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The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of the following endoscopic sinus procedures: ethmoidectomy, maxillary antrostomy, polypectomy, turbinectomy / turbinate reduction, sphenoidotomy, and frontal recess dissection.

The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of endoscopic sinus procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.

This document describes a 510(k) premarket notification for the PolypVac Microdebrider. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, specifically the PolypVac Microdebrider (K161101) and the Medtronic Xomed XPS 3000 (K041413).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical "acceptance criteria" in the format of a table with thresholds and corresponding performance values for the new PolypVac Microdebrider. Instead, it relies on demonstrating that the device functions as intended, meets design specifications, and is substantially equivalent to predicate devices based on various non-clinical tests.

The "Testing Type" and "Results Supporting Substantial Equivalence" columns in Table 2 serve as a proxy for acceptance criteria and reported performance:

• Dimensional Testing
• Pull Force Testing - Bond Strength
• Predicate Comparison - Resection Rate | "The subject PolypVac Microdebrider passed all functional testing and met all product specification requirements, thereby demonstrating equivalence to the predicate PolypVac device and suitability to the expanded indications for use."

The comparison of technological characteristics in Table 1 (pages 4-5) implicitly provides performance comparisons (e.g., "Same" for mechanism of action, compatibility, human factors, materials/biocompatibility, and sterility; "Blades of similar diameter are offered" for design features like blade diameter). In particular, the "Predicate Comparison - Resection Rate" implies that the new device's resection rate performance was comparable to the predicate. |
| Validation Testing | "Cadaver Simulated Use Testing" | "Simulated use testing was completed successfully, no adverse events were observed. This testing demonstrates that the subject PolypVac Microdebrider is capable of safely performing the following procedures: turbinate reduction / turbinectomy, uncinectomy / maxillary antrostomy, ethmoidectomy, frontal recess dissection, and sphenoidotomy." |

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

• Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the bench testing or the cadaver simulated use testing. For the cadaver study, it implies a sufficient number of cadavers/procedures were used to successfully complete the testing without adverse events across a range of procedures.
• Data Provenance: Not explicitly stated, but the testing would typically be conducted at the manufacturer's R&D facilities or a contract research organization. Given it's a premarket notification to the US FDA, the data is intended for the US market. The testing is non-clinical bench and cadaver testing, not human subject data. It's prospective in the sense that the studies were designed and conducted specifically for this submission.

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

There is no mention of experts establishing a "ground truth" for the non-clinical bench or cadaver testing in the same way as, for example, a clinical study interpreting images. The "ground truth" for these tests would be the established engineering specifications and the successful completion of the simulated surgical procedures.

• In the cadaver study, the success was based on the device's capability of safely performing the procedures and the absence of adverse events, which would be assessed by the surgical operators (likely qualified surgeons or trained personnel) conducting the simulations. However, the exact number and qualifications of these individuals are not provided.

4. Adjudication Method for the Test Set

Not applicable in the context of this non-clinical testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., imaging reads). Here, the tests evaluate mechanical performance, functionality, and simulated surgical outcomes, which would be objectively assessed against design specifications and technical success criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed nor necessary in support of this premarket notification." Therefore, there is no effect size of human readers improving with or without AI assistance.

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

Not applicable. The PolypVac Microdebrider is a mechanical surgical device, not an AI algorithm. Its performance is inherent to its design and function, not based on an algorithm that operates independently or with human input.

7. The Type of Ground Truth Used

For the non-clinical testing:

• Bench Testing: The "ground truth" is defined by the device's technical specifications and engineering requirements (e.g., specified dimensions, bond strengths, motor functionality, resection rates comparable to predicate devices).
• Cadaver Simulated Use Testing: The "ground truth" is the successful and safe execution of the listed surgical procedures on cadaveric tissue, with the absence of adverse events. This implies functional performance equivalent to established surgical practice.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI or machine learning system that requires a "training set."

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

Not applicable, as no training set was used or required.

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Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.

The provided document is a 510(k) Pre-market Notification for a medical device called the "PolypVac Microdebrider." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive efficacy studies with explicit acceptance criteria related to a specific disease or condition.

Therefore, the document does not contain information about explicit acceptance criteria for disease diagnosis or treatment effectiveness based on a study of the device's performance against ground truth (e.g., sensitivity, specificity, AUC, or other accuracy metrics). Instead, the acceptance criteria are related to the functional performance and safety of the device, and the "study" is a series of non-clinical bench tests comparing it to a predicate device.

Here's the information as requested, adapted to the content provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in numerical terms (e.g., number of devices tested or number of trials). The "Test Set" here refers to the units of the PolypVac Microdebrider that underwent non-clinical bench testing.
• Data Provenance: The testing was non-clinical, bench testing. The country of origin for the data generation is not specified, but the applicant, Laurimed LLC, is based in Redwood City, CA, USA. The data is prospective in the sense that new testing was conducted on the modified device.

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

• This device is a surgical instrument. The "ground truth" for its performance is assessed through engineering and biocompatibility testing against predefined specifications and industry standards (ISO, ASTM).
• Experts: Not applicable in the context of clinical "ground truth" (e.g., disease diagnosis). The tests were conducted by personnel with expertise in engineering, materials science, and sterilization validation. Specific numbers and qualifications of these individuals are not provided in this regulatory document.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus on clinical ground truth (e.g., image interpretation). For bench testing, the results are typically objectively measured against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed or necessary in support of this premarket notification." This type of study is not relevant for a surgical microdebrider seeking 510(k) clearance based on substantial equivalence to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a physical surgical instrument, not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of AI is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility, ASTM for packaging), and comparison to the established performance characteristics of the predicate device. This includes functional performance (e.g., resection, fluid flow), material biocompatibility, and packaging integrity.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. The design and validation are based on engineering principles and comparison to an existing device, not on statistical learning from a dataset.

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

• Not applicable. As there is no training set, there is no ground truth established for it.

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Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has has been previously established.

The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device and device cleaner. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.

The provided text describes the Laurimed PolypVac Microdebrider and its substantial equivalence to a predicate device. However, it does not present acceptance criteria in a quantitative table or the specific details of a study designed to prove the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc. for a diagnostic or AI-driven medical device.

The studies mentioned are non-clinical (bench-top and cadaver) and aim to demonstrate substantial equivalence to a predicate device, focusing on mechanical performance and safety, rather than diagnostic accuracy.

Here's an analysis of the information provided based on your request, highlighting the absence of certain details relevant to evaluating an AI/diagnostic device:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text in the format of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) and corresponding reported performance.

The non-clinical studies aimed to demonstrate "non-inferiority" in specific mechanical and functional aspects compared to the predicate device. If we interpret "acceptance criteria" loosely as the demonstration of non-inferiority in these performance characteristics, then we can summarize the findings as follows:

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

• Bench-top Performance Testing: "two sample tissue models" were used. The number of tests or runs performed on these models is not specified. Data provenance is implied to be laboratory-generated.
• Cadaver Predicate Comparison Testing: A "cadaver model" was used. The number of polyps excised or the number of simulated polypectomy procedures is not specified. Data provenance is implied to be laboratory-generated using a cadaver.
• Type of Study: Both are non-clinical, in-vitro (bench-top) or ex-vivo (cadaver) studies.

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

• Bench-top Performance Testing: No explicit "experts" were used to establish ground truth in the sense of clinical interpretation. The evaluation was based on measurable resection rates.
• Cadaver Predicate Comparison Testing:
  • Operators: Three (3) independent board-certified ENT surgeons performed the excisions.
  • Reviewer for Post-resection images: A "blinded reviewer" graded the post-resection images. Qualifications beyond "blinded reviewer" are not specified (e.g., specialty, years of experience).

4. Adjudication method for the test set

• Bench-top Performance Testing: Not applicable. Performance was measured quantitatively (resection rates, clogging frequency).
• Cadaver Predicate Comparison Testing: One "blinded reviewer" graded post-resection images. This is a single-reviewer assessment, not a consensus-based adjudication method like 2+1 or 3+1.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the Laurimed PolypVac Microdebrider is. The study involved human operators (surgeons) using the device, but it wasn't an evaluation of AI assistance to human readers.

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

• No, this device is a surgical instrument, not an algorithm. Therefore, this concept is not applicable. The device relies on human operation.

7. The type of ground truth used

• Bench-top Performance Testing: The "ground truth" was the physical measurement of resected simulated polyp tissue and observation of clogging.
• Cadaver Predicate Comparison Testing: The "ground truth" was based on:
  • "grams of unresected tissue" (objective measurement after surgeon's attempt).
  • Grades from a "blinded reviewer" on post-resection images (subjective assessment, but based on physical evidence).

8. The sample size for the training set

• Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning model. There is no concept of a "training set" for its development as described in the provided text.

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

• Not applicable. As above, there is no training set for this type of device.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of a traditional medical device (a microdebrider) through non-clinical performance and safety testing. It does not provide the kind of acceptance criteria or study design details typically associated with AI-powered diagnostic devices, which involve performance metrics like sensitivity, specificity, and human reader studies. The "acceptance criteria" here are implicitly achieving non-inferiority to a predicate device in functional and mechanical performance.

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The TruCath Spinal Injection System is indicated for use in injections into the epidural space. Not for use with other catheters or needles.

The Trucath Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for use in injections into the epidural space of the spine. The Trucath Spinal Injection System is supplied as a sterile, single patient use, disposable device.

The provided document is a 510(k) summary for the Trucath Spinal Injection System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-driven device.

This submission is for a medical device that appears to be a physical product (a catheter/needle system), not a software or AI/ML device. Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information provided.

Based on the provided text, here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device. For physical devices like this, acceptance criteria would typically relate to performance aspects like material strength, sterility, leakage, fluid flow, dimensions, etc., which are usually covered in internal design specifications and verification/validation testing.
• Reported Device Performance: The document states: "Results of non-clinical testing demonstrated that the Trucath Spinal Injection System is safe and effective for its intended use" and "non-clinical testing was conducted to validate the performance of the device and ensure the Trucath Spinal Injection System functions as intended and meets design specifications." However, no specific performance metrics or acceptance criteria values are reported.

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

• Not applicable / Not provided. The document refers to "non-clinical testing," which typically involves bench testing, material testing, and potentially some animal testing (though not mentioned here). It does not involve "test sets" in the context of data for AI/ML models.

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)

• Not applicable / Not provided. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts. For a physical medical device, "ground truth" would be established by validated test methods and measurements against engineering specifications.

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

• Not applicable / Not provided. Adjudication methods are relevant for resolving discrepancies in expert labeling of data, which is not part of this device's submission.

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

• No, an MRMC study was not done. This type of study is specific to AI-assisted diagnostic devices where human readers interpret images or data. The Trucath Spinal Injection System is a physical interventional medical device.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable / Not provided in the AI/ML sense. For this physical device, "ground truth" for performance would likely come from established engineering and biological test standards (e.g., ISO standards for medical devices, material testing, sterility checks, etc.). The document only states "non-clinical testing" was done to validate performance against design specifications.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it's not an AI/ML model.

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

• Not applicable. This device does not use a training set.

In summary:

The provided 510(k) summary is for a physical medical device (Spinal Injection System) and focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It explicitly states that "non-clinical testing was conducted to validate the performance of the device and ensure the Trucath Spinal Injection System functions as intended and meets design specifications." However, it does not provide the specific performance data, acceptance criteria values, or details of the test methodologies that would be necessary to answer most of your detailed questions, as those questions are primarily relevant for AI/ML-driven medical devices.

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The Laurimed Discectomy System is indicated for use in aspiration of disc material during open discectomies in the lumbar region of the spine.

The Laurimed Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Dilator, Straight Cannula, Curved Cannula (qty. 2) and Trocar), a Device Cleaner, and a Discectomy Device
The Laurimed Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.

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

Based on the provided 510(k) summary, there is no specific acceptance criteria or study that proves device performance in a clinical or standalone setting using human data. The submission relies solely on a comparison to a predicate device and non-clinical (i.e., bench or lab) testing.

Here's a breakdown of why and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. The summary explicitly states "Summary of Non-Clinical Data." This indicates that no human test set data was used or presented in this 510(k) summary. The testing was likely limited to bench or laboratory evaluations to demonstrate functionality and safety characteristics (e.g., cutting efficacy, aspiration flow, material compatibility, sterilization effectiveness).

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

• Not applicable / Not provided. Since there's no clinical test set with human data, there's no mention of experts establishing ground truth for such a set.

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

• Not applicable / Not provided. As no human test set was used, no adjudication method 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:

• No. This device is a surgical tool (discectomy system) and does not involve AI or human readers for image interpretation. Therefore, an MRMC study or AI-assisted performance is not relevant to this submission.

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

• No. This device is a physical surgical tool, not an algorithm. Standalone performance as typically understood for AI/software devices is not applicable. The "standalone" performance here would refer to the device's mechanical and functional performance, which was assessed through non-clinical testing.

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

• Not applicable / Not provided. For the non-clinical testing mentioned, the "ground truth" would likely be defined by engineering specifications, material properties, and established test methodologies (e.g., force measurements, flow rates, visual inspection of cut tissue substitutes). No clinical or expert-based ground truth is discussed.

8. The sample size for the training set:

• Not applicable / Not provided. This is a hardware medical device, not an AI or software algorithm that requires a training set of data.

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

• Not applicable / Not provided. As above, no training set data is relevant to this device.

In summary, this 510(k) submission for the Laurimed Discectomy System primarily relies on:

• Substantial Equivalence: A direct comparison to a legally marketed predicate device (Laurimed Percutaneous Discectomy System, K082194) regarding intended use and technological characteristics.
• Non-Clinical (Bench) Testing: To validate the device's performance, ensure it functions as intended, and meets design specifications. This testing covers aspects like safety and effectiveness without involving human subjects.

The absence of clinical study data, expert adjudication, or AI-related metrics is typical for many Class II medical devices cleared via the 510(k) pathway, especially those that are similar in design and function to existing predicate devices and do not introduce novel technology requiring extensive new clinical evidence.

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The Laurimed Spinal Injection System is intended for use in procedures where injection is required.

The Laurimed Spinal Injection System is indicated for use in spinal epidural iniections for the administration of contrast media, anesthetic agents to provide regional anesthesia, and anti-inflammatory medications. Not for use with other needles or catheters.

The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusions of contrast media, anesthetics, and anti-inflammatory medications into the epidural space of the spine.

The Spinal Injection System is supplied as a sterile, single patient use, disposable device.

The provided text describes a 510(k) summary for the Laurimed Spinal Injection System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study to prove performance.

Therefore, most of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study design for proving the device meets acceptance criteria is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

Table of Acceptance Criteria and Reported Device Performance

Missing Information Summary

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
2. 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 no clinical study with ground truth establishment is described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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. The device is a medical instrument, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical instrument, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study requiring ground truth is described. The document refers to "non-clinical testing" and "design specifications."
7. The sample size for the training set: Not applicable, as the device is not an AI/ML product requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Information Present (Regarding Acceptance Criteria & Study)

• Acceptance Criteria: Not explicitly stated as specific, quantifiable criteria in the document. The general statement made is that "non-clinical testing was conducted to validate the performance of the device and ensure the Spinal Injection System functions as intended and meets design specifications." This suggests an internal set of design specifications served as the acceptance criteria, but their details are not provided.
• Study Proving Acceptance: The document refers to "non-clinical testing" that demonstrated the device is "safe and effective for its intended use" and "functions as intended and meets design specifications." This implies engineering and performance tests were conducted. However, no details about the methodology, specific tests, results, or comparison data are included in this 510(k) summary. The primary study mentioned is a "Technological Comparison" to a predicate device (Laurimed Spinal Injection System K080140) to establish "substantial equivalence."

In summary, the provided 510(k) document is a high-level summary focused on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device rather than detailing specific acceptance criteria and the comprehensive study data that proved those criteria were met.

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The Laurimed Percutaneous Discectomy System is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar region of the spine.

The Laurimed Percutaneous Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Introducer Needle with Stylet, Guidewire, Dilator, Cannula, Trocar, and Cannula Clamp), a Device Cleaner, and a Discectomy Device. The Laurimed Percutaneous Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.

The provided text describes a medical device, the Laurimed Percutaneous Discectomy System, and its regulatory clearance process through a 510(k) submission. However, it does not include the information requested regarding acceptance criteria, a study proving device performance against those criteria, or details about ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, along with a summary of non-clinical testing.

Here's a breakdown of why I cannot fulfill your request with the given input:

• Acceptance Criteria and Reported Device Performance: The document states, "Results of non-clinical testing demonstrated that the Laurimed Percutaneous Discectomy System is safe and effective for its intended use." and "non-clinical testing was conducted to validate the performance of the device and ensure the Laurimed Percutaneous Discectomy System functions as intended and meets design specifications." However, it does not provide a table of specific acceptance criteria or the reported performance data for those criteria.
• Sample size for test set and data provenance: No information is provided regarding a "test set" in the context of an algorithm or AI. This device is a physical surgical tool.
• Number of experts and qualifications for ground truth: Not applicable, as there is no mention of algorithms, AI, or ground truth established by experts for a test set.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable, as this is a physical device, not an AI system being compared to human readers.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable. The "ground truth" for a physical device would typically be its functional performance in accordance with design specifications and its safety profile. In this case, it's assessed through non-clinical testing.
• Sample size for the training set: Not applicable, as there is no mention of a "training set" for an algorithm or AI.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/algorithm-based device. Therefore, the information requested, which is highly relevant to AI/ML device evaluations, is not present in this text.

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The Laurimed Spinal Injection System is intended for use in procedures where injection is required.

The Laurimed Spinal Injection System is indicated for use in spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.

The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusion of local anesthetics into the epidural space of the spine.

The Spinal Injection System is supplied as a sterile, single patient use, disposable device.

The given 510(k) notification for the Laurimed Spinal Injection System (K080140) outlines the device's substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data. However, it does not contain the specific information required to answer your questions regarding acceptance criteria and a study that proves the device meets those criteria.

The document is a summary of the 510(k) and focuses on demonstrating substantial equivalence to legally marketed predicate devices, as well as reporting on non-clinical performance to ensure the device functions as intended and meets design specifications. It does not include details about specific acceptance criteria tables, clinical study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information from the provided text. The document states:

• "Results of the non-clinical performance testing demonstrated that the Spinal Injection System is safe and effective for its intended use."
• "non-clinical testing was conducted to validate the performance of the device and ensure the Spinal Injection System functions as intended and meets design specifications."

These statements confirm that testing was performed, but they lack the granular detail about the acceptance criteria, study design, and results asked for in your prompt. Medical device submissions like this often include detailed test reports as part of the full submission, but only the summary is available here.

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