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Provides illumination to enhance visibility in the clinical working area during ultrasonic scaling procedures with the Steri-Mate handpiece.
When the lighted sleeve is installed on the Steri-Mate handpiece, the soft tapered grip provides multiple pinch points, to enhance ergonomics and improve clinicia, confort.
The Steri-Mate handpiece with the lighted sleeve is steam sterlizeable which reduces the risk of cross contamination.

Device Description

The Steri-Mate Handpiece Sleeve with LED Light is an accessory that easily slides over the Steri-Mate handpiece (predicate device) to generate a focused light to illuminate the clinician's working area during an ultrasonic procedure. The sleeve uses the energy generated from the Steri-Mate handpiece to generate light output when the ultrasonic unit's foot control is activated.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Steri-Mate Handpiece Sleeve with LED Light." This document describes the device, its intended use, and its technological characteristics, along with regulatory correspondence. However, it does not contain information about acceptance criteria, specific device performance numbers, or detailed study methodologies (like sample sizes, ground truth establishment, or expert qualifications) that would typically be found in a clinical study report.

Therefore, I cannot provide a table of acceptance criteria vs. reported device performance or other detailed study information asked for in your prompt because that specific information is not present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Steri-Mate Handpiece for Cavitron JET Unit, K941392) based on the prior use of components, performance data (not detailed in this section), and biocompatibility data.

Here's what I can extract and what is explicitly missing:

Missing Information Summary:

The provided text does not contain the following details required to answer your prompt fully:

Quantitative Acceptance Criteria: There are no specific numerical thresholds or performance targets mentioned for the device.
Reported Device Performance: While "performance data provided" is mentioned, the actual data or metrics are not detailed in this summary.
Study Details: There is no description of any specific study (e.g., clinical trial, pre-clinical study, or validation study) with methodologies, sample sizes, ground truth establishment, expert involvement, or adjudication methods.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No mention of such a study.
Standalone Performance: No mention of specific standalone algorithm performance (as this is a physical device, not an AI algorithm).
Training Set Information: No information about a training set, as this is not an AI/machine learning device.

Based on the provided text, here is what can be inferred or explicitly stated:

This device is a physical accessory (a sleeve with an LED light) for an existing dental handpiece, not an AI or software device that would typically involve extensive performance metrics, ground truth, or expert review in the way your prompt implies for AI/diagnostic devices. The "performance data" mentioned would likely pertain to aspects like light output, durability, and ergonomic benefits, which are not quantified here.

The "study" referenced implicitly in the 510(k) process is the demonstration of substantial equivalence to a predicate device (K941392). This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Key points from the text related to "proof" and "criteria":

Safety and Effectiveness Justification: The manufacturer states, "We believe that the prior use of the components of the Steri-Mate Handpiece Sleeve with LED Light in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the Steri-Mate Handpiece Sleeve with LED Light for the indicated uses."
Biocompatibility Testing: The device "passed biocompatibility testing for L929 MEM Elution Test - ISO, Oral Irritation Test - Acute Exposure - ISO and Kligman Maximization Test - ISO." These are the specific "acceptance criteria" and "study" (tests) mentioned in the document.

Reformatted information based on your request, highlighting missing data:

Information Type	Device: Steri-Mate Handpiece Sleeve with LED Light
1. Table of Acceptance Criteria and Reported Device Performance	Acceptance Criteria (Implied by biocompatibility)
	* L929 MEM Elution Test - ISO: Passed
	* Oral Irritation Test - Acute Exposure - ISO: Passed
	* Kligman Maximization Test - ISO: Passed
	Reported Device Performance (from text, not quantitative)
	* Provides illumination to enhance visibility.
	* Soft tapered grip provides multiple pinch points, enhances ergonomics, and improves clinician comfort.
	* Steam sterilizable, reduces risk of cross-contamination.
	(Note: Quantitative performance metrics for illumination, ergonomics, or comfort are not provided in this summary. "Performance data provided" is mentioned generally but not detailed.)
2. Sample size and data provenance (test set)	Not applicable/Not provided for a typical "test set" as for an AI device. The referenced biocompatibility tests would have their own sample sizes for biological samples, but these are not disclosed.
3. Number of experts and qualifications (ground truth for test set)	Not applicable. Ground truth in the context of an AI device is not relevant here. Biocompatibility tests are standardized laboratory procedures, not dependent on expert consensus on "ground truth."
4. Adjudication method (test set)	Not applicable. This concept belongs to studies where human readers or algorithms make assessments that need to be adjudicated against a ground truth. This is a physical medical device.
5. MRMC comparative effectiveness study and effect size	No. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks. This device is an accessory with an LED light, not a diagnostic AI.
6. Standalone performance (algorithm only)	No. This is a physical device, not an algorithm.
7. Type of ground truth used	Not applicable in the context of typical diagnostic AI ground truth (pathology, outcomes, expert consensus). For biocompatibility, the "ground truth" is the established scientific methods and pass/fail criteria of the ISO tests. For the general device, "ground truth" would relate to its physical properties meeting their design specifications and being safe for intended use, which is assessed through various engineering and safety tests, not detailed here beyond biocompatibility.
8. Sample size for the training set	Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established	Not applicable. There is no "training set" for this physical device. The safety and effectiveness are established through reference to predicate devices, material biocompatibility, and likely other engineering tests (e.g., light output, durability, sterilization efficacy) which are generally summarized as "performance data provided" in the 510(k) without specific detail in this summary.

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