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The Richter Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, non flavored, non scented; straight walled with a reservoir tip. The nominal length is 185 mm, nominal width, 54 mm and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492 and ISO 4074.

The provided document is a 510(k) premarket notification for a male latex condom. It describes the device, its intended use, and its conformance to established standards. However, it does not include a study that proves the device meets specific acceptance criteria with detailed performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies.

Instead, the document states: "This condom conforms to current established national and international voluntary standards including ASTM D3492 and ISO 4074." It also mentions: "This condom has the same technological characteristics as the predicate condoms identified above. It is made from natural rubber latex and the design is in conformance with ASTM D3492 and ISO 4074 Male Latex Condom Standards."

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria with reported device performance or answer most of the specific questions about a study, as the detailed study data is not present in this document.

However, I can infer the acceptance criteria based on the referenced standards. For the purpose of answering your request, I will interpret the conformance to ASTM D3492 and ISO 4074 as the acceptance criteria, and the statement of conformance as the "reported device performance."

Here's the closest possible answer based on the provided text:

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

Note: The specific numerical values for each criterion are detailed within ASTM D3492 and ISO 4074, which are not included in this document. The document only states conformance to these standards, implying that the device meets all their stipulated requirements.

2. 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 document. Testing under ASTM D3492 and ISO 4074 would involve specific sampling plans, but these details are absent.
• Data Provenance: Not specified. The manufacturer is Richter Rubber Technology SBN BHD, Malaysia. It is plausible that testing took place in Malaysia or a contracted lab. The document does not state if the data was retrospective or prospective.

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

• Not applicable/Not specified. For condom testing as per ASTM/ISO standards, ground truth is established by objective physical and mechanical measurements according to specified test methods, not by expert consensus (e.g., radiologists).

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

• Not applicable/None. Performance is determined by objective measurements against predefined thresholds in the standards directly, not through adjudication of expert opinions.

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 physical product (male latex condom), not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study is irrelevant to its evaluation.

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

• Not applicable. This is not an algorithm or AI device.

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

• The ground truth is established by objective, standardized physical and mechanical test methods and measurements as defined in ASTM D3492 and ISO 4074. For example, for "burst volume," the ground truth is the measured volume of air the condom can contain before bursting under specific conditions.

8. The sample size for the training set

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

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

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

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The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.

The KAVS catheter is an intravascular catheter that is introduced into the patient's vein for short-term therapeutic use. The catheter has a balloon at the distal end, that when expanded, will temporarily block the blood flow in that segment of the vein. This allows the physician to inject medication through the central lumen of the catheter for patient treatment. Once the treatment is complete the physician can then remove the medication, prior to removing the catheter.

The KAVS catheter is a double-lumen catheter made of radio-opaque polyurethane, which is equipped with a latex balloon at the distal end. At the proximal end of the coaxial catheter there is a double attachment, consisting of a Luer-lock adapter for access to the main catheter lumen, for injection of prescribed medication, and a laterally mounted Luer-lock adapter with a stopcock for filling the balloon. The rounded catheter tip is closed, underneath the balloon there are three openings, which serve as outlet openings for the main catheter lumen.

The provided document is a 510(k) premarket notification for a medical device called the KAVS Catheter. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study demonstrating its performance against specific acceptance criteria in the manner typically seen for new diagnostic or AI-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted directly from this document. This submission is for a catheter, a physical device, not a diagnostic algorithm or a device requiring extensive clinical performance studies in the same way an AI system would.

Here's a breakdown based on the information available in the document, and what is not applicable:

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

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this type of device focus on equivalence to predicate devices in terms of safety, effectiveness, and performance.
• Reported Device Performance: Not detailed in terms of quantitative clinical outcomes. The performance is described functionally (temporarily blocks blood flow, allows medication injection, prevents wash away).

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 document does not describe a clinical study with a "test set" in the context of an AI or diagnostic device. The submission relies on demonstrating substantial equivalence to existing devices through design comparison, material characteristics, and intended use.

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. No such "ground truth" establishment for a test set is described.

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

• Not applicable. No adjudication method for a test set 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 is not an AI-assisted device, nor does the submission describe an MRMC study.

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

• Not applicable. This is a physical device, not an algorithm.

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

• Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and market experience. The KAVS Catheter aims to match this established profile.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable. As above, no training set is relevant to this submission.

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