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0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.

Excelsior Medical Corporation's 0.9% Sodium Chloride Injection. USP prefilled syringe products are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The saline solution is delivered through the luer lock of a venous access device to maintain catheter patency via hydraulic displacement. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling. total parenteral nutrition, or hemodialysis.

0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows:

• 2.5 mL in 3 mL Syringe
• 3 mL in 10 mL Syringe
• 5 mL in 10 mL Syringe
• 10 mL in 10 mL Syringe
  The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.

The provided text does not describe an acceptance criteria or a study proving that a device meets the acceptance criteria for a medical device that utilizes artificial intelligence (AI). The document is a 510(k) premarket notification for a 0.9% Sodium Chloride Injection, USP (a saline vascular access flush). This is a physical, sterile medical product, not an AI-driven device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI device cannot be extracted from this document.

The document discusses non-clinical testing performed for the saline solution and prefilled syringes, which includes:

• Raw material qualification
• Stability Studies
• Sterilization validation
• Extractables/Leachables

These tests are standard for a sterile drug product/device combination and are not related to AI performance. Biocompatibility testing was deemed not required because the products were considered the same as predicate devices, except for the source of the sodium chloride raw material.

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Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling, total parenteral nutrition, or hemodialysis.

This document does not contain information about acceptance criteria and device performance in the context of a study. The provided text is a 510(k) summary for the Heparin Lock Flush, USP, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a specific study with performance metrics against pre-defined acceptance criteria.

The 510(k) summary outlines the following:

• Device Description: The Heparin Lock Flush, USP
• Intended Use/Indications for Use: Flushing of IV catheters and IV tubing for maintaining patency.
• Technological Characteristics: A comparison table with predicate devices (K061497 and K023740) highlighting similarities in solution, concentrations, single-use nature, sterility, barrel material, plunger rod material, piston, tip cap material, tip cap colorants, and packaging.
• Purpose of Submission: To add alternate suppliers of the heparin sodium (USP) raw material.
• Non-Clinical Testing: A list of studies performed or relied upon:
  • Raw material qualification
  • Biocompatibility (ISO 10993-1)
  • Stability Studies
  • Sterilization validation (ISO 17665-1 and -2)
  • Extractables/Leachables
  • Testing of final product to Heparin Lock Flush Solution USP Monograph
• Conclusion: The change in heparin source is supported by the cited studies, and no new questions of safety and effectiveness are raised, leading to the conclusion of substantial equivalence.

The document does NOT include the following information, which would be necessary to answer the prompt:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for any test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

This is expected as 510(k) submissions for devices like a Heparin Lock Flush typically rely on demonstrating equivalence to existing devices through material characterization, manufacturing controls, and non-clinical testing rather than clinical performance studies with specific acceptance criteria as one might see for an AI/ML diagnostic device.

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SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.

SwabCap is a plastic threaded cap that houses a small sponge saturated with 70% isopropyl alcohol. The device is designed to securely fit on swab-able luer access valves to disinfect the valve surface and maintain antiseptic conditions between line accesses. SwabCap" is a sterile, single-use device, provided as a stand-alone product.

This FDA 510(k) summary for the SwabCap® device (K130975) focuses on demonstrating substantial equivalence to a predicate device (SwabCap® K083508) rather than providing a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial for a novel AI device. The submission is primarily aimed at extending the indications for use (from 96 hours to 7 days of disinfection) for a modified version of an already cleared device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, sample size for training set, ground truth for training set) are not applicable or explicitly mentioned in this type of regulatory submission as they would be for an AI/ML medical device.

However, I can extract the relevant information and infer some aspects based on the provided document.

Acceptance Criteria and Device Performance

The acceptance criteria here are implicitly related to maintaining the efficacy of disinfection for an extended period (up to 7 days) while demonstrating safety and substantial equivalence to the predicate device. The performance is assessed through non-clinical testing.

Study Details (Based on available information)

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

   • Sample Size: Not specified in the provided summary. As this is a non-clinical submission for a device component, these "test sets" would likely refer to laboratory samples (e.g., luer access valves, material samples) subjected to standardized testing protocols, not a human patient cohort.
   • Data Provenance: Not specified. Experiments would typically be conducted in a controlled lab setting, likely in the US where the manufacturer is located, or by certified contract research organizations. The testing described is prospective, in that it evaluates the device's performance under controlled conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable/mentioned. For non-clinical antimicrobial efficacy, toxicology, and sterilization testing, the "ground truth" is established by validated laboratory assays and adherence to relevant standards (e.g., ISO, ASTM, USP). The expertise would be in microbiology, material science, and toxicology, employed by the testing facility, rather than clinical experts for ground truth labeling.

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

   • Not applicable. This concept is relevant for human interpretation tasks, not for non-clinical laboratory testing of device efficacy. Assays have defined endpoints and criteria for success, typically interpreted by a single qualified lab technician or scientist according to a protocol.

4. 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 not an AI/ML device, and thus an MRMC study is not relevant.

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

   • Not applicable. This is not an AI/ML algorithm; it is a physical medical device (disinfectant cap). Its performance is inherently "standalone" in the sense that it mechanically disinfects, without human interpretation in its function.

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

   • Validated Laboratory Assays: This includes standardized microbiological methods to quantify bacterial reduction/inhibition, chemical analysis to verify alcohol concentration, and material science tests for biocompatibility and structural integrity. The "ground truth" is the quantitative result of these assays compared against predetermined acceptance limits derived from regulatory standards and scientific principles.

7. The sample size for the training set

   • Not applicable. This is not an AI/ML device requiring a training set.

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

   • Not applicable. This is not an AI/ML device.

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The flush syringe is intended for flushing of IV catheters and IV tubing. SwabCap® is intended for use on a swab-able luer access valve as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between the line accesses. SwabCap® will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed. The SwabFlush™ product is provided as: 1. 10 ml fill in 10 ml saline flush syringe with integrated SwabCap®. 2. 5 ml fill in 10 ml saline flush syringe with integrated SwabCap®. 3. 3 ml fill in 10 ml saline flush syringe with integrated SwabCap®.

SwabFlush" is a saline intravenous flush syringe that is combined with an integrated SwabCap®. Each SwabFlush" syringe contains a sterile, non-pyrogenic isotonic solution of 0.9% Sodium Chloride Injection USP, 9 mg NaCl per ml, with an osmolarity of 0.3 l mOsm/mL, pH 4.5 - 7.0. A SwabCap® is a luer access valve cap that contains 70% isopropyl alcohol as a disinfectant. A SwabCap® is designed to securely fit on swab-able luer access valves. The product is intended for single-use and is provided sterile. The SwabFlush" provides the healthcare professional with immediate access to the SwabCap luer access valve disinfectant cap after an IV flush.

Here's a breakdown of the acceptance criteria and study information for the Excelsior Medical Corporation's SwabFlush™ device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • The document mentions "All results met the criteria established in the testing" for non-clinical tests (K101270 p.3). However, specific numerical sample sizes for each test mentioned (e.g., ISO standards, biocompatibility, sterilization validations, ship testing, controlled aging) are not provided.
   • For the "Design Validation" to verify clinical need in a "simulated clinical setting," the sample size of participants or test runs is not specified.
   • Data Provenance: This information is not explicitly stated. Given it's a 510(k) submission, the studies would likely be conducted by the manufacturer, Excelsior Medical Corporation. It doesn't specify if the studies were retrospective or prospective, though "Design Verification" and "Design Validation" generally imply prospective testing. There's no mention of the country of origin of the data beyond the manufacturer's location in Neptune, NJ.

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

   • This information is not provided in the document. The studies mentioned are primarily non-clinical and simulated clinical setting evaluations. If expert assessment was used for "Design Validation," the number and qualifications of experts are not described.

3. Adjudication Method for the Test Set:

   • This information is not provided. Given the nature of the tests (compliance with ISO standards, physical tests, chemical verification), adjudication methods like 2+1 or 3+1 typically used for subjective diagnostic interpretations are not applicable here. The "criteria established in the testing" (K101270 p.3) implies objective pass/fail metrics.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

   • No, an MRMC comparative effectiveness study was not done or described. The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical as well as simulated clinical testing of the device itself, rather than comparing human reader performance with and without AI assistance.

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

   • Yes, the tests described (Design Verification and Design Validation) represent standalone performance of the device (SwabFlush™) itself. These tests evaluate the syringe's ability to meet various technical specifications and the combined device's ability to function as intended, independent of human operators beyond standard usage. However, it's not an "algorithm only" evaluation as the device is a physical product.

6. The Type of Ground Truth Used:

   • The "ground truth" for the non-clinical tests was based on established objective standards and specifications:
     • ISO 7886-1 and ISO 594-1&-2 standards.
     • ISO 10993 for biocompatibility.
     • Defined Sterility Assurance Levels.
     • 0.9% Sodium Chloride Injection USP monograph requirements.
     • ISTA or ASTM standards for ship testing.
     • Internal product design requirements and established criteria.
   • For the "Design Validation," the ground truth was "the clinical need expected for a typical flush procedure in a simulated clinical setting" (K101270 p.3), which implies the device's functional performance under intended use conditions.

7. The Sample Size for the Training Set:

   • As this is a physical medical device (syringe with an integrated cap) and not an AI or algorithm-based device, there is no "training set" in the conventional sense of machine learning. The device design and manufacturing processes are validated through the non-clinical and simulated clinical testing mentioned.

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

   • Since there is no "training set" for an AI model, this question is not applicable. The device's design is based on established engineering principles, materials science, and medical device regulations, not on a data-driven training process. The "ground truth" for its development and testing aligns with the predefined standards and functional requirements outlined above.

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SwabCap ™ is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. SwabCap ™ will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed.

The SwabCap™ is designed to securely fit on swab-able luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, preservative free and DEHP free.

The provided text describes a medical device called "SwabCap™" and its regulatory clearance based on substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance data in the format requested. Instead, it focuses on the administrative aspects of its FDA 510(k) clearance.

Therefore, I cannot populate the table or provide detailed answers to most of your questions as the information is not present in the provided text.

Here's what I can extract from the document regarding the device and its claims, alongside areas where information is missing:

Device: SwabCap™

Intended Use: For use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. It is claimed to disinfect the valve 5 minutes after application and act as a physical barrier for up to 96 hours.

I cannot create a table of acceptance criteria and reported device performance because this information is not provided in the document. The document states that the device is "substantially equivalent" to predicate devices based on intended use, design, technology, antimicrobial agent, and performance, but it does not detail the specific performance metrics or acceptance criteria used to establish this.

Here’s a breakdown of the specific information requested and whether it's available:

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

   • Not available. The document asserts substantial equivalence based on performance but does not quantify or present specific acceptance criteria or corresponding performance results.

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

   • Not available. There is no mention of specific studies or test sets (like clinical trials or lab tests with sample sizes) used to support the performance claims. The clearance is based on substantial equivalence to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not available. Since there are no detailed de novo performance studies described, there's no mention of experts establishing ground truth for a test set. The review process involved FDA officials evaluating the submission for substantial equivalence.

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

   • Not applicable/Not available. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a medical accessory, not an AI imaging or diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not available directly for this device. The concept of "ground truth" as typically used for AI or diagnostic devices is not explicitly stated. The regulatory decision is based on comparing the device's characteristics and claims to those of legally marketed predicate devices, implying that the established safety and effectiveness of the predicates serve as a benchmark.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

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

What the document does tell us:

• Predicate Devices:
  • Effectiv™ Cap, Hospira, Inc., K080579
  • Curos Port Protector, Ivera Medical, K080466
  • Alcohol Prep Pad, Professional Disposables Inc. (510(k) Number: Unknown)
• Key features of SwabCap™ for comparison:
  • Intended Use: Same as the description above.
  • Antimicrobial Agent: 70% Isopropyl Alcohol (similar to predicates)
  • Additional Claims: DEHP, Latex, and Preservative Free.
  • Sterilization: Gamma Irradiated.
  • Packaging: Individually wrapped with peel-off foil lid.
• Basis of Clearance: Substantial equivalence to the listed predicate devices based on intended use, design, technology, antimicrobial agent, and performance. The clearance is a reaffirmation of a prior determination, with an administrative change to its categorization.

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Excelsior Sterile Field Saline Flush Syringe(s) are intended for use in flushing IV catheters and IV tubing.

The Excelsior Medical Saline pre-filled Syringe(s) in Sterile Field Packaging will contain 10ml of 0.9% sodium chloride solution, USP in a 10 ml syringe. This device will be marketed as one or two syringes packaged in a sterile pouch. Each syringe will contain a white tip cap and associated label with a clear backeround. In addition, the syringe label will contain a lot number, expiration date and graduation marking. Each filled and labeled syringe will be packaged in a pouch which is a two part envelope that contains printed information on one side and is clear on the other side.

The provided document describes the predicate device and the new device being submitted for 510(k) clearance, which is the "Excelsior Saline pre-filled Syringe(s) In Sterile Field Packaging."

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not explicitly state a specific test set sample size in terms of the number of devices or units tested for the "Stability Study" mentioned.
• The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

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 to this type of submission. This device is a medical product (saline syringe), not an AI or diagnostic imaging device that requires interpretation by experts to establish ground truth for a test set. The performance is assessed through laboratory and stability testing, not expert interpretation of data.

4. Adjudication method for the test set:

• This information is not applicable for the same reasons as point 3. There is no expert interpretation or consensus required for typical performance testing of a pre-filled saline syringe.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

• A MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for a pre-filled saline syringe.

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

• A standalone performance study of an "algorithm" was not done as this device is a physical medical product, not a software algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" is established through physical and chemical testing against predetermined specifications and industry standards for saline solutions, sterility, and syringe performance. This includes:
  • Chemical composition analysis: Verifying the 0.9% sodium chloride concentration (USP).
  • Sterility testing: Ensuring the product is sterile.
  • Physical performance testing: Checking syringe integrity, dose accuracy, flush mechanics, and packaging efficacy.
  • Stability testing: Evaluating the product's integrity and sterility over time.

8. The sample size for the training set:

• The concept of a "training set" is not applicable here as this is not an AI or machine learning device. The "training" for such a device would refer to its design and manufacturing process adhering to established specifications and quality control.

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

• As "training set" doesn't apply directly, the "ground truth" for the design and manufacturing of such a device is established by adherence to regulations (e.g., 21 CFR 880.5200), international standards (e.g., ISO standards for medical devices and sterility), pharmacopoeial monographs (e.g., USP for sodium chloride injection), and internal company specifications based on scientific principles and predicate device performance. These standards and specifications define what constitutes a safe and effective saline flush syringe.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states that "Design Verification is based on the Stability Study." This study, along with other unspecified tests implied by the claim of substantial equivalence, demonstrated that the Excelsior Medical Saline Syringe(s) in Sterile Field Packaging performed equivalently to the predicate devices. This equivalence was specifically noted in terms of solution (0.9% sodium chloride), sterilization, shelf-life, and labeling. The conclusion drawn is that the device is safe and effective when used as intended, which led to the FDA's determination of substantial equivalence. The FDA letter confirms that the device has met the requirements for clearance to market under the general controls provisions of the Act.

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Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy

Excelsior Medical Heparin Lock Flush Syringes are polypropylene latex-free syringes which contains a labeled volume of a sterile, non-pyrogenic solution of Heparin Lock Flush Solution, USP derived from porcine intestinal mucosa in 0.9 sodium chloride USP with a pH range of 5.0 - 7.5.

This is a 510(k) summary for a medical device: Excelsior Medical Heparin Lock Flush Syringes. The document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria in the typical clinical study format.

Therefore, many of the requested sections about clinical study details (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training data) cannot be fully answered from the provided text.

Here is an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document states that the device was tested according to "specifications documented in Design Verification Testing Reports and independent laboratory testing." It concludes that the device "functioned as intended and met all pass criteria as expected." However, the specific acceptance criteria and the detailed performance results are not provided in this 510(k) summary. The summary focuses on comparing the new device's characteristics to its predicate devices to establish substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document refers to "Design Verification Testing Reports and independent laboratory testing" but does not provide details on sample sizes for these tests.
   • Data Provenance: Not specified, but likely from laboratory testing (e.g., sterility, chemical analysis, functional tests) rather than human clinical data.

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

   • This information is not applicable or not provided. This type of detail is typically associated with clinical studies involving interpretation (e.g., imaging devices), not physical device performance testing for a syringe and its contents. The ground truth would be established by validated analytical methods, not expert consensus.

3. Adjudication method for the test set:

   • This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are used in clinical studies where human interpretation of results is involved (e.g., radiologists reading scans). This document describes performance testing for a physical device, where results are typically objective measurements.

4. 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 study was not done. This type of study is relevant for diagnostic devices, especially those using AI, that assist human readers in interpreting clinical data. This device is a pre-filled syringe, not a diagnostic tool assisted by AI.

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

   • Not applicable. This section is for AI/algorithm-based devices. The Excelsior Medical Heparin Lock Flush Syringe is a physical medical device.

6. The type of ground truth used:

   • Laboratory Testing Parameters/Specifications: The ground truth for this device's performance would be established by predefined quality and functional specifications (e.g., sterility, pH range of the solution, heparin concentration, syringe integrity, flush volume). These are determined through established scientific and manufacturing standards for medical devices and pharmaceuticals.

7. The sample size for the training set:

   • Not applicable. This pertains to AI/machine learning models. For a physical device, there isn't a "training set" in the AI sense.

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

   • Not applicable. See point 7.

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Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Syringes are intended for flushing IV catheters and IV tubing.

The modification which is the subject of this Special 510(k) is substitution of the current dust cover packaging with Sterile Field packaging. All other aspects of the product design remain unchanged.

The provided text describes a 510(k) submission for Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes. However, it does not provide acceptance criteria and detailed study information as requested. The submission is for a modification involving a change in packaging (from dust cover to Sterile Field packaging), with all other aspects of the product design remaining unchanged.

The document highlights that the "technological characteristics... do not differ" from the predicate device and that "The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device." This implies that the acceptance criteria would be based on demonstrating that the new packaging maintains sterility and does not compromise the device's existing performance, but specific quantified criteria and a detailed study report are not present in this document.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text.

Here is what I can glean and what is missing:

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

Missing: Specific, quantifiable acceptance criteria (e.g., sterility assurance level, packaging integrity test results, shelf-life data with new packaging).

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely from Excelsior Medical Corporation's internal testing. The tests are "Non-Clinical Tests," so they would not involve human participants or specific geographic data provenance in the way clinical studies do.

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

• This is a packaging/device modification submission, not a diagnostic or AI-driven device. Therefore, the concept of "experts to establish ground truth" (in the medical diagnostic sense) is not applicable to the non-clinical tests mentioned. The "ground truth" here would be established by validated test methods and passing criteria for physical and performance characteristics.

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

• Not applicable as this is not a diagnostic study requiring expert adjudication of cases.

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 or a diagnostic device involving human readers.

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

• Not applicable. This is not an algorithmic device.

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

• For the non-clinical tests, the "ground truth" would be objective measurements against pre-defined specifications (e.g., sterility test results, material strength tests, leak tests, etc.). The document only states "acceptable performance."

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

In summary: The provided 510(k) summary is for a minor device modification (packaging change) and focuses on demonstrating substantial equivalence. It does not contain the detailed study results, acceptance criteria, or specific methodologies that would be presented for a novel device or a device with clinical efficacy claims, especially those involving AI or human interpretation. The "tests conducted to verify the design modifications" are described as "non-clinical tests," implying laboratory or engineering evaluations.

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Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Syrex Pre-Filled Syringe, Heparin Lock Flush Solution, USP 10 and 100 Units/ml

This document is a 510(k) clearance letter for a medical device, the Syrex Pre-Filled Syringe, Heparin Lock Flush Solution. It is a regulatory approval document and does not contain information about acceptance criteria, device performance studies, or clinical trial data as typically found in a scientific study or clinical report.

Therefore, I cannot provide the requested information based on the input text. The input text primarily deals with:

• General regulatory information regarding medical device clearance.
• Confirmation of substantial equivalence to a predicate device.
• Instructions for compliance with FDA regulations.
• Indications for Use statement for the device.

To address your request, information from a different type of document, such as a clinical study report, a scientific publication, or the device's design validation documentation, would be necessary.

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