(93 days)
The Noxilizer Surgical Ruler is a sterile, single use, manual measurement device intended to be used in various general surgical procedures.
The Noxilizer Surgical Ruler is a 6" x ½" stainless steel surgical ruler with laser engraved markings in both inches and centimeters. The Noxilizer Surgical Ruler is a single-use, sterile device distributed in individuals packages.
The provided text describes the Noxilizer Surgical Ruler and its performance testing to demonstrate substantial equivalence to predicate devices for 510(k) clearance. The document focuses on shelf-life validation and biocompatibility testing. It does not describe AI/algorithm-related acceptance criteria or studies involving human readers or AI assistance. Therefore, a direct answer to the prompt's specific questions about AI performance, multi-reader multi-case studies, and human reader improvement cannot be provided from this text.
However, I can extract information related to the acceptance criteria and study proving the device meets its acceptance criteria, as pertaining to shelf-life and biocompatibility, which are the relevant performance metrics discussed for this device.
Here's a summary of the acceptance criteria and study details for the Noxilizer Surgical Ruler based on the provided text:
Device: Noxilizer Surgical Ruler
Type of Device: Manual measurement device (surgical ruler) - Not an AI/algorithm-based device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-Life: | ||
| Visual Inspection | No sign of sterile barrier being compromised (per ASTM F1886) | All post-aging samples passed visual inspection. |
| Tensile Testing | (Sample mean) – k * s ≥ 1.0 pound per linear inch (PLI) | |
| (k = 2.566 for 95% confidence, 95% reliability) | All samples had a tensile test value of 2.59 PLI or greater, exceeding the acceptance criteria. | |
| Bubble Leak Testing | No streams of bubbles detected (per ASTM F2096) | All samples tested passed bubble leak testing. |
| Sterility Testing | All samples negative for growth | All samples were negative for growth at the end of the incubation period. |
| Biocompatibility: | ||
| Cytotoxicity | No biological reactivity (Grade 0) per ISO 10993-5:2009 | No biological reactivity (Grade 0) of cells exposed to test article extracts. Test article not considered to have a cytotoxic effect. |
| Sensitization | Not considered significant (Grade I reaction or less) per ISO 10993-10:2010 | Elicited no reaction at the challenge (0% sensitization), classified as having weak allergenic potential (Grade I reaction). Meets requirements. |
| Irritation | Test article sites do not show a significantly greater biological reaction than control sites per ISO 10993-10:2010 | Test article sites did not show a significantly greater biological reaction than control article. Meets requirements. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Shelf-Life Studies:
- Tensile Testing: "The sample size was sufficient for a 95% confidence interval, 95% reliability." (Specific number not provided, but implies statistical sufficiency).
- Bubble Leak Testing: "The sample size was sufficient for a 90% confidence interval, 95% reliability." (Specific number not provided, but implies statistical sufficiency).
- Sterility Testing: "intact samples" (specific number not provided).
- Biocompatibility Studies: "The rulers used as the test articles" (specific number not provided).
- Data Provenance: The studies were internal validations and conducted by "outside test houses under GLP conditions." The geographic origin of the data is not explicitly stated but implies US-based testing given the FDA submission. The studies are prospective in nature, as they involve testing newly manufactured devices under controlled conditions to evaluate performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable as the device is a manual ruler, not an AI or diagnostic device that requires expert ground truth establishment for a diagnostic output. The "ground truth" for the performance tests (e.g., tensile strength, sterility, biological reactivity) is based on quantitative measurements and established biological assays, not expert consensus on images or medical findings.
4. Adjudication Method for the Test Set
This is not applicable for the type of device and testing performed. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in human expert interpretations, typically in diagnostic imaging studies. The testing here involves objective measurements/assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
This is not applicable as the Noxilizer Surgical Ruler is a manual device and does not involve AI assistance or human readers for its intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the Noxilizer Surgical Ruler is a manual device and does not involve any algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these tests consisted of:
- Objective Measurements: For shelf-life, this includes physical measurements like tensile strength and absence of leaks.
- Established Microbiological Methods: For sterility, this involves culturing samples in SCD media and observing for growth.
- Standardized Biological Assays: For biocompatibility, this involves assays detecting cytotoxicity (cell viability), sensitization (allergic response), and irritation (tissue reaction) according to ISO standards. These are laboratory-based, quantitative or semi-quantitative readouts, not expert consensus or pathology reports in the clinical diagnostic sense.
8. The Sample Size for the Training Set
This is not applicable as this is a physical, manual device and does not involve machine learning or training sets.
9. How the Ground Truth for the Training Set was Established
This is not applicable as this is a physical, manual device and does not involve machine learning or training sets.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.