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The TDM SurgiTech TD-Wand is intended for use in procedures that require precise cuts where only light or no hemostasis is desired using the cut mode and procedures where a greater level of hemostasis is desired using the coag and blend modes.

TDM SurgiTech, Inc. ("TDMi")'s TD-Wand is a sterile, single use, disposable, monopolar device for use only with IEC 60601-1 certified electrosurgical units ("ESUs") that accept 3-pinned connectors. The TD-Wand combines blunt dissection with electrosection and electrocoagulation at its ceramic tip. The ceramic tip's bulbs provide blunt dissection capabilities between tissue planes similar to a cannula, bulbous scissors, or other blunt instrument. As such, initiation of the dissection path may be facilitated with the use of traditional surgical instruments. The device employs two types of recessed stainless steel electrodes that distribute electrosurgical current:
(1) For cutting, the Cutting Electrode is comprised of 3 segments protectively recessed between four ceramic bulbs at the axial tip. When activated, the Cutting Electrode, along its 3 recessed segments, distributes a cut or blended cut/coag waveform yielding a cutting effect that may also have a hemostatic effect depending upon the "blended" waveform chosen.
(2) For coagulation, the Coagulation Electrode, via the 7 termini protectively recessed atop the ceramic domes in the chevron shape, distributes coagulation waveforms producing a disbursed surface coagulation effect.

The provided text pertains to a 510(k) premarket notification for a medical device called the "TD-Wand," an electrosurgical cutting and coagulation device. The document summarizes the device, its indications for use, and the testing performed to demonstrate its substantial equivalence to a predicate device. However, it does not describe acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, or AUC) or a study proving the device meets such criteria related to AI/algorithm performance.

The testing described is primarily focused on mechanical integrity, electrical safety, thermal injury analysis, and biocompatibility, which are standard for electrosurgical devices but do not involve AI or algorithms that would have performance metrics like sensitivity, specificity, or human-in-the-loop improvements.

Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI performance) are not applicable or cannot be extracted from this document, as the device is not an AI-powered diagnostic tool.

Below is an attempt to address the relevant points based on the available information:

Acceptance Criteria and Study for TD-Wand (Electrosurgical Device)

The document describes engineering and biocompatibility testing for the TD-Wand, an electrosurgical device, to demonstrate its substantial equivalence to a predicate device, rather than performance criteria for an AI or diagnostic algorithm. Therefore, the requested information regarding AI-specific performance metrics, ground truth establishment, and expert involvement for diagnostic assessment is not present.

1. Table of Acceptance Criteria and Reported Device Performance

• Static Axial Compression results were evaluated.
• Dynamic Compression Bending results were evaluated.
  Conclusion: TD-Wand is substantially equivalent to the predicate device in mechanical integrity. |
  | Electrical Safety | Compliance with specified IEC/EN/ANSI/AAMI standards. | - Complies with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), EN 60601-1:2006, ANSI/AAMI ES60601-1:2005 + A2.
• Tested to IEC/EN 60601-1-2 Third Edition (2007-03).
• Tested to IEC 60601-2-2: 2009. |
  | Thermal Injury | Thermal zones are substantially the same as or less substantial than those generated by the predicate and traditional paddle electrode. | Conclusion: Thermal zones of the TD-Wand were substantially the same and in many cases not as substantial as those generated by the predicate Epitome electrode and/or the traditional paddle electrode, regardless of tissue type or power setting. |
  | Biocompatibility | Compliance with ISO 10993 for various tests. | - Cytotoxicity (ISO 10993-5): Cell culture treated with test sample exhibited no reactivity (Grade 0).
• Sensitization (ISO 10993-10): Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade 0).
• Intracutaneous Irritation Reactivity (ISO 10993-10): Rabbits treated with test samples were non-irritating (Less than 1.0 difference between test and control).
• Pyrogenicity (Materials Mediated Rabbit Pyrogen Test): Albino rabbits treated with test samples exhibited a negative response (Max Temperature Increase: 0.1°C), non-pyrogenic.
  Conclusion: Fully biocompatible in compliance with ISO 10993. |

Regarding AI-Specific Information:

Since this document describes an electrosurgical device and its safety/performance, not an AI or diagnostic algorithm, the following points are not applicable and cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI diagnostic study. The testing refers to physical and biological tests, not data sets for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI diagnostics (e.g., expert consensus on medical images) is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a surgical tool, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI performance. The "ground truth" for the device's testing relates to established engineering standards, biological responses, and comparison to a predicate device's physical attributes.
8. The sample size for the training set: Not applicable, as this is not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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• Symptomatic relief of chronic intractable pain
• Adjunctive treatment for the management of post-traumatic or post-surgical pain

The Chronic Pain Suppressor CPS-2000 is a rechargeable battery operated Interferential Current Therapy device that utilizes an output circuit to generate a symmetric monophasic sine or square waveform of electrical current. Delivered along a patient cable and lead wires to electrodes placed on the skin. The physician prescribed and programmed output passes through the skin and actives the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.

Here's an analysis of the provided text regarding the Chronic Pain Suppressor CPS-2000's acceptance criteria and studies, based on the information available:

The provided document is a 510(k) summary for the Chronic Pain Suppressor CPS-2000. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/ML device submission would.

Therefore, many of the requested sections about specific performance metrics, sample sizes, expert involvement, and ground truth are not applicable to this type of traditional medical device submission. The device is an Interferential Current Therapy device, not an AI/ML diagnostic tool.

Analysis of Acceptance Criteria and Supporting Study for Chronic Pain Suppressor CPS-2000

The provided 510(k) summary (K033358) for the Chronic Pain Suppressor CPS-2000 focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a performance study against specific, quantitative acceptance criteria for clinical efficacy. The "acceptance criteria" here are implicitly related to meeting the standards of general safety and effectiveness comparable to existing devices of its type, as established through compliance with voluntary standards and descriptive characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

• UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
• IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
• AAMI/ANSI NS4:1986/(R)2002 Transcutaneous Electrical Nerve Stimulators (specifically items 3.1-3.1.2.1, 3.1.3-3.2.5, 4.1-4.2.3.2) - Note: While the device is an Interferential Current Therapy device, certain aspects of TENS standards may be considered relevant for electrical stimulation safety and performance characteristics. |

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

• Not Applicable (N/A) for clinical test set: This 510(k) summary does not describe a clinical performance study with a "test set" of patients in the context of typical clinical trial data submission for an AI/ML device. The evidence for substantial equivalence relies on descriptive characteristics and conformance to voluntary standards rather than new clinical data from a specific patient cohort.
• Data Provenance: N/A.

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

• N/A: No clinical test set requiring expert-established ground truth is described in this 510(k) summary. The submission relies on regulatory and engineering specialists confirming compliance with standards and comparing technical specifications to predicate devices.

4. Adjudication Method for the Test Set

• N/A: No clinical test set requiring adjudication is described.

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

• No: An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. Such studies are typically for diagnostic devices or AI/ML-assisted interpretation, which is not the nature of the Chronic Pain Suppressor.

6. If a Standalone Performance Study Was Done

• Standalone (Technical) Performance: Yes, in the sense that the device's technical specifications and safety characteristics were evaluated for conformance to voluntary standards (UL, IEC, AAMI/ANSI NS4). This demonstrates the device's ability to operate safely and within expected electrical parameters. However, this is not a "standalone clinical performance" study for diagnostic accuracy or clinical efficacy against a novel endpoint.
• Results: The device was found to conform to the specified voluntary standards, indicating its technical safety and performance meet recognized benchmarks.

7. The Type of Ground Truth Used

• N/A (for clinical ground truth): The "ground truth" here is conceptual, relating to the established technical requirements and safety parameters defined by the voluntary standards (e.g., electrical output specifications, electromagnetic compatibility limits, safety features). There is no "pathology" or "outcomes data" ground truth established for a clinical cohort.

8. The Sample Size for the Training Set

• N/A: There is no "training set" as this is not an AI/ML device.

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

• N/A: There is no "training set," so the concept of establishing ground truth for it is not applicable.

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An orthosis worn on the wrist for medical purposes:

• to support and/or immobilize for functional improvement.
• for conservative treatment of symptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist.
• to keep wrist motion to a minimum while worn allowing the body to recover from the damage of repetitive motion or other injuries.
• to provide temporary relief of associated symptoms of some wrist conditions.

Not Found

I am sorry, but the provided text from K031576 does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance for the Spartan Orthopaedic Wrist Brace, Model SCT-1.

This document is an FDA 510(k) clearance letter, which means the device was found substantially equivalent to a predicate device already on the market. This type of clearance typically relies on demonstrating similarity to existing devices rather than extensive new clinical studies with detailed acceptance criteria and performance reports as would be expected for novel or higher-risk devices.

Therefore, I cannot provide:

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 or their qualifications for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness study.
6. Information on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states the device's indications for use and confirms its substantial equivalence to a legally marketed predicate device. It does not include performance data or studies defining and meeting specific acceptance criteria.

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