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The Terumo SurGuard®3 Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The Terumo SurGuard®3 Safety Hypodermic Needle [hereinafter referred to as "SurGuard 3 (Short Sheath 2)"] consists of a hypodermic needle with a hinged safety sheath attached to the connector hub which can be attached to either a luer slip or luer lock syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheathcollar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation.

The document describes the Terumo SurGuard®3 Safety Hypodermic Needle and its modifications. However, the provided text does not contain detailed information about acceptance criteria and a study that comprehensively proves the device meets those criteria in the format requested.

Specifically, the document states:

• "No deviations from recognized consensus ISO standards were identified, except where the design of the device resulted in a modified method or acceptance criterion." (page 10)
• "The device complies with the acceptance criteria established based on the predicate, as shown in the table below: Table 5.6: Performance Testing per Internal Standards" (page 10)
• "Performance testing demonstrates that the new Terumo SurGuard®3 Safety Hypodermic Needle conforms to the recognized consensus ISO standards (ISO 7864 and ISO 23908) and meets internal standards acceptance criteria." (page 10)

This indicates that acceptance criteria were established and met, but the specific numerical criteria for each test and the detailed results demonstrating conformance are not provided. The results are summarized as "Meets acceptance criteria" or "Meets standard."

Additionally, the document explicitly states:

• "This 510(k) does not include data from clinical tests." (page 11)

Therefore, much of the requested information regarding study details (sample size, data provenance, ground truth establishment, expert involvement, MRMC studies) is not available in the provided text.

Here's a summary of what can be extracted or inferred:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: Not specified, but generally, such performance testing is conducted by the manufacturer (Terumo (Philippines) Corporation). The nature of the tests (mechanical, sterilization, biocompatibility) suggests laboratory testing rather than human subject data. Retrospective/Prospective is not applicable in this context.

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

• Not applicable as the testing involves physical/mechanical performance and adherence to ISO standards and internal criteria, not expert interpretation of outputs.

4. Adjudication method for the test set

• Not applicable as the testing involves physical/mechanical performance and adherence to ISO standards and internal criteria.

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 a medical device (hypodermic needle) and not an AI/imaging device. The document explicitly states: "This 510(k) does not include data from clinical tests." (page 11)

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

• No. This is a medical device (hypodermic needle) and not an AI/imaging device.

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

• For the physical and mechanical performance tests, the "ground truth" would be the established specifications, engineering tolerances, and requirements set forth by ISO standards (ISO 7864, ISO 23908, ISO 11137-1, ISO 14971) and the manufacturer's internal standards.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device.

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

• Not applicable as this is not an AI/machine learning device.

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TERUMO® SURFLO® I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.

The TERUMO® SURFLO® I.V. Catheter is a device consisting of a catheter assembly (catheter, caulking pin, and catheter hub) and needle assembly (needle, needle hub, filter cap and filter). The device is an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

Here's an analysis of the acceptance criteria and supporting studies for the TERUMO® SURFLO® I.V. Catheter, based on the provided 510(k) summary:

This device is not an AI device, therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, training set details) are not applicable. The provided document details a traditional medical device submission for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TERUMO® SURFLO® I.V. Catheter are based on conformity to recognized consensus ISO standards and specific internal performance tests. The reported performance indicates that the device Meets Standard or Meets acceptance criteria for all tests.

Biocompatibility Tests:

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

The document does not specify the exact sample sizes (number of units tested) for the performance tests. It states that "Performance testing was conducted to ensure the safety and effectiveness... and demonstrate substantial equivalence to the predicate device."
The data provenance is from the manufacturer, Terumo (Philippines) Corporation, and the tests were performed on the new device, comparing it to the legally marketed predicate device (K891087) manufactured by Terumo Medical Corporation, Elkton, Maryland. These are considered prospective tests performed on the device being submitted for clearance.

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

This information is not applicable as the device is a physical medical instrument (intravascular catheter), not an AI/software device that relies on expert interpretation for ground truth. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set

This information is not applicable because the performance tests involve objective measurements and comparisons against established standards, not subjective interpretations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and AI assistance can impact their performance. This is not relevant for an intravascular catheter.

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

No, a standalone performance test in the context of an algorithm's performance was not done. The "standalone" performance here refers to the device's physical and biological characteristics as it would be used, independent of human interaction other than proper insertion and operation.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Established consensus standards: International Organization for Standardization (ISO) standards (e.g., ISO 10555 series, ISO 594 series, ISO 11137 for sterilization, ISO 10993-1 for biocompatibility).
• Predefined acceptance criteria: Internal specifications for physical properties and functionality (e.g., fitting forces, leakage, flashback, needle penetration).
• Demonstrated performance of a legally marketed predicate device: The new device's performance is compared to that of the predicate device (K891087) to establish substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

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

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The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

The TERUMO® NEEDLE is a hypodermic sterile single lumen needle, consisting of a stainless tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe or an intravascular administration set.

The provided text describes the 510(k) summary for the TERUMO® Needle, a hypodermic single lumen needle. The focus of this document is to demonstrate substantial equivalence to previously cleared devices rather than to present a de novo study with detailed acceptance criteria and performance metrics for a new device.

Therefore, many of the specific details requested in your prompt regarding acceptance criteria and performance studies, such as sample sizes for test sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training sets, are not applicable to this type of submission. This document primarily relies on the equivalency of the new device to existing devices based on several performance tests.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in the format typically seen for novel device efficacy studies. Instead, it states that:

• Performance Tests Performed:
  • Protector Pit
  • Adhesive Hold
  • Conical Fitting
  • Seal Strength
• Outcome Statement: "None of the data raises any new issues on safety and effectiveness." This implies that the device met the internal specifications and standards set by Terumo (Philippines) Corporation for these tests, which are presumably deemed equivalent to those of the predicate devices. However, the specific numerical acceptance thresholds and the quantitative results are not disclosed in this summary.

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

• Sample Size: Not specified. The document only mentions that performance tests were "performed on the TERUMO® Needle manufactured by Terumo (Philippines) Corporation."
• Data Provenance: The device is manufactured by Terumo (Philippines) Corporation. The data would therefore originate from their internal testing. It's a prospective internal test for the new device variant to confirm its manufacturing quality and performance against established specifications.

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

• This is not applicable. The performance tests listed are mechanical and material engineering tests (e.g., strength of adhesive, fit of conical parts, seal integrity). These do not typically involve human expert interpretation or "ground truth" establishment in the way that diagnostic imaging or clinical decision support AI devices would. The "ground truth" for such tests would be defined by engineering specifications and objective measurements.

4. Adjudication method

• Not applicable, for the same reasons as #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 a physical medical device (a hypodermic needle), not an AI algorithm or a diagnostic imaging system. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• For the listed performance tests (Protector Pit, Adhesive Hold, Conical Fitting, Seal Strength), the "ground truth" would be established by engineering specifications and objective measurements against industry standards (e.g., ISO standards for Luer connectors) and the manufacturer's internal quality control criteria, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The device's design and manufacturing processes are informed by established engineering principles and prior experience with similar devices, not by a data-driven training process.

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

• Not applicable, as there is no training set.

In summary, the 510(k) process for a device like a hypodermic needle heavily relies on demonstrating equivalence to predicate devices through design, materials, intended use, and a set of standard performance and safety tests. The detail of these tests, while crucial for the submission, is often summarized at a high level in the public 510(k) summary, with the most critical information being the confirmation that "None of the data raises any new issues on safety and effectiveness," thereby establishing substantial equivalence.

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The TERUMO® SurGuard®3 Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TERUMO SurGuard®3 Safety Needle is compatible for use with standard luer slip and luer lock syringes.

Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The Terumo SurGuard 3 Safety Hypodermic Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheath-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger, thumb or surface activation.

The safety sheath has a finger guide area consisting of a circular dent (for thumb activation) and ramp (for finger activation) which gives the user a concrete confirmation that the user's finger is in the appropriate position in performing the activation. The ramp has steps to provide strong grasp when activating the sheath, There are two stoppers located at the end of the circular dent and ramp which prevent the user's finger from going towards the cannula during activation. Another method of activation is by manually pressing the safety sheath over the needle using a firm surface.

The locking mechanisms are positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use.

The Terumo SurGuard 3 Safety Hypodermic Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe.

The manufacturer, TERUMO (PHILIPPINES) CORPORATION, conducted multiple performance tests to demonstrate the substantial equivalence of their TERUMO® SurGuard®3 Safety Hypodermic Needle and with attached syringe. This submission primarily introduced new needle gauge sizes, lengths, and a 1cc/ml syringe size, along with a modified shorter safety sheath design, compared to their previously cleared device (K113422).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly list numerical acceptance criteria values for each test. Instead, it states that the results of the verification testing "met the acceptance criteria of the functional performance tests of both devices" (referring to the proposed and predicate devices). The general acceptance criterion for these tests appears to be that the proposed device performs comparably to or as well as the predicate device, confirming its safety and effectiveness.

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: The document does not specify the exact sample sizes (number of devices) used for each individual performance test (Sheath Activation, Puncture, etc.). It mentions that the "Simulated Use Study" involved "healthcare workers with varied amounts of experience," but doesn't quantify the number of participants or devices used in that study.
• Data Provenance: The studies were conducted by TERUMO (PHILIPPINES) CORPORATION. The country of origin for the actual testing data would therefore be the Philippines. The studies appear to be prospective in nature, as they involve testing newly manufactured devices to verify their performance against specifications and predicate devices. Accelerated aging for shelf-life testing also falls under a prospective study design.

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)

• The document does not mention the use of experts to establish a "ground truth" in the typical sense for a diagnostic device. The performance tests are largely objective, measuring mechanical and functional aspects of the device against predefined specifications or the performance of a predicate device.
• For the "Simulated Use Study," it states that "healthcare workers with varied amounts of experience" performed the activations. Their "experience" implies a level of expertise, but specific qualifications or a "ground truth" establishment process by experts as one might find in clinical image analysis are not described. Their role was to assess if the device could be "safely activated" and if the "Instructions for Use were adequate."

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

• Given the nature of the performance tests (functional, mechanical, physical measurements), an adjudication method like "2+1" or "3+1" (common in human-read diagnostic studies) is generally not applicable. These tests typically involve objective measurement or observation against a pass/fail criterion.
• For the "Simulated Use Study," the report states it "was concluded that the proposed Terumo SurGuard 3 Safety Hypodermic Needle met its intended use, and the Instructions for Use were adequate." This implies an overall assessment of the outcomes rather than an adjudication of individual 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices (especially those involving human interpretation of images or data, often with AI assistance). The TERUMO® SurGuard®3 Safety Hypodermic Needle is a physical medical device, not a diagnostic tool, and therefore MRMC studies are not applicable to its evaluation.

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

• The concept of a "standalone algorithm" is not applicable here as the TERUMO® SurGuard®3 Safety Hypodermic Needle is a physical medical device and not an AI algorithm. Its performance is inherent in its physical design and manufacturing.

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

• For the functional and physical performance tests, the "ground truth" is implied by the pre-defined engineering specifications, international standards (ISO), and the performance of the legally marketed predicate device (K113422). The device is essentially compared against these objective benchmarks.
• For the "Simulated Use Study," the "ground truth" was whether the device could be "safely activated" as intended, considering the Instructions for Use. This is verified through direct observation of actions by healthcare workers rather than an established "ground truth" from external sources like pathology or outcomes data.

8. The sample size for the training set

• This device is not an AI algorithm or a diagnostic tool that requires a "training set" in the context of machine learning. Therefore, the concept of a training set sample size is not applicable.

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

• As the device is not an AI algorithm, there is no "training set" and thus no "ground truth for the training set" to be established.

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The TERUMO® SurGuard®3 Safety Needle device is intended for use in the aspiration and iniection of fluids for medical purposes. The TERUMO SurGuard 3 Safety Needle is compatible for use with standard luer slip and luer lock syringes.

Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The TERUMO SurGuard®3 Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the sheath tooth-cannula and sheath wings-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger or thumb, or by surface activation.

The safety sheath has a finger guide area consisting of a circular dent (for thumb activation) and ramp (for finger activation) which gives the user a concrete confirmation that the user's finger is in the appropriate position in performing the activation. The ramp has steps to provide strong grasp when activating the sheath. There are two stoppers located at the end of the circular dent and ramp which assist in preventing the user's finger from going towards the cannula during activation. Another way of activation is by manually pressing the safety sheath over the needle using a firm surface.

The locking mechanisms are positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use. The needle gauge sizes fall within the 18 to 25 gauge range and the needle lengths are 1" to 2".

The TERUMO SurGuard®3 Safety Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe. The syringe sizes are 3, 5, and 10cc/ml.

This 510(k) summary for the Terumo SurGuard®3 Safety Needle focuses on demonstrating substantial equivalence to a predicate device (Terumo SurGuard®2 Safety Needle) rather than providing extensive details about a specific study proving acceptance criteria. In 510(k) submissions, manufacturers often rely on substantial equivalence to existing devices and performance data that supports the safety and effectiveness of the changes made, rather than a full de novo acceptance criteria study for every parameter.

Based on the provided text, a detailed acceptance criteria table with reported performance from a specific study, as well as many of the requested study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details), are not explicitly provided in this 510(k) summary. The document primarily discusses design modifications and general safety and biocompatibility testing.

However, I can extract what is available and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for the SurGuard®3, nor does it present "reported device performance" in a quantitative, study-specific manner as one might expect for a new performance claim. Instead, it focuses on demonstrating that the modifications to the SurGuard®2 design (specifically the dual locking mechanisms and additional activation methods) do not raise new safety or effectiveness concerns.

The implicit 'acceptance criteria' used for 510(k) often revolve around comparability to the predicate device and meeting relevant standards. The performance aspects discussed are qualitative improvements in safety feature activation.

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

• Sample Size: Not specified in the provided text for any specific performance testing that would generate these criteria. The document mentions "Manufacturing controls include visual, functional and sterility tests" but does not detail the sample sizes for these.
• Data Provenance: Not explicitly stated as "country of origin" for any specific test data. The device is manufactured by Terumo (Philippines) Corporation. Testing is generally assumed to be conducted in accordance with international standards, but the specific location of testing is not detailed here. It's retrospective in the sense that it's a submission of data to support a regulatory claim, but the nature of the data (e.g., if it involved human subjects or collected historical data) is not specified.

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

• This information is not provided in the summary. For a medical device like a safety needle, "ground truth" often refers to objective physical measurements or established scientific standards rather than expert consensus on a subjective judgment.

4. Adjudication Method for the Test Set

• This information is not provided in the summary, as it's not relevant to the type of device and testing discussed (which focuses on physical and biological properties rather than interpretive expert agreement).

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 type of study is relevant for diagnostic imaging AI devices, where human readers interpret medical images. The SurGuard®3 Safety Needle is a physical medical device, not an AI-powered diagnostic tool.

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 not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for this medical device's performance would primarily involve:
  • Objective physical measurements: Demonstrating the locking mechanisms engage, that the sheath covers the needle, the gauge and length specifications, etc.
  • Established standards: Compliance with ISO standards for sterilization (ANSI/AAMI/ISO 11137) and biocompatibility (ISO 10993).
  • Functional tests: Verification of aspiration/injection capability and compatibility with syringes.
• The summary does not detail specific "ground truth" establishment methods beyond stating compliance with standards and successful testing.

8. The Sample Size for the Training Set

• This is not applicable as the device is not an AI/machine learning model that requires a "training set."

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

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

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