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The GripMate™ autoinjector is intended for use with Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes (a 1 mL BD Hypak Biotech glass syringe, containing a ½'' fixed needle of 29G, and drug product solutions with a viscosity between 1.7 and 2.3 mPas). The GripMate™ autoinjector is a reusable injection device for patients with multiple sclerosis age 18 and older for the subcutaneous injection of Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes.

The GripMate™ is a non-sterile, reusable, spring-loaded injection device. The device consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection. The device does not have any fluid path and does not have any contained within the syringe. The user has the option to adjust the needle extension using the device Needle Hider Feature. Injection occurs upon the activation of a trigger button which drives the syringe in a three-step sequence which includes needle penetration, injection and needle cover. Once the injection is completed the device provides visual indication to confirm that the full drug dose has been delivered.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the GripMate™ autoinjector.

Here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document discusses various functional and mechanical tests. While it lists some quantitative specifications for the "Candidate Device GripMate™", it doesn't explicitly present acceptance criteria alongside the measured performance results in a formal table format. However, we can infer some criteria from the "Comparison" column and the descriptions of the tests.

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

The document broadly states "Design verification and performance testing have been conducted to verify GripMate™ meets design specifications and performs as intended" and lists various functional and mechanical tests. It does not provide specific sample sizes for any of the test sets.

Regarding data provenance:

• Country of origin of data: Not explicitly stated, but the applicant "Synthon Hispania S.L." is in Spain, and the correspondent "Lachman Consultant Services, Inc." is in the United States. Functional and biocompatibility testing was performed by "certified testing laboratories," implying external entities, but their location is not specified.
• Retrospective or prospective: The description of the studies ("Design verification and performance testing have been conducted") suggests these were prospective tests specifically performed to demonstrate the device's performance for this submission.

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

The document describes "Human Factors Testing" which involved a "simulated use Human Factors study." While this implies user interaction and potentially expert evaluation, the number of experts and their specific qualifications are not provided. It's also not clear if "ground truth" in the traditional sense was established by experts for performance metrics (e.g., whether an injection was "successful"), or if it relied on objective measurements.

4. Adjudication method for the test set:

Not applicable or not explicitly stated for the described tests. The performance data seems to be based on direct measurements and observations from functional and mechanical tests rather than subjective human assessment requiring adjudication. For human factors testing, the adjudication method (if any) is not detailed.

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 is not applicable. The GripMate™ is an autoinjector, a physical medical device, not an AI-powered diagnostic or decision support system. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this device.

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

This is not applicable. As mentioned above, this is a physical medical device, not an algorithm. Performance tests were conducted on the device itself.

7. The type of ground truth used:

For the functional and mechanical tests, the "ground truth" would be the objective physical measurements and observations of the device's operation against its design specifications and relevant ISO standards (e.g., measured injection time, force, needle extension, visual/audible indicators working as designed). For biocompatibility, it's conformance to ISO 10993. For human factors, it's the assessment of whether use-related risks are adequately mitigated. There is no mention of pathology or outcomes data as ground truth, as it is a device for drug delivery, not a diagnostic tool.

8. The sample size for the training set:

This is not applicable. The GripMate™ is a physical medical device for drug injection, not an AI/ML model that requires a "training set."

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

This is not applicable, as there is no training set for this device.

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AccuSert Needle Inserter is intended for use at home or hospital environment to assist inserting EMED subcutaneous administration needle sets into the subcutaneous tissue at 90 degrees. Single patient use only.

The EMED AccuSert Needle Inserter is a manually operated, reusable, spring-loaded injection device. This device is used to insert EMED subcutaneous infusion administration sets. The device is contraindicated for use with other sets. The AccuSert Needle Inserter consists of a plastic body containing a stainless-steel spring and a needle carrier component.

The provided text is related to a 510(k) premarket notification for the AccuSert Needle Inserter. However, it does not contain the detailed acceptance criteria and study results typically found in the clinical study section of a 510(k) submission for a device that involved an AI/ML component or complex efficacy claims.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, the Sil-Serter Inserter (K010377). This typically involves comparing technological characteristics, intended use, and performance without necessarily requiring extensive human-in-the-loop or standalone AI performance studies.

Here's a breakdown based on the information provided and what is missing:

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

• Acceptance Criteria Mentioned (Implicitly or Explicitly):

  • Cocking Force: 9-7 lbf (AccuSert) vs. Less than 7 lbf (Predicate). Note: The range for AccuSert (9-7) seems unusual, usually it's a min-max or a single value/range. This could be a typo in the document.
  • Trigger/Release Force: Less than 7 lbf (AccuSert) vs. Less than 7 lbf (Predicate).
  • Insertion Force: 1.0-2.5 lbf (AccuSert) vs. 1.67 lbf (Predicate).
  • Life Cycle: Designed to withstand 550 cycles (AccuSert) vs. 600 cycles (Predicate).
  • Biocompatibility: Meet ISO 10993 standards (Chemical Characterization, Cytotoxicity, Sensitization, Skin Irritation).
  • Usability: Intended users could use the device safely and effectively without user errors or difficulties that could cause harm.
  • Mechanical Integrity/Functionality: Retains mechanical properties and functions, passes visual/functional tests, chemical resistance, and drop test.

• Reported Device Performance:

  • Cocking Force: "9-7 lbf" (AccuSert). The document states "validated as appropriate though Usability Validation that demonstrated that the intended users could use the device safely and effectively without user errors or difficulties that could cause harm."
  • Trigger/Release Force: "Less than 7 lbf" (AccuSert).
  • Insertion Force: "1.0 -2.5 lbf" (AccuSert). The document states "AccuSert was designed with adequate force to insert the intended needle sets with the minimum force and impact to the patient skin as confirmed by conducted performance testing."
  • Life Cycle: "Designed to withstand 550 cycles" (AccuSert). The text states: "The number of simulated uses for the AccuSert Needle Inserter includes data derived from testing of multiple Inserters as well as performance testing to validate expected usable life duration."
  • Biocompatibility: "AccuSert Needle Inserter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation." (Passed all listed tests).
  • Usability: "The conducted Human Factors Validation Testing serve as objective evidence that the instructions for use provide the user with sufficient information to understand how the device is used." It also states for Cocking Force and Trigger/Release Force that "validated as appropriate though Usability Validation that demonstrated that the intended users could use the device safely and effectively without user errors or difficulties that could cause harm."
  • Mechanical Integrity/Functionality: "Results from performance testing indicate that the product meets the established performance requirements." (Implies passing visual/functional, chemical resistance, and drop tests).

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 for Test Set: Not explicitly stated for performance tests (e.g., how many devices were subjected to life cycle testing, drop tests, etc.). For usability/human factors, the sample size is also not specified.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory/engineering tests ("Design Verification," "Biocompatibility," "Usability Evaluation").
• Retrospective or Prospective: These appear to be prospective design verification and validation tests, not historical data analyses.

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 / Not Provided: This question is highly relevant for AI/ML devices where expert interpretations form ground truth. For a mechanical device like a needle inserter, ground truth is established through physical measurements, engineering standards, and usability testing with representative users, rather than expert interpretation of medical images or conditions. The document mentions "Human Factors Validation Testing" and "Usability Validation" with "intended users" but does not specify the number or qualifications of experts establishing ground truth in the way this question implies. Ground truth here relates to meeting pre-defined physical and usability specifications.

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

• Not Applicable / Not Provided: Adjudication is typically used in clinical studies or expert review processes to resolve discrepancies in diagnoses or interpretations for AI/ML ground truth generation. For direct performance testing of a mechanical device, results are typically objective measurements against specified criteria. Usability studies have methods for assessing user errors and difficulties, but "adjudication" in the sense of reconciling conflicting expert opinions is not 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

• No: The document explicitly states: "No clinical study is included in this submission." An MRMC study is a type of clinical study, specifically for diagnostic devices (often AI-assisted). This device is a mechanical inserter, not a diagnostic tool, and its 510(k) submission relied on non-clinical performance and substantial equivalence.

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

• Not Applicable: This is a mechanical device, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant. The device's "standalone" performance is its mechanical performance (cocking force, insertion force, life cycle, etc.), which was tested as described under "Design Verification."

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

• Engineering Specifications and Usability Objectives: For this device, ground truth is defined by:
  • Pre-defined engineering specifications (e.g., target force ranges, number of cycles).
  • Biocompatibility standards (ISO 10993).
  • Human Factors/Usability standards (ANSI/AAMI HE75, IEC 62366-1) which define what constitutes safe and effective user interaction and freedom from critical errors.
  • Physical performance standards (ISO 28620 for drop test).
  • The "truth" is whether the device performs within these acceptable parameters during testing.

8. The sample size for the training set

• Not Applicable: This is a mechanical device, not an AI/ML model that requires training data.

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

• Not Applicable: See point 8.

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The Orbit Inserter is indicated to aid the user with the insertion of the cannula into the subcutaneous tissue for compatible infusion sets listed on the labeling.

The Orbit Inserter is intended to be used to assist patients and their caregivers by providing a mechanism to automate the insertion of compatible Ypsomed Infusion Sets primarily in a home setting.

The Orbit Inserter is a manually operated, spring-loaded insertion aid for automatic insertion of compatible Orbit infusion sets. It assists the user with insertion of the infusion set cannula into the subcutaneous tissue. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The Orbit Inserter is made of plastic and is powered by a stainless-steel spring.

This document is a 510(k) Summary for the Orbit Inserter, a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or algorithms, nor does it present data from diagnostic imaging studies or multi-reader multi-case studies typically associated with AI performance evaluations.

Therefore, many of the requested points in your prompt are not applicable to the content of this document. I will answer the applicable questions and explain why others do not apply based only on the provided text.

Here's a breakdown of the acceptance criteria and study information for the Orbit Inserter based on the provided text:

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

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

The document mentions "after 550 activations" for Life-cycle Testing, which implies a sample size of at least one device tested for 550 activations. It doesn't explicitly state the number of devices or the data provenance (country of origin, retrospective/prospective). However, the company, Ypsomed AG, is based in Switzerland.

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

This is not applicable. The device is a mechanical inserter, not an AI or diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" here is the device's physical performance according to engineering and usability specifications.

4. Adjudication method for the test set

This is not applicable. As it's a mechanical device performance test, there's no need for adjudication by multiple experts in the sense of agreeing on a diagnosis or marking a lesion. The results are objective measurements and observations against pre-defined specifications.

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 is not applicable. This document describes a mechanical medical device, not an AI system. Therefore, no MRMC study, human readers, or AI assistance is relevant to its performance evaluation.

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

This is not applicable. The device is a mechanical inserter; there is no algorithm or AI component to test in a standalone manner.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and ISO standards for mechanical, visual, functional, and biological properties, as well as summative user validation for usability. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a mechanical device. This concept applies to machine learning models.

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

This is not applicable for the same reason as point 8.

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The MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.

The modified MiniMed Quick-serter (MMT-305) is a non-sterile, single patient, multi-use, hand held accessory product designed to be used as an insertion aid for compatible devices, including specific infusion sets. It is used to insert the introducer needle and cannula through the skin and into the subcutaneous tissue. The MiniMed Quick-serter is intended to be used by a patient or clinician as a means to insert an infusion set with minimum discomfort and technique dependency.

The MiniMed Quick-serter consists of a plastic barrel containing a stainless steel spring and a handle. The device user places and securely seats the infusion set into the MiniMed Quick-serter is loaded and locked by pulling the handle (compressing the spring) until it clicks/locks into place. The serter is placed in contact with the insertion site and fired to release the infusion set. This is done by depressing the green side buttons to release the spring, which drives the infusion set forward and the insertion needle and cannula are inserted into the user's subcutaneous tissue. The release button on the top of the device is then pressed to ease the release of the infusion set from the serter.

The provided text describes a 510(k) submission for the "MiniMed Quick-serter" (MMT-305) and compares it to a predicate device (MMT-395). This device is a syringe needle introducer, and the submission is focused on demonstrating substantial equivalence, not necessarily on detailing a study proving the device meets acceptance criteria in the way one would for a novel AI/software medical device.

Therefore, the information I can extract will be specific to the type of device and submission, which involves engineering and biocompatibility testing rather than clinical study protocols for diagnostic accuracy or comparative effectiveness with human readers.

Here's the breakdown based on the provided text:

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

The document lists performance testing that was conducted to verify the device's mechanical properties and functions. The "acceptance criteria" are implied by the statement "Results from performance testing indicate that the product meets the established performance requirements." Specific numerical acceptance criteria are not explicitly detailed for each test in this summary, but the reported device performance for some characteristics is given in the comparison table.

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

The document does not specify the sample size for individual tests. The tests performed are engineering/mechanical verification, biocompatibility, and usability evaluations, not clinical studies with a "test set" in the context of patient data. The data provenance is internal to Medtronic MiniMed, and the tests are prospective, conducted on the device itself.

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 is not applicable to the type of device and testing described. "Ground truth" in this context would refer to established engineering standards, material science properties, and biocompatibility guidelines. The "experts" involved would be engineers, material scientists, and toxicologists conducting and evaluating the tests. No specific number or qualifications are mentioned for this section of the submission. A "Usability Evaluation" was performed, which would involve users, but details on "experts" for ground truth are not provided.

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

This is not applicable. Adjudication methods are typically for clinical trials or diagnostic studies where there might be disagreement in expert opinions on patient data. The tests described are objective engineering and biocompatibility evaluations.

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 is not applicable. The device is a mechanical introducer, not AI software or a diagnostic tool.

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

This is not applicable. The device is a mechanical device with a human user performing the insertion.

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

The "ground truth" for the performance data in this submission aligns with:

• Established engineering standards: For tests like Cocking Force, Trigger Force, Life Cycle testing, Drop Test, etc., the ground truth is based on predefined engineering specifications and internal standards.
• International standards and regulatory guidance: For biocompatibility testing, the ground truth is based on standards such as ISO 10993-1, -5, -10, -18 and FDA #G95-1 guidance.
• Industry standards: For tasks like Ship Test (ASTM D4169) and Cleaning studies (AAMI TIR12, TIR30).

8. The sample size for the training set

This is not applicable. The device is a mechanical product, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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The Whisper JECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a BD 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.

The WhisperJECT™ autoinjector is a reusable, spring-loaded injection device that is for general use with 1.0 ml pre-filled glass syringes. WhisperJECTTM autoinjector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.

The provided text is a 510(k) summary for the WhisperJECT Autoinjector. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not include detailed information regarding specific acceptance criteria, reported device performance against those criteria, or the study specifics that would prove the device meets these criteria. The section "Performance Data 5.8" only states that the device will be assessed using ISO 11608:2012 and that it is intended to meet all requirements and specifications. It explicitly says "WhisperJECT™ auto-injector is intended to meet all requirements and specifications prior to being marketed. As per SHL Pharma's commitment included in section 9.0, WhisperJECT autoinjector device will only be marketed after required testing has been completed and all acceptance criteria met." This means the results of the studies were not included in this 510(k) summary.

Therefore, I cannot provide accurate answers to most of your questions based only on the provided text.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that performance data will be assessed and that the device is intended to meet all requirements, but it does not provide the actual acceptance criteria or the reported performance data.

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

Not available in the provided document. The document mentions that applicable sections and methods specified in ISO 11608:2012 will be used for assessment, but it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable/Not available in the provided document. As this is a medical device (autoinjector) and not an AI/diagnostic software, the concept of "ground truth established by experts" in the way it's typically applied to diagnostic AI models (e.g., radiologists interpreting images) is not directly relevant here. The performance is assessed against engineering and physical standards (ISO 11608:2012).

4. Adjudication Method for the Test Set

Not applicable/Not available in the provided document. See point 3.

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

No. This is a medical device (autoinjector), not a diagnostic AI system with human-in-the-loop performance measurement. Therefore, an MRMC study with human readers assisting AI or without AI assistance is not applicable.

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

Not applicable. As this is a physical medical device (autoinjector), the concept of an "algorithm only" standalone performance is not relevant in the context of AI. The performance assessment mentioned (activation force, needle extension, injection time, completeness of injection, functionality, and robustness) refers to the physical device's characteristics.

7. The Type of Ground Truth Used

Not applicable. As this is a physical medical device, the "ground truth" refers to engineering specifications and performance standards as outlined in ISO 11608:2012 (e.g., calibrated measurements of force, time, distance, successful drug delivery) rather than expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. See point 8.

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The Lobster device is intended for use with a ImL glass syringe, containing a fixed needle of 27G to 29G gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.
For single patient or individual use only.

The Lobster Auto-injector is a reusable, spring-loaded injection device that is for use with 1.0 ml pre-filled glass syringes with staked needle. Lobster Auto-injector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.

The provided text describes the 510(k) summary for the Lobster Auto-injector, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with an AI component.

Therefore, the information required to answer the prompt (acceptance criteria, details of a study proving the device meets them, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, and training set details) is not present in the provided text.

The text does mention performance data in Section 5.8:

"Lobster Auto-injector was assessed using the applicable sections and methods specified in the ISO standard, ISO 11608:2012, "Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems". Activation force, needle extension, injection time, completeness of injection, functionality, and robustness were assessed; Lobster auto-injector met all requirements and specifications."

However, this is a general statement about meeting ISO standard requirements for mechanical performance, not a detailed description of an AI-driven system's study. The ISO standard itself would contain the "acceptance criteria," but those are not explicitly stated here.

In summary, the provided document does not contain the information requested to describe the acceptance criteria and the study that proves an AI-driven device meets them. The Lobster Auto-injector is a mechanical auto-injector, not an AI or imaging device.

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The Autoject® II for glass syringe is a non-sterile fully automatic injection device. The device is intended for the self-administration of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked needle phobia. It has been developed to provide a safe and simple procedure to the patient.

The 'Autoject® II for glass syringe' is composed of simple plastic injection moulded parts and stainless steel springs. The device is a non-sterile, handheld mechanical device intended for self-administered, subcutaneous delivery of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked needle phobia. It has been developed to provide a safe and simple procedure to the patient.

Here's a breakdown of the acceptance criteria and study information for the Autoject® II for glass syringe, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The submission device generally meets or improves upon the performance of the predicate device. The only significant difference highlighted is the reduced maximum stress exerted on the syringe, which is an improvement.

Study Information

1. Sample size used for the test set and the data provenance:
   • The document does not specify the exact sample size for each individual test (e.g., number of devices tested for force, length, etc.).
   • The data provenance is from non-clinical performance data conducted by Owen Mumford Ltd in the United Kingdom. It is a retrospective comparison against an existing predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • This information is not provided in the document. The tests seem to be objective engineering and performance verification tests rather than human-expert-based evaluations for ground truth.
3. Adjudication method for the test set:
   • This information is not applicable/provided as the tests are objective performance measurements, not based on expert adjudication.
4. 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:
   • No, an MRMC comparative effectiveness study was not done. The device is a mechanical injection device, not an AI-powered diagnostic or assistive tool for human readers.
   • The document explicitly states: "Clinical performance data has not been submitted, and is therefore not included in this Special 510(k) document."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • This question is not applicable as the device is a mechanical auto-injector, not an algorithm or AI system.
6. The type of ground truth used:
   • The "ground truth" for the performance comparisons comes from engineering specifications, physical measurements, and Finite Elemental Analysis (FEA) for the mechanical properties and operation of the device, directly compared to the predicate device's established performance.
7. The sample size for the training set:
   • This question is not applicable as the device is a mechanical auto-injector, not a machine learning model that requires a training set.
8. How the ground truth for the training set was established:
   • This question is not applicable as the device is mechanical and does not use a training set.

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The Flexi-Q DV Auto-injector is indicated for the transfer and automated subcutaneous injection of FDA approved drugs and biologics in compatible vials.

The Flexi-Q DV Auto-injector is intended for use in the home environment by the patient or care-giver after training by a Health Care Professional.

The Flexi-Q DV Auto-injector (also called: FUDAI DV)) is designed to allow people with or without minor dexterity problems (or with a help of a care giver) to aspirate a drug in solution form from a standard 13mm vial and automatically inject themselves subcutaneously with the drug.

The device is comprised of the following parts;

• -Housing: The outer shell/covering of the device. The Housing which encloses and protects the inner components including the syringe, is designed to be used while held with one hand and provides the user with visibility of the solution/ drug before, during and after injection via a window.
• -Syringe: A standard 1mL long glass syringe is assembled within the Housing. The syringe includes a staked 1/2 27G needle and an elastomeric syringe piston. The syringe is marked with a single graduation line indicating the dose volume to be aspirated and delivered (any dosage between 0.3 to 1.0mL is possible; e.g., 0.3 or 0.4 or 0.5 or 0.6 etc. up to 1.0mL). i.e., different Flexi-Q Auto-injector versions will be available, each for a single dosage volume, and according to physician prescription, the patient will use the Flexi-Q Auto-injector version specifically marked for his/her prescribed dose volume. The "single dose - single device" Flexi-Q auto-injectors are illustrated in page 11-13, Figure I. The syringe needle is used to penetrate the Vial Adaptor septum (for solution/reconstituted drug aspiration) and then to administer the subcutaneous injection to the patient.
• -Needle Shield: The needle shield covers the needle before injection. When depressed against the skin, the shield "unlocks" the Trigger Button to allow activation and injection. After the injection is completed, the shield locks in place, keeping the needle from being accessible and helping protect the user from accidental needle stick injury.
• Plunger Rod: A rigid rod that is connected to the syringe piston and protrudes out of the Auto-injector's Housing. The Plunger Rod is used to aspirate the solution/reconstituted drug into the syringe and adjust the volume to be injected to the predefined dosage.
• Trigger Button (Red INJECT Button): This button enables the user to activate the injection process after is has been unlocked by the user pressing the shield against the skin at the injection site. Once pressed the device advances the injection needle into the subcutaneous tissue followed by injection of the drug.
• One Vial Adaptor (Gray Connector): The Sterile, Single use Vial Adaptor . functions as a connector between the Auto-injector and the drug vial and provides a fluid path to enable aspiration of the drug. The syringe needle penetrates a septum (assembled inside the Vial Adaptor) made of thermoplastic elastomer while a plastic spike (part of the Vial Adaptor) penetrates the vial stopper. While attached to the Auto-injector, the Vial Adaptor conceals the Needle Shield and thus preventing inadvertent activation.

In certain cases when additional vial may be used (per drug prescription), additional sterile vial adaptor(s), may be used.

The provided 510(k) summary for the Flexi-Q DV Auto-injector (K111467) does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria, especially in the context of an AI-powered device or a direct clinical effectiveness study with human readers.

Based on the document, the device is a mechanical auto-injector, not an AI-powered medical device. Therefore, many of the questions related to AI performance, ground truth establishment for AI models, and multi-reader multi-case studies are not applicable.

The document primarily focuses on establishing substantial equivalence to predicate devices (Mixject Dispensing Pin and Autoject 2) based on intended use and principle of operation. It does not describe specific performance studies with quantitative acceptance criteria for the Flexi-Q DV Auto-injector itself beyond stating that the "evaluation of the Flexi-Q DV Auto-injector does not raise any additional concerns regarding safety and effectiveness."

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document for the Flexi-Q DV Auto-injector. The document establishes substantial equivalence by comparing its intended use and principle of operation to predicate devices, implying that if it functions similarly, it meets acceptable performance. Quantitative performance metrics or specific acceptance criteria are not detailed in this summary.

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

Not explicitly stated. The document does not describe a specific "test set" in the context of clinical or performance validation data for the device. The evaluation mentioned is likely a part of the regulatory submission process, which may involve bench testing and engineering analysis rather than a human-user test set as typically understood for AI or diagnostic devices.

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

Not applicable. This question is typically relevant for studies involving the interpretation of data (e.g., medical images) where expert consensus is needed to define the "ground truth" against which an algorithm is evaluated. The Flexi-Q DV Auto-injector is a mechanical device, and its performance would be assessed through engineering tests and usability evaluations, not by establishing a ground truth in the same manner.

4. Adjudication Method for the Test Set

Not applicable. As the document doesn't describe a test set or ground truth establishment relevant to data interpretation, an adjudication method is not described.

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

No, an MRMC comparative effectiveness study was not done or described. This type of study is typically performed for diagnostic devices (especially those involving image interpretation) to evaluate the impact of an AI system on human reader performance. The Flexi-Q DV Auto-injector is a mechanical auto-injector, not a diagnostic AI system.

• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.

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

Not applicable. The Flexi-Q DV Auto-injector is a mechanical device, not an algorithm. There is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

Not applicable in the context of AI or diagnostic interpretation. For a mechanical device like an auto-injector, "ground truth" might refer to engineering specifications, physical measurements (e.g., injection volume accuracy, injection force, needle penetration depth), or successful drug delivery as per design. These specific performance metrics or their "ground truth" type are not detailed in the summary.

8. The Sample Size for the Training Set

Not applicable. The device is a mechanical auto-injector and does not rely on a "training set" in the machine learning sense. Its design and manufacturing are based on engineering principles and quality systems, not data-driven model training.

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

Not applicable. As there is no training set for an AI model, there is no corresponding ground truth for it.

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The Auto Safety Injector 2 (ASI-2) is indicated for assisting the self-administered subcutaneous injection of fixed doses of FDA-approved drug products with non-viscous (aqueous) liquid formulations, which are presented in standard 1 ml long BD Hypak® pre-filled syringes with staked needles.
The ASI-2 is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.

The ASI-2 is a single-use, automatic, disposable and hidden-needle auto-injector for the self-administration of liquid drug products.

The provided text describes the 510(k) summary for the "Auto Safety Injector-2 (ASI-2)". It does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established.

Instead, the document focuses on:

• Device Identification: Trade name, common name, classification name, predicate device.
• Device Description: Single-use, automatic, disposable, hidden-needle auto-injector for self-administration of liquid drug products.
• Intended Use/Indications For Use: Assisting self-administered subcutaneous injection of fixed doses of FDA-approved, non-viscous liquid drug products in standard 1 ml long BD Hypak® pre-filled syringes with staked needles. Primarily for home use by patients, or by HCPs/caregivers.
• Technological Characteristics: Similar to the predicate device, with the key difference being that ASI-2 is not specifically intended for viscous liquid formulations.
• Performance Tests: States that "Extensive design verification, functional and performance testing have been conducted" and that these demonstrate the device is "safe and effective for the intended use and is substantially equivalent to the legally marketed predicate device." However, no specific details about the acceptance criteria or results of these tests are provided in this summary.
• FDA Clearance: The document includes the FDA's 510(k) clearance letter (K082587).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only states that such testing was done and that the device was found substantially equivalent, without giving the specifics of those tests.

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The Compact Auto Safety Injector (CASI) is indicated for assisting the selfadministered subcutaneous injection of fixed doses of FDA approved drug products with viscous liquid formulations, which are presented in standard 1ml long BD Hypak® pre-filled syringes with staked needles. The CASI is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.

The CASI is a single-use, automatic, disposable and hidden-needle auto-injector for the self-administration of liquid drug products.

The provided document is a 510(k) summary for the Compact Auto-Safety Injector (CASI) and a subsequent FDA clearance letter. It outlines the device's description, intended use, and comparison to a predicate device, as well as a general statement about performance testing.

However, the document does not contain specific details regarding acceptance criteria, reported device performance tables, sample sizes for test or training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, or specific results of MRMC or standalone studies.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device, a common pathway for medical device clearance in the US.

Here's a breakdown of the information that can be extracted and what is missing:

1. Acceptance Criteria and Reported Device Performance

Missing. The document states that "Extensive design verification, functional and performance testing have been conducted" and that "The information provided in this premarket notification demonstrates that the CASI device is safe and effective for the intended use and is substantially equivalent to the legally marketed predicate device." However, it does not provide a table specifying acceptance criteria or the numerical performance metrics achieved by the CASI device against those criteria.

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

Missing. The document mentions "extensive design verification, functional and performance testing" but does not provide details on the sample size of the test sets used for these evaluations. It also does not specify data provenance (e.g., country of origin, retrospective/prospective).

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

Missing. This information is not present in the provided 510(k) summary. The testing described appears to be primarily engineering-focused (design verification, functional, and performance testing) rather than clinical studies requiring expert ground truth establishment in a diagnostic context.

4. Adjudication method for the test set

Missing. As the document doesn't detail the types of tests that would require adjudication (e.g., image interpretation), this information is not provided.

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

Missing. The CASI is an auto-injector device, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

Missing. Again, this is an auto-injector, not an algorithm. The "performance tests" would refer to mechanical and functional aspects of the device itself, not an algorithm's standalone performance.

7. The type of ground truth used

Missing. Given the nature of the device (an auto-injector), "ground truth" would likely relate to objective measurements of its mechanical function (e.g., dose delivery accuracy, needle retraction success, injection force, usability). The document does not specify what objective standards or methods were used to determine the "truth" for these functional tests.

8. The sample size for the training set

Missing. As this device is not a machine learning or AI-based product, there would be no "training set" in the computational sense. The "design verification" and "performance testing" are typically conducted on prototypes or production units of the device.

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

Missing. As there is no "training set" in the AI sense, this information is not applicable and therefore not provided.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence of a medical device (an auto-injector) to a predicate device. It confirms that performance tests were conducted to ensure safety and effectiveness but does not delve into the detailed methodological aspects of those tests that would be relevant for an AI/ML-based device evaluation (e.g., specific acceptance criteria tables, sample sizes, expert involvement, or AI-specific study types).

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