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The gentleheel® Adult Incision Device is a single-use lancing device intended to obtain microliter capillary blood samples. The gentleheel® Adult Incision Device has a sharps prevention feature to protect the user from a needlestick injury.

The gentleheel® Adult Incision Device is designed to be an easy to use, safe, one handed incision device for acquiring blood samples from the patient's finger to obtain sufficient blood volumes for capillary blood draws. The gentleheel Adult Incision Device utilizes a blade resulting in improved blood flow requirements. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with a human fingertip. The user is instructed to remove the trigger lock. When the gentleheel Adult Incision Device is placed against the patient's finger and the user presses the trigger mechanism it automatically makes the incision the blade in a continuous motion from inside the housing, into the fingertip, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel Adult Incision Devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

The provided text describes the 510(k) premarket notification for the gentleheel® Adult Incision Device (K242664), which is a single-use lancing device. This device is an additional indication for use of the previously cleared gentleheel® device (K220917 and K172712).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are inferred from the summary of testing mentioned. The document focuses on demonstrating substantial equivalence to a predicate device, and thus the performance is reported in the context of meeting safety and functional requirements.

2. Sample Sizes and Data Provenance for Test Set

• Sample Size for the test set: Not explicitly stated in terms of number of participants for the clinical use testing. It only mentions "clinical use testing was completed on adults."
• Data Provenance: The document does not specify the country of origin for the data. The clinical use testing for the adult indication was "completed on adults." It appears to be a prospective study for a specific cohort (adults) to expand the indication of use.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the document. The studies mentioned are primarily performance and clinical use trials, not studies relying on expert consensus for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

• This information is not applicable and is not provided in the document. The studies described are performance and clinical use studies for a lancing device, not studies requiring adjudication among experts for a diagnostic output.

5. MRMC Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is typically for diagnostic imaging devices where human readers interpret results with and without AI assistance. This device is a lancing device, not an imaging or diagnostic AI-powered device.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. This device is a mechanical lancing device, not an AI algorithm.

7. Type of Ground Truth Used

• The "ground truth" for the clinical use testing was the successful collection of microliter capillary blood samples from adults via fingertip lancing, and confirmation that the device's sharps prevention feature functioned as intended. For the performance tests, the ground truth would be adherence to defined engineering specifications (e.g., cutting profile dimensions, trigger force, structural integrity post-drop, and proper function of the sharps prevention feature).

8. Sample Size for the Training Set

• This information is not applicable as this device is a mechanical lancing device and does not involve machine learning or an "algorithm" requiring a training set.

9. How Ground Truth for Training Set was Established

• This information is not applicable as there is no training set for this mechanical device.

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The intended use of this device is for newborn babies of any ethnicity where a blood sample is desired, and a self-retracting safety feature is desired to protect the clinician performing the blood sampling.

The gentleheel® is designed to be an easy to use, safe, one handed heel incision device for acquiring blood samples from the heels of newborns. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with an infant's foot. The user is instructed to remove the trigger lock. When the gentleheel is placed against the infant's heel and the user presses the trigger mechanism it automatically makes the incision by starting the blade in a continuous motion from inside the housing, into the infant's heel, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

The gentleheel comes in models for Newborn (NGH), Preemie (PGH), Micro-Preemie (MPGH), and Toddler (TGH). The models are differentiated by the styles and colors of the housing (see following definitions).

The provided text describes a 510(k) summary for the "gentleheel" device, which is an infant heel stick lancet. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a novel study. Therefore, much of the requested information regarding specific acceptance criteria metrics, detailed study design, and statistical results from a primary clinical study is not available in the provided document.

However, I can extract information related to the device's characteristics and the types of testing performed to support its safety and substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or effect sizes for human reader improvement. Instead, it details that performance and safety testing was completed for the gentleheel®.

The categories of performance and safety tests mentioned are:

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

The document does not describe a clinical "test set" in the context of typical AI/diagnostic device studies. The testing described is primarily mechanical, biocompatibility, and simulated-use testing. Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), or ground truth establishment based on patient data is not applicable or provided.

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

Not applicable, as the provided document does not detail a clinical study with a "test set" requiring expert ground truth establishment for a diagnostic output. The device is a manual surgical instrument, not an AI diagnostic tool.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. The gentleheel is a manual surgical instrument, not a device that involves human readers or an AI assistance component in its primary function that would necessitate an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable, as the device does not employ an algorithm or AI.

7. The Type of Ground Truth Used:

For the performance and safety testing mentioned, the "ground truth" would be established by:

• Biocompatibility: Adherence to ISO 10993-1 standards and laboratory test results.
• Functionality (Cutting Profile, Trigger Force, Reverse Safety): Engineering specifications and mechanical measurements.
• Durability (Drop Testing): Pre-defined physical integrity standards.
• Sharps Prevention Feature: Mechanical operational verification against design requirements and FDA guidance.

8. Sample Size for the Training Set:

Not applicable, as the device does not involve training of an algorithm or AI model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as the device does not involve training of an algorithm or AI model.

Summary of the Document's Focus:

The document is a 510(k) summary demonstrating substantial equivalence for the gentleheel® device to previously cleared predicate devices (K172712 and K883968/K911997). The core argument is that the proposed device:

• Has the "same principles of operation, intended use, and technological characteristics" as the predicates.
• Maintains the "same" materials (medical grade stainless steel, plastics), dimensions, cut profiles, and safety features (single-use, integral sharps injury prevention, automatic blade retraction).
• Has undergone biocompatibility, cutting profile, trigger force/reverse safety, drop testing, and simulated use testing to demonstrate its continued safety and performance against established standards and its prior clearance.

The "testing" mentioned is to confirm these characteristics and ensure they are maintained or are equivalent to the predicate devices, not to establish novel performance metrics against a clinical ground truth for a new diagnostic capability.

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Non-sterile, single use device designed to create a physical barrier between the mouth and nose of the wearer and potential contaminants in the imment. They are designed to be worn in the operating room, dental offices, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microogransims, bodily fluid and particulate matter.

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The provided text is an FDA clearance letter for a medical device, specifically surgical masks. It does not contain information about the acceptance criteria for an AI/ML powered device, nor does it describe a study proving such a device meets acceptance criteria.

Therefore, I cannot fulfill the request using only the provided input. The document is about the regulatory clearance process for a common medical device (masks), and not an AI/ML product.

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The GRI-Alleset ComfortGuard™ Surgical Isolation Gown is a non-sterile disposable, single-use gown intended to protect both the health care worker and patients from the transfer of microorganisms, bodily fluids and particulate matter in moderate risk patient isolations. This gown in not intended for use in an operating room environment and should not be worn during surgical or invasive procedures or when there is a potential for a high risk of contamination.

Additionally, the GRI-Alleset ComfortGuard™ Surgical Isolation Gown meets the requirements defined per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) for AAMI Level 3 barrier protection.

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I am sorry, but the provided text from the FDA 510(k) notification for the ComfortGuard™ Surgical Isolation Gown does not contain any information about an AI/ML-based medical device study or its performance criteria.

The document is a standard FDA clearance letter for a medical device (a surgical isolation gown), confirming its substantial equivalence to a legally marketed predicate device. It discusses regulatory matters such as:

• Device name and product code
• Regulation numbers and class
• General controls provisions of the Act
• Requirements for registration, listing, labeling, and good manufacturing practice
• Adverse event reporting
• Indications for Use

Specifically, concerning performance, it states: "Additionally, the GRI-Alleset ComfortGuard™ Surgical Isolation Gown meets the requirements defined per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) for AAMI Level 3 barrier protection." This refers to a physical barrier standard for gowns, not a performance study of a diagnostic AI/ML algorithm.

Therefore, I cannot extract the information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training/test sets) because this type of information is not present in the provided document.

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