Search Results
Found 9 results
510(k) Data Aggregation
(75 days)
Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of preguancy if you lose your erection before withdrawal and some spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom
The device which is the subject of this application is a latex rubber condom (Class II medical device defined as "Condom (rubber) Contraceptive 85-LTZ") and is defined by ASTM 3492-93 as a Type I, Style 2, Class A rubber condom, and further defined by ISO 4074-6 (currently under revision). The device which is defined by these standards is also lubricated, contains a spermicide (Nonoxynol-9) and for the purposes of selection for labeling as "extra strength" is tested in the strength categories to a higher standard (See Exhibit A in K970791 as well as Exhibit 1) with added FDA certified color. The purpose of this medical device is for the prevention of pregnancy and the protection against sexually transmitted diseases, including HIV.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Custom Services International, Inc. condom device (K972430):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Minimum Requirements) | Reported Device Performance |
|---|---|
| Leakage: AQL 0.4 (no more than 4 devices per 1000) | "be free of holes and leaks at an AQL level of .4" "The applicant medical device meets the standards required" |
| Air Burst: 1 mPa to 20 liters of air at an AQL of 1.5 (per ISO 4074-6) | "air burst testing per ISO 4074-6 (under revision) of 1 mPa to 20 liters of air at an AQL of 1.5" "The applicant device has been tested and has met or exceeded all the voluntary standards concerning the applicant medical device" |
| Tensile Strength: Not less than 15 mPa | "tensile strength of not less than 15 mPa" "The strength standards (tensile, breaking force, thickness, and air burst) have been increased by the applicant to justify the addition of the term 'extra strength'... will meet all of the mechanical requirements outlined for the device covered by K970791" |
| Minimum Breaking Force: 18 N | "minimum breaking force of 18 N" "The strength standards (tensile, breaking force, thickness, and air burst) have been increased by the applicant to justify the addition of the term 'extra strength'... will meet all of the mechanical requirements outlined for the device covered by K970791" |
| Minimum Elongation: 625% | "minimum elongation of 625%" |
| Nonoxynol-9 Spermicide Content: Minimum 25 mg per device (SOP#2-021 specifies 30 mg ± 5 mg) | "each device contain a minimum amount of 25 mg. of Nonoxynol-9 spermicide." "SOP#2-021 which requires an independent insertion of the Nonoxynol-9 in the amount of 30 mg. ± 5 mg." "This testing includes Nonoxynol-9 content for shelf life data to prove and assure that the production process produced devices which were in compliance with the required standards" |
| Dimensions (ASTM 3492-93): 180 mm ± 20 mm length, 52 mm ± 2 mm width, .05 mm minimum thickness | "180 mm ± 20 mm in length, 52 mm ± 2 mm in width, .05 mm in thickness at a minimum, meeting all standards established by the predication K970791." |
| Colorfastness: AQL 0.50 (for colored devices) | "colorfastness verified. Colorfastness testing is designed to demonstrate that the color does not migrate from the device." "The applicant also verifies that the colorant is colorfast by testing to an AQL level of .50." |
| Shelf Life: 2 years (based on Nonoxynol-9, latex component meets 5-year standard) | "meet or exceed the voluntary standards at the end of the shelf life." "The applicant, however, intends to label its medical device for a two year shelf life based on the shelf testing of its supplier of Nonoxynol-9." "The latex component used in its medical devices comply with a five year standard." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Production samples were collected over "ten 8 hours shifts, spread over multiple days." These samples were divided in half to create "as manufactured" and "aged" samples.
- Specific numerical sample sizes (e.g., number of condoms per shift) are not provided in the text.
- Data Provenance: The manufacturing facility is located in the Peoples Republic of China. The testing involved "in process" samples and "aged" samples. The text does not explicitly state whether the data is prospective or retrospective, however, the description of collecting samples over production shifts and then subjecting them to aging tests suggests a prospective approach to gather data for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the use of human experts to establish "ground truth" for the device's physical and chemical properties. The ground truth for these properties is established by adherence to recognized industry standards (ASTM 3492-93, ISO 4074-6) and internal specifications.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to the device performance against objective, quantitative standards, not subjective assessments requiring expert adjudication.
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 medical device (condom), not an imaging or diagnostic AI product, so MRMC studies are not relevant.
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 medical device and does not involve an AI algorithm. The performance evaluation is based on direct physical and chemical testing of the condom itself.
7. The Type of Ground Truth Used
The ground truth used for this device's acceptance is based on:
- Industry Standards: ASTM 3492-93 and ISO 4074-6 (currently under revision). These standards define the physical properties and leakage/air burst requirements.
- Regulatory Guidance: FDA guidance on spermicide content (minimum 25 mg Nonoxynol-9).
- Internal Specifications: The applicant's own "increased standards" for "extra strength" properties (e.g., tensile strength greater than 20% of the standard, other categories 10% greater).
- Laboratory Verification: Tested parameters were "independently verified by an FDA certified independent laboratory" (Nelson Laboratories, Inc.).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set." The manufacturing process data is used for process validation and quality assurance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
(75 days)
Lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom
Condom, smooth surface, reservoir end, approximately 180 mm in length and 52 mm in width (Type 1, Style 2, Class A) colored rubber contraceptive device, lubricated with silicone and the active ingredient Nonoxynol-9 spermicide.
Here's a breakdown of the acceptance criteria and study information for the device, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Metric) | Reported Device Performance (Claimed by Manufacturer) |
|---|---|
| Air burst testing (ISO 4074-6) | Meets 1 mPa to 20 liters of air |
| Leakage (AQL level) | 0.4% (no leakage detected) |
| Tensile strength | Not less than 15 mPa |
| Minimum breaking force | 18 N |
| Minimum elongation | 625% |
| Nonoxynol-9 spermicide content | 30 mg ± 5 mg (minimum 25 mg required by FDA) |
| Dimensions (ASTM 3492-93) | 180 mm ± 20 mm length, 52 mm ± 2 mm width, 0.03 mm min. thickness |
| Colorants | FDA certified, approved for long-term food contact in polymers (used in rubber) |
| Shelf Life (Mechanical Standards) | Complies with 5-year standard (latex component) |
| Shelf Life (Nonoxynol-9) | Labeled for two years (based on supplier testing of Nonoxynol-9), with ongoing studies to potentially extend this. |
Study Details
-
Sample size used for the test set and the data provenance:
- Test set sample size: "Production samples were collected over a period of six 8-hour shifts, spread over multiple days." The samples were divided in half to provide "as manufactured" and "aged" samples. The exact number of samples or condoms is not specified beyond this description.
- Data provenance: While the manufacturing facility is in the People's Republic of China, the text doesn't specify the country of origin for the data itself. The study appears to be prospective in the sense that the manufacturer performed testing specifically to demonstrate substantial equivalence, including accelerated aging.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information is provided regarding the use of experts or their qualifications for establishing ground truth on the test set. The testing relies on established industry standards (ASTM, ISO) and laboratory methods.
-
Adjudication method for the test set:
- No information about an adjudication method is provided. The testing appears to be objective, based on physical and chemical measurements against pre-defined standards.
-
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:
- No MRMC or comparative effectiveness study involving human readers or AI assistance was conducted. This device is a physical product (condom), not an AI-assisted diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm or software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on established voluntary standards (ASTM 3492-93 and ISO 4074-6, under revision), and regulatory guidance from the FDA (e.g., minimum Nonoxynol-9 content, requirements for avoiding misbranding/adulteration). These standards define the acceptable physical properties and chemical composition of the medical device.
-
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model requiring a "training set."
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
(59 days)
Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic.
Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic.
The device which is the subject of this application is a latex rubber condom (Class II medical device defined as "Condom (rubber) Contraceptive 85-HIS") and is defined by ASTM 3492-93 as a Type I, Style 2, Class A rubber condom, and further defined by ISO 4074-6 (currently under revision). The device which is defined by these standards can be lubricated or nonlubricated, and for the purposes of selection for labeling as "extra strength" is tested in the strength categories to a higher standard (See Exhibit A in K970767 and K970792 as well as Exhibit 1) with added FDA certified color. The purpose of this medical device is for the prevention of pregnancy and the protection against sexually transmitted diseases, including HIV.
Here's an analysis of the provided text regarding the condom's acceptance criteria and study information:
This document is a 510(k) summary for a condom device, not an AI/ML medical device. Therefore, many of the requested fields related to AI/ML device studies (e.g., sample size for AI test and training sets, AI reader studies, ground truth establishment for AI) are not applicable and cannot be found in the provided text.
The information primarily focuses on the device's classification, intended use, and substantial equivalence to predicate devices, along with adherence to established standards for condom manufacturing.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only refers to existing standards and a higher quality standard for "extra strength" without detailing specific quantitative acceptance criteria or reporting precise performance metrics from a study beyond asserting it meets these standards.
| Acceptance Criteria (Inferred/Reference) | Reported Device Performance |
|---|---|
| Defined by ASTM 3492-93 as Type I, Style 2, Class A rubber condom | Device is defined as Type I, Style 2, Class A rubber condom. |
| Defined by ISO 4074-6 (currently under revision) | Device is defined by ISO 4074-6. |
| "Higher quality standard for added strength" (referencing Exhibit A in K970767 and K970792) | "ExtraWear condom is stronger than the InnerWear condom" (laboratory tests of physical properties). |
| Meets standards for contraception and protection against STDs | Indicated for prevention of pregnancy and protection against STDs. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device submission. The submission doesn't describe a "test set" in the context of an AI/ML study, but rather conformity to existing product specifications and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for a condom device is established through manufacturing standards and physical property testing, not expert interpretation in the way it is for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable.
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/ML device.
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 this device is based on physical property measurements and adherence to established industry standards (ASTM 3492-93, ISO 4074-6) for condom manufacturing and performance. The statement "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom" indicates that the ground truth for "extra strength" is derived from specific laboratory measurements rather than expert consensus or pathology in a medical imaging context.
8. The Sample Size for the Training Set
Not applicable for this type of device. There isn't a "training set" for physical product testing; instead, samples are taken from production batches for quality control.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Ask a specific question about this device
(54 days)
Nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Condom, smooth surface, reservoir end, approximately 180 mm in length and 52 mm in width (Type 1, Style 2, Class A) colored rubber contraceptive device, nonlubricated or lubricated with silicone.
This 510(k) summary is for a condom, a mechanical contraceptive device. The provided text is a 510(k) notification letter, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study report with specific acceptance criteria and performance data for the device itself.
Therefore, many of the requested elements for a scientific study of an AI/algorithm-based device are not directly applicable or available in this document. The information primarily pertains to regulatory approval based on demonstrating equivalence to already approved condoms.
Here's a breakdown of the available information and why other points are not applicable:
-
Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a format typical for an AI/algorithm study. The acceptance criteria for condoms relate to physical properties and manufacturing standards, not algorithmic performance. The document states the device is "substantially equivalent" to predicate devices, implying it meets the same established performance criteria for condoms.
-
Sample sized used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/algorithm. The regulatory approval is based on manufacturing standards and performance tests for condoms, which are not detailed here beyond the general statement of substantial equivalence.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of expert consensus isn't relevant for a physical condom. The "ground truth" for a condom is its physical properties and effectiveness as a contraceptive, established through well-defined laboratory tests (e.g., burst strength, leakage) and clinical trials (for effectiveness), which are not detailed in this 510(k) summary.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device like a condom.
-
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, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for a condom's efficacy and safety is established through a combination of:
- Laboratory Testing: Physical properties like burst strength, volume, and absence of holes, as per international and national standards (e.g., ISO, ASTM). These tests are typically conducted by manufacturers according to their quality control processes.
- Clinical Studies (for initial condom approval): Efficacy and safety are established through large-scale clinical trials comparing use of condoms to other or no contraceptive methods. The 510(k) process for this specific device relies on the fact that the predicate devices have already demonstrated this.
-
The sample size for the training set: Not applicable for this type of device.
-
How the ground truth for the training set was established: Not applicable for this type of device.
Summary of relevant information from the provided document:
- Device Name: Condom, smooth surface, reservoir end, approximately 180 mm in length and 52 mm in width (Type 1, Style 2, Class A) colored rubber contraceptive device, nonlubricated or lubricated with silicone.
- Intended Use: Nonlubricated rubber male condom for use as a contraceptive and prophylactic.
- Regulatory Class: Class II, Condom (rubber) Contraceptive - 85HIS.
- Predicate Devices: K963319 (nonlubricated), K963321 (lubricated), and Ansell Inc. Condom (K901112) listed under the trade name Lifestyle®.
- Demonstration of Acceptance Criteria: The filing states the device is "substantially equivalent" to the predicate devices. This implies that the device meets the same established performance standards (e.g., physical integrity, burst volume, hole detection) that allowed the predicate devices to be marketed. The specific numerical acceptance criteria and performance data are not detailed in this 510(k) summary but would be part of the underlying design control and testing documentation held by the manufacturer. The "study" proving this is implicitly the battery of tests conducted by the manufacturer to demonstrate compliance with relevant standards and equivalence to the predicate devices, though these specific tests are not reported in this summary. The primary "proof" is the FDA's concurrence that it is substantially equivalent.
Ask a specific question about this device
(91 days)
Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested. "
Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom
ExtraWear™, Gentlemen's Choice™, Extra Strength Latex Condom with Nonoxynol-9
The provided document is a 510(k) premarket notification letter and the "Indications for Use" statement for a medical device (a latex condom). It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically described for AI/ML device evaluations. This document is from 1997, predating the widespread use of AI/ML in medical devices and the associated rigorous evaluation frameworks.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies from these documents. The questions in the prompt are structured around modern AI/ML device validation, which is not applicable to a 1997 condom approval document.
Ask a specific question about this device
(91 days)
Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic. Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for the ExtraWear™, Gentlemen's Choice™, Extra Strength… Lubricated Latex Condom:
The provided document is a 510(k) clearance letter from the FDA, not a detailed study report. As such, it does not contain the specific acceptance criteria or the study data that proves the device meets those criteria in the format requested.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performs as safely and effectively. The letter also mentions general controls and relevant regulations for medical devices.
However, based on the limited information, we can extract some points about the indications for use and a very high-level statement about testing:
Indications for Use:
"Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic."
Statement about testing (from the "Indications for Use" section):
"Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
Addressing your specific questions based on the available text (and noting where information is absent):
-
A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document is an FDA clearance letter, not a detailed technical report of the device's performance against specific criteria. It only states that laboratory tests show the ExtraWear condom is "stronger than the InnerWear condom." No numerical values for strength or specific acceptance criteria are given.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The document refers generally to "Laboratory tests of physical properties" but provides no details on sample size, data provenance, or study design (retrospective/prospective).
-
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)
This information is not present in the provided document. The concept of "ground truth" established by experts, as typically applied in AI/diagnostic device studies, is not applicable or discussed in this 510(k) clearance letter for a condom. The testing mentioned appears to be physical property tests, which would be measured objectively rather than through expert consensus.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document. Adjudication methods are typically relevant for subjective assessments or when discrepancies arise in expert reviews, which is not indicated for the type of testing broadly mentioned here.
-
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 information is not present in the provided document. An MRMC study or AI-assisted improvement for human readers is entirely irrelevant to a physical device like a latex condom.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided document. This concept applies to AI algorithms, not a physical device like a condom.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Based on the statement "Laboratory tests of physical properties," the "ground truth" would likely be objective physical measurements rather than expert consensus, pathology, or outcomes data. However, the exact methods are not detailed.
-
The sample size for the training set
This information is not present in the provided document. The concept of a "training set" applies to machine learning models, which is not applicable to this device.
-
How the ground truth for the training set was established
This information is not present in the provided document. As above, "training set" and its "ground truth" establishment are not relevant to this device.
Summary of what can be gleaned about the study:
The only study mentioned is "Laboratory tests of physical properties" which determined "the ExtraWear condom is stronger than the InnerWear condom." No further details on the methodology, sample sizes, or specific results are provided in this regulatory letter. A critical limitation is explicitly stated: "However, the breakage rate during sex has not been tested." This implies that while laboratory strength tests were conducted, real-world performance data regarding breakage was not part of this submission for substantial equivalence.
Ask a specific question about this device
(163 days)
Ask a specific question about this device
(163 days)
Ask a specific question about this device
(163 days)
Ask a specific question about this device
Page 1 of 1