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The Enhance Allograft Wedge Instrument on Tray (7903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. This tray is intended for use with the following instruments:

The Enhance Allograft Wedge Instrumentation Tray (T903) is not intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to mainal instruments. Sterilize the instrument. Sterilize the instrument tray using the following sterilization parameters:

Double wrap tray using an FDA cleared wrap.

The Enhance® Allograft Wedge Instrumentation Tray (T903) is constructed primarily of aluminum with perforations to facilitate sterilant penetration, evacuation and drying. The tray dimensions are approximately 21 x 10" and it is designed to fit any standard autoclave. The tray is manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the tray is perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although the tray is reusable it will not be serviced or repaired. Interior structures of the trays have the ability to separately hold individual instruments during the entire duration they are in contact with the tray.

The document provided is a 510(k) premarket notification for a medical device called the "Enhance Allograft Wedge Instrument Tray". This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of acceptance criteria and performance for a new AI/software device. The product in question is a sterilization tray, which is a physical containment device, not a software or AI-based medical device.

Therefore, the requested information elements related to AI/software performance, ground truth, expert consensus, sample sizes for training/test sets, and multi-reader multi-case studies are not applicable to this document.

However, I can extract the general acceptance criteria and information regarding non-clinical performance and a comparison to the predicate device.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Performance Testing):

• Tray lid, base and internal tray: 5052-H32 grade aluminum, anodized
• Rivets, Handle Wire, Handle Clip, Latch Component, Channel: 301SS, 302SS, 304SS, Silicone
• Latches, Screws, Nuts, Washers and Brackets: 17-4 PH SS, 304-2B SS, 316SS, 18-8 SS
• Brackets, Internal: Silicone
• Silk Screen Ink: Sericoil 301 TP Black
  Predicate Device Materials (ConMed Linvatec Anodized Aluminum Sterilization Trays):
• Tray lid, base and internal tray: 5052-H32 grade aluminum, anodized
• Handles: 304SS
• Latches: 304SS
• Brackets and protective mat: Silicone (21 CFR177.2600)
  The new device uses similar materials, with some additional elements specified. |
  | Design | Perforated tray/lid to organize, sterilize, transport, and store instruments. | Same as predicate device. Perforated tray and lid used to organize, sterilize, transport, and store instruments between uses. Interior structures of the trays have the ability to separately hold individual instruments. Approximately 21 x 10" dimensions, fits standard autoclave. |
  | Sterilization Method | Steam sterilization using FDA-cleared wrap. Specific validated parameters. | Same as predicate device. Validated for Steam (wrapped) Pre-vacuum cycle: 270°F (132°C) for 4 minutes exposure, 20 minutes dry cycle, 118°F (48°C) cool down for 25 minutes (total duration 25 minutes). Validated for Steam (wrapped) Gravity cycle: 250°F (121°C) for 30 minutes exposure, 15 minutes dry cycle, 118°F (48°C) cool down for 37 minutes (total duration 37 minutes). Requires double wrap with an FDA cleared wrap. Validation conducted using a maximum load of 14 lbs (6.4 kg). Only single unstacked trays during sterilization. |
  | Sterility Assurance Level | SAL 10^-6 | SAL 10^-6 reported, same as predicate device. |
  | Performance Testing (General)| Meet requirements of ANSI/AAMI ST77:2013, handle strength, cleaning, biocompatibility, packaging, transportation, user validation. | ConMed conducted verification and validation testing including performance testing in accordance with ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization as well as: handle strength verification, cleaning, biocompatibility, packaging and transportation and a non-clinical user validation. Based on this testing, it was determined the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device (K090560). |
  | Equivalence Claims | Substantially equivalent to predicate device (K090560) in design, manufacturing materials, intended use, principles of operation, and technical characteristics, raising no new issues of safety or effectiveness. | The document concludes that the Enhance Allograft Wedge Instrument Tray is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate device, and the performance testing data demonstrates it is as safe, as effective, and performs as well as the predicate device. |

Since this is a submission for a physical medical device (sterilization tray) and not an AI/software product, the following requested items are not applicable and cannot be answered from the provided text:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical device's performance testing in this context. Performance testing would likely involve laboratory or simulated use tests.
• 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): Not applicable, as there's no "ground truth" in the AI/ML sense for a sterilization tray.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of the study/testing described:

The study was a non-clinical performance evaluation and comparison to a predicate device to establish substantial equivalence for regulatory approval.

• Validation Testing: ConMed conducted verification and validation testing.
• Standards Adhered To: ANSI/AAMI ST77:2013 (Containment Devices for Reusable Medical Device Sterilization).
• Specific Tests Mentioned: Handle strength verification, cleaning, biocompatibility, packaging and transportation, and a non-clinical user validation.
• Sterilization Parameters Tested: Pre-vacuum and Gravity steam sterilization cycles with specific temperatures, exposure times, dry cycles, and cool-down periods.
• No Clinical Performance Data: The submission explicitly states, "This submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

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