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The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.

The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The device is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.

The provided text is for a K100884 510(k) submission for the Stryker Knifelight, which is a medical device (a lighted surgical knife), not an AI algorithm or a diagnostic tool that would typically involve acceptance criteria and a study to prove its performance in the way described in the prompt.

Therefore, much of the requested information (like performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets) is not applicable to this type of device and submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study for a new AI algorithm.

However, I can extract the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This submission is for a labeling change and a legal manufacturer location change for an existing device. The primary method of demonstrating safety and effectiveness for a 510(k) for such changes is substantial equivalence to a predicate device, not through specific performance metrics against pre-defined acceptance criteria in the way an AI algorithm would be evaluated.

Therefore, there are no specific numerical acceptance criteria or reported device performance metrics in the provided text. The "performance" is implicitly deemed equivalent to the predicate device.

Regarding the study that proves the device meets acceptance criteria:

Based on the provided text, there is no study in the sense of a clinical trial or performance evaluation with specific data points to prove the device meets acceptance criteria. The submission is a 510(k) premarket notification focused on substantial equivalence for a labeling change and legal manufacturer location change.

The entire submission implicitly "proves" that the device still meets regulatory requirements (which are the implicit "acceptance criteria" here) because:

• It is substantially equivalent to a legally marketed predicate device (Stryker Knifelight, K961122).
• The proposed modifications (manufacturer location, disposal info, warnings, contraindications) do not alter the fundamental safety or effectiveness of the device that was previously cleared.

Breakdown of other requested information:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a test set of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method for a test set is mentioned.
• 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 not an AI device, and no MRMC study is mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical instrument, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth established for a study.
• 8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
• 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.

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The Illuminated Retractor is a manual surgical instrument with an integrated light source that will be sold separately as a single use only device. This can be used with the Knifelight to facilitate ligament or tissue division, or it can be used by itself to retract soft tissue.

The Stryker Illuminated Retractor is a manual surgical instrument with an integrated light source that will be sold separately as a single use only device. This can be used with the Knifelight to facilitate ligament or tissue division, or it can be used by itself to retract soft tissue.

The provided document, K981717, is a Premarket Notification 510(k) Summary for the Stryker Illuminated Retractor. This document primarily focuses on establishing substantial equivalence to previously marketed devices and does not contain detailed information about acceptance criteria, specific device performance studies, or quantitative results from such studies. Therefore, it is not possible to complete the requested table or answer most of the questions based solely on the provided text.

Here's an explanation of why and what information is missing:

Explanation Regarding Missing Information:

The document explicitly states: "The Stryker Illuminated Retractor is equivalent to existing marketed products by companies such as Ruggles and Stryker. Intended use, function, and safety risks are all substantially equivalent." and "The Stryker Illuminated Retractor does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Therefore, the Stryker Illuminated Retractor is substantially equivalent to these existing devices."

This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical or performance studies with specific outcome metrics and acceptance criteria. The FDA's letter confirms substantial equivalence but doesn't detail performance metrics.

What We Can Infer (and what we cannot):

• Acceptance Criteria & Device Performance: The document does not define specific acceptance criteria (e.g., minimum brightness, durability cycles, precise surgical outcomes) or report quantitative performance data. The "performance" assessment is based on a qualitative claim of equivalence.
• Study Details: There's no mention of a formal study with a defined test set, training set, ground truth, expert involvement, or statistical analysis.
• Sample Size: No sample sizes are provided for any testing, as no specific performance testing is described beyond the general equivalence claim.
• Data Provenance: Not applicable as no specific data or studies are mentioned.
• Experts: No experts are mentioned as being involved in establishing ground truth or evaluating the device's performance in a study context.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not mentioned, and highly unlikely for a device of this nature in a 510(k) submission focused on substantial equivalence.
• Standalone Performance: Not mentioned.
• Ground Truth Type: Not applicable, as performance studies establishing ground truth are not described.
• Training Set Sample Size & Ground Truth: Not applicable, as no machine learning or AI component is mentioned, and therefore no training set.

Summary of Information from the Provided Text:

• Device Name: Stryker Illuminated Retractor
• Classification Name: Surgical Instrument Illuminated Retractor, Surgical Instrument Light
• Common/Usual Name: Illuminated Retractor
• Proprietary Name: Stryker Illuminated Retractor
• Intended Use: A manual surgical instrument with an integrated light source, sold separately as a single-use-only device. Can be used with the Knifelight to facilitate ligament or tissue division, or by itself to retract soft tissue.
• Regulatory Class: Class II
• Basis for Marketing: Substantial Equivalence to existing marketed products (Ruggles and Stryker).
• Safety and Effectiveness Claim: "Does not raise any new safety and efficacy concerns when compared to similar legally marketed devices."

Conclusion:

Based strictly on the provided text, it's impossible to fill out the table or answer the specific questions about acceptance criteria and detailed study information, as the document is a 510(k) summary focused on establishing substantial equivalence for a medical instrument, not a report on a detailed performance study with quantitative results.

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The Stryker Knifelight is a manual surgical instrument used for the release of ligaments or other tissue including, but not limited to, the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site. The Stryker Knifelight allows for a minimally open technique with minimal disturbance of surrounding tissue.

The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The light source is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the surgical blade has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. A standard elevator may be available with the device to facilitate ligament or tissue division.

The provided text describes a surgical knife with an integrated light source, not an AI-powered device or a study involving acceptance criteria and performance metrics typically associated with AI. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics cannot be extracted from the given document.

The document is a 510K Summary for the Stryker Knifelight, which focuses on demonstrating substantial equivalence to existing legally marketed devices.

Here's a breakdown of what can be inferred and what cannot, based on your request:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not describe specific acceptance criteria or performance metrics in a quantitative manner as would be done for an AI device (e.g., sensitivity, specificity, AUC). It focuses on substantial equivalence in terms of intended use, function, and safety risks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe any specific "test set" or clinical study data in the context of device performance evaluation. It's a regulatory submission demonstrating equivalence, not a clinical trial report.

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)

• Cannot be provided. There is no mention of a "test set" or "ground truth" establishment by experts in the context of performance evaluation in this document.

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

• Cannot be provided. No test set or adjudication method is described.

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

• Cannot be provided. This device is a manual surgical instrument, not an AI-powered system, so MRMC studies and AI assistance are not relevant.

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

• Cannot be provided. This is not an algorithm-only device.

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

• Cannot be provided. No clinical ground truth is established or discussed in this context. The "ground truth" for a 510K submission is typically that the device is demonstrably equivalent to a predicate device.

8. The sample size for the training set

• Cannot be provided. This device does not involve a training set as it's not an AI/machine learning product.

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

• Cannot be provided. Not applicable.

Summary of the provided document:

The document is a 510K Summary for the Stryker Knifelight.

• Device Name: Stryker Knifelight
• Classification: Surgical Knife (Class I), Surgical Instrument Light (Class II)
• Intended Use: Manual surgical instrument for the release of ligaments or other tissue (e.g., carpal tunnel ligament), featuring an integrated light source for improved visualization and protective retractors for surrounding tissue.
• Regulatory Mechanism: Demonstrates substantial equivalence to existing marketed products (e.g., from Biomet and Medtronic) based on intended use, function, and safety risks.
• Conclusion: The device "does not raise any new safety and efficacy concerns when compared to similar legally marketed devices," thus establishing substantial equivalence.

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