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The 1NEED Pro is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.

The 1NEED Pro is a minimally invasive microneedling device that microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The 1NEED Pro is comprised of a reusable pen body, a sterile, single use microneedling cartridge and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending of the skin being treated. Charging is accomplished by attaching the 1NEED Pro pen body to the power adapter.

The provided text describes a 510(k) premarket notification for a microneedling device named "1NEED Pro." While it discusses the device's intended use, technological characteristics, and results from non-clinical bench testing, it does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of clinical performance (e.g., efficacy in improving acne scars).

The document focuses on demonstrating substantial equivalence to a predicate device (K230420) based on similar indications for use and technological features, and the results of various engineering and safety bench tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to efficacy (e.g., reduction of acne scars) or details about a clinical study. The document explicitly mentions "Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)" but then only lists "Bench testing."

Here's a breakdown of what can be extracted based on the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance (Related to Efficacy - Missing)

• There is no information on acceptance criteria for clinical effectiveness (e.g., a specific percentage improvement in acne scar appearance) or reported device performance against such criteria. The document focuses on demonstrating that the device performs similarly to its predicate and passes engineering/safety tests.

2. Sample Size Used for the Test Set and Data Provenance (Missing for Clinical Efficacy)

• The document lists various bench tests (e.g., Motor Speed Puncture Rate Testing, Needle Penetration Depth and Extension Accuracy Testing, etc.). For these engineering tests, the sample sizes and data provenance are not specified.
• For clinical efficacy, this information is entirely missing, as no clinical study is described.

3. Number of Experts Used to Establish Ground Truth and Qualifications (Missing)

• This information is typically relevant for studies involving human assessment (e.g., assessing the severity of acne scars before and after treatment). Since no clinical efficacy study is described, this information is missing.

4. Adjudication Method (Missing)

• Similar to point 3, adjudication methods are used in clinical studies to resolve discrepancies between expert assessments. Since no clinical efficacy study is described, this information is missing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not Conducted/Not Described)

• The document does not mention any MRMC study. It focuses on the device performing as well as the predicate through technological comparison and non-clinical tests.

6. Standalone (Algorithm Only) Performance (Not Applicable/Missing)

• The "1NEED Pro" is a physical microneedling device, not an algorithm or AI software for diagnosis or image analysis. Therefore, a standalone performance study in that context is not applicable.

7. Type of Ground Truth Used (Missing for Clinical Efficacy)

• For the described bench tests, the "ground truth" would be engineering specifications or expected physical properties, which were then measured against.
• For clinical efficacy, this information is missing as no clinical study defining a ground truth for acne scar improvement is described.

8. Sample Size for the Training Set (Not Applicable/Missing)

• The device is a physical microneedling pen, not a machine learning algorithm that requires a training set in the conventional sense. Therefore, this information is not applicable.

9. How the Ground Truth for the Training Set was Established (Not Applicable/Missing)

• As above, this is not applicable for a physical device.

Summary of available information from the document related to "acceptance criteria" and "proof":

The document argues for substantial equivalence primarily based on:

• Same intended use: "The 1NEED Pro is a microneedling device intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older." This is identical to the predicate device.
• Same technological characteristics and mode of action: Both the 1NEED Pro and the predicate device use microneedling for the stated indication. Specific characteristics like power source, control mechanism, speed, puncture rate, needle details (number, gauge, material, shape, spacing), penetration depth settings, and sterility of cartridges are compared and deemed similar.
• Non-clinical (bench) testing: These tests demonstrate that the device meets engineering specifications and safety requirements. The conclusion states: "Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device."

The listed bench tests are:

• Motor Speed Puncture Rate Testing
• Needle Penetration Depth and Extension Accuracy Testing
• Needle Bonding Strength Test
• Use Life Testing
• Cartridge Life Testing
• Anti-suction Testing
• Microbial Ingress Testing

The document does not provide specific numerical acceptance criteria or results for these bench tests in a detailed table or report. It only lists that these tests were conducted and concluded the device is "as safe, as effective, and performs as well as the legally marketed predicate device." This implies that the device met the internal specifications and performance levels established as acceptable for these bench tests, leading to the conclusion of substantial equivalence. However, the exact criteria and results are not detailed in this 510(k) summary.

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