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The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs.

The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use.

The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock'unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick.

The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.

The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The LDS Needle and OcuSafe® LDS Needle have a removable cap that is removed prior to the needle's use. The SteriCap® LDS Safety Needle and VitreJect® LDS Safety Needle have a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Needle / SteriCap® LDS Needle are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needle and OcuSafe® LDS Needle are suitable for intravitreal use.

The provided text describes a 510(k) submission for several needle devices, primarily focusing on the addition of a "low dead space (LDS)" specification. The submission claims substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The primary new acceptance criterion mentioned is for "Low Dead Space (LDS)".

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

• Low Dead Space (LDS) Testing:

  • Sample Size: 58 samples (for 95% confidence and 95% reliability)
  • Data Provenance: Not specified (country/retrospective/prospective)

• Other Testing (Biocompatibility, Performance, Sterilization, etc.): The specific sample sizes for each of these tests are not provided in the summary. The text implies these tests were conducted as part of the overall validation process, often following international standards (ISO, USP, AAMI, ASTM). No information about data provenance (country, retrospective/prospective) is given for these tests. The text states these characteristics "did not change from devices under the respective previously cleared 510(k)s," suggesting that much of this data might be carried over from previous submissions for very similar devices.

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 device is a physical medical needle, not an AI or imaging device that requires expert interpretation for a "ground truth" establishment in the traditional sense of clinical studies. The "ground truth" for the performance characteristics (e.g., dead space volume, material strength, biocompatibility endpoints) is established through standardized laboratory testing and measurement against pre-defined engineering and biological criteria outlined in the referenced ISO, USP, AAMI, and ASTM standards. The summary does not specify the number or qualifications of individuals conducting these laboratory tests.

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

Not applicable. This is not a study requiring expert adjudication of diagnoses or findings. The "test set" here refers to physical samples undergoing laboratory measurements.

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 (needle) and does not involve AI assistance or human readers for diagnostic interpretation.

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

Not applicable. This is a medical device (needle) and does not involve an algorithm.

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

The "ground truth" for verifying the device's characteristics is based on:

• Direct Measurement/Quantitative Analysis: For specifications like low dead space volume (≤ 5µL), needle length, gauge.
• Standardized Laboratory Tests: For biocompatibility endpoints (e.g., cytotoxicity, endotoxin levels), material properties, sterilization efficacy, and packaging integrity. These tests compare results against established thresholds defined by international standards (ISO, USP, AAMI, ASTM).
• Engineering Specifications: For physical characteristics and design integrity.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this summary.

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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Sterile Syringe with Fixed Safety Needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks.

Sterile Syringe with Fixed Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe and fixed needle with a safety mechanism. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The proposed device is available in a variety combination of syringe volume and needle size.

This document is a 510(k) Premarket Notification from Gemtier Medical (Shanghai) Inc. for a "Sterile Syringe with Fixed Safety Needle for Single Use." The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about an AI/ML-driven medical device. The acceptance criteria and study described are for a physical medical device (syringe and safety needle), focusing on its mechanical, material, and safety performance, rather than an AI algorithm's performance on data.

Therefore, I cannot provide the detailed information requested in the prompt, as it pertains to AI/ML acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types).

The document specifically mentions:

• No clinical study is included in this submission. (Page 10)
• The studies performed are non-clinical tests verifying the physical device's specifications, such as needle performance according to ISO standards, syringe performance, sharp injury protection, simulated clinical study for the safety feature, biocompatibility testing, sterility, shipping, and shelf-life. (Pages 8-9)

Because the provided text is about a physical medical device and not an AI/ML product, the questions related to AI/ML device performance and evaluation methodologies are not applicable.

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