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The TM Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TM 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 needle-stick.

The TM Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.

The provided document is a 510(k) summary for the ThinkMed Medical Technology Co., Ltd. TM Safety Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of a device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance studies cannot be extracted from this document.

The document only states that "Non clinical tests were conducted to verify that the subject device met all design specifications and was substantially equivalent to the predicate devices" and "The non-clinical test results demonstrated that the subject device complies with the following standards: ISO 7864, ISO 9626, ISO 23908."

To answer your questions accurately, a detailed test report or a full submission document with specific study methodologies and results would be required.

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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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