(59 days)
The Allegiance Kwik Kold™ Peri Cold Pack is an over-thecounter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision.
The Allegiance Kwik Kold™ Peri Cold Pack is comprised of a multi layer pouch which is secured to a perineal pad and then wrapped in a one ply polyester material The cold source pouch consist of ammonium nitrate and water. The water "bubble" is housed in a separate plastic pouch surrounded by ammonium nitrate. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the cold source occurs by folding and shaking the unit, thus resulting in a cooled solution from an endothermic reaction lasting approximately 30 to 35 minutes with a coldest temperature of approximately 33° F.
This document appears to be a 510(k) summary for a medical device, the Allegiance Kwik Kold™ Peri Cold Pack, rather than a study report describing the acceptance criteria and performance of an AI/ML powered medical device. Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) is not available in the provided text.
The provided text focuses on demonstrating substantial equivalence to predicate devices and describes basic physical and biological safety testing for the cold pack itself.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Attributes) | Reported Device Performance |
|---|---|
| Coldest Temperature | Approximately 33°F |
| Time at coldest temperature | Approximately 30 to 35 minutes |
| Temperature at five minutes | Not explicitly stated in numerical value, but implied to be within acceptable range for cold therapy |
| Chemical composition | Same as predicate devices |
| Method of activation | Same as predicate devices |
| Skin sensitization | Passed (evaluated as per ISO 10993 Part 1) |
| Primary skin irritation | Passed (evaluated as per ISO 10993 Part 1) |
| Cytotoxicity | Passed (evaluated as per ISO 10993 Part 1) |
| Active chemical mixture primary skin irritation | Passed (found toxicologically acceptable for intended usage) |
Notes on the Acceptance Criteria:
- The document implies that the acceptance criteria for "coldest temperatures achieved are comparable" and "performance attributes are equal" to predicate devices. The specific acceptable range or threshold for these characteristics (e.g., darkest comfortable temperature, duration of cold) is not explicitly defined in a quantitative manner but is stated as "comparable" or "equal" to predicate devices.
- For biological tests (skin sensitization, irritation, cytotoxicity), the acceptance criteria are "passed" as per ISO 10993 Part 1.
2. 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 available in the provided text, as this is a safety and effectiveness summary for a physical medical device, not an AI/ML study.
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)
This information is not available in the provided text. Ground truth as typically understood in AI/ML contexts is not relevant for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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 information is not available in the provided text, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not available in the provided text, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" for the performance characteristics like temperature and duration was established through physical testing and measurements (e.g., using thermometers, stopwatches) in a laboratory setting. For biological compatibility, the "ground truth" was established by standardized biological testing (e.g., guinea pig maximization, in vitro cytotoxicity assays) as per ISO 10993 Part 1.
8. The sample size for the training set
This information is not available in the provided text. This device does not use a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this physical device.
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Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500
APR -3 1997
SUMMARY OF SAFETY AND EFFECTIVENESS Appendix F
Manufacturer:
Allegiance Healthcare Corporation Surgical Group Thermal Business Unit 808 Highwav 24 West Moberly, Missouri 65270
Maryalice Smith 1500 Waukegan Road McGaw Park, Illinois 60085
(847) 785-3322
November, 1996
Allegiance Kwik Kold™ Peri Cold Pack
Perineal Cold Pack
Cold and Hot Disposable Pack
Allegiance Peri KTM Perineal Cold Pack
The Allegiance Kwik Kold™ Peri Cold Pack is comprised of a multi layer pouch which is secured to a perineal pad and then wrapped in a one ply polyester material The cold source pouch consist of ammonium nitrate and water. The water "bubble" is housed in a separate plastic pouch surrounded by ammonium nitrate. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the cold source occurs by folding and shaking the unit, thus resulting in a cooled solution from an endothermic reaction lasting approximately 30 to 35 minutes with a coldest temperature of approximately 33° F.
The Allegiance Kwik Kold™ Peri Cold Pack is an over-thecounter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision.
Regulatory Affairs Contact
Telephone:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification:"
Predicate Device:
Description:
Intended Use:
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The Alleaiance Kwik Kold™ Peri Cold Pack is substantially Substantial Equivalence: equivalent to the Allegiance Peri K™ Perineal Cold Pack, Jack Frost Perineal Cold Pack, Florida Medical Perineal Cool Comfort Pack, and Hospital Medical Services Peri + Plus Peri Cold Pack in that the - intended use is the same
- -performance attributes are equal -chemical composition is the same -method of activation is the same
- -coldest temperatures achieved are comparable
All materials used in the composition of this cold pack are evaluated and tested as identified in ISO Standard 10993 Part 1. The materials were subjected to skin sensitization (guinea pig maximization), primary skin irritation and cytotoxicity testing. Physical tests performed include: coldest temperature, time at coldest temperature, and temperature at five minutes. The active chemical mixture was subjected to Primary Skin Irritation testing. This mixture was found to be toxicologically acceptable for its intended usage. This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use.
Summary of Testing:
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.