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Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.

The provided document is an FDA 510(k) premarket notification for an Insulin Syringe. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device, which is implied by your detailed request.

The document describes typical non-AI medical device testing, such as:

• Bench Testing: Verifies physical performance characteristics (e.g., needle tube length, bond strength, leakage, fit of plunger, dead space, penetration force, particulate contamination).
• Biocompatibility Testing: Assesses biological safety (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogens).
• Sterilization and Shelf-life Testing: Validates sterilization method and confirms shelf life.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria, performance metrics (like sensitivity, specificity, AUC), sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or training set details because this information is not present in the provided text. The device in question is a physical insulin syringe, not an AI/ML-based diagnostic or therapeutic device.

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AccuFill Bone Substitute Material is an injectable, seff-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

AccuFill Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration fluid and mixed. Once mixed, the resulting paste is used to fill osseous defects. The paste can be administered to the treatment site by injection or by manual application. AccuFill hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite ("PCHA"), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. AccuFill is an osteoconductive material that is resorbed and replaced by natural bone over time.

AccuFill BSM is available in two packaging configurations: (1) AccuFill BSM is sold in a jar and can be mixed in a bowl or mixing syringe; (2) AccuFill BSM is also sold in a prefilled mixing syringe. AccuFill BSM is delivered to the osseous defect site with stainless steel AccuPort cannulas.

The provided text describes the regulatory clearance of a medical device, AccuFill Bone Substitute Material, through the 510(k) pathway. This pathway establishes substantial equivalence to legally marketed predicate devices, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as would be done for a novel, high-risk device.

Therefore, the information typically required to describe acceptance criteria and a study proving a device meets these criteria (such as sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not present in this document.

The document primarily focuses on:

• Regulatory Clearance (510(k)): Confirming the device is substantially equivalent to predicates.
• Device Description: What the device is and how it works.
• Indications for Use: What the device is intended for.
• Predicate Devices: The devices to which AccuFill is compared for substantial equivalence.
• Performance Testing: A list of non-clinical tests performed to demonstrate performance and substantial equivalence to predicates (e.g., simulated use, working time, setting time, compression strength, biocompatibility, sterility, shelf-life). These are engineering and material science tests, not clinical studies assessing human performance or diagnostic accuracy.

Based on the provided text, I cannot complete the requested tables and details regarding acceptance criteria and clinical study performance as they pertain to a human-in-the-loop or AI-driven diagnostic device. The document is for a bone substitute material, and the "performance testing" described is for its physical and biocompatible properties, not for diagnostic accuracy or human reader improvement with AI assistance.

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CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. CarriGen PF is a mixing syringe pre-filled with the previously cleared CarriGen Porous Bone Substitute Material. The CarriGen PF system eliminates the need to transfer the CarriGen powder to the mixing syringe. After mixing, CarriGen is administered to the treatment site by manual application. The material can be shaped into a desired form in situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. CarriGen Porous Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

This document describes a 510(k) premarket notification for CarriGen® PF, a resorbable calcium salt bone void filler device. The information provided demonstrates the device's substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and performance studies for an AI/ML medical device.

Specifically, this document does not describe:

• A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm. The acceptance criteria mentioned are for the physical properties of a bone void filler.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML test set.
• MRMC or standalone studies for an AI/ML algorithm.

Therefore, I can only provide the information that is available in the document, which primarily pertains to the physical and chemical properties of the bone void filler, not an AI/ML device.

Here's an analysis of the provided text based on your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance (Based on Device Type - Bone Void Filler)

The document primarily focuses on the physical and chemical performance characteristics of the CarriGen® PF bone void filler, not an AI/ML algorithm.

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

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the CarriGen PF meets the pre-determined acceptance criteria for the verification activities." However, it does not provide a table with specific acceptance criteria values and corresponding reported performance values. It only lists the types of performance testing conducted:

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided text. The testing mentioned is for the physical and chemical properties of the material, not a data-driven AI test set.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable or not specified, as this is for material testing, not patient data for an AI/ML algorithm.

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

• Not applicable. This information is relevant for AI/ML performance studies involving human expert interpretations of data (e.g., medical images). The document describes testing of a physical medical device.

4. Adjudication method for the test set

• Not applicable. This information is relevant for AI/ML performance studies involving multiple human readers.

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 document describes a traditional medical device (bone void filler), not an AI/ML software.

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

• Not applicable. This document describes a traditional medical device (bone void filler), not an AI/ML software.

7. The type of ground truth used

• For material properties: The ground truth for the performance testing (e.g., working time, setting time, compression strength, biocompatibility, endotoxin levels) would be established by standardized testing methods and specifications (e.g., ASTM standards, ISO standards, USP monographs for biocompatibility and endotoxin). The "truth" is determined by the physical and chemical measurements aligning with the pre-defined acceptable ranges for these properties.
• For AI/ML: Not applicable in this document.

8. The sample size for the training set

• Not applicable. This document describes a traditional medical device (bone void filler), which does not have a "training set" in the context of an AI/ML algorithm. Its properties are inherent to its formulation and manufacturing process.

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

• Not applicable. No training set for an AI/ML algorithm is mentioned.

In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review of a physical medical device (a bone void filler). It details the device's indications for use, description, predicate devices, and the types of performance testing conducted to demonstrate substantial equivalence of its physical and chemical properties. It does not contain any information relevant to the development, testing, or performance of an artificial intelligence or machine learning-based medical device.

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The Nurture Rest (including models 100-1-C) is indicated for premature infants undergoing oxygen therapy to maintain an airway and for whom treatment may be facilitated by this repositioning and stabilization device. The premature infants are being continuously monitored for oxygen saturation levels and heart rate in the Neonatal Intensive Care Unit (NICU) by medical professionals.

Nurture Rest is an infant sleep positioning device used by medical staff to position and secure premature infants in a prone, supine, or side position to limit mobility within an incubator in the neonatal intensive care unit (NICU). The Nurture Rest is shaped like the female anatomy in order to encourage a "Kangaroo Care" style positioning technique that mimics being held against a female body/chest while also keeping the infant's head, neck, and spine aligned. This device gives nurses a useful tool in their daily role of repositioning and caring for these special premature infants. The infants for whom the device is used are undergoing oxygen therapy to maintain an airway (intubation, nasal CPAP, bubble CPAP, high flow nasal cannula, or nasal cannula) and are continuously monitored for oxygen saturation levels and heart rate. The Nurture Rest consists of a washable, flame-retardant cloth material.

There are two models of the device (Models 100-1-O and 100-2-C). Both devices are appropriate for prone, supine and side positioning of premature infants. One model of the device (Model 100-1-O) has customizable opening at the head to allow for prone face-down positioning of micro-preemies for whom positioning with the head turned to the side would increase the chance of hemorrhaging due to increased intracranial pressure. The other model (Model 100-2-C) does not have an opening and is for prone with head turned positioning. The device comes with pillows to help stabilize the infant and swaddling straps to minimize motion of the arms and body of the infant. As with standard NICU practices, the Nurture Rest enables the infant to be re-positioned and treated as needed (typically every 4 to 6 hours), which allows NICU staff to cluster care in order to let the infants rest and grow in between physical and emotional stimulation.

The Nurture Rest device is a pediatric position holder for premature infants in the Neonatal Intensive Care Unit (NICU). Below is a summary of its acceptance criteria and the study that proves the device meets them.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the traditional sense, as the studies primarily involve bench, simulated, and material testing.
  • For the bench top and usability testing, the 'sample' involved the "Nurture Rest" device itself and a "doll which was representative of actual premature patients." The number of devices or dolls tested is not explicitly stated.
  • For biocompatibility, durability, coefficient friction, bioburden, storage, and packaging/ship testing, the 'sample' refers to units of the Nurture Rest device. The specific number of units tested is not provided.
• Data Provenance: Not explicitly stated as retrospective or prospective data from human subjects. The studies are primarily lab-based (bench, simulated, material testing) and do not involve data from patients. The testing was conducted by Neonatal Loving Kare, Inc. or their contracted labs. The country of origin of the data is not specified but implicitly within the US given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This information is not applicable or not provided in the document. The ground truth for the performance tests was established by objective measurements and functional assessments against predetermined criteria, rather than expert consensus on diagnostic interpretations or outcomes. For usability, the study involved "NICU nurses," but the number and their specific qualifications (e.g., years of experience) beyond being NICU nurses are not detailed.

4. Adjudication Method for Test Set

Not applicable. The reported studies are primarily objective performance, usability, and material tests, not clinical evaluations requiring adjudication of subjective assessments.

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

No. An MRMC comparative effectiveness study was not done. The device is a physical pediatric position holder, not an AI or diagnostic imaging device that would typically undergo such a study. The document describes a comparison to a predicate device primarily based on technological characteristics and intended use, not a comparative clinical effectiveness study against human performance.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device, not an algorithm or software. Therefore, a standalone (algorithm only) performance study is not applicable.

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria was based on:

• Objective functional performance: Whether the device could physically position and retain a representative doll (simulated use).
• Material properties standards: Adherence to biocompatibility standards (ISO 10993-1) and comparison of properties like coefficient of friction and bioburden to existing NICU standards/products.
• Usability observation: Direct observation and assessment of NICU nurses using the device during simulated scenarios to confirm safe and effective use.
• Durability and integrity standards: Confirmation that the device maintains its form and function over time and through transport.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning algorithms that require a "training set."

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

Not applicable, as there is no training set for this type of device.

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The Life Innovations Infant Sleep Beanie is an over-thecounter repositioning device to aid in the prevention of deformational (or positional) plagiocephaly arising from consistent back-sleeping postures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.

The Life Innovations Infant Sleep Beanie is a form fitting infant beanie hat placed strategically on a baby's head while lying awake, sleeping or during travel.

This device, the "Infant Sleep Beanie," is a Class I medical device (pediatric position holder) and, as such, is exempt from stringent performance requirements typically associated with Class II or Class III devices. The submission explicitly states: "The FDA has not established special controls or standards for this device."

Therefore, the typical structure for reporting acceptance criteria and a study proving those criteria are met is not applicable in this case. The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's how to address each point given the provided information:

Acceptance Criteria and Device Performance for Infant Sleep Beanie (K082367)

This device, classified as a Class I pediatric position holder, is exempt from specific performance-based acceptance criteria established by the FDA. Therefore, the device's acceptance is primarily based on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting predefined numerical performance targets from a clinical trial. The provided submission does not contain a performance study with defined acceptance criteria.

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

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

Not applicable. The submission does not describe a performance study with a test set. This 510(k) is a premarket notification for a Class I device, which relies on demonstrating substantial equivalence to predicates rather than clinical performance data.

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. No test set requiring expert-established ground truth is described.

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

Not applicable. No test set requiring adjudication is described.

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 not an AI-powered diagnostic tool, and no MRMC study or comparative effectiveness study is mentioned.

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

Not applicable. This device is a physical pediatric position holder, not an algorithm, and therefore "standalone performance" in that context is not relevant.

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

Not applicable. No ground truth is established or used as there is no performance study described. The basis for marketing this device is its substantial equivalence to other legally marketed pediatric position holders.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth.

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The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 months with gastroesophageal reflux to rest comfortably in a semi-upright position; it is used for sleeping and playtime in supine, prone, and side-lying positions.

Device Name: RES-Q Infant Wedge & Sling
Classification/Common Name: Holder, Infant Positioner
Code FRP, CFR 880.5680
Class 1

The provided text is a 510(k) summary for the RES-Q Infant Wedge & Sling, which is an infant positioner. It does not contain information about a study with acceptance criteria, reported device performance, or details typically associated with the evaluation of AI/ML devices or diagnostic tools.

The document states: "FDA has not established special controls or performance standards for this device."

Therefore, I cannot provide the requested information from the given text as it is not present. This device is a Class I medical device, which typically has lower regulatory scrutiny and does not require extensive performance studies and acceptance criteria as would be expected for a diagnostic or AI-powered device.

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The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly

Kozy Comfort™ Infant Positioner is a polyurethane based infant positioner.

The provided 510(k) summary for the "Kozy Comfort™ Infant Positioner" (K062143) does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The document states: "FDA has not established special controls or performance standards for this device." This indicates that the device was approved based on substantial equivalence to predicate devices, rather than through a performance study against specific acceptance criteria.

Therefore, for each of your requested points, the answer is that the information is not available in the provided text.

Here's a breakdown based on your request, explicitly stating why the information is not present:

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

   • Not available. The document states no special controls or performance standards exist for this Class I device. As such, no defined acceptance criteria are presented, nor is there a study reporting performance against such criteria.

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

   • Not available. No performance study is mentioned or referenced.

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 available. No performance study requiring expert adjudication or ground truth establishment is described.

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

   • Not available. No performance study or test set requiring adjudication is described.

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 available. This device is an infant positioner, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

   • Not available. This device is an infant positioner, not an algorithm.

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

   • Not available. No performance study requiring ground truth is described.

8. The sample size for the training set

   • Not available. No training set is applicable or described for this type of device.

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

   • Not available. No training set or ground truth establishment is applicable or described.

In summary, the provided 510(k) summary is for a Class I medical device (infant positioner) that was cleared based on substantial equivalence to existing predicate devices, without the need for performance studies against specific acceptance criteria. Therefore, the information you requested about performance studies, data, and ground truth is not part of this 510(k) submission.

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The Head Bed™ infant positioner is indicated for infants aged 0-6 months to aid in the prevention of deformational plagiocephaly.

The Head Bed device is a U-shaped soft polyurethane foam cushion covered in flame retardant cloth material. Outside dimensions are 17.5cm (w) x 18.5cm (1) x 4cm (h). Inside dimensions are 13.5cm (h) x 6.5cm (w). The device is adequately soft so as to provide support for the infants head without being abrasive. The removable cloth cover is flame retardant and machine washable.

The provided text is a 510(k) summary for the "Head Bed™ Infant Sleep Positioner." This document establishes substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include information about the performance claims (e.g., sensitivity, specificity, accuracy) that would be evaluated in such a study.

The document details the device description, intended use, and a comparison to a predicate device ("NightForm™ Infant Sleep Positioner"). It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on substantial equivalence based on design, materials, and intended use, not on specific performance metrics or clinical study results demonstrating efficacy or safety beyond the predicate.
2. Sample size used for the test set and the data provenance: Not applicable as no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
4. Adjudication method for the test set: Not applicable as no performance study is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool; it's a physical infant positioner.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable as no performance study is described.
8. The sample size for the training set: Not applicable as no performance study is described, and this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable as no performance study is described, and this is a physical device, not a machine learning model.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting results from a performance study against specific acceptance criteria. Such a study would typically be required for devices making new performance claims or those classified differently.

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The Wuzhou Syringe, with/without needle for single use only, is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The Wuzhou Syringe, with/without needle, is a standard piston syringe that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The syringe is designed for manual use. It is available in 1, 2, 3, 5, 10, 20, 30, 50, 60 and 100ml volumes, with luer slip, luer lock, centrally or eccentrically tip configurations. Syringe with 50 ml volume is irrigating syringe.

The provided text describes a 510(k) premarket notification for a medical device, the Wuzhou Syringe, with/without needle. This submission demonstrates substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through novel performance data.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of regulatory submission. The information provided focuses on conformance to established standards and comparison to a legally marketed predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of specific acceptance criteria for a novel performance study, the document asserts conformance to various international and national standards. These standards define the "acceptance criteria" for the device's design, materials, and functional properties. The reported device performance is implicitly "conforms to" these standards and is "substantially equivalent" to the predicate device.

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

• Sample Size: Not specified. Performance data, if collected for compliance with the listed standards, would typically involve specific sample sizes as per the respective standard's requirements (e.g., for mechanical, sterility, and biocompatibility testing). However, specific test set sample sizes for a clinical performance study are not provided or required for this type of submission.
• Data Provenance: The document implies that the device "complies with" various standards. This suggests that internal testing or third-party laboratory testing was conducted according to these standards. The manufacturing company is based in Wenzhou, China, so testing likely occurred in China or at accredited international labs. The data would be "prospective" in the sense that it was generated for the purpose of demonstrating compliance.

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

• Not Applicable. This submission is based on conformance to engineering and biological standards, not on expert-adjudicated clinical ground truth for a diagnostic or prognostic performance claim.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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 manual piston syringe, not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable. This device is a manual piston syringe, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is established by the definitions and requirements within the referenced international and national standards (e.g., ISO, GB) and the characteristics of the legally marketed predicate device. For example, the "ground truth" for sterility would be a negative bacterial growth result when tested according to ISO 11135. The "ground truth" for material composition is the actual composition of the materials used in manufacturing.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device.

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

• Not Applicable. See point 8.

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The Robin Hood Vest ™ is intended for use in healthy infants aged 0-15 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, the condition known as deformational (or positional) plagiocephaly.

The Robin Hood Vest ™ is a sleeveless vest, with a pocket on the back for an insertable foam wedge, that an infant wears while sleeping. The device positions a foam wedge under the infant during sleep to direct the head so that it does not always rest on the same spot.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Robin Hood Vest™, which is a pediatric position holder. It declares the device's substantial equivalence to a predicate device based on its intended use and description, but it does not detail any performance studies, acceptance criteria, or specific data about the device's effectiveness or accuracy in preventing skull deformities.

Therefore, I cannot provide the requested table and information about a study based on the given text.

Summary of what cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory submission and substantial equivalence, not performance metrics.
2. Sample size used for the test set and the data provenance: Not present. No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
4. Adjudication method for the test set: Not present. No test set or adjudication is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not relevant or present. This device is a physical pediatric position holder, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant or present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

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