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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:
  In US: Pre-Vacuum Steam at 132 ℃ (270 °F) for 4 min with a 20 minutes dry time Outside US: See the Reprocessing Guide available in your country
  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, which is 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.

Based on the provided text, the device in question is an "Instrument Case" (K231604) and the performance data presented is for its cleaning, sterilization, and lifecycle durability, not for a complex AI/ML diagnostic or image analysis system. Therefore, many of the typical acceptance criteria and study components for AI-driven medical devices (like MRMC studies, ground truth based on expert consensus/pathology, training set details, etc.) are not applicable here.

This document describes a "Special 510(k)" submission for an updated Instrument Case, where the key is demonstrating substantial equivalence to a predicate device (K223672) through non-clinical data. The updates are minor (additional etchings and validation for a few more instruments).

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a clear table (Table 2) outlining the tests, acceptance criteria, and results for the Instrument Case.

Study Details (as applicable to this type of device)

Since this is for a physical medical device (Instrument Case) and not an AI/ML diagnostic, the following points address what's relevant from the provided text and note where typical AI/ML study details are not applicable:

2. Sample sizes used for the test set and the data provenance:

   • Sample Size: The document does not specify exact numbers of Instrument Cases tested for each specific test, but implies multiple units ("All units" met criteria for cleaning, "devices were inoculated" for sterilization, "Validation of 25 cycles of reprocessing" for lifecycle testing). Given the nature of a component, this is likely a small sample (e.g., 3-5 devices) for each test type, subjected to repetitive cycles (e.g., 25 cycles for lifecycle).
   • Data Provenance: Not explicitly stated, but these are laboratory bench tests conducted to regulatory standards (AAMI, ISO). The manufacturer is Cochlear Bone Anchored Solutions AB in Sweden, but the testing would be conducted in certified testing labs, not tied to a specific clinical population or country in the way clinical data for AI/ML devices would be. These are non-clinical, controlled bench tests. The tests themselves are prospective as they are specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For a physical device like an instrument case, "ground truth" is established by direct measurement and observation against objective criteria (e.g., visual inspection for soil, chemical analysis for protein/hemoglobin, bacterial growth assessment, physical damage assessment). No human expert interpretation (like a radiologist reading an image) is involved beyond the technician performing the tests and recording the results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. As described above, the acceptance criteria are objective and quantitative (e.g., µg/cm², SAL target, visual absence of damage). There is no multi-reader or adjudication process for interpreting "ground truth" for these physical performance tests.

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:

   • Not Applicable. This is a physical medical device (sterilization case), not an AI/ML diagnostic or image analysis tool that would assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device. There is no algorithm. The "standalone" performance here refers to the device's ability to meet its performance specifications (cleaning, sterilization, durability) without human intervention beyond setting up and running the test parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the Instrument Case's performance is based on objective, quantitative measurements and direct visual inspection following standardized protocols and accepted industry standards (AAMI, ISO). Examples include:
     • Chemical assays for residual protein and hemoglobin.
     • Microbiological testing for Sterility Assurance Level (SAL).
     • Physical inspection for moisture, corrosion, and damage.
     • Toxicological assessment based on chemical characterization.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a physical device like this. Training sets are specific to AI/ML model development.

9. How the ground truth for the training set was established:

   • Not Applicable. There is no training set.

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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

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.

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Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended for use in healthcare facilities to store, transport, organize, and sterilize surgical instruments such as retractor frame components, lighting accessories, and blade or frame accessories between used in combination with an FDA cleared sterilization wrap. Validated sterilization parameters include pre-vacuum steam and gravity.

Thompson Surgical Instruments “MIS Spine Frame Instrument Case,” model 50000MSF, is intended to hold surgical instruments such as retractor blades, retractor frame components, lighting accessories, and blade or frame accessories during storage, transportation, and sterilization, as indicated. It is composed of materials that can be reused with steam sterilization methods and DCG graphics may be used. It has a distribution of perforations on the outer surfaces and between case levels that allow for optimal steam penetration. Vent to volume is .110. It is reusable and provided to the customer in a non-sterile conditions. This case can be described as an accessory for the Thompson Retractor.

The provided document describes the Thompson Surgical Instruments MIS Spine Frame Instrument Case (K151347), which is a device for storing, transporting, organizing, and sterilizing surgical instruments. The testing focuses on its ability to perform sterilization effectively.

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device appears to be its ability to achieve a six-log reduction of an indicator organism during sterilization cycles, demonstrating effective sterilization. The cleaning and biocompatibility tests also represent criteria for safety and effectiveness.

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

• Sample Size for Test Set: The document does not specify a precise numerical sample size for the "test set" (i.e., the number of MIS Spine Frame Instrument Cases or biological indicators used). It states that the device "and the predicate containing the maximum load were inoculated with biological indicators." This implies at least one of each device type was used per sterilization cycle condition. Given the nature of sterilization validation, multiple runs for each cycle condition would typically be performed, but the exact number isn't provided.
• Data Provenance: The study was conducted by Thompson Surgical Instruments, Inc. as part of their 510(k) submission to the FDA. This indicates the testing was performed internally or by a contracted lab for the manufacturer. The data is prospective as it was generated specifically to demonstrate the performance of this device for regulatory submission. The country of origin of the data is implicitly the United States, where the submitting company is based and where FDA regulations apply.

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

N/A. This type of device does not typically involve expert review for ground truth in its performance testing. The "ground truth" for sterilization efficacy is established by the biological indicators (BIs) which contain a known quantity of resistant microorganisms. A six-log reduction is a quantitatively measurable outcome. For cleaning, "pass" indicates meeting pre-defined cleanliness criteria. For biocompatibility, MEM elution test results are directly interpreted. Human experts are not used to establish a subjective "ground truth" for these performance characteristics.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are typically used for studies involving subjective human interpretation of data, such as medical image analysis, where discrepancies between expert opinions need to be resolved. For objective tests like biological indicator reduction, cleanability pass/fail, and cytotoxicity, an adjudication method is not relevant. The results are based on direct measurement against defined criteria.

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

N/A. This device is a medical instrument case, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance in interpretation is not applicable. The study assesses the physical and functional performance of the device itself.

6. Standalone (Algorithm Only) Performance Study

N/A. This device does not involve an algorithm or AI. Its performance is entirely physical and functional, assessed through empirical laboratory testing.

7. Type of Ground Truth Used

The ground truth for the performance studies is primarily:

• Biological Indicators: For sterilization efficacy, the ground truth is the complete kill of a known concentration of highly resistant test microorganisms (e.g., Geobacillus stearothermophilus spores for steam sterilization), quantifiable by a log reduction.
• Defined Cleanliness Criteria: For cleanability, the ground truth is adherence to established visual and/or analytical criteria for cleanliness (e.g., no visible soil, acceptable levels of residual protein, hemoglobin, etc.).
• Standardized Cytotoxicity Assays: For biocompatibility (MEM elution test), the ground truth is based on the cellular response to leachables from the material, interpreted against standard reference controls.

8. Sample Size for the Training Set

N/A. This device does not involve machine learning or AI, and therefore no "training set" is applicable. The studies are empirical tests of the manufactured device.

9. How Ground Truth for the Training Set was Established

N/A. As there is no training set, this question is not applicable.

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