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The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses:

1. Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.

2. Soft tissue debridement and removal, particularly in intrabony lesions.

The Contour P-Insert System (CPIS) is an accessory to the Dmetec Surgystar Piezosurgery System (DSPS). The CPIS comprises two sets of components. CPIS tips and CPIS shafts, as follows:

• CPIS Shafts: The two CPIS shaft models (45 and 90) are machined from 431 stainless steel. Both models ● have an identical female threaded proximal end that is designed and configured to attach to the DSPS handpiece distal male threaded end. On the shafts' distal end, both models have an identical male threaded section that is designed and configured to attach the various models of CPIS tips. These models
  45 and 90 differ primarily in that the CPIS 45 has a mid-shaft bend of 20.59 while the CPIS 90 does not.

• CPIS Tips: The three CPIS tip models (Tri, WC and QT) are machined from PEEK ● (polyetheretherketone). All three tip models have an identical female unthreaded hole on the proximal end that is designed and configured to attach to the distal male threaded end of the CPIS shafts. These tips have different grooves, edges and vertices that abrade, ablate, cut and recontour oral tissues as intended by the operator.

• CPIS Inserts: The CPIS inserts are created by the end user by attaching one CPIS tip to one CPIS shaft. By combining each of the three tip models with each of the two shafts models, six versions of CPIS insert can thus be created, depending on the clinical needs and professional judgement of the end-user. These resultant CPIS inserts are designated as follows: CPIS 45/WC, CPIS 45/QT, CPIS 90/Tri, CPIS 90/WC and CPIS 90/QT. The CPIS inserts are attached to the DSPS using the DSPS torque wrench.

During use by the end user, the DSPS is powered, generating high frequency mechanical micro-vibrations in the handpiece, that is transmitted to the CPIS insert. The tip sides and tip end of the CPIS inserts are brought into contact with the patient's various oral tissue types to accomplish dental procedures where ablation, abrasion, cutting and/or recontouring of the target tissue is desired.

The provided text describes the Contour P-Insert System (CPIS), an accessory for dental piezo-surgery systems, and its substantial equivalence to predicate devices based on non-clinical testing. Here's a breakdown of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative, focusing on functionality, safety, and effectiveness in performing specific dental procedures. The reported performance likewise describes the successful fulfillment of these criteria.

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

The document does not explicitly state the exact sample sizes for each specific test in the "CPIS Functionality and Efficacy Report" and "Tooth Surface Damage Study." It generally refers to "100% of the CPIS samples" for compatibility tests and "all samples in all groups" for efficacy tests. More precise numbers are not provided.

The provenance of this data (e.g., country of origin, retrospective or prospective) is not specified. However, the tests are described as non-clinical tests, implying they were likely conducted in a laboratory or controlled setting (e.g., using models, cadavers, or animal tissue as proxies for human tissue, though the document does not specify). There is no mention of human clinical data.

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

The document does not mention the use of experts to establish a "ground truth" for these non-clinical tests in the way one might for diagnostic imaging or clinical studies. The "ground truth" for these tests appears to be based on direct observation of physical interactions (e.g., fit, loosening) and outcomes of mechanical actions (e.g., amount of bone removed, effectiveness of debridement, presence/absence of tooth surface damage) against predefined objective criteria. No independent expert review or adjudication of results against a gold standard established by experts is described.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for the non-clinical tests described. The "outcomes" are direct, measurable results of the tests (e.g., 100% fit, specific range of bone removal, discernible damage).

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

No MRMC comparative effectiveness study was conducted or mentioned. The device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a surgical accessory, not an algorithm. Its performance is always in the context of human operation.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical efficacy and safety tests is based on:

• Direct observation of mechanical fit and interaction: For compatibility tests (torque wrench, handpiece connection).
• Quantitative and qualitative measures of physical outcomes: For efficacy tests (e.g., "effectively debrided," "more than 1mm but less than 3mm of bone removed") and safety tests (e.g., "no discernible tooth surface damage," "extensive tooth surface damage").
• Compliance with established biological safety standards: For biological evaluation (ISO10993 series).
• Compliance with established sterilization standards: For sterilization validation (ISO standards).

These are essentially experimental outcomes from carefully designed non-clinical tests rather than "expert consensus," "pathology," or "outcomes data" in a clinical sense.

8. Sample Size for the Training Set

Not applicable. The Contour P-Insert System is a physical medical device (an accessory for a piezosurgery system), not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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