(396 days)
The products are used to store medical devices before, during, and after sterilization.
The products are intended to enable sterilization of the enclosed medical devices but are not intended to maintain sterility on their own; instead, they are used in conjunction with an FDA-approved sterilization wrap that is legally available on the market.
The products have no medical indications. Sterilization cycle times are as follow: Exposure time: 3 min Temperature: 132 ℃ Drying time: 20 min
The maximum validated load weight for all devices listed below is 4.5 kg (approx. 9.92 lbs).
All measurements are in millimeter and are coded as follows [WidthxHeightxLength].
UNIVERSAL PERFORATED BASKET 1 (33001); 732x117x282) UNIVERSAL PERFORATED BASKET 2 (33002); (743x200x282) UNIVERSAL PERFORATED BASKET 3 (33003); (538x117x250) UNIVERSAL PERFORATED BASKET 4 (33004); (538x117x250) UNIVERSAL PERFORATED BASKET 5 (33005); (549x200x250) PERFORATED BASKET FOR SMALL PARTS (33006); (128x40x121) PERF. BASKET – KNEE ARTHROSC. BASIC SET (33007); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 1 (33008); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 2 (33009); (549x150x250) PERF. BASKET FOR KNEE ARTHROSC. PREP TAB (33010); (549x150x250) PERF. BASKET FOR VERTEBRIS LUMBAR (33011); (549x150x250) PERF. BASKET FOR SHOULDER ARTHROSCOPY (33012); (538x117x250) PERF. BASKET FOR VERTEBRIS FORAMINOTOMY (33013); (525x65x255) PERF. BASKET FOR VERTEBRIS STENOSIS (33015); (549x150x250) PERFORATED BASKET FOR CAMERA HEAD (38002); (448x73x200) PERFORATED BASKET, UPPER URINARY TRACT 1 (38003); (635x75x132) PERF. BASKET FOR CYSTOSCOPE/TELESCOPE (38004); (467x75x132) PERFORATED BASKET FOR DISCOSCOPE (38005); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 1 (38006); (467x75x132) PERF. BASKET FOR VIDEO MEDIASTINOSCOPE (38007); (256x85x250) PERFORATED BASKET FOR TELESCOPE (38008); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 2 (38009); (467x90x132) PERFORATED BASKET FOR STEREO TELESCOPE (38010); (477x139x196) PERFORATED BASKET FOR NEPHROSCOPE (38011); (467x75x172) PERFORATED BASKET FOR MORCESCOPE (38012); (467x75x172) PERFORATED BASKET FOR CYSTO-URETHROSCOPE (38013); (451x64x80) PERFORATED BASKET FOR 3D TELESCOPE (38014); (583x80x200) PERF. BASKET FOR STANDARD TELESCOPE 1 (38015); (297x54x59) PERF. BASKET FOR STANDARD TELESCOPE 2 (38016); (481x54x59) PERF. BASKET FOR STANDARD TELESCOPE 3 (38017); (619x54x59) PERFORATED BASKET FOR PAIN THERAPY (33014); (525x95x255)
The PERFORATED BASKETS all have the same basic configuration, a metal basket base and a basket lid, with optional product specific instrument carriers (for multiple levels) or adapters and an additional basket for small parts. The base part and the lid of the PERFORATED BASKET are connected by a locking mechanism, which assures a tight connection of both parts.
The provided text describes the acceptance criteria and study proving the performance of "Perforated Baskets" for sterilization.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Test Method (Standard) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Manual Cleaning | AAMI TIR 30: 2011, ANSI/ AAMI ST98: 2022 | 1: Visible soil: not visible | 1: passed |
| 2: Protein/cm2 [µg/cm2]: 10^-6 | passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). It mentions "For each device it was evaluated whether specific testing was necessary" and lists "all devices" in relation to the maximum validated load weight, implying that all listed "Perforated Baskets" were part of the evaluation for performance testing.
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)
This information is not provided in the document. The ground truth for cleaning and sterilization effectiveness is based on scientific standards and quantitative measurements (e.g., protein, hemoglobin levels, SAL), which do not typically require expert consensus in the same way as, for example, image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method. The tests conducted are objective, quantitative measurements against established standards.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (perforated baskets for sterilization), not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was conducted for the device's ability to facilitate cleaning and steam sterilization. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for performance evaluation is based on established scientific and industry standards for cleaning effectiveness (AAMI TIR 30: 2011, ANSI/ AAMI ST98: 2022) and sterilization assurance (EN ISO 14937, Annex D). These standards define quantitative thresholds and methodologies for determining success.
8. The sample size for the training set
This information is not applicable and not provided. The "Perforated Baskets" are not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The "Perforated Baskets" are not an AI/ML device that requires a training set.
§ 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).