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Single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. Additionally, the PLUS device is designed with a larger viewing window indicated where pharma company offering is a low fill volume and instructions request visualization. The PLUS device is designed with a robust plunger and built in extended finger flanges indicated where pharma customer offering is viscous.

The modification to the predicate device is the addition of the X100L PLUS device to the UltraSafe Passive Needle Guard X-Series family. The SSI UltraSafe PLUS Passive Needle Guard is an antineedlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is non-sterile and single use. The activation of the UltraSafe PLUS Passive Needle Guard device remains the same. Upon completion of the guard will slide forward, cover and lock over the needle of the syringe. It is a visual and/or audible recognition that the device safety feature has activated. The SSI devices are categorized as skin contact with a duration of category A- limited (

The provided 510(k) summary describes the UltraSafe PLUS Passive Needle Guard, an accessory for pre-filled ISO standard glass syringes designed to prevent accidental needlesticks. The submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: 500 devices.
   • Data Provenance: The study was a "simulated use study" conducted internally by Safety Syringes, Inc. (as indicated by "Safety Syringes, Inc. maintains a Quality System... Test procedures, test protocols, and reports are maintained within the Quality System"). The country of origin is not explicitly stated, but the company is based in Carlsbad, CA, USA. The study design is prospective as it involves testing new devices to confirm performance.

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

   • Not applicable. This device is a mechanical safety accessory, and its "ground truth" (i.e., whether it activated correctly or not, or impeded injection) is determined by direct observation during simulated use, not by expert interpretation of complex data. No expert review or consensus was required for establishing the outcome of the mechanical activation.

4. Adjudication method for the test set:

   • Not applicable. The "ground truth" was directly observed mechanical function (activation/non-activation, successful injection). There was no need for adjudication as there were zero failures observed which simplifies the outcome to a clear pass/fail for each device.

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 medical device (a needle guard) and not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study is not relevant to its evaluation.

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

   • Not applicable. As noted above, this device is a mechanical safety accessory, not an algorithm. The study performed was a "simulated use study" that inherently involves human interaction with the device during the injection process. The performance reported is that of the device in this simulated use, which is its intended "standalone" operational mode.

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

   • The ground truth was based on direct observation of mechanical function during simulated use, specifically:
     • Successful completion of injections.
     • Activation of the safety device (guard sliding forward, covering, and locking over the needle).
     • Absence of premature activation.
     • Protection against sharps injury.
   • Essentially, it's a functional performance ground truth, directly observable and measurable during the test procedure.

8. The sample size for the training set:

   • Not applicable. This device is a mechanical one and does not involve 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 for this type of device.

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Single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

The SSI UltraSafe Passive Needle Guard (X-Series) is an anti-needlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is nonsterile and single use. The activation of the SSI UltraSafe Passive Needle Guard device remains the same. Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe. It is a tactile and visual recognition that the device safety feature has activated. The modifications to the predicate device include additional plungers manufactured from Purell PolyOne X50109 polypropylene homopolymer, Ineos H20Z-00 polypropylene homopolymer or medical grade Delrin SC690 NC010. The SSI devices are categorized as skin contact with a duration of category A- limited (

The provided text describes the 510(k) summary for the UltraSafe Passive Needle Guard, a medical device designed to prevent accidental needlesticks. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a table format. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards. The "acceptance criteria" are implied by the performance data and the conclusion of substantial equivalence.

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Single use devices that are indicated for use as an accessory with prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

The Safety Syringes UltraSafe Delivery System/Needle Guard devices are antineedlestick accessories for pre-filled ISO Standard glass syringes. ISO Standard glass syringes are supplied in multiple sizes. These devices are designed to fit syringe sizes 0.5 mL, 1.0 mL, 1.0 mL long, 1.5 mL, 2.25 mL, 3.00 mL, and 5.0 mL.

This 510(k) summary describes a modification to an existing medical device, the Safety Syringes UltraSafe Delivery System/Needle Guard devices, which are anti-needlestick accessories for pre-filled ISO Standard glass syringes. The modification is an expansion of the Indications for Use to include self-injecting patients and those who assist them, beyond the original limitation to healthcare professionals.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a formal table of acceptance criteria or specific quantitative performance metrics for the device. Instead, it describes a qualitative assessment related to the expanded user group.

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

• Sample Size: The document does not specify the exact sample size used for the "testing" mentioned. It refers to "typical nonhealthcare users" without providing a number.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a premarket notification for a US FDA approval, it's highly likely the testing was conducted in the US. The "testing" appears to be a prospective assessment of user comprehension and device interaction.

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

The document does not describe the use of "experts" to establish ground truth for the usability testing with non-healthcare personnel. The assessment appears to be based on the ability of the users themselves to perform the task as intended. If "ground truth" refers to the correct execution of the device's function, it's implied that the device design and IFU served as the standard.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Given the nature of the evaluation (user comprehension and device interaction), it's unlikely a formal adjudication process (like 2+1 or 3+1) was used as would be common in diagnostic AI studies. The "testing" would more likely involve observation and direct assessment of task completion and understanding.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and their performance is compared with and without AI assistance. This device is an anti-needlestick accessory, not a diagnostic tool requiring interpretation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not done. This concept is relevant for AI algorithms. The device itself is a physical accessory designed to be used by humans. The "testing" mentioned focuses on human-in-the-loop performance, specifically the ability of non-healthcare users to correctly use the device.

7. Type of Ground Truth Used

The "ground truth" for the "testing" described is implicitly the intended and correct use of the device as per its design and Instructions for Use (IFU). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic medical device study. Instead, it's about evaluating user compliance and understanding.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning algorithms. This document describes a physical medical device. Therefore, there is no "training set" in the context of AI/ML. The device's design would have undergone engineering and design validation, but not "training" in the computational sense.

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

As there is no "training set" in the AI/ML context for this device, a method for establishing its ground truth is not applicable or described. The performance of the device itself (e.g., its anti-needlestick effectiveness) would have been established through prior design verification and validation activities for the original device, likely involving engineering tests, material compatibility tests, and potentially simulated use tests. However, the document focuses only on the change in Indications for Use and the associated human factor/usability testing for the new user population.

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The UltraSafe Passive™, X-Series, Needle Guard is intended for use as a safety mechanism designed to reduce the occurrence of accidental needlesticks to healthcare professionals during disposal of a used syringe and needle assembly. The UltraSafe Passive, X-Series, Needle Guard is snapped onto the barrel of an ISO Standard pre-filled glass syringe, in a retracted position. Upon completing the injection, the UltraSafe Passive, X-Series, Needle Guard passively activates and covers the exposed needle. When the Passive Needle Guard is activated, it provides protection from an accidental needlestick. The healthcare professional disposes the used syringe and needle assembly in a sharps container.

UltraSafe Passive™, X-Series, Needle Guards are single use devices that are indicated for use as an accessory with ISO Standard pre-filled glass syringes to protect healthcare professionals from accidental needle sticks.

The UltraSafe Passive™, X-Series, Needle Guard is an accessory for ISO Standard pre-filled glass syringes. ISO Standard pre-filled glass syringes are supplied in multiple sizes. They fit with ISO Standard pre-filled glass syringes ranging from 0.5 mL to 5.0 mL of fill volume.

The guards are designed to meet the requirements specified in ISO 11040-4 Prefilled syringes - Part 4 Glass barrels for injectables (March 1995).

The provided text describes a 510(k) submission for the UltraSafe Passive™, X-Series, Needle Guard. The submission focuses on demonstrating substantial equivalence to a predicate device, the UltraSafe® Injection System Needle Guard - B-Series, rather than establishing de novo acceptance criteria associated with a specific diagnostic performance outcome.

Instead of traditional diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy), the study evaluates the safety, performance, and usability of the new passive device compared to the manually activated predicate device through a controlled simulated clinical use test.

Here's an analysis of the "acceptance criteria" and the study based on the provided text:

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

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

• Sample Size: Not explicitly stated beyond "nurses involved in this study" and "study participants." The exact number of nurses is not provided.
• Data Provenance: The study was a "controlled simulated clinical use test." It is prospective in nature, as it involved active participation of users with the device. The country of origin is not specified but given the company information (Carlsbad, CA, USA) and the FDA submission, it can be inferred that the study was likely conducted in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable in the context of this device. The "ground truth" here is subjective user feedback and comparative assessment by "nurses" on safety, performance, and usability, rather than an objective diagnostic or clinical outcome requiring expert consensus for ground truth establishment.

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

Not applicable. There was no "ground truth" to adjudicate in the traditional sense of diagnostic accuracy. The study involved user ratings and comparisons.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical safety accessory, not an AI or imaging device that would involve human "readers" interpreting cases. The study was a comparative user evaluation of a medical device's safety features and usability.

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

Not applicable. This device is a physical accessory where "human-in-the-loop performance" (i.e., use by healthcare professionals) is its primary mode of operation and evaluation.

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

The "ground truth" was established through user evaluation and comparative ratings by nurses during a simulated clinical use test. It's based on subjective feedback and direct comparison of the new device (X-Series) against the predicate device (B-Series) on parameters of safety, performance, and usability. There is no objective medical ground truth (like pathology or clinical outcomes) being assessed for this type of device.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of mechanical device evaluation. The "iterative user evaluations" conducted by Safety Syringes, Inc. prior to the controlled simulated clinical use test might be considered analogous to developmental testing, but not a formal "training set" in the context of AI/machine learning.

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

Not applicable as there was no formal "training set" with ground truth in the traditional sense for this device.

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The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly and a reusable Syringe Plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges for injection of anesthetic solution for profound anesthesia of oral tissues.

The Needle Guard sheath manually slides forward over the needle in between injections and after injection(s) have been completed. The Needle Guard helps protect dental healthcare professionals from accidental needlesticks.

The intended patient population is unrestricted and includes children and adults of all ages.

The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly to help prevent needlestick and a reusable Syringe Plunger assembly that is used to administer local anesthetic solutions.

This document is a 510(k) summary for the UltraSafe Dental™ Injection System, which is a medical device submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document primarily provides:

• Company and device information.
• Device description (sterile, single-use Needle Guard assembly and a reusable Syringe Plunger assembly).
• Intended use (injecting anesthetic into oral tissues with a needlestick prevention mechanism).
• Intended patient population (unrestricted, all ages).
• Intended environment of use (dental offices, clinics, oral surgery).
• Indications for use (for use with 1.8mL anesthetic cartridges; Needle Guard slides manually to protect from needlesticks).
• FDA's determination of substantial equivalence to a predicate device.

Therefore, I cannot populate the requested table and details because the provided text does not contain the necessary information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

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The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit.

The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for a wide range of clinical conditions.

The UltraSafe® Model C200 Injector with Needle Guard is a product which is intended to be used with a sterile medication cartridge with needle to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which consists of a safety guard that can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle. The guard requires a two-handed action in order to cover the needle point after use. The Model C200 Injector is made of K-Resin KR01, KR03, and ABS Resin.

The provided text describes the K972877 Premarket Notification for the UltraSafe® Injection System Model C200 Injector with Needle Guard. This document focuses on the substantial equivalence of the new device to existing predicate devices, rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics in the way a clinical trial for a novel drug or a complex AI diagnostic device would.

Here's an analysis based on the provided text, addressing your points as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as this is a 510(k) for a medical device seeking substantial equivalence, not a clinical effectiveness trial for a new therapeutic or diagnostic.

However, we can infer some implied criteria and reported performance based on the comparison to predicate devices:

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

The provided text does not specify a "test set" in the context of performance metrics or a study. The information presented is descriptive and comparative based on the device's design, materials, and intended function. There is no mention of a particular sample size for testing users or assessing effectiveness in a clinical setting in this document. The data provenance is primarily from the manufacturer's internal assessments and comparisons to predicate devices.

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

This information is not available in the provided text. The document is a regulatory submission for substantial equivalence based on device design and comparison, not a study requiring a ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set

This information is not available in the provided text. As there is no explicitly defined "test set" with performance metrics requiring adjudication, this concept does not apply to the provided document.

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

An MRMC study is not applicable to this device. This device is a manual medical instrument (injector with a needle guard) and does not involve AI or "human readers" in a diagnostic or interpretive sense.

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

This information is not applicable as the device is a mechanical injector, not an algorithm.

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

This information is not available or applicable in the context of a "ground truth" for performance evaluation in the way it would be for a diagnostic or AI device. The "ground truth" for this device revolves around its physical properties (e.g., strength of the guard, ease of use with standard procedures) and safety features (prevention of needle sticks), which are presumably assessed through engineering tests, usability studies, and adherence to established biocompatibility standards.

8. The sample size for the training set

This information is not applicable as the device is a mechanical medical instrument, not an AI model requiring a training set.

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

This information is not applicable as the device is a mechanical medical instrument, not an AI model.

Summary of the Study (as described in the document):

The document describes a comparison study (or more accurately, a descriptive comparison for the purpose of a 510(k) submission) to demonstrate substantial equivalence of the UltraSafe® Injection System Model C200 Injector with Needle Guard to its predicate devices.

The "study" or justification for equivalence is based on the following:

• Design and Functionality Comparison: The C200 is intended for the same use (delivering medication from a cartridge) as the predicate Sanofi-Winthrop Injector. Its needle guard is designed to prevent needle stick injuries, similar to the concept of the UltraSafe Aspirating Syringe.
• Performance Comparison:
  • The C200's needle guard reportedly has "considerably greater strength than the predicate device." However, the standard or test method for this strength comparison is not detailed.
  • It's stated to be "as easy to assemble and use" as the Sanofi-Winthrop Injector. This is a qualitative assessment.
  • It provides the "same useable needle length" as an unguarded needle, ensuring equivalent performance of hypodermic procedures.
• Material Equivalence and Biocompatibility: The C200 uses the "same materials" (K-Resin KR01, KR03, and ABS Resin) as the Safety Syringes predicate device, and these materials have "passed biocompatibility tests."
• Safety Features: The primary safety feature is the needle shield that can be snapped into place after use, eliminating recapping and minimizing accidental needle sticks. A key operational safety aspect highlighted is the "two-handed action" required to cover the needle.

In essence, the "study" presented here isn't a traditional scientific study with detailed experimental protocols, control groups, and statistical analysis of performance metrics. Instead, it's a submission for regulatory clearance asserting that the new device is fundamentally similar in design, materials, and intended use, and performs equivalently to legally marketed devices, with an improvement in needle guard strength.

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The UltraSafe® Model T200 Injector with Needle Guard is designed to hold a TUBEX® Sterlie Cartridge-Needle Unit 2.5 ml. in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit.

The UltraSafe® Model T200 Injector is used with a Tubex® Sterile Cartinge-Needle Unit 2.5 ml. to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for parenteral methods of administration.

The UltraSafe® Model T200 Injector with Needle Guard is a product which is intended to be used with a TUBEX® Sterile Cartridge-Needle Units 2.5 ml to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle.

This device is a medical injector system and the documentation provided is a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone performance metrics.

Therefore, many of the requested specific details regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, F1 score, effect size in MRMC studies, sample sizes for test and training sets with ground truth specifics) are not available in the provided text. The document is primarily a descriptive comparison and regulatory submission.

However, based on the input, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document mentions "The Model T200 Injector with Needle Guard has been tested," but does not provide details on the number of devices or subjects tested.
• Data Provenance: Not specified. It's implied to be internal testing by Safety Syringes, Inc. The document does not mention country of origin explicitly 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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Not specified. The document describes a statement of substantial equivalence rather than a detailed clinical or performance study with adjudication.

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 study was not done. This device is a mechanical injection system, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable.

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

• No, this is not applicable. The device is a physical injection system, not an algorithm. The "standalone performance" refers to the device's inherent mechanical safety and functionality, which is implicitly what the "testing" mentioned in the document aimed to assess.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance would be derived from specific measurable engineering and functional tests (e.g., force required to activate safety mechanism, needle exposure length, material strength tests) and perhaps user performance assessments (e.g., ease of use, ability to perform typical hypodermic procedures). The document states the device "has been tested" and "found to have considerably greater strength," indicating these types of tests were performed.
• For biocompatibility, the ground truth would be established through standardized biocompatibility tests as per medical device regulations.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical medical device, not an AI/machine learning model, so there is no concept of a "training set."

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

• Not applicable. As above, there is no training set for this type of device.

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Each UltraSafe® Injection System Needle Guard is attached to an ISO standard glass syringe that is pre-filled and equipped with a shield that covers the needle during disposal intending to reduce the occurrence of accidental needle sticks to users. This device is used for a wide range of patients from children to adults and parenteral methods of administration.

The UltraSafe® Needle Guerd is an accessory to the ISO 11040-4 standard glass syringe that is pre-filled. The device is totally disposable. It is a safety guard that can be mated with a pre-filled syringe of the same size. After use of the syringe, the guard is activated covering the needle and thus protecting the caregiver by eliminating the need to recap the needle and minimizing accidental needle stick injuries during disposal of the syringe/needle.

This document is a 510(k) Premarket Notification for the UltraSafe® Injection System Needle Guard, which is a safety accessory for pre-filled syringes. The submission primarily focuses on establishing substantial equivalence to a predicate device.

Acceptance criteria and device performance are not explicitly detailed in a quantitative table with specific metrics and thresholds. Instead, the document provides a qualitative comparison to the predicate device, emphasizing safety features and material equivalence.

Here's an analysis of the provided information regarding acceptance criteria and study details:

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

Specific quantitative acceptance criteria (e.g., "force to activate guard > X N", "puncture resistance > Y psi") are not provided nor is quantitative performance data. The document relies on a descriptive comparison to the predicate device.

• Acceptance Criteria (Implicit/Qualitative):

  • Needle Guard requires two-handed action to cover the needle.
  • Needle Guards possess "considerably greater strength than the predicate device."
  • Easy assembly and use with a pre-filled syringe.
  • Provides the same usable needle length as an unguarded needle in the "ready-to-use" position.
  • Allows typical hypodermic procedures equivalently to standard, unguarded needles.
  • Biocompatible materials (same as predicate).
  • Provides a shield that covers the needle during disposal to reduce accidental needle sticks.

• Reported Device Performance (Qualitative):

  • "The Needle Guard requires a two-handed action in order to cover the needle point after use."
  • "The Needle Guards have been tested and found to have considerably greater strength than the predicate device."
  • "The Guard is easy to assemble and use with a prefilled syringe."
  • "With the Needle Guards in the "ready-to-use" position, they provide the same useable needle length as an unguarded needle."
  • "The user can perform typical hypodermic procedures equivalently to standard, unguarded needles."
  • "The material has passed biocompatibility tests." (Implicitly, the UltraSafe® material has passed, as it is the same as the predicate).

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

• Sample Size for Test Set: Not specified. The document mentions "The Needle Guards have been tested," but does not provide details on the number of units tested or the methodology.
• Data Provenance: Not specified. There is no mention of the country of origin or whether testing was retrospective or prospective.

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. The submission relies on engineering and material testing, not expert interpretation of outputs like in AI/imaging devices.

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

• Not applicable. There is no mention of adjudication, as the assessment is based on physical performance and material properties rather than subjective interpretation requiring consensus.

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-powered diagnostic or assistive devices, which is not the nature of this needle guard.

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

• Not applicable. This device is a mechanical safety accessory, not an algorithm. Its performance is inherent to its design and material properties, not an AI or software component.

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

• The "ground truth" for this device would be established through engineering performance testing (e.g., strength, ease of use, ability to cover the needle) and biocompatibility testing to confirm material safety. This isn't a "ground truth" in the conventional sense of clinical diagnoses.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

• Not applicable. As there is no training set for an AI model, this question is not relevant.

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