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The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I. Il and/or III in the following facial areas: qlabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.

The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles.

The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50-60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A.

The frequency of the handpiece can be adjusted from 100-150Hz and is indicated on a display. The needle penetration is adjusted by the needle protrusion setting dial, which can be adjusted between 0.0 (min.) and 1.9 mm (max.).

The standard safety needle cartridge (6-needle plate) contains 6 stainless steel microneedles of 1.5 mm length (0.35 mm gauge) and an internal safety membrane. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use ONLY.

The provided text is a 510(k) Summary for the Exceed Unlimited microneedling device. It describes the device, its intended use, and compares it to a predicate device (Exceed Microneedling device) to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria for a study demonstrating device performance, nor does it present the results of such a study in a quantitative manner (e.g., a table of performance metrics). Instead, it primarily focuses on non-clinical performance testing and risk mitigation measures to establish substantial equivalence.

Based on the provided text, I can infer some aspects and highlight what is explicitly stated versus what is absent:

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

• Absent. The document does not provide a table of acceptance criteria nor reported quantitative device performance metrics from a study. It only lists performance characteristics that were tested during non-clinical performance testing.

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

• Absent directly. The document mentions "non-clinical performance data" and "accuracy of needle penetration depth and puncture rate in pig skin." While this indicates the type of test, it does not specify the sample size used (e.g., number of pigs, number of punctures, number of test runs).
• Data Provenance: The pig skin tests would be considered experimental/laboratory data, not human patient data. The document does not mention the country of origin for these tests. It implicitly would be from the manufacturer's testing facilities or a contracted lab. The tests are not from retrospective or prospective human clinical studies for performance metrics.

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

• Absent. This information is relevant for human-in-the-loop studies or studies relying on expert-verified data, typically clinical studies. Since the described performance testing is non-clinical (on pig skin), the concept of "experts establishing ground truth" in the diagnostic sense is not applicable here. The "ground truth" for the pig skin tests would be the measured physical properties (e.g., actual penetration depth, puncture rate) using high-speed cameras or other measurement tools.

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

• Absent. Adjudication methods are typically used in clinical trials where multiple readers or experts assess outcomes. As the described performance testing is non-clinical/technical, this concept does not apply.

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:

• Absent. This device is a microneedling device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function and was not performed or described.

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

• Not applicable in the typical sense of AI/software. This is a hardware microneedling device. Its "performance" is evaluated by its physical characteristics (e.g., needle penetration accuracy, frequency, safety features). There isn't an "algorithm only" performance metric in the way it would apply to a diagnostic AI. The performance data mentioned (e.g., accuracy of needle penetration) are inherent to the device's mechanical operation.

7. The type of ground truth used:

• For the non-clinical performance testing mentioned ("Accuracy of needle penetration depth and puncture rate in pig skin with high-speed camera measurement"), the ground truth would be physical measurements (e.g., actual depth measured from camera footage or other instruments). It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This section is relevant for machine learning models. The Exceed Unlimited is a physical medical device, not a software AI model that requires a training set.

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

• Not applicable. As per point 8, there is no training set for this type of device.

In summary, based solely on the provided text, the document focuses on demonstrating substantial equivalence through non-clinical performance and safety testing, rather than presenting a performance study with acceptance criteria and quantitative results. The provided information is insufficient to complete the requested table and fully answer all questions, as many are relevant to AI/diagnostic software devices, not a microneedling device.

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The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The Exceed micro needling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless-steel nicro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece holder, Handpiece cover, Footswitch, Power supply
The control unit switches the device on and off and contains the power source (5.5-12 V, DC (150mA)). The control unit adjusts the frequency of the needle strom 100-150Hz using a digital display and a kevpad. The control unit receives power via a coaxial connector from a standard 100-240V, 50-60Hz, 1.2A wall socket transformer with an output of 15V. The handpiece contains a motor that moves the needles and a needle protrusion dial that allows the user to control the depth of the needle protrusion. The handpiece contains a scale that allows for the needle protrusion depth to be adjusted by the operator. The scale has a tolerance of +/-0.15 mm. The standard safety needle cartridge is a 6-stainless steel micro needle plate of 1.5 mm length. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use only. This standard safety needle cartridge is used for microneedling only. The length of needles is 1.5 mm. In combination with the handpiece needle protrusion can be adjusted between 0.0 mm (min) and 1.5 mm (max).

This document is a 510(k) summary for the Exceed Microneedling device, demonstrating its substantial equivalence to a predicate device. It includes information on the device's intended use, technological characteristics, and results from non-clinical and clinical performance testing. However, it does not explicitly define acceptance criteria as a standalone table with numerical thresholds for performance metrics. Instead, the "acceptance criteria" are implied by the clinical study's objective: to assess effectiveness by demonstrating a "clinically meaningful result" (defined as a >1 grade improvement on the Lemperle scale) in specific facial areas, and to assess safety by monitoring adverse events.

Here's an attempt to structure the information based on your request, inferring "acceptance criteria" from the study's stated goals and results:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical Study/Test Set): 48 subjects were recruited for the study and 48 subjects completed the study.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data in "human-readable" form. However, the submitter's address is listed as "Gustav-Krone-Str. 3, 14167 Berlin, Germany," implying the study could have been conducted in Germany or overseen by the German entity. The study was conducted at a "single center." The study appears to be prospective as it involves recruitment of subjects, a treatment protocol, and follow-up assessments over time.

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

• Number of Experts: Three (3) physicians.
• Qualifications of Experts: They are described as "physicians" who independently analyzed randomized digital images using the Lemperle (2001) grading scale. No further specific qualifications like years of experience or specialization are provided in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: The digital images were randomized and "analyzed independently by 3 physicians." The document does not specify an adjudication method like 2+1 or 3+1 if there were discrepancies in grading. It reports the results as aggregate percentages (e.g., "Subjects graded as having a ≥1 grade improvement"). It seems the consensus of the three reviewers was used, or the average/majority was taken, but the exact arbitration process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This study evaluates the effectiveness and safety of a microneedling device itself, not an AI system. The "multi-reader" aspect refers to the three independent physicians assessing patient outcomes after treatment with the device, not assessing AI performance or AI-assisted human performance.

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

• Not applicable. This document describes a medical device (microneedling device), not an algorithm or AI. Therefore, no standalone algorithm performance was evaluated.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for effectiveness was established by expert consensus (independent grading by 3 physicians using the validated Lemperle (2001) grading scale based on digital images). For safety, the ground truth was based on physician-reported adverse events and patient-reported outcomes (erythema, pain, discomfort, skin peeling).

8. The Sample Size for the Training Set

• Not applicable. This device is hardware for a procedure, not an AI model that requires a training set. The clinical study described served as a validation/test set for the device's performance in humans.

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

• Not applicable. As stated above, this is not an AI device requiring a training set.

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