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The Hantech Pre-filled 0.9% Normal Saline Flush Syringes, are in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the manufacturer for the appropriate device.

The Hantech Pre-filled 0.9% Normal Saline Flush Syringes is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The device will be marketed as 10mL syringe with a 3mL, 5mL or10mL fill volume according to the market needs. It is terminally sterilized by steam sterilization. The product has a shelf life of 1 years.

The provided document (K231363) is a 510(k) summary for Hantech Pre-filled 0.9% Normal Saline Flush Syringes. This type of device is a sterile medical product, not an AI/ML-driven diagnostic or image analysis tool.

Therefore, the concepts of acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, and training sets do not apply in the context of this device and the information provided in the 510(k) summary.

The document describes non-clinical bench testing to demonstrate the substantial equivalence of the Hantech Pre-filled 0.9% Normal Saline Flush Syringes to a legally marketed predicate device. The "acceptance criteria" here refer to the predefined standards and limits for the physical, chemical, and biological properties of the syringe and its contents, as well as the sterilization process, which are based on recognized international and national standards (e.g., ISO, USP).

Here's an interpretation of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table summarizing the non-clinical testing performed. The "Acceptance criteria" column lists the standards/criteria the device must meet, and the "Conclusion" column indicates "Pass" for all tests, meaning the device met these criteria.

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

The document explicitly states "Summary of clinical Testing: N/A," meaning no clinical trials were conducted. The testing described is bench testing (laboratory-based, non-human, non-animal testing) of the physical product, its components, and its contents. The sample sizes for each specific test (e.g., how many syringes were tested for dimensions, or how many batches for chemical composition) are not provided in this summary document. Data provenance would be the manufacturer's internal testing facilities in China. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate compliance.

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

This question is not applicable. The "ground truth" for a medical device like a syringe is established by validated measurement methods and recognized standards, not by expert consensus on clinical findings. For example, the pH of the saline is measured by a pH meter against a standard, not by an expert's opinion.

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, like image reading, not for objective bench testing of a physical product.

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

No, an MRMC study was not done. This type of study is typically performed for diagnostic devices (e.g., AI in radiology) where the performance of human readers, with and without AI assistance, is compared. This device is a pre-filled saline syringe.

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

No, this concept is entirely irrelevant for a medical device such as a pre-filled saline syringe. This applies to AI/ML algorithms.

7. The Type of Ground Truth Used:

The "ground truth" (or more accurately, the reference standard) for this device's performance is based on:

• Recognized consensus standards: International Organization for Standardization (ISO) standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series)
• United States Pharmacopeia (USP) monographs and general chapters: (e.g., USP for pH, USP for identification tests, USP for particulate matter, USP for Bacterial Endotoxins, USP31- for Sterility tests, USP monographs for Sodium Chloride Injection)
• Manufacturer's internal specifications: Which must meet or exceed these recognized standards.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML 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 Pre-Filled Normal Saline Flush Syringe is intended to be used only for the flushing vascular access devices.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "TK Pre-Filled Normal Saline Flush Syringe."

The letter acknowledges the submission of a premarket notification and states that the device is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements but does not include details about performance testing, study designs, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot generate the requested table and information based on the given input.

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Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.

The provided document is a 510(k) summary for a medical device called "Pre-Filled Normal Saline Flush Syringe." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. It does not describe a study involving an AI/CADe device or human readers. Therefore, I cannot provide information regarding acceptance criteria and studies typical for AI/CADe devices, such as those related to multi-reader multi-case studies, effect size of AI assistance, expert qualifications, or ground truth establishment for training and test sets in an AI context.

However, I can extract the acceptance criteria and performance data for the non-clinical (bench) tests conducted on the Pre-Filled Normal Saline Flush Syringe to demonstrate its safety and effectiveness.

Here's the information based on the provided text, specifically from Section VII "Summary of Non-clinical Testing (Bench)":

1. Table of Acceptance Criteria and the Reported Device Performance

Note on ISO standards in the table: There appears to be a typo for test IDs 4.2 and 4.3 in the provided document (ISO 10995 instead of ISO 10993 for biocompatibility tests). I have kept the text as written but noted the likely correct standard.

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

• Sample Size: "Real time aged samples from three non-consecutive lots were tested for all performance criteria."
• Data Provenance: The document does not specify the country of origin for the test samples or explicitly state if the study was retrospective or prospective. It implies prospective testing of manufactured lots.

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 non-clinical, bench testing study for a physical medical device, not an AI/CADe device requiring expert-established ground truth from medical images or patient data.

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

Not applicable, as this is bench testing. The results are based on objective measurements against established standard criteria.

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 device is not an AI/CADe device, and the study did not involve human readers or AI assistance.

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

Yes, in a sense. The "device" in this context is the physical syringe. The performance tests conducted are standalone tests of the device itself (its materials, chemical contents, physical properties, and biocompatibility), without specific human-in-the-loop performance measurement beyond standard laboratory procedures.

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

The "ground truth" for this device's performance is established by internationally recognized consensus standards (e.g., ISO, USP, AAMI TIR) which define the acceptable limits and test methodologies for the physical, chemical, and biological properties of the device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.

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The AMSafe® Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap.

This document describes the premarket notification (510(k)) for the AMSafe® Pre-Filled Normal Saline Flush Syringe. The information provided outlines the device's technical characteristics, intended use, and comparison to a legally marketed predicate device (K183473). The study performed is a non-clinical bench testing study, not an AI/ML-based clinical study, therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are detailed in "Table 5-2" on page 6 of the document.

Additionally, shelf life was evaluated:

• Test: Shelf life
• Method: ASTM F1980-16
• Acceptance Criteria/Conclusion: Verify that the device will remain within specification during the prescribed shelf life when stored under labeled conditions. (Implied Pass, as per overall conclusion).

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

The document describes non-clinical bench testing of manufacturing characteristics and chemical composition, not an AI/ML-based study with a "test set" composed of patient data. Therefore, the concept of sample size for a test set (e.g., number of images, patient records) and data provenance (country of origin, retrospective/prospective) as typically understood for AI/ML studies are not applicable. The tests were performed on samples of the device itself. The specific number of units tested for each criterion is not provided, but it would typically be a predetermined number based on the statistical requirements of the specific test methods (e.g., ISO, ASTM, USP standards).

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

Not Applicable. This was a bench study, not an AI/ML study requiring expert labeling of data. The "ground truth" for these tests are the established physical, chemical, and biological standards and methodologies outlined in the referenced ISO, ASTM, and USP documents.

4. Adjudication Method for the Test Set

Not Applicable. This was a bench study; there was no human-in-the-loop expert adjudication process as would be typical for AI/ML algorithm evaluation.

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

No, an MRMC study was not done. This is a review of a physical medical device (pre-filled syringe), not an AI/ML diagnostic or assistive tool where human reader performance would be a relevant metric.

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

Not Applicable. This document describes the performance of a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established industry standards and pharmacopeial specifications. This includes:

• Physical Properties: Standards like ISO7886-1, ISO80369-7, ASTM F2338-09.
• Chemical Composition: United States Pharmacopeia (USP) monographs such as USP, USP, USP6-466, USP6-471, USP, USP, USP, USP.
• Biocompatibility: ISO10993 series (ISO10993-11, ISO10993-10, ISO10993-5) and ASTM F756-17.
• Sterility Assurance: The mention of 10-6 SAL (Sterility Assurance Level) indicates adherence to established sterilization standards.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML 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 a physical device, there is no ground truth establishment process in that context.

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The AMSafe® 0.9% Sodium Chloride Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12mL syringe with a 3mL, 5mL, or 10mL fill volume, and a 20mL syringe with 20mL fill volume. The products are in two different packages, one is poly blister package and the entire packaged device are gamma radiation sterilized for sterile delivery to a sterile field; another is PP wrapper as a dust cover for non-sterile field. The solution is sterile normal saline for injection and meets the requirements of USP.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the AMSafe® Pre-Filled Normal Saline Flush Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of an AI-powered diagnostic device. Therefore, much of the requested information regarding acceptance criteria and study design for an AI device is not applicable to this document.

However, I can extract information related to the device's acceptance criteria for performance (bench testing) and the testing done to prove it meets those criteria.

Here's an attempt to answer your questions based only on the provided text, recognizing its limitations for an "AI-powered diagnostic device":

Device: AMSafe® Pre-Filled Normal Saline Flush Syringe

Type of Device: Prefilled plastic piston syringe with 0.9% sodium chloride for injection, USP, intended for flushing intravenous administration sets and indwelling intravenous access devices. This is a medical device, not an AI-powered diagnostic device.

Study Type: Non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. No clinical study with human subjects, AI assistance, or MRMC design was conducted.

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

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

• Sample Size for Test Set: The document describes "non-clinical testing" and lists various tests, each presumably with its own sample size of syringes or solution, but these specific sample sizes are not detailed in the provided text.
• Data Provenance: The tests are standard industry bench tests (e.g., ISO, USP, ASTM standards). The country of origin for the data is not explicitly stated within the context of the testing, but the company is Amsino International Inc., based in Pomona, CA, USA, suggesting testing likely occurred in or for a US regulatory submission. The data is from prospective bench testing, not retrospective or prospective clinical data.

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

• This device is not an AI diagnostic, so there is no concept of "ground truth" derived from expert consensus of images/data in the way it applies to AI devices. The "ground truth" for the performance tests (e.g., pH, chemical content, sterility) is established by the specified reference standards (USP, ISO, ASTM) and the inherent measurable properties of the device and its contents. The results are objective, quantitative measurements following validated methods, not subjective interpretations by experts.

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

• Not applicable as this is not an AI diagnostic device requiring human expert adjudication of diagnostic outcomes. The results are objective measurements against pre-defined criteria.

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 device is a pre-filled saline syringe, not an AI-powered diagnostic. This type of study is irrelevant to its purpose and regulatory pathway.

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. The tests performed are standalone bench tests of the physical and chemical properties of the syringe and its contents.

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

• The "ground truth" for these tests is based on established scientific and engineering standards and methods (e.g., USP monographs for chemical purity and content, ISO standards for device properties, ASTM for packaging). It is a direct measurement against defined physical, chemical, and biological specifications, not a diagnostic ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device; therefore, there is no concept of 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, no ground truth needed to be established for it.

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This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

The subject device is a polypropylene plastic syringe filled with 0.9% Sodium Chloride for Injection, USP, and capped with a polypropylene plastic cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12 mL syringe with a 3 mL, 5 mL, or 10 mL fill volume.

This document describes a 510(k) premarket notification for a medical device called "Normal Saline Flush" by Nurse Assist, Inc. The purpose of the submission is to demonstrate substantial equivalence to previously marketed predicate devices. It is not a study proving clinical effectiveness of an AI device.

Therefore, many of the requested categories for describing an AI study are not applicable to this document. I will fill in the relevant information from the provided text.

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

• Seal Testing: no leaks (15 in-Hg for 15 minutes)
• Sterility: confirmation of sterile barrier and product sterility (no growth present) | - Visual Inspection: no major compromise of packaging
• Seal Testing: no leaks
• Sterility: confirmation of sterile barrier and product sterility—no growth present |
  | Shelf Life (Stability) | - Visual: no leaks, holes or cracks
• Seal: no leaks
• Appearance/Color: clear liquid
• Odor: no objectionable or unusual odors
• pH: 4.5 – 7.0
• Sodium Chloride: 0.885 – 0.945%
• Heavy Metals: USP & limits
• Sterility: confirmation of sterile barrier and product sterility (no growth present)
• Particulate: USP limits | - Visual: no leaks, cracks or holes
• Seal: no leaks
• Appearance/Color: no discoloration or cloudiness
• Odor: no objectionable odors
• pH: within upper and lower limits
• Sodium Chloride: within upper and lower limits
• Heavy metals: USP : less than 10 ppm (0.001%), USP : less than 2 ppm
• Sterility: confirmation of sterile barrier and product sterility—no growth present
• Particulate: less than 3,000 for 10 μm and 300 for 25 μm |
  | Biocompatibility (Qualitative) | - Cytotoxicity: Grade 0 (no reactivity)
• Hemocompatibility: Non-hemolytic
• Acute Systemic Toxicity: Non-toxic
• Intracutaneous Irritation: Non-irritant
• Contact Sensitization: Non-sensitizer
• Pyrogenicity: Nonpyrogenic | - Cytotoxicity: Grade 0 (no reactivity)
• Hemocompatibility: Hemolytic index of 0.0% (non-hemolytic)
• Acute Systemic Toxicity: Non-toxic
• Intracutaneous Irritation: Non-irritant
• Contact Sensitization: Non-sensitizer
• Pyrogenicity: Nonpyrogenic |
  | Endotoxin | Less than 0.25 EU/ml | All samples tested at an endpoint of 0.03 EU/ml. Sensitivity of Lysate (AntiLog10 of Mean): 0.03 EU/ml (This implies the results were below or at the detection limit, and below the acceptance criteria.) |

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

This document pertains to the physical and chemical properties, and biocompatibility of a medical device (a saline flush syringe), not an AI algorithm. Therefore, there is no "test set" in the context of an AI study. The data provenance is from non-clinical laboratory testing of the device. The country of origin of the testing is not specified but is implicitly associated with the manufacturer, Nurse Assist, Inc. (Haltom City, TX 76117, USA).

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. This is not an AI study. The "ground truth" for these tests are laboratory standards, analytical methods, and biological responses to the device materials.

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

Not applicable. This is not an AI study.

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 study.

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

Not applicable. This is not an AI study.

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

The "ground truth" for this device consists of established scientific and regulatory standards for device safety, performance, and sterility. This includes:

• Physical integrity specifications (e.g., no leaks, cracks).
• Chemical composition standards (e.g., pH range, sodium chloride concentration, heavy metals limits).
• Sterility assurance levels (S.A.L. of $10^{-6}$).
• Biocompatibility standards (e.g., ISO, ASTM, USP guidelines for cytotoxicity, hemocompatibility, toxicity, irritation, sensitization, pyrogenicity).
• Endotoxin limits (USP ).

8. The sample size for the training set

Not applicable. This is not an AI study.

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

Not applicable. This is not an AI study.

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FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)

The Normal Saline Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and 0.9% Sodium Chloride Iniection, USP. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms:

1 mL fill in 6 mL Syringe LL
2 mL fill in 6 mL Syringe LL
2.5 mL fill in 6 mL Syringe LL
3 mL fill in 6 mL Syringe LL
3 mL fill in 12 mL Syringe LL
5 mL fill in 6 mL Syringe LL
5 mL fill in 12 mL Syringe LL
10 mL fill in 12 mL Syringe LL

The barrel of the syringe is the reservoir for the product. It shall be overfilled during repackaging as per Pharmacopoeial Forum, Volume 26, Number 2: page 471. Plunger and plunger rod are the two moving parts of the DEVICE. The solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.

The DEVICE will be filled using aseptic technique utilizing pre-sterilized components in a Class 100 environment. The sterile components of the DEVICE (hypodermic syringe, tip cap and 0.9% Sodium Chloride Injection, USP) will be purchased from qualified vendors.

The DEVICE is used to maintain patency of in-dwelling intravenous access devices (IVAD). The solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.

The provided text describes a 510(k) summary for Medefil's Normal Saline Flush Syringe, focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, specific studies proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the request. The document describes the device, its intended use, and how it differs from a predicate device.

Therefore, I cannot provide the requested information based on the given text.

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Maintain patency of vascular devices

Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for Preefil® Normal Saline Flush Syringes, focusing on its substantial equivalence to a predicate device and its intended use. It does not detail specific performance metrics, studies, or evaluation methodologies beyond the comparison with another flush device. Therefore, I cannot generate the requested table and information.

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FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)

Normal Saline I. V. Flush Syringe

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Normal Saline I.V. Flush Syringe." This document does not describe any acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a legally marketed predicate device, rather than a study demonstrating its performance against specific acceptance criteria. The 510(k) pathway for medical device clearance often relies on demonstrating equivalence rather than conducting new clinical trials with performance metrics and acceptance criteria for novel devices.

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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The ROCAP Normal Saline Flush Syringe is indicated for use to maintain patency of indwelling venous access devices.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Normal Saline IV Flush Syringe" (ROCAP Division of Sabratek Corporation). This letter grants clearance based on substantial equivalence, which means the device is considered as safe and effective as a legally marketed predicate device.

Crucially, this document is an FDA clearance letter and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

A 510(k) clearance evaluates substantial equivalence to a predicate device, not necessarily a new study proving specific performance metrics against pre-defined acceptance criteria. While the manufacturer would have submitted data to the FDA to demonstrate substantial equivalence, this specific letter does not include the details of that data or any explicit acceptance criteria.

Therefore, I cannot provide the requested information from this document. To answer your questions, one would need access to the 510(k) submission itself or other regulatory documents that detail the performance studies and acceptance criteria.

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