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SKORE Vanilla, SKORE Strawberry, SKORE Banana, SKORE Tangerine Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

SKORE Smooth Condoms - SKORE Colors & Flavors and SKORE Smooth Condoms -SKORE Vanilla are made of a natural rubber latex sheath and are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. The subject device is an update to the SKORE (Colors & Flavors) condoms cleared under K202403 to modify the texture (dotted to smooth), use a different yellow pigment, and introduce a new flavor (vanilla). The subject devices in this submission consists of

• SKORE Colors & Flavors SKORE Strawberry; SKORE Banana; SKORE . Chocolate; SKORE Tangerine; These condoms are parallel straight walled, teat ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject devices include the colors, Red; Yellow; Brown; Orange; and flavors Strawberry, Banana, Chocolate and Tangerine.
• SKORE Flavors SKORE Vanilla; This condom is parallel straight walled, teat ● ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject device include the flavor Vanilla and has a natural (no pigment) color.

This report refers to a 510(k) premarket notification for TTK Healthcare Limited's SKORE Smooth Condoms (SKORE Colors & Flavors, and SKORE Vanilla). The document indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device by meeting established international and national standards for condom quality.

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

• Mechanical Performance Testing: "Three lots of the subject devices" were tested. The exact number of individual condoms tested within these lots is not specified.
• Shelf Life Testing: The sample size is not explicitly stated, but it's based on "testing data" to support a 5-year shelf life.
• Biocompatibility Testing: The specific sample sizes for each biocompatibility test are not provided in this document.
• Data Provenance: The manufacturer is TTK Healthcare Ltd. located in Puducherry, India. The studies were likely conducted internally or by contracted labs, but the specific country of origin for the data generation beyond the manufacturer's location is not further detailed. The testing appears to be prospective as it was conducted specifically to support this 510(k) submission.

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

This document describes performance testing against established standards (ISO, ASTM, CFR). It does not involve establishing ground truth through expert consensus in the way a clinical study for an AI algorithm would. The "ground truth" for these tests is defined by the objective metrics and thresholds within the cited standards.

4. Adjudication Method:

Not applicable. This is not a study requiring adjudication of expert opinions or classifications. The performance is measured against objective standards.

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

No. This is not a medical imaging device or an AI algorithm where human reader performance is a factor. This document concerns the physical and biological properties of a condom.

6. Standalone Performance Study (Algorithm Only):

No. This is not an AI algorithm. The performance studies evaluate the physical product itself.

7. Type of Ground Truth Used:

The ground truth used is based on established international and national standards and specifications for condoms, such as:

• ISO 10993 (Biological Evaluation of Medical Devices) for biocompatibility.
• ISO 4074:2015 (Natural rubber latex male condoms - Requirements and test methods) for mechanical performance.
• ASTM D3492:2016 (Standard Specification for Rubber Contraceptives (Male Condoms)) for mechanical performance.
• 21 CFR 801.435 for shelf life.

8. Sample Size for the Training Set:

Not applicable. This is not an AI product 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 device.

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SKORE Red, SKORE Yellow, SKORE Brown, SKORE Orange & SKORE Strawberry, SKORE Cherry, SKORE Banana, SKORE Pinacolada, SKORE Tangerine, SKORE Chocolate and SKORE Cool Mint, Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

SKORE Condoms (Colors & Flavors) and SKORE Condoms (Flavors) are made of a natural rubber latex sheath and are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. The subject devices in this submission consists of

• SKORE Colors SKORE Red; SKORE Yellow; SKORE Brown; SKORE Orange. . These condoms are parallel straight walled, teat ended, with a smooth surface Natural Rubber Latex Condoms in the colors Red. Yellow, Brown, and Orange; having a length of 190 ± 10 mm, width of 53±2mm and a thickness of 0.065 ±0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.
• SKORE Colors & Flavors SKORE Strawberry; SKORE Cherry; SKORE . Banana; SKORE Pinacolada; SKORE Tangerine; SKORE Chocolate; SKORE Cool Mint. These condoms are parallel straight walled, teat ended, with a dotted surface having a length of 190 ± 10 mm, width of 53 ± 2 mm and a thickness of 0.065 ± 0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.

The provided text describes a 510(k) summary for male natural rubber latex condoms (SKORE Colors & Flavors, SKORE Colors). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel efficacy or safety through clinical trials comparing a device to a human interpretation. Therefore, the information typically requested regarding acceptance criteria, study design for proving those criteria, human reader involvement, ground truth establishment, and training set details as they would apply to an AI/ML powered device, are not directly applicable in this context.

However, I can extract the relevant performance criteria and testing performed to demonstrate the device's conformance to established condom standards, which serve a similar function to "acceptance criteria" for a medical device of this type.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Specifications) and Reported Device Performance:

Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Performance Testing."

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

• Sample Size: "Three lots of the subject devices" were tested for mechanical performance. The specific number of individual condoms tested within these three lots is not provided. For biocompatibility, the number of samples used for each test (e.g., for cytotoxicity, irritation, sensitization) is not specified.
• Data Provenance: Not explicitly stated regarding country of origin for the samples. The submission is from TTK Healthcare Ltd. in Puducherry, INDIA. The testing appears to have been conducted as part of the regulatory submission process. The testing would be considered prospective for the purpose of demonstrating compliance.

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

• This question is not applicable as the device is a physical product (condom), not an AI/ML powered diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" is determined by established engineering standards and biological testing protocols.

4. Adjudication Method for the Test Set:

• This question is not applicable for the same reasons as #3.

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 question is not applicable as the device is a physical product, not an AI-assisted diagnostic tool.

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

• This question is not applicable as the device is a physical product, not an algorithm.

7. The type of ground truth used:

• Mechanical Performance Ground Truth: Established by recognized international and national standards:
  • ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods
  • ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms)
• Biocompatibility Ground Truth: Established by recognized international standards:
  • ISO 10993-1: Biological Evaluation of Medical Devices.
  • ISO 10993-11:2006/(R)2010 (Acute Systemic Toxicity)
  • ISO 10993-5:2009 (Cytotoxicity)
  • ISO 10993-10:2010 (Vaginal Irritation, Penile Irritation, Skin Sensitization)

8. The sample size for the training set:

• This question is not applicable as there is no "training set" for physical product evaluation in this context.

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

• This question is not applicable for the same reason as #8.

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