(252 days)
Plethysmography Module:
The device provides non-invasive measurement of pulse waveform and heart rate by photoclectric plethysmography.
Electrogastrography (EGG) Module:
A device that receives, records, and produces a visual display of the myoelectrical signal produced by the stomach as an aid to diagnosis of various gastric disorders.
The ACEM is an electronic accessory signal acquisition device. The ACEM includes five (5) signal conditioning circuits: respiration, plethysmograph, ECG and two channels of the EGG. Respiration and ECG have previous clearance under the InSight 510(k) K012232. The new plethysmograph accessory consists of a small, red LED placed against the finger and a photoelectric sensor to measure changes in the light intensity. The filter signal is amplified and digitized.
The added EGG signal conditioning unit receives signals from the body through standard pad electrodes. The signals are filtered and digitized.
Both the plethysmograph and EGG signals are forwarded to the Sandhill InSight System (K012232) for display.
The provided document is a 510(k) summary for the ACEM (Sensor Pac, signal acquisition) device. It describes the device's intended use and technological characteristics, as well as its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, ground truth establishment methods, or information about MRMC studies.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided document. The document primarily focuses on establishing substantial equivalence to predicate devices and electrical safety. It states:
- "Bench data confirms the plethysmograph and EGG channels meet the product specifications."
This implies that there were product specifications and that bench data was used to demonstrate adherence to them, but the specifications themselves and the exact performance results are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the document. No specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) is described. The relevant section states:
- "Bench data confirms the plethysmograph and EGG channels meet the product specifications."
This suggests internal testing, but no details are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not present in the document. There is no mention of human experts or ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not present in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
This information is not present in the document. The document does not describe any studies involving human readers or comparative effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The device (ACEM) is a signal acquisition device that forwards signals to another system (Sandhill InSight System, K012232) for display. It is not an AI algorithm that produces an interpretation or diagnosis on its own. Therefore, the concept of "standalone performance" for an algorithm, as typically applied to AI, does not directly apply here. The "bench data" mentioned would likely be an assessment of the hardware's ability to accurately acquire and condition the physiological signals according to its specifications.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI models (e.g., pathology, outcomes data, expert concensus) is not applicable to this device in the context of the provided information. The ACEM is a signal acquisition device. Its "performance" would be related to the accuracy and reliability of signal capture and conditioning, likely verified against known physical inputs or established measurement standards, rather than a diagnostic "ground truth." The document states:
- "Bench data confirms the plethysmograph and EGG channels meet the product specifications."
This implies that the "ground truth" for this device's performance would be the expected electrical or physiological signals that the device is designed to measure, and its ability to accurately and reliably capture them.
8. The Sample Size for the Training Set
This information is not present in the document. As this device is a signal acquisition hardware and not an AI algorithm, a "training set" in the machine learning sense is not relevant.
9. How the Ground Truth for the Training Set was Established
This information is not present in the document, as it is not an AI algorithm, and therefore, a training set with established ground truth is not applicable in the context of this 510(k) summary.
Summary of Study Information Provided:
The document describes electrical safety testing and bench data testing to confirm product specifications.
- Acceptance Criteria (Implied): The device must meet IEC 60601-1 and IEC 60601-1-2 safety standards. The plethysmograph and EGG channels must meet their respective product specifications.
- Study Proving Acceptance Criteria:
- Electrical Safety Testing: The ACEM was demonstrated electrically safe through testing and meeting IEC 60601-1 and IEC 60601-1-2 safety standards.
- Performance Bench Testing: Bench data was used to confirm that the plethysmograph and EGG channels meet the product specifications.
- Sample Size for Test Set: Not specified, but likely refers to a series of controlled bench tests.
- Data Provenance: Implied to be internal bench testing.
- Experts for Ground Truth: Not applicable/not specified.
- Adjudication Method: Not applicable/not specified.
- MRMC Study: No.
- Standalone Performance (Algorithm): Not applicable, as it's a hardware signal acquisition device.
- Type of Ground Truth: For safety, adherence to international electrical safety standards. For performance, meeting "product specifications" through bench data, likely implying accuracy against known inputs.
- Training Set Sample Size: Not applicable.
- Training Set Ground Truth Establishment: Not applicable.
In essence, the 510(k) summary for the ACEM device is based on demonstrating substantial equivalence to predicate devices and verifying electrical safety and basic functional performance through bench testing, rather than a clinical trial or AI model validation study.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.