quantitative acceptance criteria for each test. For instance, for the "Tubing bond strength test," the document doesn't specify what minimum bond strength (e.g., in pounds-force) was considered acceptable.

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

• Sample Size: The document does not specify the sample size for any of the individual non-clinical tests. It simply states that "all test results meet their acceptance criteria."
• Data Provenance: The tests were conducted by Baxter Healthcare Corporation. The document does not specify the country of origin of the data beyond the company's location (Deerfield, Illinois, USA). The tests are inherently non-clinical (laboratory/bench testing) rather than clinical retrospective or prospective studies.

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

This question is not applicable to this type of regulatory submission. The "ground truth" for non-clinical performance tests is typically established by engineering specifications, recognized industry standards (like ISO standards mentioned for Luer tests), and risk analysis, rather than expert consensus on medical images or patient outcomes. The performance is measured against predefined engineering and safety benchmarks.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies where expert review and consensus are needed to determine an outcome (e.g., presence of a disease). For non-clinical bench testing, the results are typically quantitative measurements compared against predefined acceptance criteria, and thus do not require an adjudication process involving multiple human experts in the same way.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers in interpreting data (e.g., medical images). The submitted device is an IV connector and extension set, which is a medical device for fluid administration, not a diagnostic or AI-assisted interpretation tool.

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

No, a standalone algorithm performance study was not done. This device is a physical medical product, not an AI algorithm.

7. The Type of Ground Truth Used

For this submission, the "ground truth" is based on engineering specifications, recognized industry standards (e.g., ISO Luer tests), and design verification tests derived from risk analyses. It's about demonstrating that the physical device components (connections, bonds, materials) perform as expected under specified conditions (pressure, flow rate, stress) to ensure safety and effectiveness for its intended use, rather than comparing against pathology, clinical outcomes, or expert consensus on a diagnostic finding.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI model that requires a training set of data.

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

This question is not applicable. As stated above, this submission is for a physical medical device, not an AI model requiring a training set.

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To administer fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of a stand-alone stopcock, stopcock manifold gangs, Intravenous (I.V.) administration sets with stopcock(s), and I.V. extension sets with stopcock(s). They are single use disposable devices intended for use for continuous or intermittent fluid administration or withdrawal of fluids. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K962581 (cleared August 28, 1996), K961225 (cleared June 21, 1996) and K022895 (Elcam Plastic, cleared October 18, 2002).

The stand-alone stopcock is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path. It is used to control the fluid flow pathway by rotating the flow control handle.

The stopcock manifold gangs consist of individual stopcocks assembled in series through common Luer fittings to form a manifold or gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The Luer connectors on either end of the stopcock gang allow connection to an administration or extension set for fluid administration through an indwelling intravascular catheter.

The I.V. administration sets with stopcock(s) (i.e. solution sets, secondary medication sets, Continu-Flo sets) are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They contain the stopcock(s) that can be used for the administration of secondary medication.

The I.V. extension sets with stopcock(s) are used for the administration and withdrawal of fluids. They consist of the stopcock connected to the extension set.

Currently, Baxter uses three stopcock designs in the stopcock system. The basis for this premarket notification is the standardization to one stopcock design. No new materials of construction are being introduced into Baxter's stopcock system as part of this change. This change does not impact the intended use or the fundamental scientific technology of the device. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.

The provided document describes a Special 510(k) Premarket Notification for "Stopcock and I.V. Solution Administration Sets with Stopcocks." This submission is for a device modification, specifically the standardization to one stopcock design, and not for a new device requiring extensive clinical trials for performance evaluation against acceptance criteria as is common for AI/ML devices. Therefore, much of the requested information regarding AI/ML device studies (e.g., sample size for test sets, expert qualifications, HRMC studies, standalone performance) is not applicable or present in this document.

However, the document does list acceptance criteria in the form of bench tests that were conducted and states that "All test results meet the acceptance criteria."

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria values for each test, nor does it give specific reported device performance values. Instead, it makes a general statement that all tests met the acceptance criteria.

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

The document does not specify the sample size used for each bench test or the data provenance.

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

Not applicable. This is a medical device modification submission based on bench testing, not an AI/ML diagnostic or prognostic device requiring expert consensus for ground truth.

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

Not applicable. Bench tests do not typically involve human adjudication in the same way clinical studies or image interpretation studies do.

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-assisted device.

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

Not applicable. This is not an AI-assisted device.

7. The type of ground truth used

The ground truth for the performance evaluation was established through bench test specifications and internal risk analyses. The tests were designed to evaluate the functional performance of the device against predefined engineering and safety standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "training" in this context refers to manufacturing and design verification processes, not machine learning model training.

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

Not applicable. As noted above, this is not an AI/ML device. For traditional device manufacturing, "ground truth" for design and testing is established through established engineering standards, risk analyses, and regulatory requirements.

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The Buretrol Solution Sets are intended for use in the administration of fluids from a container into the patient's vascular system through a vascular access device.

The Buretrol Solution Sets are sterile, single use disposable devices indicated for use in the administration of fluids from a container into the patient's vascular system through a vascular access device. The sets contain a burette chamber which can be used to mix supplementary medication in a measured amount of diluent from the main container. The sets can be adjusted for either metered volume solution administration (intermittent) or continuous solution administration. The sets can be converted from intermittent to continuous administration by closing the air vent at the top of the burette and allowing continuous infusion from the main container. There are different configurations of the burette, based on presence of and differences in valve type.

This document describes the acceptance criteria and study for the Special 510(k) Premarket Notification for Buretrol Solution Sets.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document reviews manufacturing changes rather than a new device; thus, it relies on design verification tests. The specific sample sizes for each performance test (e.g., Spike Leakage, Burette Squeeze) are not explicitly stated in the provided text. The data provenance is presumed to be from Baxter Healthcare Corporation's internal testing. The study is a retrospective analysis of the device's functional and biocompatibility performance based on existing designs and materials.

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

This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a medical device, not a diagnostic algorithm that requires expert ground truth for interpretation (e.g., image analysis). The "ground truth" here is the pass/fail result of engineering and materials science tests against pre-defined acceptance criteria.

4. Adjudication Method for the Test Set:

This information is not applicable for the type of non-clinical device testing described. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation by multiple human experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms with and without AI assistance in a clinical setting, which is not the subject of this 510(k) summary.

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

No, a standalone algorithm performance study was not done. This device is a physical medical administration set, not an AI or software-based medical device.

7. The Type of Ground Truth Used:

The "ground truth" used for these tests is engineering specifications and recognized standards (e.g., ISO Luer tests, ISO 10993 for biocompatibility). The tests verify that the physical characteristics and functional performance of the Buretrol Solution Sets meet these established criteria.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for this device.

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For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.

The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of the Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets. They are single use disposable devices intended for use with a vascular device for continuous or intermittent fluid administration. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K883638 (cleared on September 23, 1988), K925126 (cleared on June 18, 1993), and K940697 (cleared on August 30, 1994).

The Interlink Lever Lock Cannula is intended to function exclusively with the Interlink Injection Site as a fluid path injection device. It has a female Luer that allows the connection of a svringe or the distal end of an Interlink Secondary Medication Set to an Interlink injection site of an Interlink solution set or an Interlink CONTINU-FLO set.

The Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They can be used for gravity or pump infusion of I.V. fluids. Interlink CONTINU-FLO Sets contain the Interlink Injection Site that can be used for the administration of secondary medication. They also contain a check valve which prevents blackflow of solution from the secondary medication container into the primary container during the administration of secondary medication. Interlink Secondary Medication Sets are used in conjunction with Interlink CONTINU-FLO sets to administer intermittent fluids to the patient.

The basis for this premarket notification is a modification to the Interlink Lever Lock Cannula, which is an integral part of the Interlink System. The modification consists of replacing the solvent carrier used in the silicone lubrication process of the Interlink Lever Lock Cannula. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.

Here's an analysis of the provided text regarding the Interlink System, focusing on acceptance criteria and supporting studies:

This 510(k) pertains to a modification of an existing medical device, the Interlink System, specifically replacing the solvent carrier in the silicone lubrication process of the Interlink Lever Lock Cannula. Therefore, the "study" described is a set of non-clinical tests to demonstrate that the modified device remains substantially equivalent to the predicate device and suitable for its intended use. There is no clinical study involving human or AI performance described in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with specific thresholds for each test. Instead, it lists a series of performance assessments conducted to show the device is "suitable for its intended use" and "equivalent to the predicate device." The reported performance is implicitly that the device passed these tests, thus demonstrating suitability and equivalence.

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

The document does not specify the sample sizes used for any of the non-clinical tests.
The data provenance is within Baxter Healthcare Corporation, as they conducted the risk analyses and design verification tests. These are internal, non-clinical tests, so concepts like "country of origin of the data" or "retrospective/prospective" in the context of patient data do not apply.

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

This document describes non-clinical engineering and performance tests, not clinical performance based on expert review. Therefore, no experts were used to establish ground truth in the traditional clinical sense. The "ground truth" for these tests would be the established engineering specifications and ISO standards that the device is expected to meet.

4. Adjudication Method for the Test Set

Since these are non-clinical engineering tests, no clinical adjudication method (like 2+1 or 3+1) was used. The results of the tests would be objectively measured against predefined engineering specifications and ISO standards.

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

No MRMC comparative effectiveness study was done or described in this document. This submission is for a material modification to an existing device and relies on non-clinical performance testing.

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

This device is not an algorithm or AI-driven system. Therefore, the concept of a "standalone" algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests would be:

• Engineering specifications: Internal design requirements for the device's performance (e.g., specific force ranges for insertion/removal, integrity under certain loads).
• Industry standards: Notably, the ISO Luer tests indicate adherence to established international standards for Luer connectors.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI. It is a physical medical device.

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

As there is no training set, this question is not applicable. The "ground truth" for the device's design and performance is established through engineering principles, regulatory compliance, and industry standards.

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Intended for the subcutaneous infusion of fluid medicines.

FlowEase [Subcutaneous] Infusion Set is a single use disposable device intended for the subcutaneous infusion of fluid medicines.

The FlowEase [Subcutaneous] Infusion Set consists of a copolyester blend Female ISO 594-2 Luer Lock Connector attached to a 24 inch length of non-DEHP PVC Tubing that is connected to a non-DEHP PVC Hub with wings. The Hub holds a 24-Gauge thin wall AISI 304 stainless steel Needle with a 90° bend at the distal end.

A medical grade UV-curable acrylated urethane Adhesive is placed on the outside bend of the needle to secure it within the Hub.

The FlowEase [Subcutaneous] Infusion Set also includes a HDPE Bantam Slide Clamp used to start and stop fluid flow. The needle is supplied covered with an LDPE Needle Protector, and the Female Luer Lock Connector is covered with an ABS Male ISO 594-2 Luer Lock Cap.

The FlowEase [Subcutaneous] Infusion Set will be marketed with a 24-Gauge thin wall needle that will be available in three needle lengths: 6 mm, 9 mm, and 12 mm. Each set will be packaged with a commercially available dressing, used to hold the device in place on the patient.

The FlowEase [Subcutaneous] Infusion Set is provided Gamma sterilized and non-pyrogenic. Each Set is packaged individually in a medical grade thermoformed copolyester tray with a Tyvek® lid, labeled according to needle size.

Here's an analysis of the provided text regarding the FlowEase Subcutaneous Infusion Set, focusing on the requested information:

Analysis of Acceptance Criteria and Device Performance Study

Based on the provided 510(k) summary, specific acceptance criteria and detailed device performance studies (like those for an AI/ML medical device) are not explicitly described in the manner requested. This document is a traditional 510(k) premarket notification for a Class II medical device, an infusion set. For such devices, "acceptance criteria" are generally met through adherence to recognized standards, functional testing, and demonstrating substantial equivalence to predicate devices, rather than through performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML devices.

The document primarily focuses on demonstrating substantial equivalence to already cleared predicate devices.

Let's address each of your points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

   As noted above, specific performance metrics with acceptance criteria like sensitivity/specificity are not detailed here. The "performance" described is about meeting general functional and safety requirements through testing against established standards.

   Acceptance Criteria (Implied)	Reported Device Performance
   Functional performance	Verified through functional testing.
   Biocompatibility	Verified through biocompatibility testing.
   Safety	Verified through functional and biocompatibility testing.
   Sterility	Provided Gamma sterilized.
   Non-pyrogenic	Provided non-pyrogenic.
   Risk Management	Conducts risk analysis according to ISO 14971:2007.
   Substantial Equivalence	"Substantially equivalent to the predicate devices with regard to technological characteristics, performance, and intended use."

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

   This information is not provided in the document. For a traditional medical device like an infusion set, "test set" and "data provenance" often refer to laboratory or bench testing on a certain number of devices, rather than a clinical dataset in the way an AI/ML study would define it. The document states "functional and biocompatibility testing" was done, but specific sample sizes and the nature/origin of the data are not detailed. It is highly likely this was bench/lab testing, not human subject data.

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

   This information is not provided and is generally not applicable to the type of device and submission method (traditional 510(k) for an infusion set) described. Ground truth as established by experts (e.g., radiologists) is typical for diagnostic AI devices, not for a physical device like an infusion set where performance is measured objectively against standards.

4. Adjudication Method for the Test Set

   This information is not provided and is not applicable for this type of device and submission. Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or expert review processes, which are not detailed as part of the "functional and biocompatibility testing" for this infusion set.

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

   No, an MRMC comparative effectiveness study was not done and is not mentioned. Such studies are relevant for diagnostic devices (especially imaging-based AI) to assess how AI assistance impacts human reader performance. This device is an infusion set, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

   No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

   The "ground truth" for this device's performance relies on objective measurements from functional and biocompatibility testing performed against established standards (e.g., ISO standards for luer locks, tubing integrity, material compatibility). It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be. The overarching "ground truth" for regulatory clearance is "substantial equivalence" to predicate devices demonstrated through these tests.

8. The Sample Size for the Training Set

   This information is not provided and is not applicable. This device is a physical medical product, not an AI/ML model that requires a training set.

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

   This information is not provided and is not applicable, as there is no "training set" for this physical device.

Summary of Device and Approval:

The FlowEase Subcutaneous Infusion Set is a single-use, disposable device for subcutaneous infusion of fluid medicines. It consists of a luer lock connector, tubing, a hub with wings, a 24-gauge stainless steel needle, an adhesive, a slide clamp, and a needle protector. It comes in 6mm, 9mm, and 12mm needle lengths. The device is Gamma sterilized and non-pyrogenic.

The submission is a traditional 510(k), and the primary method of demonstrating safety and effectiveness is through proving substantial equivalence to existing predicate devices (Baxter SUB-Q-Set, RMS Subcutaneous Needle Set, and Evans SubQ). This equivalence is asserted based on:

• Similar intended use.
• Similar technological characteristics.
• Verification through functional and biocompatibility testing.
• Adherence to risk analysis principles (ISO 14971:2007).

The FDA concurred with the substantial equivalence conclusion and cleared the device for market on June 29, 2012.

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The I.V. extension set with a 0.22 micron air venting filter is indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter.

The MICRO-VOLUME Extension Set product line consists of sterile, single use disposable devices indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter. These intravascular administration sets provide a clinician the ability to increase the distance between the patient and the fluid administration source. The overall set configuration consists of a female Luer connector, non-DEHP microbore tubing, a 0.22 micron hydrophilic filter, and a male Luer lock connector at the distal end of the set. The filter housing also contains a 0.1 micron hydrophobic filter which vents air to the atmosphere. The MICRO-VOLUME Extension Set with a 0.22 micron filter is designed to remove air and particulate matter and has a maximum pressure of 45 psi (2241 kPa). The product is sterile and non-pyrogenic.

The provided 510(k) summary (K113227) is for an intravenous administration extension set, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device testing, such as sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance, is not applicable to this submission.

The submission focuses on demonstrating substantial equivalence to a predicate device for a physical medical product. The "acceptance criteria" and "study" mentioned refer to non-clinical design verification tests for the physical components of the extension set.

Here's an analysis of the provided information, tailored to the nature of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All test results meet the acceptance criteria." However, the specific acceptance criteria values for each test are not explicitly detailed in the provided document. The document lists the types of tests conducted.

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

This information is not applicable as the described tests are for physical product components and not for an AI/ML algorithm's performance on a dataset. The tests would involve physical samples of the device components. Data provenance, in this context, would relate to the manufacturing and testing environment, not to patient data.

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 the device is a physical product (IV extension set), not an AI/ML device requiring expert consensus for ground truth on patient data. Ground truth for physical tests would involve established engineering standards and validated measurement methods, not clinical experts.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Physical component tests typically rely on objective measurements against engineering specifications, rather than adjudicating subjective interpretations.

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

This information is not applicable as the device is a physical IV extension set, not an AI-assisted diagnostic or treatment device. MRMC studies are specific to evaluating the clinical impact of AI systems on human performance with medical images or data.

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

This information is not applicable as the device is a physical IV extension set and does not involve an algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" would be established by engineering specifications, international standards (e.g., ISO for Luer connections), and validated laboratory test methods. The tests (Bond Strength, Bond Pressure, ISO Luer, Biocompatibility) aim to ensure the device meets these pre-defined physical and safety criteria.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical IV extension set and does not involve an AI/ML training set. Design and manufacturing processes would involve samples for quality control and process validation, but this is distinct from AI/ML training data.

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

This information is not applicable for the same reasons as point 8.

Summary for K113227 (MICRO-VOLUME Extension Set):

This 510(k) submission is for a conventional Class II medical device – an intravenous administration extension set. The "acceptance criteria" and "study" refer to a series of non-clinical, benchtop, and biocompatibility tests designed to demonstrate the physical and safety performance of the device and its substantial equivalence to a predicate device. The document states that all conducted tests met their respective acceptance criteria, confirming the device's appropriate design for its intended use. There is no AI/ML component to this device, so questions related to AI/ML specific testing methodologies are not relevant.

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Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.

The subject of this submission is an Additive Cap which will be indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement to identify compatibility with an additional I.V. container (AVIVA). The device is marketed as a stand-alone device and is packaged in bulk.

This document describes a 510(k) submission for a medical device called an "Additive Cap." The submission is for a modification to an existing device, specifically a label change to expand its indications for use. As such, the "study" conducted is a performance test to ensure the modified device still functions as intended.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly mentions one specific performance test.

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

• Sample Size: Not explicitly stated for the "force to remove" test.
• Data Provenance: The study was conducted internally by Baxter Healthcare Corporation. It is a prospective test conducted for this 510(k) submission to evaluate the modified device. The country of origin for the data is implied to be the United States, given Baxter's location and the FDA submission.

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

This type of information is generally not applicable to a performance test for a mechanical device like an "Additive Cap," especially when the change is a label modification. The "ground truth" for such a device is its mechanical function and material properties, which are assessed through engineering and biocompatibility testing, not through expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review and consensus, typically in diagnostic imaging studies or clinical trials, not for mechanical performance tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a non-fluid path, non-sterile Additive Cap whose only change is a label modification.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a passive mechanical component, not an algorithm.

7. Type of Ground Truth Used

For the "force to remove" test, the "ground truth" is the measured mechanical force required, compared against predefined engineering specifications or performance benchmarks for the device's functionality. For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-5 in this case) and the pass/fail criteria defined by those standards.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical component, not an AI or algorithm that requires a "training set."

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

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

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The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

The HomeChoice/HomeChoice PRO Automated Personal Cycler is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice/HomeChoice PRO cycler automates peritoneal dialysis by heating the dialysis solution, pumping the solution to and from the patient, controlling dwell times, accounting for volumes of the solution according to a physician prescribed therapy and recording the ultrafiltration volume produced by the therapy.

The provided document, K102936, describes the Baxter Healthcare Corporation's HomeChoice/HomeChoice PRO Automated Personal Cycler. This submission is for a modified device with Version 10.4 software, and the evaluation is primarily based on non-clinical data to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data for algorithmic performance. The testing described is primarily for system validation, software verification, and adherence to safety standards. These tests would involve specific units of the device and pre-defined test cases, but the sample size for individual software tests or hardware tests is not enumerated.

• Data Provenance: The data provenance is non-clinical, originating from internal testing and verification performed by Baxter Healthcare Corporation. There is no mention of country of origin for any data beyond the company's address in McGaw Park, IL, USA. The studies are internal validation and verification processes.

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

As this is a non-clinical submission, there is no mention of experts establishing a "ground truth" for a test set in the traditional sense of medical image analysis or patient outcome studies. The "ground truth" for non-clinical testing refers to predefined design specifications, industry standards, and expected functional behavior, which would be established by the device's engineering and quality assurance teams.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring expert adjudication. The "adjudication" for non-clinical tests would involve confirming whether the device's performance matches the predetermined acceptance criteria, likely performed by a quality assurance team.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states "ASSESSMENT OF CLINICAL DATA: Not Applicable." Therefore, no MRMC study was conducted.

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

Yes, in essence, the "testing performed" for software validation and verification, EMC, and electrical safety can be considered standalone performance evaluation of the device and its software (the "algorithm" in this context). The device's operation, the software's execution, and adherence to safety standards were tested without human intervention influencing the device's core functions. However, this is not "standalone" in the typical AI/ML sense of an algorithm making diagnostic decisions. It's evaluating the functional integrity of the device itself.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on:

• Design Specifications: The device was evaluated for "conformance to its design specifications."
• Applicable Industry Standards: Compliance with standards like IEC 60601-1-2 (EMC) and IEC 60601-1 (Electrical Safety).
• Predicate Device Performance: The primary claim is "substantial equivalence" to predicate devices, implying that the modified device should perform as safely and effectively as the previously cleared versions.
• Pre-determined Acceptance Criteria: For all the listed tests, the results "met pre-determined acceptance criteria."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset in the typical sense. It is a medical device with embedded software. The software's development likely involved iterative testing and debugging, but not "training" on a specific dataset to learn patterns or make predictions.

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

Not applicable, as there is no training set for this type of device. The ground truth for the device's development would be its functional requirements, safety requirements, and performance specifications, established by engineering and regulatory teams during the design and development phases.

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The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.

The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.

The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.

The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.

The intravenous extension tubing kits will consist of an intravenous extension tubing set, a Vital-Hold catheter stabilization device, two foam tape strips and an APLICARE skin protectant prep pad. The intravenous extension sets may contain any of Baxter's cleared access ports (e.g., Interlink Injection Site, Clearlink Luer Activated Valve or V-Link Luer Activated Valve).

The IV extension tubing set is used with a vascular access device for administration and withdrawal of fluids.

The Vital-Hold catheter stabilization device is used to help anchor medical intravenous tubes and lines requiring mechanical stability while installed on the skin surface of a patient.

The two foam tape strips with release liners are used to assist with line stabilization.

The APLICARE skin protectant prep pad is a sterile pad saturated in skin prep solution. The prep solution prepares the skin prior to application of a dressing or bandage. When dry, the prep agent leaves a thin polymer film on the skin surface providing a clean surface for adhesion and a barrier to the natural body oils that can affect adhesion.

The IV extension tubing set, the Vital-Hold catheter stabilization device, the two foam tape strips and the APLICARE skin protectant prep pad will be integrated into one sterile unit blister package to provide the user with a "ready-to-use" set up avoiding the need to acquire/assemble components from various manufacturers)

The provided text describes an Intravenous Extension Tubing Kit and its components, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Summary, which is a premarket notification submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It focuses on the device's description, intended use, and comparison to existing devices, rather than detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information. The sections you asked for, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not present in this document.

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