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The ATI-014A insulation and continuity testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments. The ATI-021 has the same indications for use for insulation testing, but does not include continuity testing.

The tester is a non-sterile multiple use handheld device operated by 9V battery. An embedded software (firmware) is used to program a microcontroller hardware platform, that interface the user's actions with visual and audible output signals. The tester is used pre-operating room by nurses in hospitals, for the purpose of verifying the insulation (for ATI-021 and ATI-014A) and continuity (for ATI-014A) of electrosurgical instruments. The tester is tested for functionality prior to each use.

The document provided is a 510(k) summary for the Jac-Cell Medic testers (models ATI-014A and ATI-021). It focuses on demonstrating substantial equivalence to a predicate device (ATI-014), rather than providing detailed acceptance criteria and a study report as typically seen for novel device performance claims.

Based on the information available, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with defined thresholds and confidence intervals. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technical characteristics.

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

• Sample Size: The document does not specify a "sample size" for a performance study in the typical clinical or statistical sense. The assessment is based on bench testing of the subject devices (ATI-014A and ATI-021) against the characteristics of the predicate device (ATI-014). This implies testing of the manufactured device units themselves, not a dataset of patient cases.
• Data Provenance: The document only states "Bench testing confirms same performance to predicate device(s)." This indicates the testing was conducted internally by the manufacturer or a contracted lab. There is no mention of country of origin for data or whether it was retrospective or prospective, as these are not relevant for bench testing of device characteristics.

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

Not applicable. This is a bench test comparing device specifications and performance characteristics, not a diagnostic or AI-assisted interpretation of medical images/data requiring expert ground truth establishment. The "ground truth" here would be the known, objective specifications and performance of the predicate device and the measurement results from the subject devices.

4. Adjudication method for the test set

Not applicable. There was no need for adjudication as the testing involved objective measurements and comparisons of technical specifications and performance during bench testing, not subjective 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

Not applicable. This device is an electrosurgical instrument tester, not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

Not applicable. This device is an instrument tester with embedded firmware, not an AI algorithm. Its performance is inherent to its design and functional testing.

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

The "ground truth" for this substantial equivalence claim is:

• Predicate Device Specifications: The known, documented technical characteristics and performance of the legally marketed predicate device (ATI-014).
• Engineering Measurements and Standards: The measurements obtained during bench testing of the subject devices (ATI-014A, ATI-021) compared against the predicate's performance and relevant industry standards (e.g., IEC, FCC).

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. There is no training set for this device.

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The ATI-014 Insulation and Continuity Testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments.

The ATI 014FC Insulation and Continuity Tester and InsulScan Insulation Testing System have the same indications for use, basic design, both are battery operated battery operated and rechargeable.

The provided text describes a 510(k) premarket notification for an Insulation and Continuity Testing System. However, it does not include acceptance criteria, specific study designs, performance data (beyond general statements about equivalence), or details about ground truth establishment, sample sizes for training/testing, expert involvement, or adjudication methods.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory equivalence to a predicate device rather than presenting detailed performance studies.

Here's how I would answer each point given the lack of information:

Acceptance Criteria and Device Performance Study Information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified in the provided text.

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):

• Not specified in the provided text. The submission relies on demonstrating equivalence to a predicate device rather than independent clinical or performance data with expert-adjudicated ground truth.

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

• Not applicable as no specific test set or expert adjudication process is described.

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. The device is an Insulation and Continuity Tester, not an AI-assisted diagnostic tool that would involve human readers or AI improvement metrics.

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

• The document implies standalone performance comparison to a predicate device, but no specific study details are provided. This is a device for testing insulation, not an AI algorithm.

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

• Not specified. The basis for equivalence seems to be "basic design" and "indications for use" being the same as the predicate, rather than comparison against an established ground truth for instrument insulation issues.

8. The sample size for the training set:

• Not applicable/Not specified. This is a hardware device submission, not an AI/ML algorithm requiring a training set in the conventional sense.

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

• Not applicable. No training set is mentioned as this is not an AI/ML algorithm submission.

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