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The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user.

The SmartPilot YpsoMate NS-A2.25 is an optional, battery operated, reusable device designed to be used together with a compatible autoinjector (a single use, needle based, pre-filled injection device for delivery of a drug or biologic into subcutaneous tissue). Figure 1 shows the SmartPilot YpsoMate NS-A2.25 with the paired autoinjector. The SmartPilot YpsoMate NS-A2.25 records device data, injection data and injection process status. The SmartPilot YpsoMate NS-A2.25 also provides guidance feedback to the user during the injection.

Note that the SmartPilot YpsoMate NS-A2.25 does not interfere with autoinjector function.

The provided 510(k) clearance letter details the substantial equivalence of the SmartPilot YpsoMate NS-A2.25 device to its predicate. While it lists various performance tests and standards met, it does not contain specific acceptance criteria values or detailed study results for metrics like sensitivity, specificity, or improvement in human reader performance. This document primarily focuses on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the predicate, due to similar technological characteristics and adherence to relevant safety standards.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC studies), and ground truth establishment (especially for AI-driven performance) cannot be extracted directly from this regulatory document. The information primarily pertains to hardware, software, and usability testing.

However, based on the provided text, here's what can be inferred or stated about the device's acceptance criteria and proven performance:

Device: SmartPilot YpsoMate NS-A2.25

Indication for Use: The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user. Specifically compatible with Novartis/Sandoz Secukinumab (Cosentyx).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with quantitative acceptance criteria and reported performance values for metrics typically associated with AI/software performance (e.g., sensitivity, specificity, accuracy of data capture in a clinical context). Instead, it focuses on meeting established engineering, safety, and quality standards.

Here's a summary of the types of performance criteria implied by the successful completion of the listed tests:

Note: The device's primary function is to "capture and record injection information that provides feedback to the user," and it "does not capture dosing information" or "electronically controlled dosing." Therefore, criteria related to dosing volume accuracy or AI interpretation of medical images/signals for diagnosis are not applicable to this device. The focus is on the accurate capture of event data (injection start/end, result) and providing timely feedback, as well as general device safety and functionality.

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

The document describes various types of tests (e.g., Biocompatibility, EMC, Software V&V, Mechanical, Lifetime, Human Factors), but does not specify the sample sizes used for each test dataset.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that Ypsomed AG is based in Switzerland and the testing references international and US standards, the testing likely involved a mix of internal validation, third-party lab testing, and possibly user studies in relevant regions. All tests described are part of preclinical (non-clinical) performance validation, making them inherently prospective for the purpose of demonstrating device function and safety prior to marketing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts in the context of establishing ground truth for the device's functional performance, as it is not an AI-driven diagnostic or interpretative device that relies on human expert consensus for its output. Its performance is evaluated against engineering specifications and physical/software functional requirements. The "Human Factors" testing would involve users, but not necessarily "experts" adjudicating correctness in the sense of accuracy for a diagnostic task.

4. Adjudication Method for the Test Set

Not applicable. The device's performance is determined by meeting pre-defined engineering and regulatory standards and testing protocols, not by expert adjudication of its output, as it does not produce subjective or interpretative results like an AI diagnostic algorithm.

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

Not performed/applicable. An MRMC study is relevant for AI systems that assist human readers in tasks like image interpretation to demonstrate improved diagnostic accuracy. This device is an "Injection Data Capture Device" providing feedback and recording information; it does not involve human readers interpreting data that the device enhances.

6. Standalone (Algorithm Only) Performance

While the device has software and algorithms to detect injection events and provide feedback, the document does not report "standalone" performance metrics in the way an AI diagnostic algorithm would (e.g., sensitivity, specificity). Its performance is demonstrated through the verification and validation of its hardware and software components (e.g., ability to detect spring position, successful data transfer, correct LED/audible feedback). The "Influence Testing" evaluates its performance in conjunction with the autoinjector, proving it does not negatively interfere.

7. Type of Ground Truth Used

The ground truth for the verification and validation of this device is engineering specifications, physical measurements, and adherence to established regulatory and industry standards. For example:

• Biocompatibility: Measured against established thresholds for cytotoxicity, sensitization, and irritation.
• EMC/Safety: Compliance with current versions of IEC standards.
• Software V&V: Compliance with software lifecycle processes and cybersecurity standards, and correct execution of defined functions (e.g., data recording, feedback activation).
• Mechanical/Lifetime: Physical measurements (e.g., activation force, dimension checks), cycle counts, and functional checks after simulated use/aging.
• Human Factors: User performance and subjective feedback against usability goals.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of its direct function (data capture and feedback).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense (i.e., for learning to perform a complex, data-driven task like image recognition or diagnosis). Its functionality is based on programmed logic and sensor readings, not statistical learning from a large dataset.

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

Not applicable, as there is no "training set" for the type of device described. Input signals (e.g., from the inductive sensor about spring position) are processed based on predefined engineering parameters and logical rules to determine injection status, not learned from a dataset.

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Monoject Syringes with Luer tip are intended for single use by health care professionals for general purpose fluid aspiration and and/or injection.

Not Found

The provided FDA 510(k) clearance letter pertains to Monoject™ Syringes, which are physical medical devices (piston syringes) and not an AI/ML software device. Therefore, the concepts of acceptance criteria for algorithm performance, study methodology for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this document.

The letter indicates that the device has received substantial equivalence to legally marketed predicate devices, meaning it meets the safety and effectiveness requirements for its intended use, which is general purpose fluid aspiration and/or injection by healthcare professionals.

To answer your request, if this were an AI/ML device, the information would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which is present in the provided FDA clearance letter. The letter itself is a notice of clearance, not a detailed technical report of the studies performed.

Therefore, I cannot extract the requested information from the provided document as it does not contain details about an AI/ML study or its performance criteria.

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The TSK Syringe is a low dead volume syringe intended for use in patients that need injection and withdrawal of substances for examination, treatment, diagnosis or prevention.

The TSK Syringe is a syringe intended for use with a needle to inject or withdraw substances, for general use. The TSK Syringe leaves a low volume of fluid when the plunger is fully depressed.

There are two model numbers for the TSK Syringe. The technological differences are as follows:

The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TSK Syringe. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/human reader study.

This document describes a physical medical device (syringe), not a software or AI-powered medical device that would involve AI performance metrics, human reader studies, ground truth establishment, or training/test set sample sizes in the way you've outlined.

Therefore, I cannot provide the requested information from this document. The details about acceptance criteria and study design for AI-based performance evaluation are not present.

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The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The BD Plastipak™ Syringe is a three-piece, single use, sterile, hypodermic syringe with a 6% (Luer) male connector in 20 mL and 50 mL eccentric luer slip tip configurations. The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The BD Plastipak™ Syringe is provided sterile by Ethylene Oxide Gas (ETO) sterilization method.

The provided text is a 510(k) Clearance Letter for a medical device (BD Plastipak™ Syringe). It details the device's characteristics, intended use, and comparison to a predicate device. However, it does not describe an AI/ML-driven medical device or a study involving human readers or expert consensus for ground truth establishment.

The document discusses bench performance testing and biocompatibility tests for a physical device (syringe), not a software or AI-based diagnostic tool. Therefore, many of the requested criteria (like sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to this specific submission.

Despite the irrelevance of some questions to the provided document, I will structure the answer based on the questions asked, indicating "Not Applicable" or providing the information that is present in the document.

Here's an analysis of the provided 510(k) clearance letter in the context of the requested information about acceptance criteria and study data:

This 510(k) clearance letter pertains to a physical medical device, the BD Plastipak™ Syringe, not an AI/ML-driven diagnostic or image analysis tool. As such, many of the typical acceptance criteria and study methodologies applicable to AI models (e.g., ground truth established by experts, MRMC studies, training/test set sizes for algorithms, human reader improvement with AI assistance) are not relevant or described in this document.

The "study" referenced in the document primarily consists of non-clinical performance and biocompatibility testing to demonstrate the substantial equivalence of the new syringe (with a changed barrel resin) to a previously cleared predicate syringe.

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The subject device met all the predetermined acceptance criteria for the above listed performance and biocompatibility tests." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical performance results for each test. It only lists the tests performed and the standards they adhere to.

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

• Sample Size for Test Set: Not specified in the provided document. The tests are "bench performance testing" on various syringe units.
• Data Provenance: Not specified, but generally, bench testing for physical devices is conducted in a controlled lab environment by the manufacturer. It is non-clinical.
• Retrospective or Prospective: Not applicable for this type of physical device testing.

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

• Not Applicable. Ground truth for this physical device testing is established through standardized laboratory test methods and measurements against international or internal specifications, not by human experts interpreting clinical data.

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

• No. This is not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

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

• No. This is not an AI/ML device. Therefore, no standalone algorithm performance was assessed. The performance tests are for the physical syringe itself.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on measurements against established engineering specifications and international standards (e.g., ISO, ASTM, USP) for physical and material properties (e.g., force, leakage, volume accuracy, biocompatibility reactions). It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of the reported non-clinical bench testing for a physical syringe.

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

• Not Applicable. (See point 8)

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The ProfojectTM Disposable Syringe and the ProfojectTM Disposable Syringe with Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The ProfojectTM Disposable Syringe is available in a sterile state. It is a single-use device comprising a polypropylene barrel with a Luer slip or Luer lock nozzle, a polypropylene plunger, and a polyisoprene rubber plunger stopper. Syringes are available in various volume specifications, ranging from 1mL to 60mL. The syringe barrel is printed with a legible graduated scale in milliliters. The syringe is compatible with U.S. legally marketed devices featuring Luer slip or Luer lock connectors that comply with ISO 80369-7. The syringe is intended for manual use only. The plunger of the syringe is pulled back to aspirate fluids or depressed to inject or expel fluids.

The ProfojectTM Disposable Syringe with Needle is supplied in a sterile state. It is a single-use device comprising a Luer slip or Luer lock syringe and a hypodermic needle. The hypodermic needle consists of a stainless steel needle tube, a polypropylene needle hub, and a polypropylene needle cap. The hypodermic needle is available in variety of combinations of needle gauge (18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G) and needle length (15mm, 20mm, 25mm, 30mm, 38mm). Needle hubs are color-coded to identify the gauge of the needle tube. The Disposable Syringe with Needle is available in various combinations of syringe volume and needle size. It is intended for manual use only. The plunger of the syringe is pulled back to aspirate fluids or depressed to inject or expel fluids.

The provided FDA 510(k) clearance letter and summary for the Profoject™ Disposable Syringe and Profoject™ Disposable Syringe with Needle focuses on establishing substantial equivalence to a predicate device (K211211) through non-clinical testing. It does not describe a study involving an AI component, human readers, or a ground truth established in the way typical for AI/ML medical devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this is a traditional medical device submission without an AI/ML component.

Instead, the submission relies on a comparison of technological characteristics and performance testing against recognized international standards for syringes and needles to demonstrate substantial equivalence.

Here's a summary based on the provided document, addressing the relevant points and noting where information is not applicable due to the nature of the device:

Acceptance Criteria and Study Details for Profoject™ Disposable Syringe

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with a comprehensive set of international standards rather than specific performance metrics directly stated in a table for each criterion. The "reported device performance" is indicated by the statement that the tests met the requirements of these standards.

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

The document does not specify exact sample sizes for each test. It states that "the following tests have been performed" and that "the testing results demonstrate that the proposed device complies with the applicable standards requirements." For biocompatibility, performance, sterilization, package, and shelf-life testing, samples of the device were used as required by the specific standards.

• Sample Size: Not explicitly stated as a single number for a "test set." Samples were drawn and tested according to the requirements of each individual standard (e.g., ISO, ASTM, USP).
• Data Provenance: The tests were conducted by the manufacturer (CMT Health Pte. Ltd., based in Singapore) or their designated testing facilities to demonstrate compliance with international standards. This is prospective testing performed on manufactured devices.

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

N/A. This device is a traditional medical device (syringes) and not an AI/ML device requiring expert-established ground truth for a diagnostic test. The "ground truth" here is compliance with established engineering and biological safety standards.

4. Adjudication Method for the Test Set

N/A. Not applicable to engineering performance and biocompatibility testing of a physical device. Test results are compared directly against the quantitative or qualitative pass/fail criteria defined within the referenced international standards.

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

N/A. This is a traditional medical device (syringe), not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies are not relevant.

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

N/A. This device does not involve an AI algorithm. Its performance is evaluated through bench testing against established standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is defined by the objective, measurable requirements and pass/fail criteria specified within the referenced international and national standards (ISO, ASTM, USP) for its physical, chemical, and biological properties. This includes:

• Engineering specifications (e.g., dimensions, force required for operation, leak integrity).
• Material safety (biocompatibility, leachable substances).
• Sterility assurance.
• Packaging integrity.
• Shelf-life stability.

8. The Sample Size for the Training Set

N/A. This is a traditional medical device and does not involve machine learning algorithms requiring a training set.

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

N/A. No training set is applicable for this device.

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The 3DOSE 1ml Syringe is intended for use by health care professionals for general purpose fluid aspiration/ injection.

The 3DOSE 1ml Syringe is a sterile, single-use, disposable and non-reusable manual syringe which is intended for injection of fluids into the body. The syringe can be used for pulling up any mixture, and after operating the locking handle for accurate dosing according to the ml/unit scale on the plunger.

The 3DOSE 1ml Syringe is used like a classic syringe, but includes a feature that provides tactile and audible feedback to the user during dosing.

Models: 3DOSE 1ml Syringe (125 GREEN)
3DOSE 1ml Syringe (100 ORANGE)

The provided FDA 510(k) clearance letter for the 3DOSE 1ml Syringe does not detail any study involving human readers, AI, or diagnostic performance metrics typically associated with AI/ML-based medical devices. This clearance is for a piston syringe, a physical medical device, not an AI/ML software as a medical device (SaMD).

Therefore, I cannot provide information for the following points as they are not applicable to this device and its clearance documentation:

• A table of acceptance criteria and the reported device performance (in terms of diagnostic metrics like sensitivity, specificity, AUC)
• Sample sizes used for the test set and data provenance (for diagnostic performance of an algorithm)
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

However, I can extract information related to the device's technical specifications, performance standards, and the non-clinical testing performed to establish its safety and effectiveness relative to a predicate device.

Here's the summary of acceptance criteria and the study that proves the device meets them, based on the provided document, specifically for a physical medical device (syringe):

1. Acceptance Criteria and Reported Device Performance (Non-Diagnostic)

For a physical device like a syringe, acceptance criteria relate to its physical properties, functionality, and compliance with recognized standards. The "performance" reported is its compliance with these standards, indicating mechanical functionality, material safety, and sterility.

• ISO 80369-7:2016: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• ISO 80369-20:2015: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods | - Complies with ISO 7886-1:2017
• Complies with ISO 80369-7:2016
• Complies with ISO 80369-20:2015
  (Demonstrated through "Functional Performance Testing") |
  | Sterility | - ISO 11135: Sterilization of health-care products - Ethylene oxide
• ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
• ISO 10993-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | - Device is sterile, single-use, disposable.
• Sterilized using Ethylene Oxide.
• Validated shelf-life of 5 years.
  (Demonstrated through "Sterility" testing per listed ISO standards) |
  | Biocompatibility | - ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process (including Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility)
• ISO 10993-4: Tests for interactions with blood
• ISO 10993-5: Tests for in vitro cytotoxicity
• ISO 10993-10: Tests for irritation and skin sensitization
• ISO 10993-11: Tests for systemic toxicity
• USP Particulate Matter In Injections | - Biocompatibility evaluation conducted in accordance with ISO 10993-1 and FDA recognized standards.
• Syringe of testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility.
• All a-forementioned tests passed, demonstrating the device is biocompatible. (Demonstrated through "Biocompatibility Testing") |
  | Chemical Properties | - ISO 7886-1 (Section for chemical properties: Limits for acidity or alkalinity, Limits for extractable metals) | - Chemical performances inspection based on ISO 7886-1.
• Results conform to ISO 7886-1 for limits for acidity or alkalinity and extractable metals. (Demonstrated through "Chemical properties" testing) |
  | Material/Design Integrity | - Functionality of the "audible/tactile feature" (ratcheting dose mechanism)
• No negative effect on overall device performance due to new features (locking arm, plastic part, audible/tactile feedback) | - In-process quality control tests performed to confirm the audio notification mechanism works correctly and does not have a negative effect on overall performance.
• Performance testing conducted for the ratcheting lock mechanism (locking arm, plastic part) to ensure it does not raise new questions of safety or effectiveness. (Demonstrated through implicit in-house testing/QC) |

2. Sample Sizes used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical test (e.g., how many syringes were tested for extractable metals or sterility). It generally states "The collective results of the nonclinical testing demonstrate..." This implies a sufficient number of samples were tested to meet the statistical requirements of the respective ISO standards.

• Data Provenance: The tests would have been performed in a laboratory setting, likely in Turkey (Bimed Teknik Aletler Sanayi & Ticaret A.S. is based in Istanbul, Turkey) or by accredited labs contracted by them. These are prospective tests performed specifically for this 510(k) submission.

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

This concept is not applicable here as there is no "ground truth" in the clinical diagnostic sense. The "truth" for device functionality, sterility, and biocompatibility is established by compliance with internationally recognized consensus standards (ISO, USP) and physical/chemical measurements by qualified laboratory personnel.

4. Adjudication method for the test set

Not applicable. This is not a study assessing human or AI diagnostic performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating observer performance, typically in medical imaging or diagnostics, and is not relevant to a physical medical device like a syringe.

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

No. This device is not an algorithm or software. It is a manually operated piston syringe.

7. The type of ground truth used

For this device, the "ground truth" is defined by the specifications and limits set by the referenced international standards (e.g., ISO 7886-1, ISO 10993 series). For example:

• Dimensional accuracy of volume: defined by ISO 7886-1 tolerances.
• Sterility: defined by ISO 11135 and ISO 11607 series (e.g., SAL of 10^-6).
• Biocompatibility: Defined by the absence of adverse biological reactions as per ISO 10993 series tests.
• Chemical properties: Defined by limits for acidity/alkalinity and extractable metals in ISO 7886-1.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires training data.

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

Not applicable.

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GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

GPS Advanced is a sterile, single use dispenser for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The dispenser has a ratcheted plunger that advances with each squeeze of its handle. The 5 cc GPS Advanced Cannula ("GPS Advanced Cannula") is available individually packaged and can be attached to the dispenser.

GPS Advanced is provided sterile via irradiation and GPS Advanced Cannula is provided sterile via ethylene oxide.

The GPS Advanced Cannula is provided empty and needs to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

Based on the provided FDA 510(k) clearance letter for "GPS Advanced and GPS Advanced Cannula," it's important to understand that this device is a piston syringe used for delivering a bone graft substitute. As such, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are focused on the mechanical and functional performance of the syringe as a medical device, rather than the performance of an AI/ML algorithm or diagnostic tool.

Therefore, many of the typical questions asked about AI/ML device studies (like MRMC studies, standalone algorithm performance, AI training/test sets, ground truth establishment for AI) are not applicable to this type of device.

Here's a breakdown of the acceptance criteria and performance data as inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Inferences:

• The document explicitly states that "The performance data for the subject devices consists of the following evaluations: Biological Risk Assessment, Sterilization Validation, Packaging and Shelf-Life Testing, including functional evaluation." These evaluations implicitly define the acceptance criteria for those aspects.
• The statement about "consistent with those of the primary predicate and reference device" implies that the new device must perform comparably to previously cleared devices in terms of its core technological characteristics and function.

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

This information is not explicitly detailed in the provided 510(k) summary. For a mechanical device like a syringe, "sample size" typically refers to the number of units tested for various validations (e.g., how many syringes were subjected to sterilization, packaging, or functional tests). The document does not specify these numbers.

• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to test results from various engineering and biological validations of the device itself.

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

This concept is not applicable to this device. "Ground truth" in this context is established through engineering specifications, validated test methods (e.g., sterility testing, material biocompatibility standards), and direct functional testing, not by expert consensus on clinical images or interpretations.

4. Adjudication Method for the Test Set

This concept is not applicable to this device, as there's no "interpretation" or "diagnosis" being made that requires human adjudication. Device performance is determined by objective measurements and validation against established 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The GPS Advanced and GPS Advanced Cannula is a delivery device, not an AI diagnostic tool.

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

No, a standalone algorithm performance study was not done. This concept applies to AI/ML algorithms that perform a task independently (e.g., detecting a lesion on an image). The GPS Advanced and GPS Advanced Cannula is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective scientific and engineering standards and tests:

• Sterility Validation: Demonstration that the device meets established sterility assurance levels (e.g., SAL of 10^-6).
• Biocompatibility Standards: Compliance with ISO 10993 series for medical device biocompatibility.
• Functional Specifications: Ability to successfully deliver the specified volume of material, maintain pressure, resist leakage, and operate smoothly.
• Packaging Integrity Standards: Ability of the packaging to maintain sterility and physical integrity under specified conditions.
• Shelf-Life Parameters: Demonstration that the device retains its functional and sterile properties over its specified shelf-life.

8. The Sample Size for the Training Set

This concept is not applicable for this device. "Training set" refers to data used to train AI/ML algorithms. The GPS Advanced and GPS Advanced Cannula is a mechanical device, not an AI/ML system.

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

This concept is not applicable for this device, as there is no "training set" in the AI/ML sense.

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The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors.

The Novo Nordisk PDS290 Injection pens compatible for growth disorder treatment are:

• Sogroya (somapacitan-beco)
• Norditropin FlexPro

The MallyaG Injection Pen Adapter is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the MallyaG device, is also provided in the package. The information is captured through the rotation of the dosing button of the pen into a value indicating the dose increment injected.

The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors. The manufacturer, Biocorp Production, claims that the device is 99% accurate in matching recorded doses with dialed doses, with a margin of error of +/- 1 increment. This claim is supported by performance data from bench testing guided by ISO 11608-1.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance testing (bench testing). It also does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The performance testing appears to be bench-based, guided by a standard (ISO 11608-1), which typically relies on calibrated equipment and defined procedures rather than expert human assessment for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of bench testing for dose accuracy against a standard, an adjudication method for human interpretation would likely not be relevant.

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

No, an MRMC comparative effectiveness study was not done. The MallyaG Injection Pen Adapter is a device for capturing and transmitting dose information, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

Yes, a standalone performance assessment was done in the form of "Bench testing on performance, using ISO 11608-1 as a guide." This type of testing evaluates the device's ability to accurately capture and transmit dose information independently of human interaction beyond the initial setup and use.

7. The Type of Ground Truth Used

The ground truth for the performance testing (dose accuracy) was implicitly established by the dailing of specific increments on the injection pens and then comparing the device's recorded dose against that known dialed dose. This is a form of measurement against a known input/standard as guided by ISO 11608-1.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device performance. This device is an adapter for capturing data, not a machine learning or AI model that typically requires a training set. The performance testing focuses on verifying the device's accuracy in capturing physical actions.

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

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

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The Altaviz Intravitreal Syringe is intended for use by heath care professionals for general purpose fluid aspiration/injection. It is indicated for general and intravitreal use in adult patients.

The Altaviz Intravitreal Syringe is a three-piece sterile, single use, hypodermic syringe with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assembly consists of a lubricated polycarbonate barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the Altaviz Intravitreal Syringe incorporates a scale graduated in units of milliliters and is provided sterile by an irradiation sterilization method. The only difference between the Altaviz Intravitreal Syringe and the BD 1mL Luer-Lok Syringe is that the Altaviz Intravitreal Syringe is routinely tested to, and must meet, additional requirements to support intraocular use including endotoxin and particulate matter. The Altaviz Intravitreal Syringe is provided sterile by irradiation sterilization.

The provided FDA 510(k) clearance letter and summary for the Altaviz Intravitreal Syringe does not describe acceptance criteria, a study that proves the device meets specific acceptance criteria, or any information related to AI or ground truth as requested in the prompt.

The document states that "performance testing was also conducted and results confirmed that the Altaviz Intravitreal Syringe complies with the requirements of ISO 80369-7 (...) and ISO 7886-1 (...)". These ISO standards contain technical specifications and test methods for the performance of syringes. However, the document does not provide the specific acceptance criteria (e.g., maximum force, leakage rates, etc.) derived from these standards or the actual performance results of the Altaviz Intravitreal Syringe against those criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is the information that can be extracted or inferred to the best of my ability, highlighting where information is missing:

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

Information not available in the provided text:

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

• Not specified. The document only mentions "Particulate testing", "Performance testing", and "Non-Clinical Biocompatibility Testing" without detailing sample sizes or provenance of the test subjects/samples.

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. This device is not an AI/imaging device requiring expert adjudication for ground truth. The testing relates to physical and biological performance characteristics of a syringe. The ocular study was performed in rabbits, not human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI device.

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

• Not applicable. This is not an AI device.

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

• For physical and chemical tests (e.g., particulate matter, ISO standards compliance), the "ground truth" is defined by the specific parameters and thresholds set within the respective standards (USP , ISO 80369-7, ISO 7886-1).
• For biological tests (biocompatibility, ocular study), the "ground truth" is determined by established biological safety standards, material characterization, and the observed responses in the animal model.

8. The sample size for the training set

• Not applicable. This is not an AI device needing a training set.

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

• Not applicable. This is not an AI device needing a training set.

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GO-PEN® is a reusable insulin pen intended for the self-injection of NovoLog® (U-100, insulin aspart for injection) available in 10 ml vials.

GO-PEN® is an assembly of a durable pen-shaped dosing unit with a special disposable sterile reservoir that fits into the dosing unit. The GO-PEN® device can only be used with NovoLog® U-100 insulin aspart for injection. The user is intended to fill up the disposable reservoir with 1.3 mL of insulin from a 10 ml vial and mount it on the dosing unit. The GO-PEN® device allows the user to set the desired dose from 1 to 60 Units in 1 Unit increments using the dial feature. Once the GO-PEN® disposable reservoir is filled, it can be used over a period of up to 3 days at room temperature (max. 30°C/86°F) for multiple injections of precise doses of insulin. When the reservoir is empty or the time has been exceeded, the reservoir must be discarded, and a new sterile reservoir is used for the next filling. GO-PEN® is used with standard single-use hypodermic needles with a luer lock which are supplied separately by the user.

Based on the provided FDA 510(k) Clearance Letter for the GO-PEN®, here's an analysis of the acceptance criteria and study information:

The document focuses on non-clinical (bench) testing to demonstrate substantial equivalence, rather than clinical studies with human participants. Therefore, several of the requested categories related to human studies (e.g., sample size for test sets/training sets in a clinical context, expert ground truth, MRMC studies, standalone performance with humans) are not applicable or not provided in this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to ISO 11608-1:2022 and specific design specifications. The reported performance indicates that the device passed these requirements.

• Standard Atmosphere
• Cool Atmosphere
• Warm Atmosphere
• Free Fall
• Dry Heat
• Cold Storage
• Damp Heat
• Cyclical (Temperature cycling)
• Vibration
• In-Use Lifetime Test (Life-cycle test for 5 years)
• Simulated Transport
• Aging to Expiration (Functional Stability) | Passed dose accuracy requirements after all specified preconditioning conditions. |
  | Last Dose Accuracy | As defined in ISO 11608-1:2022 | Passed. |
  | Fluid Leakage (into dosing mechanism) | As defined in ISO 11608-1:2022 | Passed. |
  | Leakage (during injection) | As defined in ISO 11608-1:2022 | Passed. |
  | Visible Particles in Reservoir | As defined in ISO 11608-1:2022 | Passed. |
  | Break Loose and Glide Force | As defined in ISO 11608-1:2022 | Passed. |
  | Biocompatibility (Durable Pen – intact skin contact) | Meets ISO 10993-1:2018; evaluated for in-vitro cytotoxicity. Materials excluded from Attachment G of FDA guidance also evaluated. | Exterior materials tested and evaluated accordingly. |
  | Biocompatibility (Reservoir – externally communicating) | Meets ISO 10993-1:2018; evaluated for in-vitro cytotoxicity, skin irritation, material mediated pyrogenicity, and sensitization. | Materials of construction evaluated accordingly. |
  | Usability/Human Factors | Critical tasks (filling/labeling reservoirs, injecting, handling) passed without mistakes; user interface did not adversely impact performance or usability. | Confirmed all critical tasks passed without mistakes. |
  | Luer Testing | As defined in ISO 80369-7 and 80369-20 for:
• Dimensions
• Fluid leakage
• Sub-atmospheric pressure leakage
• Stress cracking
• Resistance to separation from axial load
• Resistance to separation from unscrewing
• Resistance to overriding | Passed all luer lock testing requirements. |
  | Insufficient Remaining Dose (IRD) Feature | Complies with ISO 11608-1:2022, §5.6(k) method (4). | Complies (pen displays un-injected dose after emptying reservoir). |
  | Life Cycle (Durable Pen) | 3 years once use begins (bench tested for 5 years). | Tested for a 5-year life-cycle; stated use life is 3 years once use begins. |

Study Proving Device Meets Acceptance Criteria

The study described is a non-clinical bench testing program.

1. Sample Size used for the Test Set and the Data Provenance:

   • Sample Size: The document does not specify the exact number of GO-PEN® devices or components used for each bench test. Regulatory submissions typically use statistically relevant sample sizes for each test to achieve confidence in the results, though specific numbers aren't listed here.
   • Data Provenance: The testing was conducted by or on behalf of GO-Pen ApS, located in Lyngby, Denmark. The nature of these are prospective tests performed specifically to support this regulatory submission, based on established international standards.

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

   • This is not applicable as the "ground truth" for bench testing involves adherence to objective physical and engineering standards (e.g., ISO, precise measurements) rather than expert human interpretation of data. The "experts" would be the engineers and technicians conducting the tests and interpreting results against the standard's pass/fail criteria.

3. Adjudication Method for the Test Set:

   • Not applicable in the sense of expert consensus for clinical data. Adjudication is automated based on whether measured parameters fall within the acceptable ranges defined by the ISO standards.

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. This is a medical device (insulin pen), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI performance metrics are not applicable.

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

   • This is not applicable as the GO-PEN® is a mechanical medical device, not an algorithm or AI. Its "standalone performance" is its mechanical function as tested in the bench studies.

6. The Type of Ground Truth Used:

   • For bench testing, the ground truth is defined by international consensus standards (e.g., ISO 11608-1:2022, ISO 80369-7, ISO 80369-20, ISO 10993-1:2018) and the device's own pre-defined engineering specifications derived from these standards. Metrics like dose accuracy are objectively measured against these established limits.

7. The Sample Size for the Training Set:

   • Not applicable. As a mechanical medical device undergoing non-clinical bench testing, there is no "training set" in the context of machine learning or AI.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set."

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