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The Embryo Transfer Catheter is intended for introduction of in vitro fertilized embryo(s) into the uterine cavity.

The stylet is intended to be used with Vitrolife's Embryo Transfer Catheters to assist in uterine access of the guide during an embryo transfer procedure.

Vitrolife´s Embryo Transfer Catheter (ETC) Assortment consists of three embryo transfer catheters (ETCs), one pre-curved variant (Model 17500, 230 mm) and two straight variants (REFs 17501, 17502) in different lengths (180 mm and 230 mm); and two stylets (Stylets) (REFs 17510, 17511) in different lengths (180 mm and 230 mm). ETC and Stylet are sterile, single-use devices used to deliver in vitro fertilized embryos to the uterine cavity.

Embryo Transfer Catheter consists of:

• A guide, also referred as outer sheath. The guide is used to navigate through the cervix canal. The guide has a distance marking, a stopper and a rounded tip to facilitate proper positioning. The guide is available in two different variants:
  • Pre-curved - stiff
  • Straight - soft and malleable
• A catheter, also referred as inner catheter. The catheter is loaded with the embryo(s) in a small volume of transfer medium and inserted through the guide to gently deposit the embryo(s) into the uterine cavity. The transfer catheter is soft, flexible and approximately 50 mm longer than the guide. The tip of the catheter has an echogenic marking to enable ultrasound guidance.

Embryo Transfer Catheter Stylet consists of:

• A plastic-coated metal wire, which is malleable. The stylet is an accessory that can be used together with Vitrolife's guides to make them stiffer.

The 17500 variant includes a stylet. The 17501 and 17502 variants do not include stylets, but the stylet can be purchased separately.

The FDA Clearance Letter for Vitrolife Sweden AB's Embryo Transfer Catheter (ETC) Assortment primarily describes the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device. This letter does not describe an AI/ML-based device, nor does it detail studies involving human experts, ground truth adjudication, or MRMC studies typically associated with AI/ML medical devices.

Therefore, many of the requested details regarding acceptance criteria and study information (particularly points 2-9 related to AI/ML device testing) cannot be extracted from the provided text.

However, I can provide the acceptance criteria and reported performance for the non-clinical tests that were performed, as outlined in the document.

Summary of Device Acceptance Criteria and Performance (Based on Non-Clinical Testing):

The acceptance criteria for this device are based on its physical properties, sterility, biocompatibility, and functionality, demonstrating its substantial equivalence to an existing (predicate) device. The studies described are primarily bench performance tests, material tests, and sterilization/packaging validations.

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Rio™ Drug Reconstitution Transfer Device is indicated for single-use reconstituting or mixing of liquid or lyophilized drug in a vial, and the aseptic transfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) for patient infusion administration.

The Rio™ Drug Reconstitution Transfer Device (Rio) is a single use, sterile, two-way, drug transfer device that is designed to connect an ICU Medical LifeCare IV container system (IV bag)(up to 500 mL) via the drug additive port, to a drug vial having either a 13mm or 20mm stopper closure for reconstituting or mixing and aseptic transfer of the drug from the vial into the solution of the IV bag. Once connected, Rio is not separated from the IV bag or vial and should be disposed of with the IV bag when administration is complete. Rio is intended to be used in a pharmacy setting or patient care area, by trained clinicians.
The Rio design consists of a needle-free port spike that connects to the compatible IV bag on one end, and a vial spike on the other end to connect a standard liquid or lyophilized/powdered drug vial. The bag spike and vial spike contain protective caps that maintain the sterility of the device until the caps are removed prior to use. Rio also includes a flow director (rotating handle) that will isolate the fluid between the vial and bag until manipulated by the pharmacist or clinician to allow two-way fluid transfer between the vial and bag.

The provided text is a 510(k) summary for the Rio™ Drug Reconstitution Transfer Device. This document focuses on demonstrating substantial equivalence to a predicate device (K192154), rather than providing detailed acceptance criteria and study results for de novo device performance validation.

Therefore, the document does not contain the specific information required to answer most of your questions about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• MRMC or standalone comparative effectiveness studies.
• Types of ground truth used.
• Sample size or methods for establishing ground truth for training sets.

The document indicates that clinical data was not needed to support the substantial equivalence determination, which means there are no clinical studies of the type you're asking about (e.g., MRMC studies).

However, I can extract the information that is present regarding non-clinical testing and how it supports the device's conformance:

Summary of Non-Clinical Testing and Conformance:

The manufacturer states that "Non-clinical verification has been conducted to evaluate the safety, performance and functionality. The results of these test have demonstrated the overall safety of the subject device and ultimately supports a substantial equivalence device."

The document generally states that "Test results from the performance testing conducted demonstrate the subject device met all acceptance criteria requirements." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results obtained for each test.

Here's what can be gleaned about the non-clinical testing performed:

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

• Acceptance Criteria: While specific numerical criteria are not provided, the testing aimed to meet various ISO and USP standards. For example, for particulates, the device had to "meet USP requirements." For sterility, it had to meet a "SAL 1x 10-6."
• Reported Device Performance: The summary states that the device "met all acceptance criteria requirements" for the listed tests. No specific numerical performance values are given.

2. Sample sized used for the test set and the data provenance:

• 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:

• Not applicable/Not specified. This is not a study involving expert readers or ground truth establishment in the context of diagnostic AI.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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. The document explicitly states: "Clinical data was not needed to support a substantial equivalence determination." This is not an AI device or a diagnostic device.

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

• No. This is a physical, mechanical device, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is established by adherence to recognized standards (ISO, USP) and engineering specifications for mechanical and material performance. For example, for particulate testing, the USP limits define the "ground truth" for acceptable particulate levels. For sterility, the SAL 1x10^-6 is the "ground truth" for validated sterility.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable.

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Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to fullthickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.

OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor scrapes, minor scalds and minor burns.

LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.

• (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
• (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.

The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.

Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.

The provided text is a 510(k) Summary for a medical device (LUOFUCON® Silicone Ag+ Foam Dressing). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/software component, which is what your request implies about typical 'acceptance criteria' and 'study' information.

Therefore, I cannot extract the information you requested about AI/software performance, such as:

• Table of acceptance criteria and reported device performance (for AI/software): The document reports performance testing for the physical dressing (e.g., adhesive property, water absorbency, pH value, MVTR, waterproofness, antibacterial effectiveness, sterility), but not for any AI/software components.
• Sample size for the test set and data provenance: Not applicable as there's no AI/software test set.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, I can provide the acceptance criteria and performance data for the physical medical device as reported in the document:

The document describes various performance tests conducted to ensure the subject device is substantially equivalent to the predicate device. It doesn't present these as strict "acceptance criteria" with numerical targets in a table, but rather lists the tests performed and implies that the device "met all design specifications" and was "Substantially Equivalent (SE)" to the predicate with identical performance specifications.

Here's a summary of the performance tests mentioned for the physical device:

Performance Testing for LUOFUCON® Silicone Ag+ Foam Dressing

Additional Context from the document:

• Study Design/Purpose: The overall study described in the 510(k) submission is to demonstrate substantial equivalence of the LUOFUCON® Silicone Ag+ Foam Dressing to a legally marketed predicate device (K223360), not to establish novel performance criteria for an AI/software component.
• Modifications: The only modification to the predicate device was the addition of a new, larger size to the Non-Bordered and Transfer models. The document states, "the material properties of the subject device and predicate device remain the same and the performance specifications are also identical, the difference in size does not affect the effectiveness of the product."
• Clinical Study: No clinical studies were conducted for the subject device.
• Biocompatibility Testing: No additional biocompatibility tests were conducted for this submission. All biocompatibility data were leveraged from the predicate device (K223360) and included tests according to ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and USP 41-N36.
• Ground Truth (for the physical device): The "ground truth" for the physical device performance is established by adherence to recognized international and national standards (ASTM, BS EN, USP, ISO). The reported performance indicates that the device met the requirements of these standards and, by extension, is substantially equivalent to a predicate device that also meets these standards.

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VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity

The VitaVitro Embryo Transfer Catheters are sterile (ethylene oxide), single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. They have a three-year shelf-life.

The device includes five catheter models that are composed of a transfer catheter and a guide catheter (some with obturator).

The 172 mm length Guide catheters have OD 2.4 mm for straight (Models ET-SI and ET-S) and OD 2.2 mm for the curved version type (Model ET-A).

The curved version type (Model ET-A) has an additional adjustable positioner which aids in positioning the device to the targeted depth within the uterine cavity during a procedure. Both types have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.

The 240 mm transfer catheter with an OD 0.95 mm is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) is connected to the connector of the transfer catheter and is used to deliver the embryos into the uterine cavity.

The 200 mm obturator with OD 1.3 mm is an optional accessory for the device. It has a rounded/blunt closed tip. The obturator is used to provide additional support (increase rigidity) during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.

The provided text describes the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) and its substantial equivalence to a predicate device. However, this document does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance as initially requested in the prompt.

The document details the non-clinical performance data for a medical device (a catheter), not a software or AI-driven diagnostic device. Therefore, the specific questions related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training/test set sample sizes are not applicable to the information provided.

The "acceptance criteria" discussed in the document are related to the physical and biological performance of the catheter, such as sterilization, biocompatibility, and functional integrity.

Here's an attempt to answer the questions based only on the provided text, recognizing that it does not align with the implied context of AI/algorithm performance:

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

Regarding the other questions, the provided text does not contain the requested information as it pertains to an embryo transfer catheter and not an AI-powered device:

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are lab tests on physical device properties and biological interaction (MEA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on established laboratory standards and measurements, not expert human interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the listed tests is based on scientific and engineering standards (e.g., ISO for biocompatibility and sterilization, ASTM for mechanical properties, USP for endotoxin), and biological assay results (MEA).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.

The MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A and MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allow for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.

This document is a 510(k) Premarket Notification from the FDA regarding Baxter Healthcare Corporation's MiniCap Extended Life PD Transfer Sets. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving that a device meets specific acceptance criteria through a study as one might conduct for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, the requested information (acceptance criteria, details of a study proving device performance, sample sizes, ground truth establishment, MRMC studies, etc.) is not applicable to this type of FDA submission (510(k) for a physical medical device, specifically a transfer set for peritoneal dialysis).

Here's why and what information is provided:

Why the requested information is not applicable:

• Device Type: The "device" in question is a physical medical device (Peritoneal Dialysis Transfer Set), not an AI/software product. The typical acceptance criteria and study designs for SaMD (which would involve accuracy, sensitivity, specificity, human reader performance, etc.) do not apply here.
• Submission Type (510(k)): A 510(k) submission aims to demonstrate "substantial equivalence" to a predicate device already on the market. It does not require a full clinical trial or a study proving independent performance against specific clinical acceptance criteria in the same way a PMA (Premarket Approval) or a SaMD submission might. The focus is on showing the new device is as safe and effective as a previously cleared device, not necessarily proving new clinical benefit or performance from scratch.
• Nature of Changes: The document explicitly states the primary change is a "material change" from Dichlorobenzoyl peroxide cured silicone to platinum cured silicone for the tubing. This triggers a need to demonstrate that this material change does not negatively impact the device's fundamental function, safety, or biocompatibility.

What information is provided in the document and how it relates to device proving safety and effectiveness for a 510(k):

Instead of a "study proving the device meets acceptance criteria" in the AI/SaMD sense, the document details "non-clinical tests" and "performance data" that support the device's safety and functional equivalence after a material change.

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

   • Acceptance Criteria: While not presented in a formal table with specific numerical targets like for an AI model's operating characteristics, the document implies acceptance criteria by stating "All results meet their acceptance criteria." These criteria would be tied to the functional tests described, ensuring the device performs as intended (e.g., no leaks, proper flow rate, withstands pressure, biocompatibility).
   • Reported Device Performance: Instead of performance metrics like accuracy, the "performance data" section lists the types of tests conducted:
     • Visual Inspection
     • Initial Pressure Test (clamp in closed position)
     • Cycling (conditioning step prior to pressure tests)
     • 8 psi Pressure Test Post Cycling (clamp in both open and closed position)
     • 5 lb Pull of Tubing to Barb Connection
     • Functionality after Iodine Exposure (over 48 hours continuous and 6 months simulated use)
     • Flow Rate (after iodine exposure)
     • Shelf Life
   • Biocompatibility Testing: Per ISO 10993-1 and FDA Guidance: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Sub-chronic Toxicity, Genotoxicity, Implantation, Hemolysis, Extractables and Leachables (per ISO 9003-18:2020), Toxicological Evaluation (per ISO 10993-17:2002).
   • No specific numerical results are provided in this summary document, only the types of tests performed and the general conclusion that "The non-clinical data supports the safety of the proposed devices and demonstrates that the proposed devices perform comparably to the predicate device that is currently marketed for the same intended use."

2. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for each test in this summary. For physical device testing, sample sizes are typically determined by statistical methods for device reliability, manufacturing process validation, and regulatory standards (e.g., ISO, ASTM standards for material testing, biocompatibility). These are generally much smaller than data sets for AI models.
   • Data Provenance: Not applicable. These are laboratory/bench tests, not clinical data from patients or specific countries.

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

   • Not Applicable. Ground truth, in the context of AI models, refers to verified labels (e.g., disease presence/absence in an image). For a physical medical device like this, "ground truth" would be the engineering specifications and performance standards established by the manufacturer and relevant regulatory bodies. Experts involved would be engineers, material scientists, toxicologists, and quality control professionals.

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

   • Not Applicable. This is a concept used in medical image annotation or clinical trial data interpretation by multiple readers. For physical device testing, results are typically objective (e.g., pass/fail a pressure test) and follow standardized protocols.

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 is a physical medical device, not an AI or imaging diagnostic device. MRMC studies are not relevant.

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

   • Not Applicable. This is a physical medical device.

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

   • Ground Truth: For this device, the "ground truth" is defined by established engineering specifications, material properties, and performance standards expected for a product of this type. It's based on objective measurements from laboratory tests and compliance with recognized standards (e.g., ISO 10993 for biocompatibility).

8. The sample size for the training set:

   • Not Applicable. This is not an AI/ML model.

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

   • Not Applicable. This is not an AI/ML model.

In summary: The provided document is a regulatory letter for a 510(k) submission of a physical medical device undergoing a material change. The information required for your query predominantly applies to software/AI medical devices, particularly those involving image analysis or diagnostic support. The "study" mentioned in the document refers to a series of non-clinical functional and biocompatibility tests designed to ensure the modified physical device maintains safety and performance comparable to its predicate.

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The Mix2Vial® Transfer Device is intended for transferring drugs contained in two vials.

The subject device, Mix2Vial® Transfer Device (M2V), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer of drugs contained in two vials. The M2V consists of two vial adapter bodies with piercing spike and wings, connected back-to-back via a Luer connection, with an in-line filter.

The female vial adapter (clear) connects to the drug vial and the male vial adapter (blue) connects to the diluent vial. The vacuum present in the lyophilized drug vial draws in the contents of the diluent vial.

The female Luer connection interfaces to a syringe and has an in-line 5um filter that strains the drug or solution when aspirated out of the vial. The male connection has a "Tight Grip" that provides a secure connection to the diluent vial having a 20mm neck diameter.

Puncturing the elastomeric closure or "stopper" of a drug or diluent vial is achieved by means of an integral polycarbonate cannulated spike located in the center of each Vial Adapter (VA) body of the M2V. Each side of the device (diluent vial side and drug vial side) is a polycarbonate molded part containing a Luer port.

After reconstitution, the drug can be administered by disconnecting the diluent vial and connecting a needleless syringe to the female Luer Lock of the female Vial Adapter. The device does not contain any medicinal substances and can be used with drug vials/diluent vials with a neck diameter of 20mm.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Mix2Vial® Transfer Device) and does not contain any information about a study involving an AI/Machine Learning device or its acceptance criteria within the context of AI performance metrics like sensitivity, specificity, or AUC.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for non-AI medical devices. The performance data discussed relates to physical and chemical properties of the device (e.g., fragmentation, particulate, Luer stability, sterility, biocompatibility, force measurements), not the performance of an AI algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to AI.
2. Sample sizes used for a test set (in the context of AI).
3. Data provenance for an AI test set.
4. Number of experts establishing ground truth for AI.
5. Adjudication method for an AI test set.
6. MRMC comparative effectiveness study results.
7. Standalone AI performance.
8. Type of ground truth (for AI).
9. Training set sample size (for AI).
10. Ground truth establishment for a training set (for AI).

The document explicitly states: "Clinical trials were not performed for the Mix2Vial® Transfer Device." This further confirms that there are no clinical performance studies, let alone AI performance studies, described in this regulatory submission.

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The device is intended for the transfer and injection of drugs contained in a vial.

The subject device, MixJect® Transfer Device (MXJ), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer and injection of drugs contained in a vial. The MXJ device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications. The MXJ device does not contain any medicinal substances and is only intended for use with drug vials having a neck diameter of 13mm. The subject device has a 3-year shelf life. The MXJ device configuration consists of four main components inclusive of a 30-gauge needle, a vial adapter including integral cannulated spike, MXJ Body, and MXJ Core. The subject device interfaces with a syringe (not supplied) that connects to the female Luer lock port located in the main body of the MXJ device. The MXJ Vial Adapter component connects to a drug vial having a neck diameter of 13mm. The Vial Adapter component contains a piercing spike and a female Luer lock connector. Puncturing of the drug vial stopper membrane is achieved by means of an integral spike located in the center of the MXJ Vial Adapter component. Once the drug vial stopper membrane is breached by the cannulated spike, fluid can travel from the drug vial into the MXJ device main body. A prefilled diluent syringe (not supplied) is then connected to MXJ female Luer lock port. The diluent is injected from the syringe into the drug vial. The reconstituted medicament is then aspirated back into the syringe. The MXJ device is then twisted in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle. After reconstitution and aspiration, the drug is ready to be administered through the attached MXJ needle. The MXJ primary device package consists of a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek® lid sealed on top of the blister pack.

The provided FDA 510(k) summary for the MixJect® Transfer Device (K230464) describes performance testing, but it does not specify explicit acceptance criteria in a quantitative manner or provide specific performance data points in a table as requested. Instead, it states that testing "confirm[s] the MixJect® Transfer Device meets all applicable design and performance requirements throughout its defined shelf life and verify conformity to the applicable external and internal standards and demonstrate substantial equivalence to the predicate device."

Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific numerical values based on this document. However, I can infer the types of performance metrics and the general conclusion of the study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific quantitative acceptance criteria and reported performance values are not provided in this document. The document primarily lists the types of performance tests conducted and generally states that the device meets requirements and standards.

Inferred Performance Metrics (from "Performance Testing" section):

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its requirements is a series of non-clinical bench performance tests and biocompatibility tests as detailed in the "Performance Data" section of the 510(k) submission.

2. Sample Size and Data Provenance:

• Sample Size for Test Set: The document does not specify the sample size (number of devices) used for each individual performance test or biocompatibility test.
• Data Provenance: The document does not explicitly state the country of origin of the data for the performance or biocompatibility tests. It indicates the manufacturer, West Pharma. Services IL, Ltd., is located in Ra'anana, Israel. The studies are retrospective in the sense that they are laboratory and bench studies conducted on the device, not ongoing clinical observations.

3. Number of Experts and Qualifications:

• Not Applicable. For non-clinical bench testing and biocompatibility assessments, the ground truth is established by objective measurements against recognized international and internal standards, rather than expert consensus on medical images or diagnoses. These tests are typically performed by qualified laboratory technicians and overseen by engineers or scientists with expertise in material science, mechanical testing, and biocompatibility, who interpret the results against established regulatory requirements and standards.

4. Adjudication Method:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is required for ground truth labeling, often for diagnostic accuracy studies. This document reports on bench and biocompatibility testing.

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

• No. The document explicitly states: "Clinical trials were not performed for the MixJect® Transfer Device." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size for human reader improvement with AI assistance is applicable or reported.

6. Standalone Performance Study:

• Yes, in the context of a medical device. The entire "Performance Data" section describes standalone performance of the device itself through a variety of engineering, material, and biological safety tests (bench tests, biocompatibility tests). These tests establish the device's inherent properties and functionality without a human-in-the-loop performance assessment (which would be a clinical trial).

7. Type of Ground Truth Used:

• The ground truth for the performance tests and biocompatibility tests is based on:
  • International Standards: e.g., ISO 8536-2, USP , ISO 80369-7, ISO 10993 series, BS EN ISO 11137 series.
  • In-house test methods: Developed and validated by the manufacturer to assess specific device functions.
  • Established biological principles and safety thresholds: For biocompatibility and sterility.

8. Sample Size for Training Set:

• Not Applicable. This device is a physical medical device (an intravascular administration set), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles, material science knowledge, and previous device iterations.

9. How Ground Truth for Training Set Was Established:

• Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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BD Vacutainer® Luer-Lok™ Access Device:

The BD Vacutainer® Luer-Lok™ Access Device is a sterile, single-use, noninvasive device intended to be used by healthcare professionals for safe, closed-system venous blood collection from a female Luer of a catheter port or blood collection set, directly into an evacuated blood collection tube(s) for in vitro diagnostic testing. This device may also be used with a blood collection set with a female Luer to collect blood cultures.

BD Vacutainer® Blood Transfer Device:

The BD Vacutainer® Blood Transfer Device is a sterile, single use, noninvasive medical device intended to be used by healthcare professionals for the safe, closed-system, needleless transfer of venous blood from a BD Luer-Lok™ tip syringe into evacuated blood collection tube(s) or blood culture bottle(s) for in vitro diagnostic testing.

The BD Vacutainer® Luer-Lok™ Access Device and the BD Vacutainer® Blood Transfer Device are sterile, single use, non-invasive devices for the safe transfer of blood into an evacuated BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle for in vitro diagnostic testing. The only difference between the devices is the BD Vacutainer® Luer-Lok™ Access device features a male Luer lock connection with compatible female Luer catheter port (blood collection set) and the BD Vacutainer® Blood Transfer Device features a female Luer lock for connection with BD Luer-Lok™ syringes.

The provided text describes a 510(k) premarket notification for two medical devices: the BD Vacutainer® Luer-Lok™ Access Device and the BD Vacutainer® Blood Transfer Device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (K200027, Luer Access Device-holder with Preattached Multiple Sample Adapter) through non-clinical performance testing.

Response to your specific questions:

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

   The document does not explicitly present a table of acceptance criteria and reported device performance in the format you requested, where specific quantitative values for acceptance criteria are listed alongside the measured performance. Instead, it states that the conducted tests verified that "the proposed devices met all design specifications and performance standards." For certain tests, it simply lists compliance with ISO standards.

   However, based on the non-clinical performance summary, we can infer some of the tests performed and general outcomes:

   Acceptance Criteria (Inferred from tests)	Reported Device Performance (Inferred from text)
   Compliance with ISO 594-1-1986	Compliant (Stated explicitly in comparison table)
   Compliance with ISO 594-2-1998	Compliant (Stated explicitly in comparison table)
   Compliance with EN ISO 9626:2016	Devices met design specifications and performance standards
   Compliance with EN ISO 15223-1:2016	Devices met design specifications and performance standards
   Compliance with EN ISO 14971:2012	Devices met design specifications and performance standards
   Compliance with EN ISO 11135:2014	Devices met design specifications and performance standards
   Compliance with EN ISO 11737-1:2019	Devices met design specifications and performance standards
   Compliance with ISO 11607-1:2019	Devices met design specifications and performance standards
   Compliance with ISO 11607-2:2019	Devices met design specifications and performance standards
   Compliance with ASTM F2096-11	Devices met design specifications and performance standards (Package Integrity test)
   Compliance with ASTM F88	Devices met design specifications and performance standards (Peel Strength Test)
   Compliance with ASTM F1980-16	Devices met design specifications and performance standards
   Compliance with ASTM D4169-16	Devices met design specifications and performance standards
   Compliance with ISO 10993 (Biocompatibility Suite)	Compliant (Stated explicitly in comparison table, and that differences in hub material do not raise new questions of safety or effectiveness due to this compliance)
   Torque to Break	Met all design specifications and performance standards
   Torque to Unseat	Met all design specifications and performance standards
   NP Cannula Pull Test	Met all design specifications and performance standards
   Air Leakage Test	Met all design specifications and performance standards
   NP Sleeve Function	Met all design specifications and performance standards
   Luer Compatibility as per ISO 594/80369-7	Met all design specifications and performance standards

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

   The document does not specify the sample size for the individual non-clinical performance tests (e.g., number of devices tested for Torque to Break, Air Leakage, etc.). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as these are in vitro engineering performance tests rather than clinical 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)

   This is not applicable to the non-clinical performance testing described. These tests involve objective measurements against engineering and biocompatibility standards, not expert interpretation of clinical data.

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

   This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or imaging studies where expert consensus is required for diagnosis or interpretation. The tests described are objective engineering and laboratory tests.

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 MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Data: Not applicable," and the devices are for blood collection/transfer, not for interpretation or diagnosis requiring human readers or AI assistance.

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

   Not applicable. These are physical medical devices for blood collection, not an algorithm or AI system.

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

   The "ground truth" for the non-clinical performance tests is compliance with established international and ASTM standards (e.g., ISO 594, ISO 10993, EN ISO 9626, ASTM F88, ASTM F2096), as well as the manufacturer's own design specifications. There is no expert consensus, pathology, or outcomes data used as ground truth for these types of tests.

8. The sample size for the training set

   Not applicable, as this is not an AI/ML device that requires a training set.

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

   Not applicable, as this is not an AI/ML device that requires a training set.

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Closed System Drug Transfer Device (CSTD) for safe preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs

The EQUASHIELD® Closed System Drug Transfer Device (CSTD) is intended for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs.

EQUASHIELD® CSTD is a sterile, single use system. The various system components are listed in the table below:

The above components are combined to create a system and are not intended to be used individually.

The variable sterile air chamber integrated into the encapsulated syringe provides selfcontained pressure equalization. The connector unit is welded to the syringe and uses the double-membrane method as high efficiency microbial barrier and for leak-proof and drug residual-free connections to the adaptors of the system. The double membrane prevents the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, spills and also prevents microbial ingress up to 7 days. The purpose of this submission is to obtain FDA clearance for new system components and material changes for previously cleared components and to revise the indication for use for clarity with respect to the functionality of the Syringe Unit.

Here's a breakdown of the acceptance criteria and the study information for the EQUASHIELD® Closed System Transfer Device (K221513) based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Non-Clinical Testing: No specific sample sizes are mentioned for the non-clinical tests (ISO standards, USP). However, these are typically bench-top tests performed on sufficient samples to demonstrate compliance.
• Biocompatibility: Not explicitly stated, but common for such tests to use a reasonable number of samples to ensure robust results.
• Sterility Shelf Life and Shipping Simulation: "Sterilized samples" were used for accelerated aging, and "final, packed, and sterile samples" were used for packaging integrity. The exact number is not specified but implicitly sufficient for the standards cited.
• Microbial Ingress: "Sterile and aged EQUASHIELD® CSTD samples" were used. The study explicitly states there were 10 repeated accesses for a period of 7 days, implying multiple devices were tested to draw a conclusion on "None of the tested samples showed growth." The exact number of CSTD samples is not specified.
• Drug Compatibility: Not explicitly stated, but "chemical analytic experiments and mechanical, functional and performance testing" would involve a sufficient number of devices.
• Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission, the data would have been generated to meet U.S. regulatory requirements. It is a prospective study as new testing was conducted specifically for this submission to support the device's performance.

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

This type of medical device submission (510(k) for a Closed System Transfer Device) does not typically involve expert review for establishing "ground truth" in the way an AI diagnostic device would. The "ground truth" for these tests is defined by established scientific standards (ISO, USP, ASTM) and benchmark compliance rather than expert consensus on diagnostic images or pathology. Therefore, there were no experts in the context of diagnostic interpretation establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data, and discrepancies need to be resolved to establish a consensus ground truth, typically for diagnostic performance.

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 Closed System Transfer Device, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the EQUASHIELD® CSTD is established by:

• Compliance with International and National Standards: ISO, USP, and ASTM standards define the acceptance criteria for various physical, chemical, and biological properties.
• Defined Performance Specifications: Each test verified that the device met its design specifications (e.g., preventing microbial ingress, maintaining sterility, drug compatibility).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model, and therefore does not have a training set.

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

Not applicable, as no training set was used.

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Daylily Single Use Sterile Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.

Daylily Single Use Sterile Embryo Transfer Catheters are sterile single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. All models of the Daylily Single Use Sterile Embryo Transfer Catheters consist of a transfer catheter and a guide catheter. Some device models (Type II and Type IV) also include a trial catheter.

The guide catheter is composed of a catheter shaft, connector, and a positioning ring (for certain Type III and IV variants). Guide catheters for some Type III and Type IV variants are also provided pre-curved. Guide catheters have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.

The transfer catheter is composed of a catheter shaft, connector, and a stainless-steel sleeve (for Type III and IV models). Transfer catheters have a rounded/blunt tip and marker bands at the proximal end of the catheter to aid in catheter placement. The transfer catheter is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) connected to the connector of the transfer catheter is used to deliver the embryos into the uterine cavity.

The trial catheter is an optional accessory for specific models (Types II and IV), composed of a catheter shaft, connector, and a polymer-coated stainless-steel core. Trial catheters have a rounded/blunt closed tip. The trial catheter is used to provide additional support during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.

The provided text describes the Daylily Single Use Sterile Embryo Transfer Catheters and reports on the non-clinical performance data to support its substantial equivalence to a predicate device.

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

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

• Mouse Embryo Assay (MEA): The 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" sets the specification for embryo development.
• Other Bench Tests: Conformity to physical and functional specifications.

8. The sample size for the training set

Not applicable. This device is 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. Since there is no training set, this question is not relevant.

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