Search Results

This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.

The OMI Retractable Safety Syringe works like this: STEP 1 After cap removal, fluid draw-up and aspiration is unchanged from conventional syringes. STEP 2 As the plunger rod is depressed and the plunger stopper makes contact with the needle hub, the elastic membrane conforms to the conical shape of the needle hub. The plunger stopper membrane stretches until the plunger rod is fully depressed and maximum fluid is expelled from the svringe. STEP 3 At the point of full plunger rod depression, the application of the injection force overcomes the strength of the web joining the inner and outer portions of the needle hub. As this web fractures and the outer portion of the needle hub moves forward, the plunger stopper membrane is simultaneously pierced by the conical end of the hub, releasing the inner portion of the hub carrying the needle to be retracted into the hollow stem of the plunger rod by the coiled spring. The activation force is controlled. The extra pressure required at the end of the injection stroke to retract the needle is minimal. The entire procedure designed for singlehanded use, with no change to common habits. STEP 4 The fracturing of the needle hub and the piercing of the plunger stopper allow the needle to be forced into the plunger rod by the coiled spring. The speed of this retraction and the minimal dead space avoids blood or fluid spatter. Retraction is accompanied by an audible "click" and the highly visible separation of the needle hub. The syringe is EO sterilized, non-pyrogenic, and latex free.

The provided text describes a 510(k) premarket notification for the OMI Ret retractable Safety Syringe. It focuses on demonstrating substantial equivalence to a predicate device, the SEZ Safety Syringe (K031163), rather than presenting a detailed study with specific acceptance criteria and performance metrics in the format of AI device evaluation.

However, I can extract the relevant information and present it in a manner that aligns with your request where possible, while noting limitations due to the nature of the legal filing.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document refers to a "clinical investigation" and "test for the comparison between OMI Ret retractable Safety Syringe and the legally marketed predicate device." This study was performed "in accordance with 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA'."

2. Sample Size for the Test Set and Data Provenance

• The document does not explicitly state the sample size used for the clinical investigation or comparison test.
• The data provenance (country of origin, retrospective/prospective) is not specified. However, the study was conducted to meet FDA regulations for a US-marketed device.

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

• The document does not provide details on the number of experts, their qualifications, or how ground truth was established for the clinical investigation. For a physical device like a syringe, "ground truth" would likely refer to objective measurements of performance (e.g., retraction force, completeness of retraction, prevention of needlesticks in simulated or actual use).

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method.

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

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (like AI in radiology) where human readers make a judgment. The OMI Ret retractable Safety Syringe is a physical medical device.

6. Standalone Performance Study

• Yes, a standalone study (referred to as a "clinical investigation" and "test for the comparison") was performed to demonstrate that the OMI Ret retractable Safety Syringe itself ("algorithm only" in AI terms) met the necessary safety and performance criteria, including comparison to the predicate device. The goal was to show "clinical acceptability."

7. Type of Ground Truth Used

• Based on the context of a safety syringe, the "ground truth" would likely involve objective measurements related to:
  • Mechanical performance: Retraction force, completeness of needle retraction, prevention of re-exposure.
  • Usability/Human factors: Ease of use, activation force, audible/visible confirmation of retraction, potential for needlestick incidents in simulated use.
  • Biocompatibility: In vitro and in vivo testing demonstrating material safety.
  • Sterility assurance.
• The document states that the findings were based on "biocompatibility testing, clinical testing, compliance with voluntary standards, and comparison to the previous device."

8. Sample Size for the Training Set

• This is not applicable as the OMI Ret retractable Safety Syringe is a physical device, not an AI/software device that would require machine learning training data.

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

• Not applicable (no training set for a physical device).

Ask a specific question about this device

The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.

The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.

The provided text describes a medical device, the "3 In 1" I.V. Administration Set, and its 510(k) summary for clearance. However, it does not detail a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/ML device would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K925465). This is a different type of validation process.

Here's an analysis based on the information provided, addressing your requested points where applicable, and noting where the information is not present for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an IV administration set), the "acceptance criteria" are generally tied to demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device. The performance data presented are primarily engineering bench tests to ensure the physical integrity and functionality of the set.

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

• Sample Size: Not specified. For bench testing of physical properties, specific sample sizes are typically used for each test (e.g., n=30 for tensile strength). This information is not provided in the 510(k) summary.
• Data Provenance: The tests were performed internally by VitalCare Group, Inc., or by a contracted lab. The country of origin of the data is implicitly the USA (where the company is based and the submission was made). The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate device performance and safety.

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

Not applicable. For a device like an IV administration set, "ground truth" as it relates to expert consensus in image analysis or clinical diagnosis is not relevant. The "ground truth" for performance is established by engineering specifications, material standards, and industry best practices. The "experts" would be the engineers and quality control personnel designing and testing the device, but their specific numbers and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists, pathologists) when establishing ground truth for diagnostic or AI performance studies. This is not a human-in-the-loop or diagnostic device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating human performance, often with and without AI assistance, typically in diagnostic or screening contexts. It is not relevant for an IV administration set.

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

No. This device does not have an "algorithm" or AI component. It is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements for IV administration sets. This would include:

• Physical specifications (e.g., dimensions, flow rates)
• Material properties (e.g., tensile strength, chemical compatibility)
• Biocompatibility standards (e.g., ISO 10993)
• Sterility assurance (e.g., ISO 11135 for EO sterilization)
• Leakage and connection integrity standards.

The 510(k) summary indicates that "Pull testing, pressure testing, joint strength testing, and drop testing has been performed," which are standard engineering tests to verify these aspects.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable, as there is no training set.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between the patient and examiner.

VitalCare Powder Free Synthetic Vinyl Examination Glove. A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare professional and similar personnel to prevent contamination between the healthcare personnel and the patient's body, fluids, waste or environment.

This document details the acceptance criteria for the "VitalCare Powder Free Synthetic Vinyl Examination Glove" and the studies performed to demonstrate its compliance.

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 the sample sizes used for each specific test (e.g., physical, dimensional, water leak, skin irritation, skin sensitization). It only refers to the tests performed to meet the standards. The data provenance (country of origin of the data, retrospective or prospective) is not specified.

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

The document does not mention the number of experts or their qualifications for establishing ground truth for any of the performance tests. The "ground truth" for these tests is defined by the objective metrics and standards themselves (e.g., ASTM D-5250-00, ASTM D-6124-01, FDA 1000ml Water Leak Test, and standard dermatological tests for irritation/sensitization).

4. Adjudication Method for the Test Set

No adjudication method is described. The performance data seems to be based on direct measurement and adherence to established standard specifications rather than subjective expert review requiring adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The device is an examination glove, and its performance is evaluated against physical and chemical standards, not through human reader diagnostic accuracy.

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

Yes, the performance tests described (ASTM standards, FDA water leak test, skin irritation/sensitization) are inherently standalone evaluations of the device's physical and biological properties. They do not involve human-in-the-loop performance in the way an AI diagnostic algorithm would.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on objective standards and test methods:

• ASTM Standard D-5250-00: For physical and dimensional testing.
• ASTM D-6124-01: For starch content to quantitatively determine the "powder-free" claim.
• FDA 1000ml Water Leak Test: For assessing barrier integrity.
• Primary Skin Irritation and Skin Sensitization tests: Standard toxicological/dermatological testing to assess biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (an examination glove), not an AI algorithm requiring a "training set."

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

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

Ask a specific question about this device

VitalCare Sterile Water and 0.9% Sodium Chloride. The10cc/30cc syringes are used for balloon inflation. Devices are not intended for wound irrigation, injection or IV Administration.

Sterile Water and 0.9% Sodium Chloride are products that have been used in the medical community for decades, the only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The syringes are manufactured from 100% medical grade polypropylene and contain no color or preservatives or additives.

The containers are filled with distilled water and distilled saline solution, sealed, capped and gamma irradiated for single use only.

This 510(k) summary (K031748) is for the VitalCare Sterile Water and 0.9% Saline 10cc, 30cc pre-filled inflation syringes. The document describes the device, its intended use, and compares it to a predicate device (Orion Life Systems Sterile Water and 0.9% 10cc pre-filled inflation syringes) to establish substantial equivalence.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for a diagnostic or AI-driven medical device submission.

Instead, this 510(k) emphasizes substantial equivalence to an already legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as the predicate device based on similar technological characteristics and intended use, rather than conducting a new, detailed performance study against specific acceptance criteria.

Therefore, many of the questions regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable to this type of submission.

However, I can extract the relevant information from the provided text based on the 510(k) submission's structure:

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

This 510(k) submission, being for a pre-filled syringe (a manufacturing and material equivalence claim), does not present specific "acceptance criteria" and "reported device performance" in the way a clinical study would for a diagnostic or AI device. Instead, the "performance" is based on the equivalence of features and contents to the predicate device.

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

Not applicable. This is a 510(k) submission for substantial equivalence of a manufacturing product (pre-filled syringes), not a clinical trial or performance study involving a patient test set or data originating from a specific country. The "test" for this type of device is primarily a comparison of its physical and chemical properties, manufacturing processes, and intended use against a legally marketed predicate device.

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

Not applicable. There was no "ground truth" to establish in a clinical sense for a test set. The validation for this type of device involves scientific and engineering assessment of material properties, sterilization methods, and product design compared to the predicate device, typically performed by the manufacturer's internal quality and R&D teams and reviewed by the FDA.

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

Not applicable. No test set requiring expert adjudication was conducted for this 510(k) submission.

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 pre-filled syringe, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a pre-filled syringe, not an algorithm or software device.

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

Not applicable. The concept of "ground truth" as used in diagnostic or AI studies is not relevant here. The "truth" for this submission revolves around demonstrating that the device's physical and chemical attributes, along with its manufacturing process, result in a product that is safe and effective and functions equivalently to the predicate device.

8. The sample size for the training set:

Not applicable. There is no "training set" for this product.

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

Not applicable. There is no "ground truth" or "training set" for this product.

Ask a specific question about this device

A patient Vinyl Exam Glove, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Vinyl, Patient Exam Gloves, Powdered

This document is a 510(k) clearance letter from the FDA for a Vinyl Powdered Examination Glove. It is primarily a regulatory communication and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) or de novo submission might.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states the device is "substantially equivalent" to pre-amendments devices and focuses on regulatory compliance (GMP, labeling, etc.). For examination gloves, the performance criteria typically relate to things like barrier integrity (e.g., freedom from holes), tensile strength, and dimensions, which are usually tested according to industry standards, but these details are not present in this regulatory letter.

Ask a specific question about this device

Wound cover for patient care.

Gauze, Sponges Various Sizes, Non-Sterile and Sterile

The provided text is a 510(k) premarket notification letter from the FDA regarding "Gauze Sponges." This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for the specific information regarding a study, as this information is not present in the provided text. The document is simply an FDA clearance for a medical device (gauze sponges) that was deemed substantially equivalent to existing devices, without the need for the types of performance studies you are asking about for AI/ML products.

Ask a specific question about this device

A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.

Disposable Nonmetal Vaginal Speculum

The provided document is a 510(k) clearance letter from the FDA for a VitalCare Disposable Nonmetal Vaginal Speculum, along with its Indications for Use. This type of document is for medical devices and does not contain the kind of information requested about acceptance criteria and studies for AI/software-as-a-medical-device (SaMD) performance.

Therefore, I cannot extract the requested information from this document. The questions you've asked are specific to the validation of AI algorithms or software, which involves performance metrics like sensitivity, specificity, sample sizes for training/test sets, expert adjudication, and comparative effectiveness studies. This 1998 FDA clearance document for a physical medical device does not provide any of that information.

Ask a specific question about this device

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

VitalCare Exam Gloves (Latex), Paude

I am sorry, but based on the provided document, I cannot answer the question regarding acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for VitalCare Latex Exam Gloves, Powdered, and it primarily focuses on the regulatory clearance process and the device's substantial equivalence to legally marketed predicate devices.

The letter does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study, including sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document confirms the device's classification and allows its marketing, but it does not provide the detailed study results or acceptance criteria you are asking for.

Ask a specific question about this device