(104 days)
The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams. The product shall only be used:
- · in a controlled surgical environment under sterile conditions such as a hospital,
- · in reprocessing environment at sterilization departments or reprocessing centers,
- · and for transport of surgical instruments.
Sterilization parameters: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time
The worse-case validated load for the Instrument Case, including instruments, is 1700 g.
The Instrument case, Figure 1, is a reusable sterilization container intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. The specific use for the Instrument case is to hold reusable instruments during transport, the sterilization process, and during surgery.
The Instrument case consists of tray and lid made of stainless steel with a small box included, a component tray. The grommets, strips and holders that keep the instruments in place are made of silicone or stainless steel, and the latches in the lid are made of a Thermoplastic resin, Santoprene. The packaging materials are made of polyethylene and polyolefin. The device dimensions are 265 x 160 x 42 mm (length x width x height) and the worst case recommended load is 1700 g.
The provided FDA 510(k) summary for the "Instrument Case" (K223672) describes the performance testing conducted to demonstrate substantial equivalence to a predicate device, primarily focusing on its ability to undergo sterilization and maintain its functional integrity. This document does not describe an AI/ML-driven medical device, nor does it involve a study with human readers, expert consensus for ground truth, or training/test sets in the context of image analysis.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the bench testing of a medical device accessory (an instrument case) for its cleaning, sterilization, and lifecycle performance, not the evaluation of an AI algorithm's diagnostic performance. Therefore, many of the requested fields regarding AI/ML study design are not applicable to this submission.
Here's a breakdown of the information that is available in the document, framed as closely as possible to your request, but highlighting where AI/ML concepts do not apply:
Acceptance Criteria and Device Performance for Instrument Case (K223672)
This submission describes the performance validation of a reusable Instrument Case, a medical device accessory, to demonstrate its substantial equivalence to a predicate device regarding its ability to withstand cleaning, sterilization, and repeated use.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Automated Cleaning (with enzymatic detergent) | No visible soil should remain on the test articles. Protein level should be 1). | PASS: The semi-volatile and inorganic substances that were detected and that were of toxicological concern had a MOS>1. |
| Biocompatibility (Cytotoxicity) | Non-Cytotoxic | PASS: The instrument case is not cytotoxic. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of Instrument Cases used for each test. For many bench tests, a small number of units (e.g., typically 3 to 10) are used to represent the product.
- Data Provenance: The testing was conducted as part of the regulatory submission process for a medical device. The manufacturer is Cochlear Bone Anchored Solutions AB, located in Mölnlycke, Sweden, and the submitting entity is Cochlear Americas in Lone Tree, Colorado, USA. The data is prospective, generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is not an AI/ML diagnostic or image analysis study requiring expert review for "ground truth." The "ground truth" for these tests are objective measurements and observations (e.g., lack of visible soil, specific protein/hemoglobin levels, sterility, absence of moisture, visual integrity, chemical characterization results, cytotoxicity). The test methodologies (e.g., AAMI TIR, ANSI/AAMI ST79, ISO standards) define the criteria and procedures for evaluation.
4. Adjudication Method for the Test Set
- Not Applicable. This is not an AI/ML study involving human readers or subjective interpretations requiring adjudication. The acceptance criteria are objective and quantitative (e.g., µg/cm² levels, SAL ≤10⁻⁶, absence of growth/moisture/visible damage/cytotoxicity).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is not an AI/ML study. No human readers or comparative effectiveness studies of AI assistance are involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This document describes the performance of a physical medical device accessory, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this device validation is based on objective measurements, laboratory assays, and adherence to established industry standards (e.g., AAMI, ISO standards) for cleaning efficacy, sterilization efficacy (biological indicator growth, SAL), visual inspection for damage, and biocompatibility (chemical characterization, cytotoxicity assays).
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML study; there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not an AI/ML study; there is no "training set" or corresponding ground truth establishment methodology as would be found in such a study.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).