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Surgical mask (with different trade names: Face Mask, Surgical Mask, Surgical Face Mask) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.

Surgical Mask is single use multi-layer mask with outer layer and inner layer (spunbond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the surgical mask to be secured on user - via earloops or ties. Earloops are of urethane elastic fiber and latex-free; and ties are of spunbond polypropylene and also latex-free. The nose piece is a pliable white aluminum strip, covered by PP covering. All of the materials used in the construction of the Surgical Mask are being used in currently marketed devices.

This is a medical device, not an AI/ML device. The provided text is a 510(k) Summary for a surgical mask, which is a physical product, not a software algorithm. Therefore, the questions regarding acceptance criteria and studies for an AI/ML device are not applicable.

The document discusses the substantial equivalence of the surgical mask to a predicate device based on material, intended use, mask style, design features, and performance test results against established consensus standards (e.g., ASTM, MIL-M, ISO).

Here's a breakdown of the relevant information provided for the surgical mask:

Acceptance Criteria and Device Performance (Surgical Mask)

The acceptance criteria for the surgical mask are implicitly defined by the performance characteristics of the predicate device (K061716) and relevant consensus standards. The study demonstrates that the device "meets" these criteria by showing its performance is similar to or better than the predicate device.

Irrelevant/Not Applicable Information for AI/ML Device Study:

The following questions are not applicable to this 510(k) submission for a surgical mask:

1. Sample sized used for the test set and the data provenance: Not applicable. Performance tests for physical masks follow specific standard protocols, not "test sets" in the AI sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical mask performance is based on standardized physical and chemical tests, not expert consensus on data interpretation.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth for a surgical mask's performance is based on physical and chemical testing according to recognized standards (e.g., ASTM, ISO).
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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Insulin pen needle is intended for use with pen injector for subcutaneous injection of insulin.

Insulin pen needle is a single-use device, which consists of needle tube, needle shield, needle seat, needle seat protection cover, and seat seal paper. Needle gauge includes 29G, 30G, 31G, and 32G. Needle length can be produced to various sizes. After sterilization by EO, it's sterile, pyrogen free, and non-toxic. Its shelf life is 5-year.

The provided text describes a 510(k) submission for an insulin pen needle. This type of medical device is generally evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than through complex clinical studies with human participants, AI algorithms, or extensive ground truth establishment. Therefore, many of the requested categories are not applicable in this context.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

• Sample Size for Test Set: Not explicitly mentioned for specific test types, but implied to be sufficient for ISO compliance and biocompatibility testing. This typically involves a statistically relevant number of samples per test as outlined by the standards.
• Data Provenance: The device manufacturer is Tiger Medical Products Ltd. in Shanghai, China. The testing was conducted by or on behalf of the manufacturer, likely in China or by certified labs. The tests are non-clinical (bench and biocompatibility).

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. This is a non-clinical device that relies on standardized performance and biocompatibility testing, not expert interpretation of diagnostic images or clinical outcomes. The "ground truth" is established by the specifications of the ISO standards and the verifiable results of the tests.

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

• None. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human interpretation is involved. For this device, performance is measured against established engineering and biological standards.

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

• Not Applicable. This is a single-use insulin pen needle, not a diagnostic or AI-powered device involving human readers.

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

• Not Applicable. This device does not incorporate any algorithms or AI component.

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

• Standardized Test Results/Compliance with ISO Standards and Biocompatibility Protocols. The "ground truth" for this device lies in its ability to meet the defined technical specifications of ISO 11608-2, ISO 9626, ISO 7864, and the biological safety requirements of ISO 10993. This is verified through laboratory testing (e.g., force measurements, flow rates, sterility tests, cytotoxicity assays).

7. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" or corresponding ground truth to establish.

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The Syringe with or without needle is intended for dispensing/administering fluids, and collecting/ sampling of fluid in medical practice.
The insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin.
The Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

This is a 510(k) premarket notification for general hospital devices (syringes and needles), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device evaluation are not applicable.

Here's the information that can be extracted relevant to acceptance criteria and device performance:

Acceptance Criteria and Device Performance for Syringes and Needles

This document describes a 510(k) submission for conventional medical devices (syringes and needles), not an AI/ML medical device. As such, the acceptance criteria are based on compliance with established international standards for these types of devices, rather than performance metrics like sensitivity, specificity, or AUC typically used for AI/ML.

1. Table of Acceptance Criteria and the Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical bench testing summary.

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

• Sample Size: Not explicitly stated in the provided document. The document mentions "Bench tests were conducted," implying laboratory testing on a sample of devices, but the exact number of units tested is not provided.
• Data Provenance: The tests were "Bench tests" which typically means laboratory-controlled testing. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as this is a non-clinical submission.

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

• Not applicable. For this type of device (syringes and needles), "ground truth" is established by adherence to engineering performance standards (ISO standards) and material specifications, verified through objective bench testing. It does not involve expert interpretation or clinical ground truth as would be relevant for an AI/ML diagnostic device.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is described because there is no subjective interpretation or clinical assessment involved in establishing ground truth for these physical devices. Compliance is determined by objective measurements against established standard parameters.

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 submission is for physical medical devices (syringes and needles), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

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

7. The type of ground truth used:

• The "ground truth" for these devices is defined by international consensus standards (ISO 8537, ISO 7886-1, ISO 594-1, ISO 594-2, ISO 7864, ISO 10993) and the design specifications of the device (e.g., nominal capacity, material composition, transparency, legibility of gradations). These are objective, measurable criteria.

8. The sample size for the training set:

• Not applicable. This submission is for physical medical devices, not an AI/ML device that requires a training set.

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

• Not applicable. See point 8.

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The Tiger SFM0001 surgical mask is intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

The Tiger surgical mask SFM0001 (colors: blue) is flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown polypropylene filter material; Ear-loops are made of urethane elastic fiber for free elastic loops. The nose piece is white aluminum strip with PP covering. All of the materials used in the construction of the Tiger flat surgical Masks are being used in currently marketed devices (see predicate information). All items are nosterilize and only for single use.

This submission describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Tiger Surgical Mask SFM0001.
The study is a series of non-clinical bench tests performed by accredited laboratories to demonstrate substantial equivalence to predicate devices.

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

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

• Fluid Resistance (ASTM F1862): 32 samples were tested. The data provenance is from Nelson Laboratories.
• Particulate Filtration Efficiency (ASTM F2299): Specific sample size not explicitly stated in the provided text, but testing was performed by Nelson Laboratories.
• Bacterial Filtration Efficiency (ASTM F2101): Specific sample size not explicitly stated in the provided text, but testing was performed by Nelson Laboratories.
• Flammability Class (16CFR 1610): Specific sample size not explicitly stated, but testing was performed by Nelson Laboratories.
• Delta-P (Mil M36954C): Specific sample size not explicitly stated, but testing was performed by Nelson Laboratories.
• Biocompatibility (ISO 10993-1): Specific sample sizes for cytotoxicity, sensitization, and irritation tests are not explicitly stated, but tests were performed by Toxikon Corporation.

The data provenance is retrospective as these are non-clinical bench tests of an already manufactured device, and the testing was conducted by independent laboratories (Nelson Laboratories and Toxikon Corporation). The country of origin for the device manufacturer is China.

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

This is a non-clinical bench study on device performance characteristics, not a diagnostic or clinical study requiring expert consensus for ground truth. The "ground truth" is based on the objective measurements and established standards of the specified ASTM, CFR, and ISO test methods. The laboratories performing these tests are accredited and their expertise lies in conducting these specific performance evaluations.

4. Adjudication method for the test set:

Not applicable. This is not a clinical study involving subjective interpretation or multiple reviewers. The results are based on objective measurements according to standardized test 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:

Not applicable. This is a study for a surgical mask, not an AI-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is a physical device (surgical mask), not an algorithm.

7. The type of ground truth used:

The ground truth used for this study is based on objective measurements from standardized test methods. For example:

• Fluid resistance is measured by the number of passes at a specific blood pressure.
• Filtration efficiencies are measured as percentages of particles/bacteria blocked.
• Flammability is categorized into classes.
• Biocompatibility is assessed against established criteria for cytotoxicity, sensitization, and irritation.

8. The sample size for the training set:

Not applicable. There is no "training set" for physical device performance testing of this nature. The tests are directly evaluating the product's performance against pre-defined standards.

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

Not applicable, as there is no training set.

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The indication for use for all the product variants is grouped into three different sections:

(a) Uncuffed, oral/nasal and Cuffed, oral /nasal:
The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management.

(b) Uncuffed, nasal only and Cuffed, nasal only:
The intended use of this device is to be intubated into a patient's trachea via the nose for airway management, specifically for use in surgical procedures involving the head, neck and face.

(c) Uncuffed, oral only and Cuffed, oral only:
The intended use of this device is to be intubated into a patient's trachea via the mouth for airway management, specifically for use in surgical procedures involving the head, neck and face.

Tiger Medical Products Ltd's Endotracheal tube is available in 90 different variants distributed among 6 main configurations and different sizes, as detailed below. It is marketed as sterile, single use, for airway management.

It consists of a clear tracheal tube with radiopaque blue stripe running its entire length, and it is graduated with multiple centimeter markings to allow easy detemination of intubated length, and is terminated with a 15mm standard connector.

It conforms to ISO 5261: 1999 and ASTM F1242: 1996 with one minor exception in the tube marking.

The six categories (or confiqurations) are listed below:

• (a) CATEGORY 1: uncuffed, oral/nasal:
  It is provided as uncuffed, murphy, oral/nasal, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes

• (b) CATEGORY 2: uncuffed, nasal only:
  It is provided as uncuffed, murphy, preformed nasal- 2 eyes, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes

• (c) CATEGORY 3: uncuffed, oral only:
  It is provided as uncuffed, murphy, preformed oral- 2 eyes, and it is provided as anones from sizes 2.0 to 10.0 inclusive, totalling 17 sizes

• (d) CATEGORY 4: cuffed, oral/nasal:
  lt is provided as cuffed, murphy, oral/nasal, and in 0.5mm ID it is provided as sizes 4.0 to 10.0 inclusive, totalling 13 sizes

• (e) CATEGORY 5: cuffed, nasal only:
  It is provided as cuffed, murphy, preformed nasal, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes

• (f) CATEGORY 6: cuffed, oral only:
  lt is provided as cuffed, murphy, preformed oral, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes

The provided text describes a 510(k) summary for Tiger Endotracheal tubes, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested sections about acceptance criteria and study details cannot be directly extracted or inferred from this document. The document argues for substantial equivalence based on similarity in design, materials, performance, and other characteristics, rather than by presenting new performance data against numerical thresholds.

Here's a breakdown of what can be gathered and what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary does not outline specific numerical acceptance criteria (e.g., tensile strength minimums, cuff pressure retention rates) or present a study showing the Tiger Endotracheal tubes met such criteria with quantified performance metrics. Instead, it relies on a qualitative comparison of "TECHNOLOGICAL CHARACTERISTICS" to predicate devices, stating conclusions like "Identical" or "Similar."

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

This information is not provided. The document makes no mention of a "test set" in the context of a performance study, nor does it refer to sample sizes used for testing. The primary focus is on comparing the technological characteristics of the new device to existing predicate devices.

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

This information is not applicable/not provided. There is no mention of a performance study requiring expert review or ground truth establishment for a test set.

4. Adjudication Method

This information is not applicable/not provided. As no expert-reviewed test set is mentioned, there is no adjudication method described.

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

This information is not applicable/not provided. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance. This device is a physical medical device (endotracheal tube), not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable/not provided. This is a physical device, not an algorithm, so a standalone performance study in that context is not relevant. The information provided is for regulatory clearance based on substantial equivalence.

7. Type of Ground Truth Used

This information is not applicable/not provided. Since no performance study generating new data for assessing ground truth is described, this detail is not relevant to the document's content. The document relies on the established safety and effectiveness of predicate devices as a basis for its claims.

8. Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not provided. As there is no training set mentioned, there is no ground truth establishment process described for it.

In summary: The provided document is a 510(k) summary for a medical device (endotracheal tubes), which aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. This regulatory pathway typically involves comparing the new device's design, materials, intended use, and technological characteristics to the predicate, rather than conducting new clinical trials or extensive performance studies with quantitative acceptance criteria and ground truth establishment in the manner that would be expected for a novel diagnostic or AI-powered device. The document explicitly states: "This device is safe and effective as the predicate device cited above."

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