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External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).

The External Drainage System includes a tubing, drainage bag, drip chamber and scale plate. It is provided sterile and can be connected to a drainage catheter, which is connected to a patient line, via a luer connection and ultimately to a drainage bag. The drainage catheter is not included in the subject device. The External Drainage System provides a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space. During the draining, the cerebrospinal fluid will be collected in a drainage bag.

The provided text describes the acceptance criteria and study results for an "External Drainage System," which is a Class II medical device used for draining cerebrospinal fluid.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of units tested) for each of the performance and biocompatibility tests. It broadly states that "The following test were performed to verify that the performance of the subject device is substantially equivalent to the performance of the predicate device. Testing included side-by-side comparison data with the predicate device."

The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission, these are non-clinical (bench and biocompatibility) tests conducted to demonstrate equivalence to a predicate device. This implies the tests were specifically designed and performed for this submission.

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

This information is not applicable to the data presented. The "ground truth" concept is typically relevant for studies involving diagnostic accuracy or clinical interpretation where expert consensus is needed to determine the true state of a condition. The tests described here are physical performance and biocompatibility assessments, not diagnostic or interpretive tasks. The "ground truth" for these tests is based on objective measurements and established scientific/regulatory standards.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in studies where human readers independently interpret data, and discrepancies need to be resolved. The tests here are objective measurements.

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

There is no mention of a multi-reader multi-case (MRMC) study or any AI assistance. This device is a physical medical device (External Drainage System), and the testing described is non-clinical performance and biocompatibility, not an AI-powered diagnostic tool.

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

There is no mention of a standalone algorithm performance study. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used

For the performance tests (e.g., device size, fluid leakage, sterility), the "ground truth" is derived from pre-defined engineering specifications and regulatory standards. For biocompatibility tests, the "ground truth" regarding safety is established by validated laboratory assays (e.g., cytotoxicity assays, sensitization tests) and their interpretation against acceptable limits set by regulatory guidance (e.g., ISO 10993).

8. The sample size for the training set

This information is not applicable as this device is not an AI/machine learning system that requires training data.

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

This information is not applicable as this device is not an AI/machine learning system that requires a training set.

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Use of the CODMAN EDS 3 CSF External Drainage System (EDS 3) is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

Use the External Drainage System Collection Bag with the CODMAN EDS 3 External Drainage System to measure and collect cerebrospinal fluid (CSF).

The Codman EDS 3 CSF External Drainage System (Codman EDS 3 System) is designed to drain cerebral spinal fluid (CSF) at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma. The EDS 3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame drip chamber assembly, and a collection bag. Note: The collection bag is sold as part of the Codman EDS 3 System, as well as sold separately.

The principle of operation of the proposed Codman EDS 3 system is identical to the currently marketed Codman EDS 3 system. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain or lumbar region through the patient line and enters into the 100 mL graduated drip chamber assembly, where it is collected over a period of time to calculate a flow rate. The drip chamber assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the drip chamber height is set, the collected CSF is then drained into the attached 700 mL collection bag.

The Codman EDS 3 CSF External Drainage System Collection Bag is a sterile, vented 700 mL capacity bag that is graduated in 50 mL increments for accurate measurement. A microbial-retentive atmospheric vent facilitates CSF flow into the bag. One bag is provided with the system and replacement bags are sold separately as an accessory to the drain.

The EDS 3 system is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.

Here is a summary of the acceptance criteria and study information for the CODMAN EDS 3 CSF External Drainage System and Collection Bag, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document describes only bench testing for design verification and validation. It does not explicitly state a 'test set' in the context of patient data or clinical trials. The evaluation was primarily based on comparing the performance of the modified device components against the predicate device in a laboratory setting. No data provenance in terms of country of origin or retrospective/prospective study type is applicable here, as no human data was used.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The study involved bench testing and engineering verification, not a clinical study requiring expert consensus for ground truth establishment.

4. Adjudication Method for Test Set

Not applicable. There was no clinical test set requiring adjudication. The verification and validation activities were based on standardized engineering and performance testing methods.

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

No MRMC comparative effectiveness study was done. The submission relies on bench testing demonstrating substantial equivalence to a predicate device, not on comparative clinical performance with human readers.

6. Standalone Algorithm Performance

Not applicable. This device is a medical drainage system, not an AI or algorithm-based device.

7. Type of Ground Truth Used

The "ground truth" for this submission was established through engineering design specifications, industry standards (e.g., ISO 11135-1:2014, ISO 10993-1:2009), and performance of the legally marketed predicate device. The modified components' performance was compared against these established benchmarks.

8. Sample Size for the Training Set

Not applicable. There was no machine learning or AI component, thus no training set was used.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

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Use of the Codman EDS3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

The Codman EDS3 CSF External Drainage System (Codman EDS3 System) is designed to collect cerebral spinal fluid (CSF) from the patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma. The EDS3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame burette tube assembly and a collection bag. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain through the patient line and enters into the 100 mL graduated burette tube assembly, where it is collected over a period of time to calculate a flow rate. The burette tube assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the burette tube height is set, the collected CSF is then drained into the attached 700 ml collection bag. The EDS3 System is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.

The provided document describes the Codman EDS3 CSF External Drainage System (K162437), which is essentially an updated version of a previously cleared device (K061568). The primary change in the subject device is the use of a different adhesive (Loctite 3924 instead of Loctite 3341) for bonding tubing lines. Therefore, the acceptance criteria and studies focus on demonstrating that this change does not negatively impact the device's safety and effectiveness.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each bench test (e.g., number of devices tested for tensile strength or shelf life). It's a summary document, and typically, detailed test reports would contain this information.

Regarding data provenance:

• Country of origin: Not specified, but likely the US given the submission to the FDA.
• Retrospective or prospective: The bench tests described are prospective in nature, as they involve testing newly manufactured devices with the new adhesive according to established protocols.

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

This question is not directly applicable in the context of this device and study. The "ground truth" for this type of device (a medical drainage system) is not established by expert consensus or interpretations in the same way it would be for an AI diagnostic algorithm. Instead, it's established by pre-defined performance specifications (acceptance criteria) based on engineering, material science, and regulatory standards. The "experts" involve the engineers and scientists who designed the tests and reviewed the results, but they are not adjudicating observational data.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective and based on measurable parameters (e.g., leak detection, force measurements, chemical analysis). There's no human "adjudication" of the test results in the way it's done for interpreting medical images. The results are directly compared to the pre-established numerical or qualitative "Pass/Fail" acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving image interpretation by human readers, potentially augmented by AI) to assess the impact on human performance. The Codman EDS3 CSF External Drainage System is a physical medical device, not a diagnostic tool where human reader performance is a direct output.

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

No, a standalone (algorithm-only) performance study was not done. This device is not an algorithm; it's a physical medical device. The "performance" refers to its physical and functional attributes.

7. The Type of Ground Truth Used:

The ground truth for this study is based on engineering specifications, material science standards (e.g., ISO 10993 for biocompatibility), and established medical device performance requirements. The acceptance criteria are essentially the "ground truth" against which the device's performance is measured. These are not pathology results, expert consensus on disease, or patient outcomes data in this context.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI, machine learning, or software algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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Use of the CODMAN EDS 3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

The EDS 3 system is designed to collect cerebral spinal fluid (CSF) and other fluids of similar physical characteristics from a patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP).

The provided document is limited in detail regarding the specific acceptance criteria and study data for the CODMAN® EDS 3™ CSF External Drainage System. The document states that the fundamental scientific technology of EDS 3 is the same as EDS II and that "Bench testing was performed for the EDS 3 system. The modified device was deemed acceptable according to the acceptance criteria; therefore, the safety and efficacy of the product was not affected." However, the exact acceptance criteria and the detailed results of this bench testing are not provided.

Therefore, much of the requested information cannot be extracted from this document.

Here's a summary of what can be inferred or directly stated from the provided text:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics. It only states that the device was "deemed acceptable according to the acceptance criteria."

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

This information is not available in the provided text. The term "bench testing" suggests a controlled laboratory environment, but details about sample size or data origin are absent.

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 available in the provided text. The testing appears to be bench testing, not clinical human-based evaluation requiring expert ground truth for interpretation.

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

This information is not available in the provided text.

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

This information is not applicable and not available in the provided text. The device is a CSF external drainage system, not an AI-assisted diagnostic tool for which MRMC studies are typically conducted.

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

This information is not applicable and not available in the provided text. The device is a physical system, not an algorithm. Bench testing would assess its standalone mechanical and fluid dynamic performance.

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

This information is not explicitly stated. For bench testing of a medical device, the "ground truth" would typically refer to established engineering and medical standards for fluid dynamics, biocompatibility, and mechanical integrity, rather than clinical outcomes or expert consensus on images.

8. The sample size for the training set

This information is not applicable and not available in the provided text. The device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not available in the provided text. The device is not an AI/ML algorithm.

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