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The NIO+ Adult is intended to provide intraosseous (IO) access in the proximal tibia and the humeral head as an alternative to emergency IV access. Per urgent mecessity, humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required. The device is intended for use in adult patients only.

The NIO+ Adult (NIO+) is intended to be used with the same patient population and same age range. The NIO+ utilizes the very same technology and has the same operation method. The main difference is that the NIO+ provides a more physically robust version of the NIO Adult (NIO-A) which was selected to serve as the primary predicate device for this submission. The NIO+ was designed to better serve in tactical settings, such as battlefields, as the device and its package are more durable. It should be noted that the NIO-A is currently in use for all segments and settings that the NIO+ is targeted for. The additional robustness of the NIO+ is achieved by utilizing raw materials that have higher mechanical properties. The sterile single unit packaging robustness was increased, by using a rigid-blister and rigid plastic cover to protect the Tyvek paper. In addition, the maximal storage temperature was increased to 50°C versus room temperature, in order to assure that the device can function such extreme temperatures.

All NIO products are intended to be used by skilled, authorized medics, nurses, paramedics and doctors who are trained to use the device in military, emergency services and hospitals environments. The products are for single use and supplied sterile.

The provided text is a 510(k) Summary for the NIO+ Adult device. It focuses on demonstrating substantial equivalence to a predicate device (NIO Adult) through non-clinical testing, rather than presenting a study that proves the device meets specific acceptance criteria in a clinical or AI-driven context.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" as it pertains to AI/algorithm performance (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance, effect size) cannot be extracted from this document because it describes a medical device (a hypodermic needle) and its regulatory clearance process, not an AI or algorithm-driven diagnostic or treatment device.

The document details the device's technical characteristics, its intended use, and the non-clinical tests performed to ensure its safety and effectiveness. It explicitly states: "No clinical Study is included in this submission."

However, I can extract the non-clinical acceptance criteria and their proven performance based on the provided document.

Non-Clinical Acceptance Criteria and Reported Device Performance

The NIO+ Adult device is a hypodermic single lumen needle intended for intraosseous (IO) access. The approval relied on non-clinical performance testing to demonstrate substantial equivalence to a predicate device (NIO Adult, K142086). The acceptance criteria are implicit in the "Discussion of Technological Characteristics" and "Non-Clinical Performance Testing" sections, where the subject device's performance is compared to the predicate or to relevant standards.

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Focus)

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The NIO-I is an Intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.

The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 0 and 3 years of age. The NIO-I provides haptic feedback via the stepped-needle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.

The provided text is a 510(k) premarket notification for the NIO-I intraosseous device. It does not contain a study comparing the device to acceptance criteria but rather a comparison to predicate devices and a summary of non-clinical performance testing. Therefore, I cannot fully answer your request.

However, I can extract the information related to the non-clinical performance testing which serves as evidence for the device's acceptable performance against established standards.

1. Table of Acceptance Criteria (from Standards) and Reported Device Performance:

The document lists several non-clinical tests and the standards they comply with. These standards implicitly contain the acceptance criteria. The reported device performance is that it successfully complied with these standards.

2. Sample sized used for the test set and the data provenance:

The document does not explicitly state the sample sizes for the individual non-clinical tests. It refers to these as "Waismed V&V tests plan" and compliance with international standards. Data provenance is not described beyond stating "non-clinical tests were conducted".

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 applicable as the document describes non-clinical performance testing and compliance with standards, not a study utilizing expert-established ground truth.

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

This information is not applicable as the document describes non-clinical performance testing and compliance with standards.

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 applicable. The device is a physical intraosseous needle and does not involve AI or human "readers".

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

This information is not applicable. The device is a physical intraosseous needle.

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

For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established within the international standards (e.g., ISO 10993, ISO 9626, IEC 62366, etc.).

8. The sample size for the training set:

This information is not applicable as the document describes non-clinical performance testing of a physical device, not an algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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The NIO-P for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients between 3 and 12 years of age.

The NIO product family (Adult and Pediatric) is an upgrade in terms of design and structure to the company's B.I.G. Bone Injection Gun product family. The NIO product family has already one cleared model, for the adult population NIO Adult (K142086). Both product families NIO and BIG are composed of a trocar needle, spring, piston, and housing that contains safety mechanisms to prevent accidental device activation. Both devices are positioned onto the appropriate insertion site. Both product families have the same principle of operation. The device resembles a syringe and, when activated, a loaded spring is released and the device injects a needle to a predetermined depth into the bone marrow cavity. The user then pulls out the trocar needle, leaving the cannula inside the bone marrow cavity. Through the cannula, fluids and drugs can be delivered to the vascular system via the bone marrow cavity. The NIO-P device is designed to detect the proper injection point. In addition, the NIO-P is also equipped with a unique, adjustable needle penetration depth according to the age group, as part of the stabilizer. Both features are designed to improve accuracy in detecting the insertion point and needle penetration depth.

This document describes a 510(k) premarket notification for the NIO-P device, a hypodermic single lumen needle intended for pediatric intraosseous access. The submission aims to demonstrate substantial equivalence to existing predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it lists several validations and studies performed to demonstrate the device's performance characteristics. The "Reported Device Performance" is implied through the successful completion of these validations and bench testing, confirming the device functions as intended and meets safety and effectiveness requirements.

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

The document primarily describes bench testing and validation studies. It does not specify sample sizes for these tests. The data provenance is implied to be from the manufacturer's internal testing (Waismed Ltd.). There is no mention of country of origin for test data, nor whether it is retrospective or prospective, as it pertains to engineering and product validation rather than clinical data.

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

This information is not provided in the document. The studies listed are bench tests evaluating physical properties and functionalities of the device (e.g., spring force, bond strength, structural deformation). These types of tests typically rely on engineering specifications and laboratory measurements rather than expert human assessment for ground truth.

4. Adjudication Method for the Test Set

Given that the studies are bench tests of physical characteristics, an adjudication method in the context of expert consensus or disagreement is not applicable and therefore not mentioned. The "ground truth" for these tests would be defined by the pre-established engineering specifications and validated measurement techniques.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing of the device's physical and functional characteristics.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a mechanical hypodermic needle for intraosseous access. It is not an algorithm-based device or software, so the concept of "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to its mechanical function, albeit with features designed to aid the human user (e.g., detecting proper injection point, adjustable penetration depth).

7. The Type of Ground Truth Used

The ground truth used for the performance studies is based on:

• Engineering specifications and design requirements: For aspects like proper insertion point, penetration depth, spring force, bone integrity, bond strength, and structural deformation.
• Established standards: E.g., ISO 7864 for Hub-Cannula/Hub-Needle Bond Strength Testing.
• Comparison to predicate device characteristics: To demonstrate that the modified device's characteristics are consistent with or improved upon the predicate and reference devices, without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. The NIO-P is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and validation are based on engineering principles and physical testing.

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

This information is not applicable for the same reasons as #8. There is no training set for a mechanical device.

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The NIO Adult is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

The NIO Adult is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.

The NIO Adult device is a modification to the company's cleared Adult B.I.G - Bone Injection Gun (K981853 and K062940) to permit intraosseous access through the Proximal Tibia and the Humeral Head.

Like the cleared Adult B.I.G., the NIO Adult device is comprised of a trocar needle, spring, piston and housing. Likewise, both devices resemble a syringe and when activated, a loaded spring is released and the device injects the needle to a predetermined depth into the bone marrow cavity.

The difference between the NIO Adult device and the cleared B.I.G. device is primarily the safety latch and trigger mechanism which is designed to provide a safer device and the minor design modifications to the plastic housing and needle dimensions in order to accommodate the modified safety mechanism.

This is a 510(k) premarket notification for a medical device called "NIO Adult," a hypodermic single lumen needle intended for intraosseous access. The document does not describe a study that uses acceptance criteria and reports device performance in the way a clinical trial or a machine learning algorithm validation would. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (B.I.G. Adult Bone Injection Gun) through a series of engineering and performance tests.

Therefore, many of the requested categories for acceptance criteria and study design are not applicable in the context of this 510(k) submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance tests, but it does not explicitly state quantitative acceptance criteria or detailed numerical performance results for each test in a table format. It generally states that the device "functions as intended" and "inserts the needle to the same penetration depth as the predicate device."

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

The document does not specify general "sample sizes" in the way a clinical study would (e.g., number of patients or cases). The tests described are engineering and bench tests, likely performed on a small number of device units or components.

• Sample Size: Not specified for each test. Typically, these types of tests involve a limited number of devices or components to demonstrate consistency and compliance.
• Data Provenance: The tests were conducted to demonstrate substantial equivalence to the predicate device, also manufactured by Waismed Ltd. The document does not specify a country of origin for the testing data itself, but the applicant company (Waismed Ltd.) is located in Herzliya, Israel. The data is retrospective in the sense that it's comparing against an existing predicate, but the testing itself would have been conducted more recently.

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

Not applicable. This is not a study involving expert human interpretation or diagnosis. The "ground truth" for these engineering tests is established by objective measurements against predefined specifications or comparison to the predicate device's characteristics.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process described, as the tests are objective engineering measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the subject of this medical device submission.

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

Not applicable. The NIO Adult is a physical medical device (a needle system), not an algorithm or software-based device.

7. The type of ground truth used

The "ground truth" for the performance tests is based on:

• Engineering Specifications: Designed performance characteristics for components (e.g., spring force, depth of penetration).
• International Standards: Compliance with standards like ISO 10993 (biocompatibility) and ISO 7864 (bond strength).
• Predicate Device Performance: Direct comparison to the established performance characteristics of the B.I.G. Adult Bone Injection Gun in areas like needle penetration depth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable.

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The B.I.G. - Bone Injection Gun is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.

The B.I.G. - Bone Injection Gun consists of a trocar needle held by a piston. The piston is surrounded by a compressed spring. All components are contained in the device's housing. When the device is operated, the compressed spring is released and propels the trocar needle into the bone marrow.

The provided document, K062940, is a 510(k) summary for WaisMed's B.I.G.™ - Bone Injection Gun. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed performance criteria or a study design description that would typically be found in a clinical trial report or a more comprehensive technical document.

Here's an analysis based on the available information:

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

   The document states: "The device was tested for both performance and safety. In all instances, the B.I.G. - Bone Injection Gun functioned as intended."
   However, specific quantitative acceptance criteria (e.g., success rate, time to access, specific failure modes and their acceptable limits) and detailed reported device performance metrics are not provided in this summary. It only offers a general statement that the device functioned as intended.

2. Sample size 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 510(k) summary. The document does not describe any specific test set size for performance and safety testing, nor does it mention the provenance of any data used.

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. The summary does not describe a clinical study involving human experts establishing ground truth. The evaluation appears to be based on functional and safety testing of the device itself rather than an assessment by experts against a reference standard in a clinical context.

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

   This information is not available. No description of adjudication methods is present, as there's no mention of a human-reviewed test set requiring such a process.

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 applicable to this device. The B.I.G. - Bone Injection Gun is an intraosseous infusion device, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to its evaluation.

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

   This information is not applicable to this device. As a mechanical medical device, the concept of "algorithm only" performance without human-in-the-loop is not relevant. The device requires human operation for its intended use.

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

   This information is not explicitly stated as part of a formal study with ground truth. For a mechanical device like the B.I.G., "ground truth" typically relates to its functional performance (e.g., successful insertion, fluid flow rate without leakage, structural integrity). The summary only states that the device "functioned as intended," implying that it met its functional design specifications, which would serve as the de-facto "ground truth" for its performance and safety tests.

8. The sample size for the training set

   This information is not applicable to this device. The B.I.G. - Bone Injection Gun is a mechanical device, not an algorithm that requires a training set.

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

   This information is not applicable to this device, as it does not involve a training set.

In summary, the provided 510(k) summary for the B.I.G. - Bone Injection Gun states that the device was tested for performance and safety and "functioned as intended." However, it lacks specific details about the acceptance criteria, study design, sample sizes, expert involvement, or any quantitative results that would typically be provided in a comprehensive study report. The premarket notification focuses on demonstrating substantial equivalence to predicate devices (WaisMed, Ltd., B.I.G. - Bone Injection Gun (K981853) and Vidacare Corporation, Humeral Head EZ-IO (K052408)) based on similar intended uses, indications, technological characteristics, and principles of operation, rather than a detailed presentation of a de novo clinical or performance study with quantified acceptance criteria.

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The B.I.GTM. Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.

The B.I.GTM. Bone injection Gun for Pediatrics is an instant, intravascular (IV) access device. The device comprises a housing with a spring loaded mechanism that inject a trocar needle into the bone marrow of a patient and allows for subsequent connection of a syringe or intravascular administration set.

This document is a 510(k) summary for the WaisMed LTD. B.I.G.TM - Bone Injection Gun for Pediatrics. It is a premarket notification for a medical device and, as such, does not typically contain the detailed information requested regarding clinical studies with specific acceptance criteria, sample sizes for training/test sets, ground truth establishment, or expert involvement in the way a clinical trial report or a journal publication would.

The provided document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed de novo clinical study with quantitative performance metrics against pre-defined acceptance criteria.

I can, however, extract related information to address some of your points based on what is available:

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

This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence based on technological features, principles of operation, and intended use, rather than presenting specific quantitative performance data against pre-defined acceptance criteria.

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 provided. The summary states "supportive data including in vitro studies, clinical data and literature survey," but does not specify sample sizes, country of origin, or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The 510(k) summary does not describe any specific process for establishing ground truth involving experts. It relies on the clinical context of intraosseous access for emergencies.

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

This information is not provided. As an adjudication method would typically be part of a detailed clinical study, its absence is consistent with the nature of a 510(k) summary focused on substantial equivalence.

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 applicable/provided. The device is a mechanical bone injection gun, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, an MRMC study related to AI assistance is not relevant.

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

This information is not applicable/provided. The device is a mechanical device for gaining intraosseous access, not an algorithm. Standalone algorithm performance is not relevant.

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

This information is not explicitly stated in the context of the requested detailed study. However, for a device like an intraosseous access gun, the "ground truth" for its effectiveness would inherently relate to the successful establishment of intraosseous access and its ability to deliver fluids/medications. This would typically be confirmed by direct observation during use, fluid flow, and patient physiological response, which falls under outcomes data in a broad sense (i.e., whether the device successfully achieves its intended physical function). The 510(k) summary states it provides "intraosseous access in the proximal tibia, as an alternative to IV access during emergencies." The "clinical data" mentioned would likely pertain to demonstrating this function.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" in the context of machine learning. The device is mechanical.

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

This information is not provided/not applicable as there is no training set for a machine learning model.

Summary of available information from the 510(k) Summary:

The 510(k) summary primarily asserts substantial equivalence to predicate devices based on:

• Intended Use: To provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies, for pediatric patients up to 12 years of age.
• Technological Features and Principles of Operation: Stated to be the same as the predicate Adults' B.I.G.TM device.
• Performance Data: "Supportive data including in vitro studies, clinical data and literature survey" were used to demonstrate that minor differences from predicate devices do not raise new types of safety or effectiveness issues. However, specific details of these studies (acceptance criteria, sample sizes, ground truth, etc.) are not provided in this summary.

This type of 510(k) summary is common for devices demonstrating substantial equivalence, where the focus is on showing similarity to already cleared devices rather than presenting a novel device with extensive new clinical trial data against pre-defined performance thresholds.

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The Bone Injection Gun (B.I.G.) is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

Bone Injection Gun (B.I.G.)

This document is a 510(k) clearance letter from the FDA for the Bone Injection Gun (B.I.G.) device, confirming its substantial equivalence to a legally marketed device. It does not contain information about the device's acceptance criteria, reported performance, or any studies conducted to prove it meets acceptance criteria.

Specifically, the document does not provide any of the following information requested:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This letter is a regulatory approval document, not a clinical study report or a technical performance specification.

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