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The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.

The Sterile Hypodermic Syringe for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of a hypodermic needle and a luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle gauge (refer to Table 1).

The provided document is a 510(k) Summary for a Sterile Hypodermic Syringe with needle for Single Use. This type of device is a physical medical instrument, not a software or AI/ML-based device.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device
• Study data proving an AI/ML device meets acceptance criteria
• Sample sizes for test sets (in the context of AI/ML)
• Number of experts for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Training set details (sample size, ground truth establishment)

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical tests (e.g., biological evaluation, sterility, mechanical performance) and comparison of technical characteristics, as summarized in the "Non-Clinical Test Conclusion" and "Substantially Equivalent (SE) Comparison" sections.

In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and performance study as requested. It pertains to a physical medical device.

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The Sterile Safety Syringe with Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. 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 needlesticks.

The Sterile Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. 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 needlesticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.

The Sterile Safety Syringe with Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Safety Hypodermic Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. The Sterile Auto-Disable Syringe with Needle for Single Use is available in various capacities of syringes.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The provided text describes a 510(k) summary for Sterile Safety Syringes and Needles. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a multi-reader multi-case (MRMC) study.

Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment for AI/ML device validation are not present in this document, as this is a traditional medical device submission.

However, I can extract information related to the non-clinical performance tests that serve as acceptance criteria for this type of device and how the device proved it met them.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this non-AI/ML device are primarily based on compliance with established international standards and demonstration of substantial equivalence to predicate devices through various non-clinical tests. The reported device performance is presented as meeting these standards and showing similar performance to predicates.

Additional Details (Based on available information and the nature of this submission):

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

   • The document does not specify exact sample sizes for each non-clinical test performed (e.g., how many syringes were tested for each performance characteristic, or how many samples for biocompatibility).
   • The data provenance is implied to be from non-clinical testing conducted by the manufacturer, Shandong Weigao Group Medical Polymer Co., Ltd. (China). These are laboratory tests, not human data. The document does not specify if the tests were performed retrospectively or prospectively relative to the submission date, but typical device testing for 510(k) is performed as part of the development and validation process.

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

   • N/A. This is a submission for a traditional medical device (syringes and needles), not an AI/ML device that requires human expert review to establish "ground truth" for interpretive tasks (like image classification). The "ground truth" for this device's performance is established by objective measurements and compliance with international standards in laboratory settings.

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

   • N/A. This concept applies to human reader studies often conducted for AI/ML devices where there might be disagreement among readers. For physical device testing, adjudication methods generally involve standardized measurement protocols and calibration, not expert 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. This is not an AI/ML device, so an MRMC study is not applicable or mentioned.

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

   • N/A. This is not an AI/ML device. The "standalone" performance here refers to the device itself meeting the defined physical and performance criteria.

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

   • The "ground truth" for this device's performance is based on objective, measurable criteria as defined by international standards (e.g., ISO, ASTM). For example:
     • Needle sharpness and bend resistance are measured via mechanical tests.
     • Syringe flow rates and accuracy are measured via fluid dynamics tests.
     • Biocompatibility is assessed through standardized biological assays.
     • Sterility is validated through microbiological testing (SAL).
     • Safety mechanism effectiveness is assessed via simulated use tests following FDA guidance and ISO standards.

8. The sample size for the training set:

   • N/A. This is a manufactured physical device, not an AI/ML algorithm that requires a "training set."

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

   • N/A. Not applicable.

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Enteral Feeding Bag and Set is intended to delivery, via a feeding pump, liquid nutrition formulas to an enteral access device (e.g. a feeding tube).

The proposed device, Enteral Feeding Bag and Set, has two models: one is enteral feeding set integrated with bag, the other is an individual enteral feeding set with a puncture needle which can be used along with other pre-filled formula container. Other components include: Roller Clamp, which is used to adjust the feeding rate; Tubings, which are used to connected components; Drip Chamber, which is intended for the user to observe the feeding condition; Echelon Fitting, which is a non-luer fitting, to connect Enteral Access Device. This fitting is provided to avoid mis-connection with I.V. devices.

This submission describes an Enteral Feeding Bag and Set, a Class II medical device, intended to deliver liquid nutrition formulas via a feeding pump to an enteral access device. The submission focuses on demonstrating substantial equivalence to a predicate device, Hospira Enteral Feeding Sets (K061432).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific acceptance criteria as quantitative targets (e.g., flow rate must be X +/- Y%). Instead, it states that "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device." This suggests that the acceptance criteria were based on meeting internal design specifications and demonstrating performance comparable to the predicate device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Laboratory testing".

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

The document states "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications..." However, it does not specify the sample size used for this testing. The data's provenance is from the manufacturer, ShanDong WeiGao Group Medical Polymer Co., Ltd, located in Weihai City, Shangdong, China. The testing would have been prospective, as it was conducted to validate the new device.

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

This information is not applicable to this type of device submission. The "ground truth" for an enteral feeding bag and set is typically established through engineering specifications, international standards (e.g., ISO standards for medical devices), and comparison with the performance of a legally marketed predicate device. It does not involve expert interpretation of medical images or clinical data in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical cases (e.g., for diagnostic accuracy). The laboratory testing for this device would have involved objective measurements against specifications rather than subjective expert consensus.

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 relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is being evaluated. For an enteral feeding set, the comparison is primarily based on functional performance against a predicate device and engineering specifications.

6. If a Standalone Study (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 an AI system. The testing performed was on the physical medical device itself.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance was established by:

• Engineering Design Specifications: The device was tested to ensure it met its own predetermined design specifications.
• Performance of the Predicate Device: The device was tested to demonstrate "substantial equivalence" to the legally marketed predicate device (Hospira Enteral Feeding Sets, K061432). This implies that the predicate device's established performance served as a benchmark for acceptable "ground truth" performance.
• Compliance with relevant standards (deduced): Although not explicitly stated as "ground truth," medical devices like this typically adhere to various international and national standards (e.g., ISO standards for medical devices, biocompatibility standards), which would form part of the underlying "ground truth" for safety and performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical product, not an AI or machine learning algorithm that requires a training set.

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

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

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The blunts include two models, which are blunt fill needle and blunt plastic cannula.

The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.

The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.

The blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is an 18G stainless needle tube with a luer slip hub. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. The hub is a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe. It is not intended to access the injection site on I.V. System. The blunt plastic cannula is a molded plastic blunt tipped cannula to penetrate pre-slit septum injection site on I.V. Safety Systems, which is designed for penetration with needleless I.V. access device, intended for injection and/or aspiration of fluid. It also has a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe to be filled. The blunt plastic cannula is used to replace hypodermic needles to prevent from the unintended injury by metal needle. These two products can be sold together in one immediate package or respectively in separate immediate packages.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) summary for a medical device (Blunt Fill Needle and Blunt Plastic Cannula), not an AI or software-as-a-medical-device (SaMD). Therefore, many of the requested fields (like "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop) performance," "effect size of how much human readers improve with AI vs without AI assistance," "sample size for the training set," etc.) are not applicable to this type of device and submission. The testing described is for physical characteristics of hardware, not performance of an algorithm.

Acceptance Criteria and Device Performance for Blunt Fill Needle and Blunt Plastic Cannula

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device, the "acceptance criteria" are compliance with established international standards and comparison to a predicate device. The "performance" is demonstrated by passing these tests.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes for each bench test conducted. It states that "Bench tests were conducted."
• Data Provenance: The tests were conducted by the manufacturer, ShanDong WeiGao Group Medical Polymer Co., Ltd, in China, to verify design specifications. This implies internal, prospective bench testing.

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

• Not Applicable. This is a hardware medical device. "Ground truth" in the context of expert consensus is not relevant here. The "ground truth" is adherence to engineering standards and functional performance requirements.

4. Adjudication Method for the Test Set

• Not Applicable. As the performance is based on objective measurements against engineering standards, an adjudication method for conflicting expert opinions is not relevant. The "adjudication" is the objective passing or failing of the specified tests.

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/SaMD device.

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

• Not Applicable. This is not an AI/SaMD device.

7. The Type of Ground Truth Used

• For the physical tests (e.g., luer slip connector compatibility, physical/chemical specs), the "ground truth" is defined by international engineering standards (ISO standards) and the functional performance requirements of the device (such as the ability to penetrate a vial stopper or connect to a syringe).
• For biocompatibility, the "ground truth" is compliance with ISO 10993 Standards.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/SaMD device. There is no "training set" in the context of machine learning.

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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Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician.

The subject device of Weigao Disposable Empty Cartridge Syringe is an empty cartridge syringe that consists of a hollow barrel and a movable plunger. The syringes are designed for manual use. The applicant syringe's main components are made of glass.

The provided text is a 510(k) summary for a medical device called "Weigao Disposable Empty Cartridge Syringe." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone performance.

The document primarily focuses on demonstrating that the device is substantially equivalent to a pre-existing device (K820164, Empty Sterile Carpuject® Cartridge) based on shared technical characteristics and safety/effectiveness.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

Information Present:

• Device Name: Weigao Disposable Empty Cartridge Syringe
• Intended Use: "Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician."
• Predicate Device: K820164, Empty Sterile Carpuject® Cartridge (by Hospira, Inc.)
• Testing Conducted (general):
  • Biocompatibility tests (following ISO 10993)
  • Performance bench tests (following ISO 11040-4, ISO 7886-1, ISO 9626)
• Device Description: "an empty cartridge syringe that consists of a hollow barrel and a movable plunger. The syringes are designed for manual use. The applicant syringe's main components are made of glass."
• Key Specifications Mentioned: "Model 1 ml Slim with scale marks (fixed with Needle 27G)"

Missing Information (Crucial for your request):

1. A table of acceptance criteria and the reported device performance: This document only states that performance bench tests were conducted following certain ISO standards (ISO 11040-4, ISO 7886-1, ISO 9626). It does not provide the specific acceptance criteria defined within those standards for this device, nor does it report the actual results of these tests (e.g., specific force measurements, leakage rates, etc.) against any criteria.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device and the testing refers to bench tests against standards, not diagnostic performance with human interpretation.
4. Adjudication method for the test set: Not applicable for this type of device and testing.
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 (syringe), not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: For physical performance tests, the "ground truth" would be the engineering specifications and requirements outlined in the ISO standards. The document only lists the standards, not the specific pass/fail criteria from them.
8. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

Based on the provided text, it's impossible to create the requested table of acceptance criteria and reported device performance, or to answer the majority of your questions. The document is a regulatory summary demonstrating substantial equivalence for a physical medical device, not a detailed study report for an AI or diagnostic tool. It indicates that certain types of tests were conducted according to international standards (ISO 10993, ISO 11040-4, ISO 7886-1, ISO 9626), but it does not specify the acceptance criteria used or the quantitative results achieved by the device.

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The Sterile Hypodermic Syringe for Single Use With/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The sterile Insulin Syringe for single use with needle is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The Retractable Auto-Disable Syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.

The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The provided 510(k) summary for K072739 describes Jierui Syringes and Needles, which are mechanical devices, not AI/ML-driven software. Therefore, the questions regarding acceptance criteria and studies typical for AI/ML performance evaluation (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and data provenance) are not applicable in this context.

Instead, the document details the substantial equivalence determination to predicate devices based on regulatory classification, intended use, sterilization specifications, performance, biocompatibility, chemical specifications, and physical/mechanical specifications.

Here's an overview of the "effectiveness and safety considerations" relevant to this medical device:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for Jierui Syringes and Needles are primarily based on achieving substantial equivalence to predicate devices and compliance with established performance standards and biological evaluation tests. The device's performance is reported in terms of meeting these standards for effectiveness and safety.

2. Sample Size and Data Provenance

Not applicable. This information is relevant for AI/ML performance studies, not for the substantial equivalence demonstration of mechanical medical devices like syringes and needles described here. The evaluation is based on compliance to standards and comparison to predicate devices, not on data sets.

3. Number of Experts and their Qualifications for Ground Truth

Not applicable. This information is relevant for AI/ML performance studies. For this device, "ground truth" is established by adherence to recognized standards (e.g., ISO 10993) and comparison to the characteristics of legally marketed predicate devices.

4. Adjudication Method

Not applicable. This is a concept related to reviewing discrepancies in expert opinions for AI/ML ground truth establishment.

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

No, a MRMC study was not done. This type of study is typically performed to evaluate the impact of AI assistance on human reader performance, which is not relevant for this mechanical device.

6. Standalone Performance Study (Algorithm Only)

No, a standalone performance study was not done. This concept is for AI algorithms, not for physical medical devices.

7. Type of Ground Truth Used

The "ground truth" for this submission is implicitly defined by:

• Compliance with recognized international standards: e.g., ISO 10993 for biological evaluation.
• Characteristics of legally marketed predicate devices: The Jierui Syringes and Needles are compared against previously cleared predicate devices (K070936, K071630, K053519, K070440) to establish substantial equivalence in terms of design, materials, intended use, and performance outputs.

8. Sample Size for the Training Set

Not applicable. This refers to AI/ML models.

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

Not applicable. This refers to AI/ML models.

In summary, the K072739 submission for Jierui Syringes and Needles demonstrates safety and effectiveness through a substantial equivalence argument, supported by compliance with relevant performance and biocompatibility standards, rather than through empirical studies involving human readers or AI algorithms on specific datasets.

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Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.

Blood collection needle is a sterile and disposable medical device. It is consist of a puncturing needle which is punctured into vein, a bottle needle which is insert to the blood collection bottle to collect blood, a needle holder which connects the puncturing needle and bottle needle, two needle caps which protect puncturing needle and bottle needle and a latex cover to protect bottle needle.

The provided text describes a 510(k) summary for a "Blood Collection Needle" and largely focuses on its substantial equivalence to a predicate device. This type of submission does not typically involve the detailed performance studies, particularly those related to AI algorithms or diagnostic accuracy, that your request for "acceptance criteria and reported device performance" (especially with specifics like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) implies.

Blood collection needles are low-risk devices where performance demonstration usually revolves around adherence to established international standards for physical characteristics, sterility, and biocompatibility, rather than diagnostic accuracy metrics.

Therefore, many of the specific questions in your prompt cannot be directly answered from the provided document because they are not relevant to the type of device (a hypodermic needle) or the nature of its 510(k) submission.

Here's an attempt to answer as much as possible, interpreting "acceptance criteria and reported device performance" as compliance with relevant standards and basic physical properties mentioned:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information and understanding of 510(k) for this device type)

1. Sample size used for the test set and the data provenance: Not explicitly stated. For compliance with ISO standards for physical characteristics and biocompatibility, samples would be drawn from production batches and subjected to laboratory testing. The data provenance would be laboratory test reports, likely conducted in China given the manufacturing location. This is not "data" in the sense of patient imaging or clinical records.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For these types of devices, "ground truth" refers to objective measurements against ISO standards (e.g., needle diameter, tensile strength, sterility testing results, cytotoxicity assays), not expert interpretation of medical images or conditions.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations, not objective performance testing against standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. MRMC studies are used for diagnostic imaging devices to assess human reader performance, often with and without AI assistance. This is a physical medical device (a needle), not a diagnostic tool where human interpretation is involved.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve algorithms or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Objective measurements against predefined ISO standard specifications and validated laboratory test methodologies for physical properties, sterility, and biocompatibility.

7. The sample size for the training set: Not applicable. This device does not use machine learning or AI models, so there is no "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary of what the document implies about "studies":

The "studies" for this device are laboratory-based performance tests and biocompatibility assessments conducted to demonstrate compliance with recognized international standards (ISO 7864, ISO 9626, ISO 10993). The conclusion of the submission is that "The applicant device is Substantially Equivalent (SE) to the predicate device," based on having the "same classification information, same indications and intended use, similar product design, same performance effectiveness, performance safety." This reliance on substantial equivalence, supported by standard compliance, is typical for 510(k) submissions of low-to-moderate risk medical devices without complex diagnostic or algorithmic components.

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