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The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

The Uroflex™ B and CystoFlex™ F Confocal Miniprobes can be used within anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

The subject devices, "Uroflex""B" and "CystoFlex""F" are identical in design and materials to the bundle and their reprocessing methods.

The provided text is a 510(k) summary for a medical device (Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™). It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Based on the provided text, there is no information present regarding specific acceptance criteria, a formal study proving the device meets acceptance criteria, or the details typically associated with AI/ML-based device performance studies.

The document states: "Verification and validation testing have shown that the Uroflex™B and CystoFlex™F Confocal Minigrobes are compatible with cystoscopes or endoscopic accessories with operating channels of diameter > 0.91 mm designed and commonly used to image the urinary tract during endoscopic procedures." However, this is a general statement and does not provide quantified acceptance criteria or detailed study results.

This submission is for a traditional medical device (confocal laser system with fiber optic probes), not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria (multi-reader multi-case studies, standalone algorithm performance, training data, ground truth establishment for training set) are not applicable to this document.

Since the requested information (acceptance criteria and study details) is not present in the provided text, I cannot complete the table or answer most of the specific questions.

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Ecoship Disposable Sharps Container is intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal of hazardous sharps. The single-use device is intended for "Overthe-Counter" use. The container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations. The manufacturer's bracket is required if the device is used on medication carts or in emergency vehicles.

Ecoship Disposable Sharps Containers are single-use sharps containers designed for point-first disposal of sharps. The containers are intended for over-the-counter use for the safe disposal of sharps, i.e. articles that can penetrate human skin. This definition includes, but is not limited to needles, scalpels, syringes with needles, disposable scissors, suture needles, stylets, trocars and broken test tubes. The containers are intended to be used in supervised areas of human and veterinary healthcare facilities. These areas may include nursing stations, laboratories, dental offices, physician offices, clinics, emergency rooms, surgical rooms, treatment rooms, research facilities, veterinarian practices and other small quantity waste generators. The devices are also intended to be used in healthcare facility mail-back programs and in home healthcare by clinical staff.

Two Ecoship Disposable Sharps Container models are described in this submission:

• D2-ES is 2 liters with fill capacity of 1.5 liters .
  • o Tare: 192 grams (6.77 oz)
  • o Dimensions: (L) 142 mm x (W) 142 mm x (H) 151 mm
• D4-ES is 4 liters with fill capacity of 3 liters .
  • o Tare: 304 grams (10.72 oz)
  • Dimensions: (L) 142 mm x (W) 142 mm x (H) 303 mm o

The document provided is a 510(k) summary for the Ecoship Disposable Sharps Container, filed by Daniels Sharpsmart, Inc. This summary outlines the device's intended use, description, equivalence to marketed devices, and performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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

• Puncture Resistance: "various sections of a container" (specific number not given).
• Toppling Resistance (CSA Z316.6-07): "a container" (singular).
• Toppling Resistance (ISO 23907): "a container" (singular).
• Impact Resistance: Five containers.
• Cold Impact Resistance: Five containers.
• Handle Strength: "a container" (singular).
• Drop Test: Six containers.
• Stacking Test: Three empty containers.
• Vibration Test: Three containers.

Data Provenance: The tests described are "non-clinical data submitted, referenced, or relied upon" for the 510(k) submission. These are laboratory-based engineering and physical tests, not human or patient data. The reference standards are international and national standards (CSA, ISO, UN, CFR), implying the tests were conducted under controlled laboratory conditions, likely in a prospective manner for the purpose of this submission. The country of origin of the testing is not explicitly stated but is implicitly tied to the manufacturer (Daniels Sharpsmart, Inc. in Chicago, IL, USA, with representatives in San Diego, CA, USA).

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 as the document describes physical engineering tests on a medical device (a sharps container), not diagnostic or clinical accuracy studies that would require expert-established ground truth. The "ground truth" for these tests is defined by the objective pass/fail criteria of the referenced engineering standards.

4. Adjudication method for the test set:

This information is not applicable for these types of physical engineering tests. Adjudication methods like "2+1" typically apply to cases where human interpretation or consensus is required (e.g., in medical image reading). For these tests, the outcome is objectively measured against a predefined standard.

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:

This is not applicable. The device is a physical sharps container, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers or AI assistance was conducted or mentioned.

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

This is not applicable. The device is a physical product and does not involve an algorithm or AI. The tests described are for the physical integrity and performance of the container itself.

7. The type of ground truth used:

For all the tests described, the "ground truth" is established by the objective, empirically measurable criteria defined within the referenced international and national engineering standards (CSA Z316.6-07, ISO 23907, UN Recommendations on the Transport of Dangerous Goods – Model Regulations, 49 CFR Part 178.608, and US OSHA 29 CFR 1910.1030). These standards specify the methodology and acceptable limits for each physical property being tested.

8. The sample size for the training set:

This is not applicable. The device is a physical product, and the described tests are performance validation tests, not machine learning model training.

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

This is not applicable as there is no training set mentioned or implied for a physical device like a sharps container.

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Sharpsmart™ S2 disposable sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps. This device is intended for "Over-the-Counter" use.

The Sharpsmart™ S2 disposable sharps container is intended to be used in patient rooms, medication rooms, operating rooms, physicians' offices or any other patient care area requiring the use of a sharps container. It is a two-piece injection-molded container made from a polypropylene copolymer. The container is designed with a closure mechanism that allows multiple lid re-openings, while ensuring secure between uses. Both handle and lid can be secured out of the way for safe, unobstructed disposal of sharps. The S2 container is capable of standalone use. A Unique bracket design is offered as an additional measure to secure mounting on vertical or horizontal surfaces to prevent toppling. The bracket is not required for the use of the container. It only offers a secondary option for the user for ease of use.

The containers are closable, puncture resistant, leak proof on the sides and bottom and stable. The label, containing an overfill warning and an easily visible fill line, is adhered to the container at the factory. The containers are translucent and are red or yellow. The label is white and red with the biohazard warning.

Sharpsmart™ S2 disposable sharps containers are available in a 1 quart size. Each product has two parts, which assemble together to form a unit. Assembly is easily visualized. They can be nested together to reduce storage space.

The container is designed and certified to comply with penetration requirements, as represented though product testing for Test methods: AS/NZS 4031:1992 and Test Method: roprosence and the Transport of Dangerous Goods. 15th revised Ed. 6.1.5.3The Sharpsmart™ S2 disposable sharps containers meet or exceed OSHA recommendations for sharps containers.

The Daniels Sharpsmart S2 disposable sharps container is a device intended for the safe disposal of hazardous sharps in healthcare facilities. The 510(k) summary provides details about its acceptance criteria and the study that demonstrates its compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sharpsmart™ S2 disposable sharps container are based on various performance tests. The device's performance is reported as having "Passed" all these tests, indicating it meets the established criteria.

These criteria align with recognized international standards for sharps containers, specifically:

• UN Recommendations on the Transport of Dangerous Goods. 15th revised Ed. 6.1.5.3
• AS/NZS 4031:1992

The summary also states that the device "meets or exceed OSHA recommendations for sharps containers."

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

The 510(k) summary does not explicitly state the sample size used for the performance tests (e.g., how many containers were tested for puncture resistance, drops, etc.). The data provenance is also not specified; however, given that the manufacturer is The Daniels Corporation PTY, LTD and the predicate device is from Solutions, Inc., it can be inferred that the testing likely occurred in a controlled lab environment and is part of a prospective study to demonstrate compliance with the referenced standards.

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

This information is not applicable. The product being reviewed is a physical sharps container, and its performance is evaluated through standardized engineering tests (e.g., puncture resistance, leak resistance, drop test). These tests do not rely on expert consensus for establishing ground truth in the same way clinical or imaging diagnostic devices might. Instead, the ground truth is defined by the Pass/Fail criteria of the specified test methodologies.

4. Adjudication Method for the Test Set

This information is not applicable. As stated above, the device performance is determined by meeting the objective Pass/Fail criteria of the engineering test methods, not through an adjudication process involving human reviewers.

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

No MRMC comparative effectiveness study was done. This type of study is typically conducted for diagnostic or imaging devices to assess human reader performance with and without AI assistance. The Sharpsmart S2 is a physical medical device (sharps container) for waste disposal, not a diagnostic tool requiring interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone study in the context of an algorithm's performance was done. The device is a physical product, and its performance is measured directly through physical tests against defined standards, not through algorithmic output.

7. Type of Ground Truth Used

The ground truth used for these tests is the objective Pass/Fail criteria defined within the referenced international testing standards:

• UN Recommendations on the Transport of Dangerous Goods. 15th revised Ed. 6.1.5.3
• AS/NZS 4031:1992

These standards specify the conditions and measurements that constitute satisfactory performance for sharps containers (e.g., no penetration, no leakage, structural integrity after impact or drops).

8. Sample Size for the Training Set

No training set is applicable. This device is a physical product, and its evaluation does not involve machine learning algorithms that require training data.

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

Not applicable, as no training set was used.

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