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The IntraTemp™ Solution Warmer (TCT-6LW) is designed to warm and maintain the temperature of surgical solutions prior to their use.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the IntraTemp™ Solution Warmer. It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.

These devices are 120 or 220 V Ac powered warming cabinets designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use. The particular cabinet configuration can be deduced from its model number: SWC = Single Warming Cabinet. DWC = Dual Warming Cabinet. G = Glass Door The temperature ranges and capacities vary according to model but all have: Adjustable Temperature Range Digital Control Dual Display Push Button Operation Rapid Warm Time High Accuracy.

The provided document is a 510(k) summary for warming cabinets (SWC/DWC Various Models) and does not contain information about acceptance criteria for a device evaluated with a study (like an AI/ML device). Instead, it's a notification to the FDA to market a medical device, demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, as the document does not describe such a study or criteria for this type of medical device (warming cabinets).

The document focuses on:

• Device Name: SWC/DWC (Various Models) Warming Cabinets
• Regulation Number and Name: 21 CFR 890.5950, Powered Heating Unit
• Product Code: LHC
• Indications for Use: To store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
• Predicate Device: K993797, Enthermics Medical Systems Fluid Warming Cabinet
• Conclusion: Based on bench and standards testing, the device is deemed as safe and effective as the predicate device, with few technological differences and no new indications for use, thus substantially equivalent.

There is no mention of an algorithm or AI component, nor any study involving a test set, ground truth, or expert review, as would be relevant for an AI/ML device. The "testing" referred to is "bench and standards testing," which typically involves engineering and performance validation against industry standards for warming cabinets, not a clinical or AI performance study.

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The EZ-IV Medical Pad Warming Unit is intended to warm alcohol and povidone iodine skin cleansing pads for use in gaining venous access during intravenous fluid and / or medication administration and to facilitate phlebotomy procedures.

The EZ-IV Medical Pad Warming Unit, is a compact, portable, tabletop size medical device, used to warm factory sealed medical prep pads (alcohol and povidone iodine), with a pre-set maximum temperature of 55° C. A lid covers the unit to minimize any heat loss from the medical pads. Inside the unit are four individual compartments, in which the sealed pads are placed. Each compartment has it's own, inner lid. The front of the device has a membrane keypad to control the device function.

The provided text describes the 510(k) summary for the EZ-IV Medical Pad Warming Unit, Model 1000. It is a device intended to warm alcohol and povidone iodine skin cleansing pads for use in gaining venous access during intravenous fluid and/or medication administration and to facilitate phlebotomy procedures.

However, the provided document does not contain the acceptance criteria for device performance, nor does it detail a study that explicitly proves the device meets such criteria in a quantitative manner typical of performance studies for diagnostic or AI-based medical devices. The "Efficacy" and "Safety" sections describe studies related to the benefits of using warmed pads and the safety of the warming unit itself, rather than performance of the device against predefined quantitative metrics suitable for a table of acceptance criteria.

The device in question is a simple warming unit, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC. Therefore, many of the questions regarding AI-specific criteria (like ground truth, expert consensus, MRMC studies, etc.) are not applicable to this submission.

Given the nature of the device and the provided document, I will answer the applicable questions based on the information available and note where information is not present or not relevant.

1. Table of Acceptance Criteria and Reported Device Performance

As no explicit acceptance criteria for device performance are stated in the provided 510(k) summary, I cannot populate a table in the typical format of a diagnostic device. However, I can infer the "performance" demonstrated by the efficacy and safety studies mentioned.

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

• Test Set Sample Size:
  • Clinical Efficacy Studies: The summary mentions "pediatric patients" for the first clinical study and "warmed alcohol and povidone iodine pads" for the second clinical evaluation. However, the specific sample sizes (number of patients or number of procedures) for these clinical studies are not provided in the document.
  • Chemical and Sterility Studies: The sample size for pads used in infrared spectrometer analyses and sterility studies is implied but not explicitly stated.
• Data Provenance: The document does not specify the country of origin for the clinical studies. The clinical studies appear to be prospective as they describe "a clinical study was conducted" and "a second clinical evaluation showed." The chemical and sterility tests are laboratory-based tests.

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

This question is not applicable as the device is a warming unit, not a diagnostic device requiring expert interpretation for "ground truth" establishment in a test set. The clinical studies likely used objective measures (number of needle sticks, time to venous access) and microbial culture results.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This question is not applicable. Adjudication methods are typically used for evaluating human-expert disagreement on diagnostic tasks. The clinical and laboratory studies reported for this device would have objective outcomes (e.g., counts, time measurements, laboratory analyses) rather than subjective assessments requiring adjudication.

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 question is not applicable. The EZ-IV Medical Pad Warming Unit is not an AI device, and therefore, an MRMC comparative effectiveness study with AI assistance is not relevant to its assessment.

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

This question is not applicable. The EZ-IV Medical Pad Warming Unit is not an algorithm or AI device. Its performance is related to its physical function (warming) and its impact on clinical procedures, not an algorithm's standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the efficacy studies:

• Clinical Outcomes Data: The ground truth for the efficacy studies appears to be clinical outcomes data, specifically:
  • "statistically significant reduction in the number of venous access attempts (needle sticks)"
  • "significant decrease in time required for venous access"
  • The "microbial analysis" likely used standard microbiological culture results or similar laboratory methods to determine microbial load reduction.

For the safety studies:

• Laboratory Analysis Results: For chemical composition, the ground truth would be based on infrared spectrometer analyses. For sterility, it would be based on standard sterility testing methods.

8. The Sample Size for the Training Set

This question is not applicable. The EZ-IV Medical Pad Warming Unit is a hardware device, not an AI or machine learning model that requires a training set.

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

This question is not applicable as the device does not involve a training set.

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The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach: a
• as a single device via a transforaminal (TLIF) approach: or -
• as as a single device via an anterior or anterolateral (ALIF) approach.
  The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
  The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

Since the extracted text refers to a 510(k) summary for a medical device (Integrity Spine Lumbar Interbody Fusion System), the "acceptance criteria" and "device performance" would typically relate to comparisons to predicate devices based on non-clinical testing, rather than explicit numerical performance metrics like sensitivity or specificity often seen in AI/diagnostic device contexts. Also, there's no mention of a "study that proves the device meets the acceptance criteria" in terms of clinical trials or AI performance evaluations with ground truth. The summary focuses on substantiating substantial equivalence through non-clinical testing.

Here's an attempt to answer your questions based solely on the provided text, acknowledging that many of your points are not directly addressed due to the nature of this particular 510(k) summary:

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

Based on the provided text, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to predicate devices through non-clinical testing. The "reported device performance" is the successful completion of these tests with results deemed equivalent. There are no explicit numerical acceptance criteria for performance provided in the document in the way one might see for diagnostic AI (e.g., sensitivity > X%, specificity > Y%).

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

The document describes non-clinical mechanical testing rather than testing on patient data. Therefore, the concept of "test set" in terms of patient data, data provenance, or retrospective/prospective studies does not apply here. The "samples" used were physical devices subjected to the specified ASTM tests. The sample sizes for these specific mechanical tests are not detailed in this summary.

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 question is not applicable to the provided document. The ground truth for this device's evaluation (substantial equivalence) is established through adherence to recognized international standards for mechanical testing (ASTM standards) and comparison to legally marketed predicate devices, not through human expert interpretation of clinical data in a diagnostic context.

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

This question is not applicable to the provided document, as it pertains to clinical data interpretation and not mechanical device testing.

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. This document describes a medical device (spinal implant) and its substantial equivalence determination, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical spinal implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" is established by the specified ASTM (American Society for Testing and Materials) standards for mechanical performance (e.g., F2077-11 for static and dynamic testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion). The performance of the predicate devices under these same standards also serves as a comparative benchmark.

8. The sample size for the training set

This question is not applicable to the provided document. There is no concept of a "training set" for a physical medical device like a spinal implant in the context of this 510(k) summary.

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

This question is not applicable to the provided document for the same reasons as point 8.

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The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.

The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile.

The provided document is a 510(k) premarket notification letter from the FDA to OR Solutions, Inc. regarding their ORS-3000LD Equipment Cover. This document focuses on regulatory approval and classification, not on the technical performance specifications or clinical study results of the device itself.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a regulatory approval letter, indicating the device's classification and its substantial equivalence to a predicate device, allowing it to be marketed. It does not delve into the detailed technical performance data or clinical studies that would typically define acceptance criteria or demonstrate meeting them.

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The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.

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The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) clearance letter from the FDA for a device called "1075LD Hush-Slush®," primarily addressing its substantial equivalence to predicate devices and outlining regulatory obligations.

Therefore, I cannot provide the requested table or answer the questions regarding study details, sample sizes, expert qualifications, or ground truth establishment.

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The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.

The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile.

This document is a 510(k) clearance letter for the ORS-1000LD Leak Detection Drape. It asserts substantial equivalence to a predicate device and outlines regulatory compliance, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested table and information as these details are not present in the provided text. The letter is a regulatory approval document, not a performance study report.

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The ORS-2000LD is designed to warm and maintain the temperature of surgical solutions prior to their use.

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The provided text is related to a 510(k) clearance letter for the "Warmer 2000LD" device, which is a "Powered Heating Unit" designed to warm and maintain the temperature of surgical solutions.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general controls and regulations but does not delve into the specific performance studies that would be required to establish acceptance criteria and device performance.

Therefore, I cannot provide the requested table and study details based on the given input.

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The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.

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This is a 510(k) premarket notification letter from the FDA to Kolster Methods, Incorporated, regarding their SSW-Sterile Solution Warmer. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. It is a regulatory approval letter based on a declaration of substantial equivalence, not a detailed study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them from the provided text.

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The UroSurge UroTherm™ Fluid Warming System is intended to varm sterile irrigating solutions to normothermic temperatures (37°C) for use in medical/surgical procedures. Not for use with blood or blood products.

UroSurge UroTherm™ Fluid Warning System

The provided text is a 510(k) Pre-market Notification letter from the FDA, which primarily confirms that the UroSurge UroTherm Fluid Warming System is substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text.

The document focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.

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