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SPYROFLEX Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Abrasions Blisters Burns (sun burns, carpet burns, friction burns, minor chemical and heat burns) Cuts Lacerations Poison Ivy Rash Scrapes

SPYROFLEX® is a sterile, conformable, absorptive dressing. SPYROFLEX dressings consists of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while maintaining a protective moist healing environment. The wound contact surface of SPYROFLEX is a porous, non-toxic adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane acts as a reservoir for wound exudate. The outer layer performs as a barrier to bacteria, dirt, and liquids.

This document is a 510(k) summary for a wound dressing, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with acceptance criteria, expert adjudication, or MRMC studies.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable or cannot be extracted from the provided text.

Here is an attempt to address the requested information based only on the provided text, indicating where information is not present:

Acceptance Criteria and Device Performance Study for SPYROFLEX® Pigmented Wound Dressing

As this is a 510(k) submission, the primary "acceptance criterion" for market clearance is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented are primarily laboratory tests to support safety and basic functionality.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The term "laboratory tests" is used generally.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests are described as "laboratory tests."

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

• Not applicable. The provided document does not describe studies involving human readers or expert-established ground truth for performance. The "ground truth" for the safety endpoints (non-toxic, non-irritating, non-sensitizing) would be derived directly from the results of the laboratory tests themselves rather than expert consensus on diagnostic images or similar.

4. Adjudication Method for the Test Set

• Not applicable. No human adjudication process is described for the laboratory tests mentioned.

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

• No. An MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically relevant for diagnostic imaging AI devices, not wound dressings.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a physical wound dressing, not an algorithm. Therefore, a standalone (algorithm only) performance study is not relevant or applicable. The "performance" described relates to its physical and biological properties.

7. Type of Ground Truth Used

• The "ground truth" for the safety claims (non-toxic, non-irritating, non-sensitizing) was established through laboratory test results. For example, irritation would be assessed via standard dermatological patch tests, and toxicity via cytotoxicity assays or similar.
• The "ground truth" for functional claims (absorptive, breathable, barrier properties) would also be established through physical and material science laboratory testing methodologies.

8. Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature".

Here's an analysis of the provided K971045 510(k) summary, aiming to extract the requested information, with the understanding that a 510(k) summary often provides limited detail on extensive clinical studies:

Assessment of Provided Information:

The provided 510(k) summary for the Basis® Flexible Tip Digital Thermometer is very brief and focuses on regulatory classification, intended use, and substantial equivalence to predicate devices. It explicitly states that the device conforms to "ASTM E1112, 'Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature'". This standard itself contains the acceptance criteria for such devices, and conformity to it is the proof of meeting those criteria.

Therefore, many of the requested details about specific study design, sample sizes, expert involvement, and ground truth establishment are not present in this summary because the primary evidence for this type of device is typically performance testing against a recognized standard (ASTM E1112), rather than a clinical trial involving expert adjudication of diagnostic images or outcomes.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Since the K971045 summary explicitly states conformity to ASTM E1112, the acceptance criteria are those defined within that standard. Without access to the full ASTM E1112 standard, I cannot list every specific criterion and a numerical "reported device performance" against each. However, I can describe the nature of the criteria and how the device implicitly "meets" them by conforming to the standard.

Study Details (Based on available info and typical device regulatory pathways for this type of device)

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 (Test Set): Not specified in the 510(k) summary. For compliance with ASTM E1112, this would involve a set of physical thermometers tested in a laboratory setting against calibrated reference thermometers under controlled conditions. It's not a "data set" in the typical AI/diagnostic sense.
• Data Provenance: Not specified. Testing would typically be conducted in a laboratory, likely within the manufacturer's facilities or by a certified testing house. It is not "patient data" provenance.

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)

• Number of Experts: Not applicable in the context of device performance testing against a physical standard. The "ground truth" for temperature measurement is established by highly accurate and calibrated reference thermometers traceable to national or international standards. It does not involve human expert interpretation or consensus.
• Qualifications of Experts: N/A (as above).

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

• Adjudication Method: Not applicable. The performance is objectively measured against a standard, not interpreted or adjudicated by human reviewers.

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

• MRMC Study: No. This type of study is not relevant for a digital thermometer as it does not involve human "readers" interpreting diagnostic images or data, nor does it involve AI assistance in the diagnostic sense.

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

• Standalone Performance: Yes, in a sense. The "standalone performance" of the thermometer algorithm is its ability to accurately measure and display temperature according to the ASTM E1112 standard. This is precisely what conformance to the standard demonstrates. There isn't typically a "human-in-the-loop" for interpreting a thermometer reading, beyond reading the displayed number.

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

• Type of Ground Truth: The ground truth for digital thermometers is established by physical reference standards (e.g., highly accurate and calibrated reference thermometers or temperature baths) that are traceable to national or international metrology standards. It is an objective physical measurement, not a subjective interpretation.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This device does not use machine learning or AI in a way that requires a training set in the typical sense. Its performance is based on its hardware and firmware design, not on being "trained" on data.

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

• Ground Truth (Training Set): Not applicable, as there is no training set for this type of device.

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MITRAFLEX Pigmented Wound Dressings are intended for use in the management of: Venous stasis ulcers, Diabetic ulcers, Pressure sores, Donor sites, Blisters, Incisions, Severe sunburn, Poison Ivy, Dermabrasions and other dermatologic procedures, Partial-thickness wounds, Superficial burns, Abrasions and lacerations, Full-thickness wounds, Skin tears, Dermal lesions, Minor chemical burns, Thermal burns, Facelifts and other plastic surgery procedures (e.g. laser resurfacing)

MITRAFLEX Pigmented Wound Dressings are sterile, absorptive dressings. MITRAFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. MITRAFLEX dressings are constructed of three layers, each specifically engineered to give MITRAFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing. The wound contact surface of MITRAFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. MITRAFLEX is impermeable to microorganisms and liquids.

The provided text is a 510(k) summary for a medical device called MITRAFLEX Pigmented Wound Dressing. It describes the device, its intended use, and its substantial equivalence to other existing devices.

However, the document does NOT contain any information regarding: acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This 510(k) summary focuses on device description and substantial equivalence, not detailed performance studies or their associated metrics.

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SPYROFLEX Pigmented Wound Dressings are intended for use in the management of.
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Blisters
Incisions
Severe sunburn
Poison Ivy
Dermabrasions and other dermatologic procedures
Facelifts and other plastic surgery procedures (e.g. laser resurfacing)
Partial-thickness wounds
Superficial burns
Abrasions and lacerations
Full-thickness wounds
Skin tears
Dermal lesions
Minor chemical burns
Thermal burns

SPYROFLEX Pigmented Wound Dressings are sterile, absorptive dressings.
SPYROFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable.
SPYROFLEX dressings are constructed of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing.
The wound contact surface of SPYROFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. SPYROFLEX is impermeable to microorganisms and liquids.

The provided text describes a medical device, SPYROFLEX® Pigmented Wound Dressing, and its intended use. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.

The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment as this information is not present in the provided document.

To summarize the parts that cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not provided.
6. If a standalone performance (algorithm only) was done: Not applicable, as this is a physical wound dressing, not an algorithm.
7. The type of ground truth used: Not applicable, as this is a physical wound dressing.
8. The sample size for the training set: Not applicable, as this is a physical wound dressing, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

The document states that "SPYROFLEX Pigmented Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing." However, no details on these "laboratory tests" (e.g., methodology, sample sizes, specific criteria, results) are provided to form acceptance criteria or their fulfillment.

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The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.

The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.

This 510(k) summary for the K962991 Basis® Baby-Temp Pacifier Digital Thermometer provides very limited information regarding performance studies and acceptance criteria, as it predates the adoption of more rigorous clinical study expectations for many device types.

Based on the provided text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The summary states the device conforms to ASTM E1112 and meets Safety Standards for Baby Pacifiers. It does not provide specific numerical performance metrics (e.g., accuracy +/- X degrees, or specific safety test results). The general statement of conformity is the reported performance against these high-level criteria.

Further Information Based on the Provided Text:

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

  • Unknown. The document does not mention any specific clinical or performance testing data, sample sizes, or data provenance. It only states conformity to standards.

• 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 / Unknown. This type of device (digital thermometer) typically relies on metrology standards and physical testing rather than expert-established ground truth in the way a diagnostic imaging device would. The document does not describe any such expert involvement.

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

  • Not Applicable / Unknown. No information on adjudication methods is provided, as typical for this type of device and submission era.

• 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 a standalone digital thermometer, not an AI-powered diagnostic device. MRMC studies are irrelevant.

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

  • Not Applicable (or inherently standalone by definition). As a digital thermometer, its "performance" is inherently standalone. The document states it conforms to standards but doesn't detail performance studies in terms of an "algorithm" or "human-in-the-loop," as would be described for, say, an AI-powered diagnostic tool. The device itself is the "standalone" component.

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

  • Metrological Standards. For a digital thermometer, the "ground truth" for accuracy would be established by reference thermometers and metrological standards as outlined or referenced in ASTM E1112. The document doesn't explicitly state how this was done, just that the device conforms.

• 8. The sample size for the training set

  • Not Applicable / Unknown. This device is not described as using machine learning or AI, so there would be no "training set."

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

  • Not Applicable. As no training set is indicated, this question is not applicable.

Summary of Study (as described in the 510(k) summary):

The "study" described in this 510(k) summary is not a traditional clinical trial or comparative effectiveness study. Instead, the basis for clearance is:

• Conformance to ASTM E1112: This standard specifies requirements for electronic thermometers, including accuracy limits, display resolution, and other physical/electrical properties. The "study" implies that the device underwent testing to ensure it met these specifications.
• Conformance to Safety Standards for Baby Pacifiers: This indicates the device's physical design, materials, and overall safety as a pacifier were tested against relevant standards.
• Substantial Equivalence: The primary "study" for 510(k) devices often revolves around demonstrating substantial equivalence to a legally marketed predicate device. In this case, the device is stated to be substantially equivalent to the Questech International, Inc. WeeCare™ Pacifier Thermometer and the Intelligent Product Limited Company Paci-Temp Pacifier with Digital Thermometer. This implies that the design, intended use, and performance characteristics (as demonstrated by conformity to standards) are similar enough to the predicate devices that no new questions of safety or effectiveness are raised.

The 510(k) summary provided offers very high-level statements of conformance rather than detailed study results.

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