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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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The Altaviz Needle Kit II is a convenience kit that includes:

A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe.

The Altaviz Needle Kit II is indicated for intravitreal use.

The Altaviz Needle Kit II is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The original version of this kit, the Altaviz Needle Kit, was cleared on December 5, 2022 (K222681), and the only difference between the Altaviz Needle Kit and the Altaviz Needle Kit II is the 29G injection needle included.

The tray of the Altaviz Needle Kit II is designed to securely store two separately packaged and previously sterilized needles: a single-use 29G injection needle and either a sterile 18G or 19G 5 micron filter needle. The tray lid provides protection and helps secure the needles during transport. No changes to the primary packaging of the needles or additional sterilization occurs prior to inclusion in the Altaviz Needle Kit II.

The 29G needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male connector (nozzle) of a piston syringe.

The 18G or 19G 5 micron filter needle is a sterile medical device for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate or ABS (respectively) designed to be connected with a male connector (nozzle) of a piston syringe. The filter needle is used to draw up fluids into a syringe.

The Altaviz Needle Kit II is a convenience kit consisting of a 29G injection needle and either an 18G or 19G 5 micron filter needle. The device is indicated for intravitreal use. The provided text outlines the substantial equivalence argument for this device, comparing it to a primary predicate (Altaviz Needle Kit) and an additional predicate (TSK Steriject 29G Hypodermic Needle). The acceptance criteria and the study proving the device meets these criteria are primarily focused on the performance of the individual components, specifically the 29G injection needle, for intravitreal use, as the "kit" itself is a convenience packaging of pre-sterilized, previously distributed needles.

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

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance tests conducted to support the device's suitability for intravitreal use, specifically for the 29G injection needle. The text states that "Additional testing to intraocular acceptance criteria for the TSK 29G needle has been performed." and details these tests under "Performance Data".

Note on "Implicit" Acceptance Criteria: The document states that the tests were performed and "passed," implying that the device met the established acceptance criteria for those standards. The specific numerical limits for these standards (e.g., maximum particulate count, EtO limits, endotoxin levels) are not explicitly stated in this summary but are defined within the referenced ISO and USP standards and FDA guidance documents.

2. Sample Size and Data Provenance

• Sample Size for Test Set: The sample sizes for the specific performance tests (particulate, irritation, EtO residuals, endotoxins) are not explicitly stated in this document. These would typically be detailed in the full test reports referenced by the standards (e.g., ISO, USP).
• Data Provenance: Not explicitly stated from the provided text. The tests were performed to demonstrate compliance with international standards (ISO, USP) and FDA guidance, suggesting a controlled laboratory testing environment, but the country of origin of the data or whether it was retrospective/prospective is not specified. Given it's premarket notification, it's typically prospective testing.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable/not stated. For a medical device focused on physical and chemical characteristics, the "ground truth" is established by adherence to validated laboratory testing methods and compliance with established international standards (ISO, USP) and FDA guidance. The evaluation does not involve medical interpretation by experts in the same way an AI diagnostic algorithm for images would.
• Qualifications of Experts: Not applicable/not stated. The "experts" in this context would be the technicians and scientists performing the tests, qualified to conduct analyses according to the specified standards, but their specific qualifications are not detailed here.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1 consensus) is relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies need to be resolved. For laboratory performance testing against predefined standards, there is no "adjudication" in this sense; the results either meet the criteria or they do not.

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

• MRMC Study: No. This type of study is typically performed for AI-assisted diagnostic devices to evaluate how AI assistance impacts human reader performance. The Altaviz Needle Kit II is a physical medical device, not a diagnostic AI tool, so an MRMC study is not relevant.

6. Standalone Performance (Algorithm Only)

• Standalone Performance: No. This concept applies to AI algorithms. The performance evaluation here is of the physical device components themselves meeting safety and performance standards for their intended use.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth is established by objective laboratory measurements and tests against predefined, quantitative, and qualitative criteria within established international standards (ISO, USP) and FDA guidance. For example, the ground truth for particulate matter is the measured particulate count compared to the maximum allowable count, and for irritation, it's the observed biological response compared to predefined irritation scales.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI algorithm, so there is no "training set." The components of the kit are physical devices that undergo manufacturing and quality control processes to ensure consistency and compliance.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set.

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The Altaviz Needle Kit is a convenience kit that includes: A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe. The Altaviz Needle Kit is indicated for intravitreal use.

The Altaviz Needle Kit is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The tray is designed to securely store two separately packaged and previously sterilized needles: a single-use 29G injection needle and either a sterile 18G or 19G 5 micron filter needle. The tray lid provides protection and helps secure the needles during transport. No changes to the primary packaging of the needles or additional sterilization occurs prior to inclusion in the Altaviz Needle Kit. The 29G needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe. The 18G or 19G 5 micron filter needle is a sterile medical device for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate or ABS (respectively) designed to be connected with a male connector (nozzle) of a piston syringe. The filter needle is used to draw up fluids into a syringe.

The Altaviz Needle Kit is a convenience kit containing a 29G injection needle and either an 18G or 19G 5-micron filter needle. The kit is intended for intravitreal use. The provided text describes the performance data and criteria used to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

USP Particulate Matter in Ophthalmic Solutions: Refers to limits on the number of particles of specific sizes (e.g., ≥10 µm, ≥25 µm, ≥50 µm) per mL or per container for ophthalmic preparations. | Particulate testing of the kit components (needles) according to USP and USP was performed and passed. This indicates that the device met the specified particulate matter limits for both injections (parenteral) and ophthalmic solutions, ensuring suitability for intravitreal use where particulate load is critical. |
| Ethylene Oxide (EtO) Residuals | ISO 10993-7: Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals: Specifies allowable limits for EtO residuals (ethylene oxide, ethylene chlorohydrin, and ethylene glycol) in medical devices after sterilization, particularly for devices with limited or prolonged contact with patients. The specific limits depend on the device's application and contact duration. For intravitreal use, very low limits are typically required due to the sensitivity of ocular tissues. | Ethylene oxide residuals were assessed per ISO 10993-7. The implication is that the device met the specified residual limits for EtO. Given the intravitreal indication, this would necessarily mean meeting the stringent requirements for devices with limited contact but high sensitivity, ensuring no toxic levels of EtO byproducts are present. |
| Endotoxins | FDA guidance "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices": This guidance typically specifies a maximum endotoxin limit (e.g., Endotoxin Units per device or per mL of extract) for intraocular devices to prevent inflammation or adverse reactions in the eye. A common limit for intraocular devices is usually 0.5 EU/mL or 2.5 EU/device. | Endotoxins were tested as recommended in FDA guidance "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices." The successful testing implies that the device met the specified endotoxin limits, critical for preventing pyrogenic reactions and inflammation when introduced into the eye. |
| Ocular Irritation | Invivo animal study (rabbits) for intravitreal injection: This criterion would assess the biocompatibility and safety of the device components when introduced into the vitreous. It involves evaluating for signs of inflammation, tissue damage, or adverse reactions in the ocular tissues of the test animals over a specified period. The acceptance criterion would be the absence of significant or unacceptable irritation/toxicity compared to a control. | Ocular irritation testing following intravitreal injection in rabbits was performed. This test indicates that the device components did not induce unacceptable irritation or adverse reactions when directly injected into the eyes of rabbits, supporting its safety for human intravitreal use from a biocompatibility standpoint. |

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

The document does not explicitly state the specific sample sizes used for each test (particulate matter, EtO residuals, endotoxins, ocular irritation). These details are typically found in the full test reports, which are not included in this 510(k) summary.

The data provenance is from laboratory testing performed specifically for this device (Altaviz Needle Kit). The type of test (e.g., animal study for ocular irritation, chemical analysis for EtO) implies prospective testing, as the device was manufactured and then subjected to these evaluations to demonstrate compliance. The country of origin of the data is not specified, but given the FDA submission, the testing would have been conducted in a facility adhering to recognized international standards and good laboratory practices.

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

This information is typically not applicable to objective chemical, physical, and biocompatibility tests like those described.

• Particulate Matter, EtO Residuals, Endotoxins: These involve standardized laboratory tests with objective measurable endpoints. "Ground truth" is established by the validated test methods and reference standards themselves, not by expert consensus.
• Ocular Irritation: While interpreted by pathologists or veterinarians, the "ground truth" here is the observed biological response in the animal model as assessed against defined criteria for irritation/toxicity. The document does not specify the number or qualifications of experts involved in the interpretation of the rabbit study results, but it would typically involve board-certified veterinary pathologists or toxicologists.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory measurements (e.g., particle counts, chemical concentrations, endotoxin levels) or standardized biological evaluations (animal studies) that rely on established protocols and quantitative/semi-quantitative assessments rather than human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI-assisted diagnostic tools where human readers interpret medical images with and without AI assistance. The Altaviz Needle Kit is a physical medical device (needles) for injection, and its performance is evaluated through material science, chemical, and biological safety testing, not through human reader interpretation of images.

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

Yes, in a way, the standalone performance of the device components was assessed. The performance data focuses entirely on the intrinsic properties and safety of the needles themselves (particulate matter, EtO residuals, endotoxins, ocular irritation). There is no "human-in-the-loop" aspect to these specific performance evaluations as they assess the device's inherent characteristics against safety and quality standards.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation can be summarized as:

• Standardized Analytical Thresholds/Limits: For Particulate Matter (USP , ), Ethylene Oxide Residuals (ISO 10993-7), and Endotoxins (FDA guidance), the "ground truth" is defined by the established regulatory and consensus standard limits that the device must meet.
• Biological Response in an Animal Model: For Ocular Irritation, the "ground truth" is the observed biological safety (lack of significant adverse tissue reaction) in a validated animal model (rabbits) following direct intravitreal injection. This is a form of outcomes data in a preclinical setting.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning or AI algorithm that requires a "training set" of data.

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

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

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