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The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

This condom is made of a polyurethane sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, silicone-lubricated condom with nominal length 180 ± 10 mm, nominal width 57 ± 2 mm, and nominal thickness of 0.028 ± 0.008 mm with dimensions evaluated per ISO 23409-2011, Male condoms - Requirements and test methods for condoms made from synthetic materials. This condom also conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane. This product has a shelf life of 5 years.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Biocompatibility: The specific sample sizes for each test (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) are not explicitly stated in the provided text.
   • Physical Performance Testing: The sample sizes for these tests are not explicitly stated. The tests were performed to comply with ASTM D6324-11 (2017) and ASTM D624-00 (2020), which would dictate standard sample sizes.
   • Package Integrity: Three (3) lots of the subject device were used.
   • Barrier Properties/Permeability (Viral Penetration Study): Three (3) test lots of the subject polyurethane condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator.
   • Shelf Life: "All samples" in accelerated stability evaluations. The exact number of samples is not specified.
   • Clinical In-Use Slip/Break: The study was conducted using the predicate device with a standard natural rubber latex condom serving as control. The specific number of participants or condoms used in this clinical study (relying on predicate data) is not provided in this document.

   Data Provenance:

   • The studies were conducted by Okamoto U.S.A. Inc. or their commissioned laboratories.
   • The clinical in-use slip/break data was leveraged from testing done on the predicate device (Trojan Supra Lubricated Polyurethane Male Condom, K100767). The origin of this predicate data (e.g., country) is not specified.
   • The studies appear to be prospective as they were conducted to demonstrate compliance for the subject device or leveraged from a previous prospective study of the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not applicable. These tests are primarily objective performance evaluations based on established standards, not expert consensus on interpretations of complex data like medical images.

4. Adjudication Method for the Test Set: Not applicable, as there is no mention of expert review or consensus in the context of adjudication for these performance tests. The results are from direct measurement and laboratory analysis against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for medical imaging or diagnostic devices where human interpretation is involved. The reported studies are for the physical and biological performance of a condom.

6. Standalone Performance: Yes. All the non-clinical performance tests (Biocompatibility, Physical Performance Testing, Package Integrity, Barrier Properties/Permeability, Shelf Life) and the leveraged clinical in-use slip/break data represent the standalone performance of the device (or its predicate for clinical performance) against defined criteria. There is no mention of a human-in-the-loop component for these evaluations.

7. Type of Ground Truth Used:

   • Biocompatibility: Established scientific standards and protocols (ISO 10993 series).
   • Physical Performance: Established industry standards (ASTM D6324-11, ASTM D624-00, ISO 23409-2011) and FDA guidance documents.
   • Package Integrity: Established industry standard (ASTM D6324-11).
   • Barrier Properties/Permeability: Established scientific protocols and industry standards (ISO 23409:2011).
   • Shelf Life: Regulatory requirements (21 CFR 801.435) and industry standard (ASTM D6324-11).
   • Clinical In-Use Slip/Break: Clinical outcome data (breakage and slippage rates) from a study following FDA guidance documents ("Clinical Testing Guidance for New Material Male Condoms").

8. Sample Size for the Training Set: Not applicable. This refers to the training of machine learning algorithms. The device is a physical product (condom), not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established: Not applicable (see point 8).

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The condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).

The device is a condom that is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, teat-ended, silicone-lubricated condom with nominal length 180 ± 2mm, nominal width 53.5 ± 2mm, and nominal thickness of 0.04 mm. This condom conforms to the recognized standards ASTM D3492-16 and ISO 4074:2015.

The provided text describes the 510(k) summary for the "Extremely Thin 003, ZERO ZERO THREE" male latex condom. It discusses the device's characteristics, its comparison to a predicate device, and performance testing data.

This document does not describe an AI/ML medical device. Therefore, a study proving an AI/ML device meets acceptance criteria, including specifics like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, cannot be extracted from this text. The acceptance criteria and performance data pertain only to the physical properties and biological compatibility of condoms.

However, I can extract the acceptance criteria and reported device performance for the condom itself based on the provided text.

Acceptance Criteria and Device Performance (for the condom)

Based on the provided text, the device is a condom, not an AI/ML-driven medical device. Therefore, the acceptance criteria and performance data relate to the physical and biological properties of the condom.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (for the condom):

As the product is a condom and not an AI/ML device, the following points address what can be inferred or what is not applicable from an AI/ML perspective.

2. Sample size used for the test set and the data provenance:
* Sample Size: For physical testing, "Three lots of devices were tested at baseline." The specific number of condoms per lot is not stated. For biocompatibility, typical regulatory testing involves a sufficient number of samples as per the respective ISO standards, but the exact count is not provided.
* Data Provenance: Not explicitly stated, however, the testing was conducted to meet international (ISO) and US (ASTM, CFR) standards, implying a controlled laboratory environment typically adhering to Good Manufacturing Practices. The origin isn't specified (e.g., country), but it's for a US-marketed product. The data collection would be prospective, as it's part of the premarket submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable: For a condom, "ground truth" in the context of expert review (like for image interpretation) is not relevant. Performance is determined by objective physical and biological tests against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable: Adjudication methods are relevant for subjective assessments, typically in clinical readings or image interpretations. Condom performance is assessed through objective measurements against specified criteria.

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 an AI/ML related study type. The product is a physical device (condom).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Applicable: This is an AI/ML related study type. The product is a physical device (condom).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the condom's performance is established by objective measurements and chemical/biological assays according to recognized consensus standards (ASTM D3492-16, ISO 4074:2015, and ISO 10993 series) and regulatory requirements (21 CFR §801.435). This includes measurements for dimensions, bursting pressure/volume, and results from biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity).

8. The sample size for the training set:
* Not Applicable: This pertains to AI/ML model development. For a non-AI/ML device, there is no "training set."

9. How the ground truth for the training set was established:
* Not Applicable: This pertains to AI/ML model development. For a non-AI/ML device, there is no "training set" or corresponding ground truth establishment in this manner.

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The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is textured surface (dotted), tapered shape with reservoir tip, silicone lubricated condom with nominal length 180 mm, nominal flat width 54 mm measured at 30 mm from the open end, a maximum width of 58 mm at the closed end, and nominal thickness of 0.070 mm. The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3. It is lubricated with silicone (viscosity 200 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008. The term Studded refers to the irregular surface of the irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The new condom is defined as a condom of increased thickness relative to some of other Okamoto condoms (e.g., Crown condom, K893039).

The provided text is a 510(k) summary for the Okamoto Studded Condom. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance results in the context of an AI/medical device study. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this text.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device "Complied with ASTM D3492:2008". The specific acceptance criteria within this standard are not explicitly listed in the 510(k) summary, nor are detailed quantitative performance results for each criterion. The document states that "The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3," which are performance metrics, but not framed as "acceptance criteria" in a table alongside reported device performance.

2. Sample Size for Test Set and Data Provenance:

The document does not detail specific sample sizes for particular tests (e.g., air burst pressure, biocompatibility). It mentions "studies conducted on the similar condoms" for shelf life. Data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable to this type of device submission. The evaluation is based on compliance with established standards and direct physical testing, not expert consensus on interpretations.

4. Adjudication Method:

Not applicable.

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

Not applicable. This device is not an AI algorithm for diagnostic interpretation where human reader improvement would be measured.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical medical device (condom), not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device is based on objective measurements conforming to established industry standards (ASTM D3492:2008, ISO 10993). For example, air burst pressure is a direct physical measurement.

8. Sample Size for Training Set:

Not applicable, as this is a physical device, not an AI model.

9. How Ground Truth for Training Set was Established:

Not applicable.

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Mega Big Boy condom is used for contraceptive and prophylactic purpose (to help prevent pregnancy, HIV/ADS and the transmission of sexually transmitted infections).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is smooth surface, flared at the closed end with reservoir tip, silicone lubricated condom with nominal length 200 mm, nominal flat width 57 mm, and nominal thickness of 0.065 mm. The air burst pressure is > 1 kPa and air burst volume is > 19 dm3. It is lubricated with silicone (viscosity 350 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008.

The provided text is a 510(k) summary for a male latex condom called "Mega Big Boy Condom." It does not describe a study involving an AI/Machine Learning device or a diagnostic/screening technology. Therefore, I cannot extract the information required to populate the requested sections about acceptance criteria, study design, ground truth establishment, or human-in-the-loop performance, as this type of information is not present in the provided document.

The document focuses on demonstrating substantial equivalence of the "Mega Big Boy Condom" to a predicate device (TROJAN EXTRA LARGE LATEX CONDOM) based on technological characteristics and performance standards for condoms (e.g., air burst pressure, air burst volume, shelf life, biocompatibility testing).

Therefore, I must state that the requested information (acceptance criteria for an AI device, study details for its performance, expert adjudication, etc.) cannot be extracted from the provided text.

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The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is smooth surfaced, straight-walled, teat-ended, silicone lubricated condom with minimum length 160mm, maximum width 54mm, and minimum thickness of 30μm as required by ASTM Standard D3492.

The provided text describes a 510(k) premarket notification for a new condom product, OKAMOTO ULTRA THIN Male Natural Latex Condom. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and adherence to ASTM standards for condom manufacturing.

Here's a breakdown of what can be extracted and what information is missing based on your request:

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

The document states the device's design is in conformance with ASTM Standard D3492-03 Specification for Rubber Contraceptives (Male Condoms). While the specific acceptance criteria from this standard are not explicitly listed in the text, the document implies that the device performance meets these standards.

The key performance characteristic mentioned for the new device is:

• Nominal thickness: 0.04 +/- 0.01 mm

For predicate devices, the nominal thickness was 0.05 +/- 0.01 mm.

Missing Information: The explicit breakdown of all acceptance criteria from ASTM Standard D3492-03 (e.g., burst pressure, freedom from holes, dimensions, etc.) and the precise reported performance values for each of these criteria for the OKAMOTO ULTRA THIN condom are not present in this document.

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

Missing Information: The document does not specify any sample size for a test set, nor does it describe data provenance (country of origin, retrospective/prospective). This type of detail would typically be found in a more comprehensive testing report.

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)

Missing Information: This information is not applicable and therefore not present. The device is a physical product (condom), and its performance is evaluated against engineering standards rather than expert-established ground truth like in medical imaging.

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

Missing Information: Not applicable. Performance testing for condoms against ASTM standards does not typically involve adjudication methods like those used for expert consensus in medical diagnostics.

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

Missing Information: This type of study is entirely irrelevant to a physical product like a condom and is therefore not present. It's a concept used for AI-assisted diagnostic tools.

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

Missing Information: This is also irrelevant to a physical product and is not present.

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

The "ground truth" for the device's performance would be the objective measurements taken on the condoms themselves against the specifications defined in ASTM Standard D3492-03. This standard outlines various tests (e.g., burst tests, visual inspections for holes,
dimensional measurements) and acceptable limits.

8. The sample size for the training set

Missing Information: This is not applicable to the development of a physical product like a condom. There is no "training set" in the context of an AI/algorithm. The "training" in manufacturing would relate to process control and quality assurance, not a dataset for an algorithm.

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

Missing Information: Not applicable for the reasons stated above.

In summary, the provided text is a regulatory submission for premarket clearance of a physical medical device (condom) and therefore does not contain the types of information (AI study data, expert consensus, MRMC studies) that would be relevant for software/AI-based diagnostic devices. The "study" referenced implicitly is the adherence to the ASTM standard for condom manufacturing and performance.

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