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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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It is intended for use by health care professionals for puncture, drainage and fluid collection of the anterior chamber of the eye. Its operation is manual. The Disposable Aqueous Humor Collector is single use only. The Disposable Aqueous Humor Collector is suitable for ophthalmic use.

Disposable aqueous humor collector is composed of a liquid collecting needle sheath, a liquid collecting needle, a needle seat, a liquid collecting needle rubber sheath, a rubber plug, a liquid collecting tube, a cylinder body, a rubber ring, push rod and buckle structure.
Models: SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27
Volume: 50μL, 100μL
Needle Gauge: 25G, 27G

The provided FDA 510(k) clearance letter and summary for the "Disposable Aqueous Humor Collector" does not contain acceptance criteria or a detailed study description of device performance, beyond general statements about compliance with ISO standards and a brief mention of an OUS study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (StaClear Syringe) by comparing specifications and stating that differences do not raise new safety or effectiveness concerns, supported by various non-clinical tests (biocompatibility, sterility, bench functional performance).

Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document refers to testing being performed, but does not present the specific acceptance criteria or the detailed results of those tests.

However, I can extract the information that is present and highlight what is missing based on your request:

Missing Information: The provided document states that "required testing was conducted to validate the cumulative modifications made to the subject devices" and that "Substantial Equivalence is being supported with full performance testing," including bench functional performance tests. It also mentions "An outside of the United States (OUS) study was performed demonstrating the effectiveness of the subject device to collect 50 uL of liquid with the 50 uL model." However, it does not detail the specific acceptance criteria for these tests, nor does it provide a full study report with reported device performance against those criteria.

Here is what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the tests.
• Data Provenance: The document mentions "An outside of the United States (OUS) study." This indicates a prospective clinical study conducted outside the US. No further details on the country of origin are provided. Bench and biocompatibility testing locations are not specified.

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

• Not Applicable. This device is a medical instrument (collector/syringe) for fluid collection, not an AI/diagnostic device that typically requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Its performance is evaluated through physical and chemical property testing (e.g., volume accuracy, needle strength, sterility).

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this type of device does not involve expert adjudication for ground truth establishment.

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

• No. An MRMC study is typically for evaluating the performance of diagnostic devices, especially those involving human interpretation of data (e.g., radiology images) with and without AI assistance. This device is a manual fluid collector, so such a study is not relevant.

6. If a Standalone Performance Study Was Done

• Yes, implicitly. The bench functional performance tests (ISO 7886-1, ISO 9626, ISO 7864), biocompatibility tests, sterility tests, and the OUS study (which demonstrated effectiveness to collect 50 µL) all represent standalone performance evaluations of the device itself, without human interpretation as a variable.

7. The Type of Ground Truth Used

• Metrological and Biological Standards: The ground truth for this device's performance is established by reference to international standards (e.g., ISO for syringes and needles), specific quantitative measurements (e.g., needle force, volume, heavy metal limits, SAL for sterility), and established biocompatibility principles (ISO 10993 series). In the case of the OUS study, the "ground truth" for liquid collection would be the actual measured volume collected by the device.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware medical device, not an AI/software device that requires a training set.

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

• Not Applicable. As it's not an AI/software device, a training set and its associated ground truth are not relevant.

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The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.

The StaClear Syringe is a single-use piston syringe intended for use by healthcare professionals for general-purpose fluid aspiration/injection. Its operation is manual. The StaClear Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. It uses standard syringe components with a low-particulate gas plasma crosslinked silicone coating called TriboLink-Si. The StaClear Syringe is suitable for ophthalmic use.

The StaClear Syringe is offered in the following configurations:

• SC250AN – Consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap.
• SC250LS – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-slip connector, plunger, and plunger stopper.
• SC250LL – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-lock connector, plunger, and plunger stopper.

The provided document is an FDA 510(k) clearance letter for the StaClear Syringe, which is a medical device, not an AI/ML algorithm. Therefore, many of the requested fields, such as "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth," and information about training sets, are not applicable to this type of device and therefore not present in the document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to established performance standards for syringes.

Here's the information that can be extracted from the provided text regarding acceptance criteria and performance:

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

The document lists various ISO and USP standards as the basis for performance evaluation. The "Acceptance Criteria" are implied to be compliance with these standards, and the "Reported Device Performance" is stated as "Identical" or "Compliant" with these standards.

2. Sample sized 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 sizes used for testing each attribute. The data provenance (country of origin, retrospective/prospective) is also not provided. The testing is described as "non-clinical testing" and "performance testing performed as per the design control system," suggesting in-house, prospective testing.

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 is a physical medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the device's performance is objective measurements against established engineering and biocompatibility standards.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring adjudication of interpretations.

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 a physical medical device and does not involve AI assistance for human readers.

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

Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance refers to the device's adherence to specified standards in direct testing.

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

The "ground truth" for this device's performance is adherence to recognized international and national standards for medical devices, specifically:

• ISO standards (e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993-1, ISO 11607-1) which define performance characteristics, materials, and testing methodologies.
• USP standards (e.g., USP , USP , USP , USP ) which define testing for particulate matter, sterility, and endotoxins.
• ASTM standards (e.g., ASTM D4169, ASTM F1980) for packaging and accelerated aging.

These standards provide objective, measurable criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve a training set as would an AI/ML algorithm.

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

Not applicable. This is a physical medical device and does not involve a training set.

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The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body. The Microliter Dosing Syringe is indicated for intravitreal use.

The Microliter Dosing Syringe is a single-use, piston syringe-based device consisting of a syringe barrel, plunger stopper, syringe tip cap and incorporates a plunger rod subassembly. It is intended for use by healthcare professionals for general purpose fluid aspiration/injection. Its operation is manual. The Microliter Dosing Syringe is single use only, non-toxic, non-pyrogenic and sterilized by e-beam irradiation. The Microliter Dosing Syringe is suitable for ophthalmic use.

The provided text is a 510(k) Summary for a medical device called the "Microliter Dosing Syringe." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets a set of performance criteria for an AI/ML algorithm.

Therefore, the document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML test or training set.

The document discusses the substantial equivalence of the Microliter Dosing Syringe to a predicate device (StaClear Syringe) based on:

• Intended Use and Indications for Use: Both are intended to inject or withdraw fluid from the body, and are specifically indicated for intravitreal use.
• Technological Characteristics: Comparisons are made across various characteristics like sterilization, shelf life, device materials, syringe volume, target dose volume, and connector type.
• Non-clinical Testing: Bench testing according to ISO 7886-1 and USP standards (e.g., , , ) was performed to demonstrate performance equivalence.
• Biocompatibility Testing: Tests were conducted according to ISO 10993 series standards (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis) to address material differences.

In summary, the provided text describes the regulatory clearance process for a physical medical device (syringe) by demonstrating substantial equivalence to a predicate, not the validation of an AI/ML-driven medical device against specific performance acceptance criteria.

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The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.

The Vitrelect Syringe is designed to provide a means of fluid injection and aspiration. It is a luer-tip piston syringe consisting of a 1 mL hollow barrel with gradient markings and a plunger with an incorporated plunger stopper. The VitreJect Syringe barrel component is available in two configurations, a luer-slip or luer-lock tip, for the fitting of a compatible hypodermic needle. The VitreJect Syringe plunger is available in two configurations: standard dead space or low dead space. It is intended for manual use by health care professionals. The VitreJect Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Syringe is suitable for ophthalmic use.

This document is a 510(k) Premarket Notification for a medical device called the "VitreJect Syringe." It aims to demonstrate that the VitreJect Syringe is substantially equivalent to a legally marketed predicate device (StaClear Syringe, K200242).

This document describes non-clinical performance and biocompatibility testing for a medical device (syringe), not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text.

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

The document doesn't present a single structured table explicitly labeled "Acceptance Criteria and Reported Performance" with quantitative thresholds for all tests. However, it lists a series of tests performed and states that the device "met the applicable requirements" or "met the established safety and performance characteristics." For some specific characteristics, it even provides the performance achieved.

Here's a summarized table based on the information provided:

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

The document does not specify the exact sample sizes (N numbers) used for each individual test. It generally states that "Performance testing was performed as per the design control system" and refers to ISO standards, which typically involve specific sample sizes.

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The document does not specify the country of origin for the data. The tests are "non-clinical testing" (in vitro and in vivo studies) performed by the manufacturer (OcuJect, LLC). It's a regulatory submission, so the data is likely manufacturer-generated to support the device's claims. The studies were prospective in the sense that they were conducted specifically for this regulatory submission to demonstrate device performance.

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

This question is not applicable as the device is a physical medical device (syringe), not an AI/ML diagnostic tool. Ground truth in this context refers to the measured physical and biological properties of the device, established through standardized testing methodologies, not expert interpretation of medical images or data.

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

This question is not applicable as the device is a physical medical device (syringe), not an AI/ML diagnostic tool. Adjudication methods are used in consensus labeling of data by human experts for AI models. The "ground truth" here is determined by direct measurement and standardized test results.

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 question is not applicable as the device is a physical medical device (syringe) and not an AI-powered diagnostic tool that assists human readers.

6. 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 physical medical device (syringe) and does not involve an algorithm.

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

The "ground truth" for this medical device is established through:

• Standardized Physical and Chemical Measurements: Performed according to ISO, USP, and ASTM standards (e.g., dead space volume, operational force, particulate matter counts, dimensional specifications).
• Biological Testing (In vitro and In vivo): Biocompatibility tests such as cytotoxicity, sensitization, irritation (intracutaneous, ocular, intravitreal, intraocular), systemic toxicity, pyrogenicity, and hemolysis.
• Chemical Characterization and Toxicological Risk Assessment: To identify extractables/leachables and assess their risk.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device (syringe) and does not involve AI/ML requiring a training set.

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

This question is not applicable as the device is a physical medical device (syringe) and does not involve AI/ML requiring a training set.

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The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.

The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use.

Here's a breakdown of the acceptance criteria and study information for the StaClear Syringe, based on the provided document:

Acceptance Criteria and Device Performance

Study Information

The document describes non-clinical bench testing and biocompatibility testing. It does not describe a study comparing human readers with and without AI assistance, nor does it describe a standalone algorithm-only performance study.

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 explicitly state numerical sample sizes for each test. For example, it lists "Cleanliness" as a test performed but does not quantify how many units were tested.
• The data provenance is not specified beyond being "non-clinical bench testing" and "TriboFilm's design control system," implying internal testing by the manufacturer. No country of origin for test data is mentioned.

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 a medical product (syringe), and the evaluation involved bench testing and biocompatibility assessment, not interpretation of medical images or diagnostic tasks. As such, "ground truth" was established by adherence to recognized testing standards and methods, not expert consensus in a clinical diagnostic sense.

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

• Not applicable for this type of device and testing. The tests performed are objective, quantitative measurements 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a syringe, not an AI-powered diagnostic tool.

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

• No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm.

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

• The "ground truth" for evaluating the StaClear Syringe against its acceptance criteria was based on:
  • International and National Standards: e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 10993 series, ASTM F756, USP , USP . These standards define acceptable performance limits and test methodologies.
  • Objective Measurements: Laboratory and material testing results.
  • Biological Endpoints: Observed responses in biocompatibility tests (e.g., absence of cell lysis, irritation, toxicity).

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not applicable. As there is no training set, this question is irrelevant.

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